Breast Augmentation Dubai | Dr Matteo Vigo

Breast Augmentation Dubai | Dr Matteo Vigo

Breast enlargement, known as augmentation mammoplasty, can enhance the body contour of a woman who is unhappy with her breast size. This procedure may also be used to improve the loss of breast volume following pregnancy and nursing. Additionally, the operation may help balance breast asymmetries. Silicone gel implants may be surgically implanted by standard routes with placement either above or below the chest muscle. The standard routes are periareolar (around the areola), inframammary (lower breast folds) and transaxillary (arm pits). Dr Vigo always suggests one of the first 2 incision for better putcomes.

The implant is composed of an outer flexible, silicone shell and filled with silicone gel. The outer surface may be smooth or textured. Implants also have various sizes, profiles and shapes to meet the individual needs of each woman.

While breast augmentation will enlarge the breasts, the surgery will not alter underlying basic defects in breast shape and form. Major asymmetries may be improved but will not be completely corrected with breast enlargement alone. A noticeable difference in the size, shape or orientation of the two breasts is considered normal and is actually the rule. If breast size and/or nipple position asymmetries are severe, additional procedures to further improve symmetry may be necessary.

Long term experience with breast enhancement surgery has demonstrated that this operation has a high patient satisfaction rate.

Your Guide to Breast Augmentation

Understanding The Breast Augmentation Dubai Procedure

Breast Augmentation Dubai: What to Expect

Preoperative Sizing in Breast Augmentation

Breast Augmentation Dubai Aftercare

Breast Augmentation: Implant Placement

 

Dr. Matteo Vigo is a member of the International Society of Aesthetic Plastic Surgery (ISAPS) is the world’s leading professional body for board-certified aesthetic plastic surgeons.

 

Breast Augmentation

Breast augmentation, sometimes referred to as a “boob job” by patients, involves using breast implants or fat transfer to increase the size of your breasts. This procedure can also restore breast volume lost after weight reduction or pregnancy, achieve a more rounded breast shape or improve natural breast size asymmetry.

WHAT BREAST AUGMENTATION SURGERY CAN DO

Increase fullness and projection of your breasts

Improve balance of breast and hip contours

Enhance your self-image and self-confidence

WHAT BREAST AUGMENTATION SURGERY CAN’T DO

Breast augmentation does not correct severely drooping breasts. A breast lift may be required along with a breast augmentation for sagging breasts to look fuller and lifted.

Breast lifting can often be done at the same time as your augmentation or may require a separate operation. I will assist you in making this decision.

WHO IS A GOOD CANDIDATE FOR BREAST AUGMENTATION?

Breast augmentation is a deeply personal procedure, and it’s important that you’re doing it for yourself and not for someone else, even if that person has offered to pay for it. Patient satisfaction is high, specifically when they want the procedure themselves.

You may be a candidate for breast augmentation if:

You are physically healthy and you aren’t pregnant or breastfeeding

You have realistic expectations

Your breasts are fully developed

You are bothered by the feeling that your breasts are too small

You are dissatisfied with your breasts losing shape and volume after pregnancy, weight loss or with aging

You are unhappy with the upper part of your breast appearing “empty”

Your breasts are asymmetrical

One or both breasts failed to develop normally or have an elongated shape

WHAT TYPES OF BREAST IMPLANTS ARE AVAILABLE?

Saline breast implants

Saline breast implants are filled with sterile salt water. Should the implant shell leak, a saline implant will collapse and the saline will be absorbed and naturally expelled by the body. Saline breast implants provide a uniform shape, firmness and feel.

Structured saline breast implants

Structured implants are filled with sterile salt water, and contain an inner structure which aims to make the implant feel more natural.

Silicone breast implants

Silicone breast implants are filled with silicone gel. The gel feels a bit more like natural breast tissue. If the implant leaks, the gel may remain within the implant shell, or may escape into the breast implant pocket.

 

Gummy bear breast implants

Form-stable implants are sometimes referred to as gummy bear breast implants because they maintain their shape even when the implant shell is broken. The consistency of the silicone gel inside the implant is thicker than traditional silicone gel implants. These implants are also firmer than traditional implants. Shaped gummy bear breast implants have more projection at the bottom and are tapered towards the top. If a shaped implant rotates, it may lead to an unusual appearance of the breast that requires a separate procedure to correct. Placement of gummy bear implants requires a slightly longer incision in the skin.

Round breast implants

Round breast implants have a tendency to make breasts appear fuller than form-stable implants. Higher profile options can achieve even more projection.

Because round implants are the same shape all over, there is less concern about them rotating out of place.

Smooth breast implants

Smooth breast implants are the softest feeling. They can move with the breast implant pocket, which may give more natural movement.

Smooth implants may have some palpable or visible rippling under the skin.

Textured breast implants

Textured breast implants develop scar tissue to stick to the implant, making them less likely to move around inside of the breast and become repositioned. Texturing offers some advantage in diminishing the risk of a tight scar capsule. Implant manufacturers occasionally introduce new styles and types of breast implants, so there may be additional options available. Whether you choose saline or silicone implants, it is important for you to monitor your breast implants and follow-up with appropriate checkups.

HOW SHOULD I PREPARE FOR BREAST AUGMENTATION?

In preparing for breast augmentation, you may be asked to:

Get a blood test

Take certain medications or adjust your current medications

Stop smoking

Avoid taking aspirin and certain anti-inflammatory drugs as they can increase bleeding

Arrange for someone to drive you to and from surgery and to stay with you for at least the first night following surgery.

WHAT SHOULD I EXPECT DURING MY BREAST AUGMENTATION RECOVERY?

During your breast augmentation recovery, your breasts will be wrapped in gauze dressings and an elastic bandage or support bra will minimize swelling and support the breasts as they heal. Immediately after surgery, you will be taken into a recovery area for close monitoring. You may be permitted to go home when you are stable for discharge, typically after an hour or so.

WHAT RESULTS SHOULD I EXPECT AFTER BREAST AUGMENTATION SURGERY?

While a breast augmentation yields larger breasts right away, the final results may take a few weeks as the swelling subsides and the skin stretches. Some patients may need to wear a bandeau to help shape their breasts, especially if they have underlying asymmetry or very small breasts to start with. Incision lines may take several months to fade.

 

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Who is a Candidate?

  • Women who want larger breasts.
  • Women who want to improve their breast shape.
  • Healthy women without connective tissue diseases.
  • Healthy women without breast malignancy.

Intended Results

  • Larger and shapelier breasts.
  • Less asymmetry and size difference.

Procedure Description

  • Breast Augmentation is usually performed in an accredited surgical facility under general anesthesia or conscious sedation with local anesthesia.
  • Surgical scar(s) are usually hidden as much as possible in skin folds.
  • Saline or silicone implants may be placed either above or below the chest muscle.

Recuperation and Healing

  • Discomfort is controlled with oral medications and long-acting local anesthesia.
  • A soft bra or compression garment is usually worn for several days postoperatively.
  • Patients are usually discharged to the care of a responsible adult and recover at home.
  • All sutures are usually removed in 1-2 weeks.
  • Light activity may be resumed in 7 days. Sports activities may be resumed in 3-6 weeks (depending on your surgeon).

Other Options

  • Breast lift — if sagging is an issue.
  • Areolar reduction.

Note

Breast Augmentation Dubai – The specific risks and suitability of this procedure for a given individual can be determined only at the time of consultation with your cosmetic surgeon. All surgical procedures have some degree of risk. Minor complications that do not affect the outcome occur occasionally. Major complications are unusual.

Breast Augmentation Dubai FAQs

Breast implants are the most tried-and-true method of increasing a breast size. With breast implants, I can consistently deliver the exact breast size that you want. You can try on the implants, I can use Crisalix 3D imaging, and I can even use a virtual reality system to show you exactly what you will look like afterwards. Breast implants have been used for over 45 years to provide women with very natural-appearing enhancements of their breasts. In some patients I can remove fat from unwanted areas using liposuction for a breast augmentation with fat transfer. In those patients we can use a specialized technique to harvest that fat and then transfer it to the breast to increase the breast size. The big advantage there is that there are no implants or foreign body in the body afterwards. This provides the most natural breast augmentation possible.
In general, placing breast implants under the muscle allows them to appear much more natural. It decreases the rate of infection associated with the implants and decreases the rate of complications associated with the implants. It allows the breast implants to sit higher for longer and have more support and less tendency to drop or droop with time. There is also lower incidence or rate of capsular contracture. In other words, the breast implants tend to stay softer for longer under the muscle than they do over the muscle. Over-the-muscle augmentation is best performed in patients who are extreme weight lifters and who are unwilling to sacrifice any bench-press or butterfly-press strength. It’s also best in patients who want more of an unnatural appearance. If your goal is to have a natural-appearing breast augmentation result that has the longest-lasting result and maintains the implants as soft as they possibly can be while also minimizing infections and other complications, I recommend breast augmentation under the muscle. If you want a very unnatural appearance or obviously augmented appearance or if you are an extreme weight-lifter, then I recommend breast augmentation over the muscle.
The answer to that really depends not only on your body frame and size but also your tastes. Selecting the right breast implant size is a multi-step process in our hands. It begins with you bringing in “wish pictures” (often found on the Internet) to tell me or show me what breasts you like. From there, I actually let you try on breast implant sizers. I let you look in the mirror at what those breast implants are going to look like and feel like on you. From there. I perform unique Crisalix 3D imaging, during which I show you a three-dimensional image of yourself with that breast implant size in to give you another way to make the decision. To confirm the decision, I’ll use a new virtual reality system that we have. I’ll actually let you step into a virtual world, where you have the breast implants in place and can look at yourself from all sorts of different angles, including down at your chest, and see the breast implants in place. I believe that by using a combination of wish pictures, trying the physical breast implants on, three-dimensional imaging, and virtual reality, we can select the perfect breast implant size for you.
Breast implant manufacturers have created what they call different profiles of breast implants. For a given breast implant size, there is a slightly different shape to the breast implant. As we go up in profile from a moderate profile implant to a moderate plus profile implant or a high profile implant, the higher profile tends to extend further away from the chest. As we go up in profile for a given breast implant size, the implants also become narrower so that a breast implant that is a high profile implant will be much narrower across the chest than would a moderate or moderate plus profile implant. The significance of that is two-fold: When we are selecting the implant profile, we want to maximize not only how much the breast implants extends away from the chest, but we also want to match the breast implant profile to your chest width because we want to make sure that the breast implants cover the entire chest width so that we can really maximize the cleavage in the middle, while not overdoing it or creating a “uni-boob” or “side boob” look. I believe that maximizing the cleavage in the middle is just as important as maximizing how much the breast implant extends away from the chest. As we are selecting the different breast implant profiles, I’ll actually have you try the breast implants on in our office. I will have you select the volume, and once you select the volume that you like, we will then match that to the width of your chest and your dimensions in order to select the perfect implant dimensions and profile for that volume. Then I will show that to you in our three-dimensional imaging system and also on our virtual reality system, so you can ensure that you are getting the perfect breast implant for you.
There are four commonly performed approaches for breast augmentation. These include the following: The first is a trans-axillary approach, which is an armpit incision. The advantage to this is, of course, that there is no scar on the breast. The disadvantage to this is that the scar is quite noticeable and can be seen anytime you wear sleeveless clothing. The next option is the trans-umbilical or “belly button” approach. The obvious advantage to this is, again, that there no scar on the breast. The disadvantage is that we have to drag the implants from the belly button up to the breast. In the process, we can create micro-fractures on the shells of the implants, which can significantly decrease their life expectancy. I definitely do not want to do this because we want to make sure that the implants will last as long as they can and give you the best and longest-lasting results. This approach significantly compromises their implants. In addition, because the access incision is placed so far away from where we are placing the breast implants, it’s very, very difficult to accurately place the breast implants. While I do remove the scar from the breast, I also create a situation where it becomes very difficult to accurately locate the breast implants. This significantly increases the risk that you experience lopsidedness or asymmetry between the two breasts. The next approach is to go through the nipple. The advantage there is, of course, that the scar hides in the collar of the nipple. The disadvantage is that I am cutting directly along the nerves that supply the nipple, which means decreased sensation and decreased ability to breastfeed. The final approach is the infra-mammary or under-the-breast approach. Hiding the scar underneath the breast makes it visible only when you are completely naked and someone is below you, lifting the breast and looking up. This is far and away, in our opinion, the best hidden of all of the incisions. It provides the best visualization for the surgeon, which ensures that you have the most accurate implant placement so that the breast implants can sit as symmetrically as possible. It is also, in our opinion, the least visible of all of the incisions. It is the incision recommended for the majority of our patients. It also allows us to stay far away from the milk ducts, which means that it will have no effect on breastfeeding over the long-term as well.
This is one of the most common questions that I receive when patients come to my clinic. The answer to this really requires an in-person examination to determine the location of the breast tissue and where we want it to be after the augmentation. At the consultation I will take specific measurements designed to help us determine whether or not doing a breast lift or just a straightforward breast augmentation is better in a given case. We will also run 3D simulations with and without breast lifts so that you can see what the benefits and the downsides of a breast lift would be for you. I will also review patients who are similar to them and on whom we have performed either breast augmentation alone or breast augmentation with lifts, so you can look at the cases side-by-side and determine which look is best for you.
Having fuller more voluptuous breasts is a very important part of feeling feminine and more confident for women. The breasts give the female body more proportion, curves and shape, which makes many women feel more sexy. There are a variety of factors that make women unhappy with their breasts. Such factors include the effects of aging, gravity which leads to sagging, post pregnancy changes and natural asymmetry. A breast augmentation helps women improve the overall appearance of the breasts and cleavage. This results in an improved self esteem, confidence and feeling sexier about your body. Reasons why women seek breast augmentation include: - Improved body proportion - Correct loss of fullness or sagging due to aging, gravy, or pregnancy - Improve cleavage appearance - Increase breast shape and size - Correct asymmetry of the breasts (one breast is larger than another) WHAT TECHNIQUES ARE INVOLVED? Breast augmentation involves the placement of an implant under the patient’s breast tissue to enhance the size and shape of the breast. The breast implants are usually inserted using an incision placed under the breast at the crease, but can also be put in via an incision in the armpit or around the nipple. Breast augmentation surgery takes about one and a half hours, and is usually done under general anaesthetic. The operation itself involves accessing and creating the pocket into which the implant will be placed, using one of the insertion routes mentioned above: breast-crease, armpit or nipple. Incision Options There are three different types of incisions that can be performed when getting a breast augmentation surgery. These incisions are Inframammary (incision below the breast), Transaxillary (through the armpit), and Peri-Areolar (along the lower edge of the Areola). Dr Vigo will go over the different options available to you during your consultation, showing you the benefits of each option and explaining exactly how they are performed including the associated recovery time for each. Inframammary An inframammary incision is the most common incision when getting a breast augmentation. This incision is made in the fold below the breast and carries a very low risk of complications. Inframammary incisions are highly recommended for large pre-filled implants such as silicone. These incisions are usually discreet as it goes along the natural crease below the breast, however, on occasion the scar may be visible due to the size or shape of the implant. All patients heal at different rates. Your incisions will be monitored after surgery and tailor your scar managment to optimize healing and appearence. Proper care and maintenance of your incisions will be closely followed with you as you heal. Peri-Areolar A Peri-Areolar incision is done around the bottom edge of the areola and is typically four to five centimeters in length. This incision is very discreet after it is healed. Often times it is impossible to notice as it goes along the natural edge of the areola. The trade off risks and benefits of their incision approach will be disscused at the time of your consultation. Some women may experience difficulty with breast feeding after this incision approach. Nipple sensitivity is also jeopardized with this approach compared to other incision sites. Transaxillary A Transaxillary incision is the least visible of the different incision options as it is made in the armpit. This ensures there are no scars anywhere near the breasts. The breast augmentation procedure is performed using an endoscope during the surgery, which allows the surgeon to see the implant inside the pocket. Having the ability to see the implant inside the pocket allows for the best surgical decisions and precise placement of the implant. Implant type is limited by the incision, as only round smooth implants can be placed through this incision. Once the pocket has been created, the surgeon may insert a trial implant to check that the size chosen is appropriate. The trial implant is removed, the definitive implant inserted and the incision wounds are stitched. You will be able to go home the same day. Postoperative pain in these procedures is easily controlled. Your chest will feel tight. Your breasts and ribs below your breasts will be tender. Patients will be mobile from day one and should be back to full exercise within six weeks. Patients are recommended to take around one to two weeks off work immediately after the operation in order to ensure you recuperate fully. Implant Placement Options There are two choices when it comes to the placement of the breast implants you select. They are subglandular (above the muscle) or submuscular (below the muscle). The benefits of each of the different placement options will be discussed with you at your consultation with a recommendation of a specific placement option depending on the natural shape of your breasts or your overall goals for getting a breast augmentation. Subglandular Subglandular placement is when the implant is placed above the muscle. During this placement, the implants are placed below the natural breast tissue and the surgery is usually quicker but the recovery time is about the same as below the muscle. One of the benefits of subglandular placement is that if future surgery may be required due to rupture or leakage, it allows for easier access to the implant. However, subglandular placement does also have its downsides, such as an increased risk of capsular contracture, concerns about breast views on mammography, and the implant may be able to be felt through the skin. Submuscular Submuscular placement is when the breast implant is put under the pectoral muscle. The benefit with submuscular placement is that the final result of the breast augmentation will look and feel more natural. Any breast imaging will be easier including mammographies, because it is easier to differentiate the implant from real breast tissue. Most patients are able to drive in a few days and you may shower the next day. Most surgeons agree that implants under the muscle are in the best position for the long term health of the patient. Dual plane augmentation When slender women with slightly drooping breasts seek breast augmentation surgery, surgeons often combine these two routes, placing the implants partly behind the breast and partly behind the muscle. Through this combined approach surgeons try to give patients the benefits of both techniques. This is called a dual plane augmentation. BEFORE BREAST AUGMENTATION SURGERY Before going into breast augmentation surgery, it is very important to get a good nights rest. You must follow the instructions given such as limitations to food or medications the day before surgery. All of this is important to get the best results and have the quickest recovery possible when getting surgery. On the day of surgery make sure you have a friend or family member drive you to the surgical facility. You may be very sleepy from anesthesia after the surgery. Before surgery, your surgeon will review the choices you selected and answer any final questions or concerns you may have. Your body will then be marked and you will be guided through exactly what will happen during the surgery.
Breast Augmentation is another name for Breast Enlargement or Breast Enhancement, and is also known as Boob Job. It is the single most requested plastic surgery in the world. For women, their breasts play an important part in their overall personality and it also gives them a lot of confidence. Many women feel the need to have breast surgeries - some for cosmetic reasons, some due to deformities, and some due to mastectomies (removal of breast due to cancer). Whatever the reason, it is important to know that it is a surgery, which would need proper medical expertise and support. So, before deciding to undergo this surgery, it is imperative to get a clear understanding of the process, and the do’s and don’ts associated with it. Being a leader in breast surgeries, and the best in the field of Breast Augmentation Dubai, I share the relevant information here for you. What is Breast Augmentation Dubai or Boob Job? Breast Augmentation is a surgical procedure which helps improve the looks of your breasts, making them larger and if needed fuller too. It is also referred to as breast enlargement or breast enhancement or breast reconstruction, or augmentation mammoplasty, or breast implants surgery. Breast augmentation can be done as an outpatient procedure with twilight anesthesia (patient goes back home the same day), or as an inpatient procedure with general anesthesia (requires overnight stay at hospital or clinic). In this procedure, a well-trained surgeon, will either insert an ‘implant’, or ‘fat’ grafted from other parts of your body into your breasts, helping them get bigger and fuller.Breast implants come in different types, shapes and sizes, and their quality has improved dramatically over the years. The method of inserting the implants differs according to the patient’s needs. More details are given below. Fat grafting breast augmentation is a technique wherein your own body fat from other parts of the body is extracted and injected into your breasts. This is mainly used when the need for enlargement is small and a more natural result is preferred. Breast Augmentation Dubai is a cosmetic surgery which is used to increase the size of breasts and enhance its shape and contour. It is considered as the most demanding job cosmetic surgery. For women, breast is an important part of their personality and better-looking breast can greatly improve their self-confidence. There are various reason for which people undergo this surgery some women do it for cosmetic reasons while some due to deformities then there are those who need them as an after treatment of cancer. Whatever the reasons are it should be kept in mind that it is a surgical procedure and one should consult with their doctor before going ahead with the procedure. Breast Augmentation Dubai will provide you with a long-term and effective solution to your worries regarding the size of your breasts. The implants will give you large, supple and natural looking breasts that will transform your body from an average to a beautiful one. Breast Augmentation Cost in Dubai primarily depends on the breast implant type you choose. Most commonly used breast implants for breast enlargement in Dubai include Saline Implants and Silicone Implants. Why Breast Augmentation? Usually breast augmentation is done to enhance the shape, size and texture of breasts, and to make them appear larger and fuller. This may be needed for cosmetic reasons or for reconstructive purposes, such as mastectomy after breast cancer, or correction of deformities. The reasons can be very personal and the decision should be made by you and your surgeon after understanding your needs, and more importantly your expectations. You should be aware that a breast augmentation surgery does not automatically correct sagging or drooping breasts. A breast lift procedure may be required to rectify sagging breasts, which can be performed together with your breast implant surgery or independently, at a later date. A well planned and executed procedure can help regain breast volume, get a better shape, reduce asymmetry, improve balance of breast & hip contours, increase fullness and size of breasts, and also help enhance self-image and self-confidence. Deciding about Breast Augmentation Dubai Breast Augmentation is a common and popular procedure which will make your appearance different from your existing one. Nevertheless, it is a surgery, thus it is important for you to decide carefully before going ahead with your decision. Common questions that we suggest you ask yourself are: Why do I need this augmentation? Will it give me more confidence and contentment? Will I be comfortable with this change? Once you have answers to this and any other personal questions, you must then take the most important steps of identifying the best breast surgeon, and breast clinic in town. This will ensure that you get the best consultation, advice, and results for your desired procedure. A top breast augmentation surgeon is one who is appropriately certified, well qualified, has loads of experience, has worked with different solutions and techniques, and is well respected amongst his peers and patients. The surgeon should have a good track record of consistent and quality results. Also during your initial consultation, remember to ask him to share the ‘before’ and ‘after’ photos depicting his work. A well-known and respected clinic for breast augmentation is one which has a good team of surgeons, anesthetists, and nursing staff. Their location should be convenient and the premises should be approved by the medical authorities. They should have a reputation of successful surgeries, and their team should be able to explain the entire aspect of the procedures to you in detail. Who is a good breast augmentation candidate? You are a good candidate for Breast Augmentation surgery in Dubai if: You have naturally small breasts or have lost volume and shape due to mastectomy or trauma to the chest. Your breasts are uneven or have lost volume and shape due to pregnancy or significant weight loss. You are physically healthy and are not suffering from any ailment that can hinder wound healing. You are not pregnant or breastfeeding. You have realistic expectations with the outcomes of surgery. Breast Augmentation Goals Breast enhancement surgery aims at improving the appearance of breasts by making the following improvements. Increases fullness and projection of breasts. Improves the size and contours of small breasts. Improves the symmetry of breasts. Makes the breasts firmer and perkier. Breast augmentation is indicated in following people: Young women with very small breasts or hypo plastic breasts Women after pregnancy or weight loss who have lost size of breasts Women with mild to moderate sagging of breasts due to pregnancy, weight loss or aging process. Asymmetrical breasts due to birth deformity. Tuberous breast deformity where the shape of the breast is very narrow and tubular. Reconstruction of breasts after breast removal surgery due to mastectomy or breast cancer. A normally healthy woman, with stable blood pressure, not pregnant, nor currently breast feeding are generally good candidates. Being a non-smoker also helps. And importantly, you should be in the age bracket where your breasts have developed fully, which is a minimum of 18 years of age. If you feel that some of these descriptions match you, come and talk to our experts, we will be able to guide you to the next steps towards having a fuller upper body. What are the types of Breast Augmentation? There are 3 main types of implants – Silicone Implants Saline Filled Implants Fat Grafting or Fat Transfer from other parts of your body SILICONE BREAST IMPLANTS Silicone implants were first produced in the early 1960s, and are still extremely popular. They are silicone shells filled with a plastic gel, which makes them feel more like real breasts than other options. The quality of the gel and the shell itself has evolved with time and research, making them quite long lasting and with a superior feel. These days highly cohesive silicone gel breast implants, also referred to as “gummy bear breast implants” are gaining popularity over traditional or regular silicone implants. The gel inside these implants is quite similar in structure to the “gummy bears” sweets – so even if there is any mishap, or leak, the gel does not drip out. More than 90% of women prefer silicone implants, which now come with up to 15 years warranty. These implants are available in both teardrop (natural anatomy shape) and round shapes. Advantages: Being softer, they feel more natural In a sub-glandular position (above the breast muscle), they hold better Lower chances of “rippling” The insert, being gelatin in nature does not leak or drip easily They are long lasting Disadvantages: To insert them, a relatively larger incision is needed In the rare case of a rupture, it is harder to detect (silent rupturing); so regular screenings are essential SALINE FILLED IMPLANTS These are also silicone shells, but are filled with sterile salt water solution, similar to the fluid that makes up most of our body. The feel of these implants is much firmer than gel, less natural, and thus fewer women prefer this as an option. Advantages: A smaller incision is needed to insert the Saline filled implant The fill level is adjustable, giving greater variability in sizes In the rare case of rupture, the saline content is immediately dispelled from the body, and the change is obviously visible Disadvantages: Their feel is not quite natural These usually require to be placed behind the muscles Due to the liquid filling, it can cause rippling Both the Silicone and Saline-filled implants come in different shapes, sizes, and texture. During your consultation with our surgeon, you will see samples of these and understand the pros and cons of each. Follow the surgeon’s advice on which would suit you the best. FAT GRAFTING In this method, instead of inserting a silicone or saline implant, the surgeon will take fat from another part of your body (liposuction), and after treating it, will inject it into the breasts, to help gain volume. This process works well if the enlargement needed is not much (1 bra cup size only), or only upper part fullness is needed, or after a conservative breast cancer surgery has been done. Advantages: Use of your own body material, rather than an external insert. Double advantage – get rid of excess fat from unwanted areas, and use for breast enlargement Disadvantages: Usually only 1 cup size change is possible with fat transfer Possibility of transferred fat to be reabsorbed by the body More expensive Can cause mammogram readings to be misleading; in some rare cases also mimic cancer, causing some panic Talk to our doctors on this method and seek their wisdom if this would work for you. Book an appointment. How to Choose Best Breast Augmentation Dubai Surgeon? The most important thing about the procedure is choosing the right surgeon for the surgery. A skilled surgeon will give you far better results compared to an unskilled doctor. The first thing that you need to ask your doctor is “How many breast augmentation have you performed?” also ask the doctor to show you before and after picture of patients who have already undergone the surgery. By doing this you will have a clear idea about the skills and aesthetic style of that surgeon. You need to make sure that the breast surgeon you are choosing is board certified surgeon which will give you surety that the surgeon is trained and qualified by checking the board certification you will also know that the surgeon is qualified for breast augmentation procedure. Also, make sure that the facility at which the procedure is going to be performed is an arcaded facility which is of great importance when it comes to your safety. Choosing price over quality can have great consequences go for the doctor that offer better results and more safety, not the cheaper ones. TYPES OF INCISIONS: There are 4 places on your body that the surgeon can do the incision to place the implant: Below your breast – at the breast fold line: This is the most popular incision spot and preferred by patients and surgeons. In medical terms, this is known as Inframammary or Submammary Incision. The scar can also be placed in the shape of a half-moon below the areola (the pigmented skin around the nipple). This is called the Periareolar Incision, and is suggested for women with a large nipple areola complex. Very selectively, this incision can also be made in the Axilla (armpit). This is considered an option when the women do not want any scars on their breasts. It is also known as Transaxillary Incisions. The least recommended method, also called as Transumbilical Breast Augmentation (TUBA), involves incisions made in the umbilical area for inserting the implant. This is not a common incision method and is only ever done for saline implants. TYPES OF PLACEMENT: Most surgeons place the implants either: Under the chest muscle – Submuscular (or Retromuscular) placement, or On top of the muscle but under the breast glands – Subglandular (or Subfascial) placement. Submuscular Placement ensures that the implant is not easily felt through the skin, because the muscle covers it. It also helps get a better image of the breast during mammography. Subglandular Placement is a faster procedure during the surgery and its recovery time is shorter too. A recent innovative technique is “dual plane” wherein the implants are inserted in “dual plane”, that means half under the muscle and half under the breast glands. This procedure is performed only in selected patients, post examination by a highly skilled plastic surgeon. Which is the right size and type of Breast Implant for me? The size and type of breast implant ideal for you is a decision that must be made in consultation with your surgeon. These decisions depend on factors such as your current breast size and shape, areola size, quality of breast skin, volume of breast tissue, your anatomy (height, weight, breast footprint, body ratios), your plans for motherhood, your expectations from the surgery, and various other factors. It is not practical to expect transition from a cup size A to cup size DD in a single surgery. Nor is it possible that you dictate to the surgeon that you need a certain size/ type of implant, with a specific incision and placement. Your surgeon should guide you to what is right for you personally. I will do a detailed assessment of all relevant factors before suggesting what size, type, incision, and placement is appropriate for your specific case to deliver the best surgical outcome. I’ll make you try some “sizers” to give you an idea of the look and feel of your enhanced breasts. My end objective will always be a natural-looking result that is apt for your body and goals. Breast Augmentation Techniques Breast Enlargement surgery can be performed using a variety of techniques – depending on the incision patterns – and methods and various kinds of implants are available. I will determine the most appropriate technique and the type of breast implants. Breast implants options available include: Saline implants – silicone shells filled with sterile salt water and are suitable for women who are 18 or more. Silicone gel implants – are filled with silicone gel and are suitable for women who are 22 or more. Silicone implants feel more like real breasts but they pose more risk in case they leak. Pre-op Preparation for Breast Augmentation in Dubai During the pre-op visit, your photos will be taken and Iwill perform your physical examination and will give you pre-surgical instructions. These instructions are based on your individual goals and requirements. Some general preparation tips for breast enlargement surgery before start: Stop using all the blood thinning medications including aspirin, ibuprofen and certain other medications – as recommended by the breast surgeon. Avoid supplements – fish oil, omega-3, vitamin E etc. Stop drinking alcohol. Quit smoking as nicotine and carbon monoxide hinder the healing process. Follow pre-surgical prescriptions. In the broader spectrum pregnancy does not affect the implant of breasts. However after the breast implant, one should give thought to future pregnancies while deciding the placement and size of your implant. The physical appearance of breast might alter a little during the pregnancy. During the pregnancy, the mammary gland will swell and will be filled with milk which will also swell the surrounding tissues. After the pregnancy when you feed your child the mammary glands will shrink again which might leave your breasts sagged and elongated. Another main problem caused to the implant by the pregnancy is Dimpling. This condition can appear anywhere near the implant this usually occurs on the top side of breasts or the sides of breasts. Dumpling occurs when the natural tissues begin to sag away from the implant and create irregular skin surface of breasts. The chances of Dimpling are rare and the condition for everyone is different. What are the choices of Breast Implant? With the development of cosmetic procedures, breast augmentation has developed in many ways people have so many choices to choose from. Now you can alter your breast in any way you want. You can improve your curves and cleavage to your desired shape. Below are a couple of choices that you can consider for breast augmentation. Different types of implants are used for different needs and wants. What type of implant should be used? There are four types of fillings used for breast implants Saline, Silicone, Highly Cohesive Silicone implant also known as Gummy Bear implant and the last one is Fat Graft implants. The type of implant used depends entirely on the receiver of surgery and the results you expect from the surgery. I will decide what type of material shall be used and the decision of the surgeon will depend upon the result that the recipient expects from the surgery. Saline and Silicone implants are made from the artificial material while Fat Graft implants are harvested from the person’s own body. These Fat Grafts are then used in breast augmentation. This implant is the most effective implant but there is a limitation to this implant because only one cup of fat can be implanted and harvested which makes it good for small amount of breast augmentation but not the large amount. What is the shape of an implant? Saline and Silicone implants come only in round shapes while gummy bear implants come in a variety of shapes as well as round shapes. Round shape will give its maximum advantage to the upper part of breasts and the breasts will appear more firm while shaped implant will give sloppy looks to the breasts. When performed by a skilled surgeon both the round and shaped implants look very natural. What types of profile exists for breast implant I will decide the type of profile that you will need for your breasts and will depend upon the existing structure of your breasts as well as the type of shape and structure you desire from your breasts. Patient with a larger frame of breasts will require a higher profile of implant to cover the entire area and to achieve the desired results while ensuring that the base of the implant is not wide at the bottom. What should be the size of a breast implant? Breast implant varies in sized so that they could fit the different needs of a person. It could be 150cc to 800cc or even larger in some cases. People require different breast implants for different results and shape to achieve the best size and shape. The size of breast implant depends on the existing breast size, the result you desire and my recommendations. By keeping all this in mind it becomes even more important to choose a skilled and qualified surgeon with the existing experience in the field to avoid any complications. What is the impact of pregnancy on Breast Implants? Broadly speaking, pregnancy does not affect the breast implants. While you should consider future pregnancies in deciding about the size and placement of implants, pregnancy by itself does not hinder your implants. However, some aesthetic impact (in looks and shape) is possible due to pregnancy. During pregnancy, the breasts naturally enlarge or engorge, which will then shrink after you stop nursing your baby, resulting in some sagging skin. Dimpling of skin is also a possibility in certain types of implants. However, both these are aesthetic issues and don’t generally affect your implants per se. In fact, many women experience none or very minimal of such effects. Please discuss in full detail with our consulting breast surgeon of your plans for pregnancy to get the right advice on the type of surgery best suited for you. Does Breast Augmentation affect the ability to breastfeed? Doctors see no harmful effects on breast milk with either saline or silicone implants. You will be able to breastfeed depending on the type and placement of your implants and the manner in which the surgery was done. Sometimes, during surgery, milk ducts, glands or nerves may be damaged, which can affect milk production or milk flow. Type of incision – The type of surgical incision made may affect your ability to breastfeed, if it is around or across your areola (“periareolar incision”). Incisions made under the breast, armpit or umbilical area are less likely to damage your milk glands, ducts and nerves. Placement of implants – The position where your breast implants are placed may also impede breastfeeding. Implants placed under the chest muscle are less likely to impact your ability to breastfeed. Many women are able to successfully breastfeed even with implants. Make sure that you mention your pregnancy plans to our consulting breast surgeon so they will advise you on what you need to do to be able to breastfeed with your implants, and also how you can monitor and ensure that your baby is getting sufficient breast milk. Is Breast Augmentation permanent? Breast implants today are definitely safer and more durable than in the past. However, they are medical devices, and like any other medical device, can fail over time, and may require a removal or replacement. The best types of breast implants today come with a 15 years life. So, depending upon your age at the time of surgery, you may need at least 1 re-operation, and you should take that into consideration. I use the highest quality breast implants that have a lifespan of 15 years. Additionally, the skill of our leading breast surgeons ensures that your surgery is done in the most technically proficient manner to ensure maximum longevity and minimal chances of revision surgery. What to expect before the procedure? Breast augmentation can either be done in a surgical center or a hospital and the patient is usually expected to go home on the day of surgery. In rare cases, patients are required to stay for the night. In some cases, the breast augmentation is performed using a local anesthesia but in most cases, general anesthesia is given to the patient. Post breast augmentation surgery checklist When the surgery is completed then you should rest at home the following day. For a speedy recovery and while you lay down for resting try to keep your head elevated with the help of pillows during your recovery. When the doctor schedules your appointment after the procedure then make sure that you visit the doctor for all the appointments. If a small amount of fluid drainage occurs at bandages then don’t panic its totally normal. Bruising is to be expected after the procedure applies ice packs to the treatment area in order to minimize the swelling. After the surgery, you will purchase the compression garments that you should wear all the time for a specific period of recovery. If you have questions or concerns regarding the breast augmentation procedure then feel free to contact me for the consultation. You can also take shower but should avoid the water from touching your wounds for the first couple of days. Stop the consumption of alcohol, tobacco, and caffeine for at least one month after your procedure. After the procedure, you won’t have an appetite, however, when your appetite returns then take light meals such as broths and soups. Take the medicine and antibiotics according to the prescription of the doctor. Doing so will help a lot in minimizing the pain as well as reducing the chance of any infection. Avoid strenuous activities such as bending or weightlifting for the first 3 to 4 days after your surgery. Drink lots of water to keep your body hydrated and avoid dehydration. Numbness in different spots of breasts is expected and avoid using the underwire bra till you start feeling good again. This can last for six weeks to six months. Swelling and bruising are to be expected in the affected area which is not permanent and will disappear over time. Your breast will regain its natural appearance and softness three months after the surgery. For the first 48 hours after your treatment keep your movements to the minimum. Small movement such as brushing your teeth and combing hairs is ok but avoid using your arms for lifting something heavy or supporting yourself. You can gradually increase the movement of your arms. The pain and swelling are normal however if it becomes intense and the swelling of breasts becomes hard or one side appears larger than the other then you should immediately contact your doctor. By following these steps you can maximize your results and can minimize your discomfort. What to expect after the procedure? Soreness, bruising and swelling is expected to last for a couple of weeks after the surgery. The scar will fade away overtime but don’t expect them to completely disappear. You will also be advised to wear compression garments to support your breast while they recover for extra support and good positioning. Medicines will also be prescribed by the doctor. During your recovery time, you should follow the instructions of your doctors while returning to your regular activity. If your job is not physically demanding then you are expected to return to your job in a few weeks. Avoid any activity that puts a strain on your body and raised your pulse and blood pressure for at least two weeks after the surgery. During your healing period, your breasts will be more sensitive to physical contact and irregular movements. If the drainage tubes are placed for fluid removal then you will need a second appointment for their removal. Keep watch for infection if you notice redness or warmth in breasts and have a fever then it is a sign of infection. Also stay alert for shortness of breath or chest pain. When these happen to you then you should contact me as soon as possible. Questions you need to ask the surgeon before the procedure The most important part of any surgery is finding the best surgeon. A good and skilled surgeon not only reduce the chances of failure but also minimizes the risks associated with that surgery. For more chance of success and less chance of failure, one needs a skilled surgeon for any surgery and breast augmentation is no different. Following are the questions that you need to ask every cosmetic surgeon before selecting him or her for a surgery. Ask the following question from your surgeon so that he or she understands that you have done your research which would help you in achieving your desired results. How to prepare for the surgery? Before you could go ahead with the surgery you need to consult your doctors about your preferences like shape, size, and appearance of your breasts. When you give complete details about your preferences surgeon will be able to determine what type of implant is best suited for you such as teardrop shape, smooth or textured. Giving full detail will also let your doctor determine the type of material that he/she will use in the breast augmentation surgery such as saline or silicone or surgical techniques like fat grafting. Before deciding to go ahead with the surgery there are a couple of things that a person needs to consider A breast implant can also create problems in breastfeeding. However, it is not always the case. Most women can breastfeed their children after the surgery but for some, it becomes a problem after the surgery. A breast implant is not a procedure for a lifetime and the effect will fade away in 10 years. There is also a possibility of implant rupture. After the implant, the age of your breast will not stop and they will continue to age but weight loss or weight gain can have a great impact on the shape of your breasts which could lead to another surgery for the correction. You need to understand that breast augmentation will not correct any sagging for and you will need to a breast lift surgery along with breast augmentation. Before a breast implant, you need to know that you will need to monitor your implant through MRI. According to recent studies, it is not a necessary step. If you ever decide to remove your breast implant you will need an additional corrective surgery so that your breast could restore its former appearance. A breast implant is a cosmetic procedure and is considered medically unnecessary so insurance will not cover it. If it is proven that it is medically necessary in your case then the insurance will cover the expenses. In case you are doing it for cosmetic reasons then you should be prepared to handle the expenses. How much do Breast Implants cost? The cost of a breast augmentation surgery depends on the following: Type of implant – Cost varies based on implant type and quality – silicone implants cost more than saline implants. Breast augmentation via fat transfer costs even more. Technique – The technique used also affects the cost – based on incision type and location of implant. Surgeon’s Expertise – The surgeon’s fee is based on their experience. Obviously, a reputed surgeon with an established track record of quality results will charge higher fees. Clinic/ Hospital – Fees also depend upon the quality of the facility chosen for the operation, and also whether the procedure is done as outpatient (with twilight anesthesia) or as inpatient (with general anesthesia). Geographic Area – Depending on the city/ area you decide to have your procedure in, your cost is likely be different. Larger metropolitan cities might cost more. You should bear in mind that the expertise of your surgeon and your comfort factor with him/ her should be one the most important considerations than just the cost of the surgery. An initially cheaper option could turn out to be an expensive proposition in the long run. For an accurate assessment of cost, you would need an initial consultation with me. Breast Augmentation – risks and complications As with any kind of surgery, there are risks that arise due to Anesthesia, the surgery itself, and in this case the implants. Though the risks are unlikely, some of the possibilities are: Due to Anesthesia – allergic reactions, chest infection, blood clots Due to Surgery – scars, bleeding, infection, change in sensation, allergic reactions Due to Implants – Capsular contracture (formation of scar or capsule around the implant), noticeable implants, implant failure or rupturing, breast droop It is important for you to choose a surgeon and clinic which has an exceptional record in minimizing risks and complications. Preparing for initial meeting The initial meeting with me is very important. It will give me an opportunity to better understand your needs, and I will be able to share my experience and explain the procedure to you. A common goal of the outcome can then be established. By this time, you should be clear on why you wish to undertake the breast augmentation surgery and what are realistic expectations. Once you are clear about that, and have possibly discussed it with your family, or close friends, share the answers with the consulting surgeon. That will allow for a better understanding between you and the doctor, making you better prepared for the procedure. Your consultation will include the following: Your reasons, need and goals from the breast enhancement surgery Your health, lifestyle and habits, ongoing medications, previous operations and relevant medical history Your motherhood plans Detailed measurements of your body/ anatomy, maybe some pictures too Options available for your surgery, and which is best suited for you Explanation of steps involved, what you can expect, potential risks You may also be asked to get a mammogram or breast ultrasound before the surgery. A bit of apprehension is natural, but don’t feel shy in discussing any issues that you may have in respect to your new look. These are essential to help plan your surgery better, and improve recovery time. What should you ask your Breast Augmentation surgeon? Now that you have gone through the basic questions in your mind, here are some of the other topics you should broach with your surgeon during your initial consultation. About The Breast Augmentation Dubai Surgeon & Clinic: How many years of experience do you have as a Plastic Surgeon? How many breast augmentation procedures have you done? What are the most common complications that your patients have had? And how were they handled? Do you have a “before” and “after” photo album for this procedure? What type of implants do you use – saline or silicone? What is your experience with each type? What is your reoperation rate? Where will the surgery be conducted? Is the clinic prepared and certified to assist liposuction surgeries? Do you have a licensed anesthetist on board? About Breast Augmentation Dubai Surgery: Am I a good candidate? What can I expect after the surgery? What precautions would I need to take pre-surgery and post-surgery? How many days will I take to recover fully? What should I do for a quick recovery? Will the shape and appearance of my body change over time? If yes, how? What are the risks involved in this procedure? What treatment option/ technique will be used for me? Where will my scar be? How long will the procedure take? How soon will I be able to resume my normal activities at home and work? What are the chances or situations in which I will need a reoperation? About Breast Implants and Expected Results: What is the nature, type & quality of implants that will be used – what shape, size and texture, and why? How long will my implants last? How will my breasts change over time? What are realistic results for my specific case? How will the implants feel? How will pregnancy impact my implants? How will the surgery impact my ability to breastfeed? How will my cleavage change? How easy is it to remove the implants? How will my breasts change if I remove the implants? How will I know my implants are intact and have not ruptured? What ongoing care do I need to take of the implants? What additional follow-ups will I need? Will I be able to get mammograms or breast ultrasounds with implants? Will the results be accurate? Can the size of the implants be increased or reduced in subsequent surgeries? Please feel free to add any more questions that you wish to this list before your consultation session. You can rest assured that besides these questions, our team of leading breast enhancement surgeons at Cocoona, will also tell you about the procedure in detail, and patiently answer all queries you need clarification on. Reach out to us. Breast Augmentation – preparing for the big day Now that the decision has been made, we will work towards the transformation you so desire. Don’t be stressed – breast augmentation is the single most requested plastic surgery in the world, and our team excels in it. Closer to the big day, an additional thorough consultation is required to finalize all details of the surgery and to once again ensure that you clearly understand the expectations and risks of the procedure. You may be required to do breast mammography or ultrasonography. You need to refrain from smoking and medications that can thin your blood. It is recommended to keep yourself fit and healthy. The nurse will provide you with all necessary support bras and prescriptions for post-surgery care. Our team of nurses, counselors and doctors will ensure you are fully equipped and ready for your surgery. Breast Augmentation recovery & follow-up Breast augmentation is a quick procedure, and generally does not require an overnight stay. Its popularity also stems from the fact that the recovery period is small. Immediately after the surgery, your breasts will be bandaged, and you will also be given a special bra that will help reduce the swelling, while also offering support to the breasts. Your prescribed medicines will include pain killers, antibiotics, and ointment for the surgical area. A complete schedule of follow up appointments will be prepared for you, and I will advise you on the physical activities that you may or may not undertake. Usually women require a week or so to get back to normal work. Walking as an exercise is recommended, for harder exercise schedules like aerobics, a few more days are needed. Carrying heavy loads is not advisable during the first 7 – 10 days. It is advisable to take a week off from work – that usually suffices for most women. I may also prescribe vitamins and provide dietary guidelines. Collectively all these will aid your recovery. Breast Augmentation results – what can you expect While you may observe an immediate increase in breast size after the breast augmentation surgery, the final results will only be apparent after the swelling disappears and the skin stretching is completed. This might take a few weeks. Then the new shape and size will be apparent for you to admire. The scars of the incision will take much longer to diminish Over time, due to aging, expiry of implant life, hormonal issues, and weight fluctuations, your breasts might change. You may want to come back to us for a quick breast lift or implant replacement to get back the shape. What is Breast Augmentation Dubai or Boob Job? Breast Augmentation is a surgical procedure which helps improve the looks of your breasts, making them larger and if needed fuller too. It is also referred to as breast enlargement or breast enhancement or breast reconstruction, or augmentation mammoplasty, or breast implants surgery. Breast augmentation can be done as an outpatient procedure with twilight anesthesia (patient goes back home the same day), or as an inpatient procedure with general anesthesia (requires overnight stay at hospital or clinic). In this procedure, a well-trained surgeon, will either insert an ‘implant’, or ‘fat’ grafted from other parts of your body into your breasts, helping them get bigger and fuller.Breast implants come in different types, shapes and sizes, and their quality has improved dramatically over the years. The method of inserting the implants differs according to the patient’s needs, and the expertise of the surgeon. Fat grafting breast augmentation is a technique wherein your own body fat from other parts of the body is extracted and injected into your breasts. This is mainly used when the need for enlargement is small and a more natural result is preferred. Why Breast Augmentation Dubai ? Usually breast augmentation is done to enhance the shape, size and texture of breasts, and to make them appear larger and fuller. This may be needed for cosmetic reasons or for reconstructive purposes, such as mastectomy after breast cancer, or correction of deformities. The reasons can be very personal and the decision should be made by you and I after understanding your needs, and more importantly your expectations. You should be aware that a breast augmentation surgery does not automatically correct sagging or drooping breasts. A breast lift procedure may be required to rectify sagging breasts, which can be performed together with your breast implant surgery or independently, at a later date. A well planned and executed procedure can help regain breast volume, get a better shape, reduce asymmetry, improve balance of breast & hip contours, increase fullness and size of breasts, and also help enhance self-image and self-confidence. Deciding about Breast Augmentation Dubai Breast Augmentation is a common and popular procedure which will make your appearance different from your existing one. Nevertheless, it is a surgery, thus it is important for you to decide carefully before going ahead with your decision. Common questions that we suggest you ask yourself are: Why do I need this augmentation? Will it give me more confidence and contentment? Will I be comfortable with this change? Once you have answers to this and any other personal questions, you must then take the most important steps of identifying the best breast surgeon, and breast clinic in town. This will ensure that you get the best consultation, advice, and results for your desired procedure A top breast augmentation surgeon is one who is appropriately certified, well qualified, has loads of experience, has worked with different solutions and techniques, and is well respected amongst his peers and patients. The surgeon should have a good track record of consistent and quality results. Also during your initial consultation, remember to ask him to share the ‘before’ and ‘after’ photos depicting his work. A well-known and respected clinic for breast augmentation is one which has a good team of surgeons, anesthetists, and nursing staff. Their location should be convenient and the premises should be approved by the medical authorities. They should have a reputation of successful surgeries, and their team should be able to explain the entire aspect of the procedures to you in detail. Breast Augmentation Dubai - Information for women considering breast implants This publication is for all women who are considering having breast implants. It summarises the issues associated with breast implant surgery and includes questions to ask in order to enable you to make an informed choice about breast implants, based on independent advice, before agreeing to surgery. The information in this publication was originally prepared for the Department of Health by women who have had breast implants, health professionals, and representatives of interested organisations. The content is based on the evidence-based recommendations of the report of the Silicone Gel Breast Implants Independent Review The Medicines and Healthcare products Regulatory Agency (MHRA), part of the Department of Health, has produced this revised version of the original booklet, which has been updated to reflect any new published evidence. Independent healthcare providers must be registered by law with the Care Quality Commission (CQC). They are required to meet essential standards of quality and safety and are monitored to make sure they continue to meet these standards. If you wish to find out more about the independent hospital in which you are considering having your operation, you should contact the Care Quality Commission. Contact details can be found in section 10. This publication is relevant to anyone considering breast implants for any reason. It refers to women because they make up the great majority of people having breast implants. Contents 1 What are the reasons for having breast implants? 2 Are breast implants an appropriate choice? 3 What types of breast implants are available? 4 Finding out about the operation 5 What are the consequences and risks? 6 General issues – other questions you may have 7 Breast implants are a long-term commitment 8 Consent for the operation 9 Checklist of questions to ask 10 Sources of further information Breast Augmentation Dubai 1 What are the reasons for having breast implants? It is important to be clear about your reasons for having breast implants. Breast enlargement is the most common cosmetic surgical procedure performed on women in the United Kingdom. Women may seek breast enlargement because they: • are dissatisfied with the size and shape of their breasts • have a congenital absence or deformity of one or both breasts • wish to regain breast shape or size, for example, after having children • wish to correct uneven breasts (asymmetry). Breast implants can bring psychological benefits for women who may feel that their breasts are unwomanly and inadequate. They can help restore lost self-esteem and improve the quality of life. However, you should think carefully about your reasons for having implants and be sure that breast implants are the best solution. Your surgeon will wish to explore with you the psychological aspects of having breast implants. Breast reconstruction Women who consider having breast implants as part of breast reconstruction following mastectomy will find the principles discussed in this leaflet of value. They are, however, also advised to seek specialist advice and information from their surgeon and breast care nurse as the procedures and possible complications are different. 2 Are breast implants an appropriate choice? Breast implants may not achieve what you hope for and you should make sure that your surgeon discusses all the options with you. You should have realistic expectations and you should not expect perfection. Your surgeon must take into account your existing breasts, the position of your nipples, your age, skin texture, healing properties and your general health. These will affect the results of your surgery. Make sure that you have access to appropriate advice and that you are not responding to external pressures to have breast implants. It is important to make your own informed decision and to weigh up the risks of breast implant surgery. You should also remember that any operation carries a risk and you may wish to consider non-surgical options. You should be aware that breast implants do not come with a lifetime guarantee. They are likely to need replacing in the future, with further surgery and expense. Detailed information about breast implants as part of breast reconstruction can be obtained from your breast surgeon and breast care nurse. 3 What types of breast implants are available? Several types of breast implants are available. Information for women considering breast implants Breast Augmentation Dubai - Ask yourself: • why do I want breast implants? • what do I expect of breast implant surgery? • am I prepared for long-term follow up and possible future surgery and expense? Medicines and Healthcare products Regulatory Agency Natural tissue The use of body tissue is rarely an appropriate solution for breast enlargement carried out for cosmetic reasons. While it is possible to move areas of body tissue, this may be a complicated procedure and is not often used for purely cosmetic purposes although it is becoming more common. Body tissue is, however, commonly used in breast reconstruction. Synthetic implants All synthetic breast implants are surrounded by a firm elastic (silicone elastomer) shell. The surfaces of the implants may be smooth or textured. At the time of preparing this information, there are two types of implant filler available in the UK: silicone gel (semi-liquid or cohesive) and saline. Note: soya bean oil-filled (Trilucent) implants are no longer available and in June 2000, the MDA (now the MHRA) advised women with these implants to have them removed. Hydrogel/PIP implants are also no longer available in the UK. The MHRA is continuing to monitor their safety but does not recommend their removal unless problems are experienced. The shell of some silicone gel implants is coated with polyurethane foam that breaks down over time. Polyurethane coated implants were reintroduced in the UK in April 2005. The MHRA informed the surgery professional bodies of the risks and claimed benefits. The letter and patient information sheet are available on the MHRA website www.mhra.gov.uk Note: The shell of some other implants can be coated with titanium. These titanium coated implants are not currently available for sale in the UK. The table on the next page summarises briefly the advantages and disadvantages of silicone gel and saline filled breast implants. Ensure that you obtain full information about the different types of implants when you discuss your particular situation with the surgeon. Manufacturers also provide information about their products, which can be obtained from your surgeon. Information for women considering breast implants Breast Augmentation Dubai - Medicines and Healthcare products Regulatory Agency A brief summary of breast implant fillers currently available in the UK All breast implants are surrounded by a firm, elastic (silicone elastomer) shell. Type of filler Description of implant Advantages Disadvantages Silicone gel Filled with a soft or firm silicone substance. Firm or cohesive gel implants contain a more solid, jelly-like gel which will keep its shape if the shell ruptures. Soft implants are filled with a more fluid-like gel. Long history of use. The soft silicone filler is the softest implant available. It is less prone to wrinkling and feels more natural than other implants. Available in either round or anatomical (breast shaped) designs. The 1998 IRG found no evidence that silicone implants pose a danger to women’s health. Insertion of firm cohesive gel may result in a slightly larger scar than surgery using an implant with a soft silicone filler. Saline Filled with a salt and water solution of similar concentration to that found in body tissue. May be pre-filled or filled through a valve at the time of surgery. Long history of use. Available in either round or anatomical (breast shaped) designs. Filled with a solution which can be absorbed and excreted by the body. May be more prone to rupture or deflation at an earlier stage than other implants. Prone to wrinkling, may feel and look less natural than other implants and may lose volume over a period of time. Less satisfactory in women with little breast tissue. Breast Augmentation Dubai - Finding out about the operation The consultation It is advisable to be referred to a surgeon by your general practitioner (GP) because your GP will have an overview of your health. You may wish to seek more than one opinion. Make sure that you obtain as much information as necessary to enable you to make a fully informed choice about your operation. Obtain answers to all of your questions and use the checklist at the end of this publication to cover your own particular circumstances. You may wish to take notes, take someone with you or, possibly, tape record the discussion with the surgeon so that you can listen to it again. This is quite acceptable and is indeed encouraged in many clinical situations. The surgeon will wish to write to your GP giving details of the operation so that if there are any problems associated with surgery in the short- or long-term, the GP is aware of the surgery. If you do not want your GP to know about your surgery you must make that clear to your surgeon. However, be aware that this may make future management of some medical conditions more difficult if your GP is not aware of all the facts. About the operation You will have the opportunity to discuss detailed aspects of the operation with your surgeon. A number of issues are included in the checklist at the end of this publication, for example, the position of the incision and placing of the implant. The operation is usually performed under general anaesthetic. It may be carried out as day surgery or you may need to stay in hospital. Information for women considering breast implants Breast Augmentation Dubai The checklist at the end of this publication suggests detailed questions about the operation that you may wish to ask. Performance of implants It is essential for healthcare professionals and manufacturers to have information about the clinical performance of implants to be able to assess their safety. To achieve this, the MHRA, a part of the Department of Health, analyses reports of suspected problems with medical devices. Clinicians and/or patients are urged to report any breast implant related adverse incidents to the MHRA’s Adverse Incident Centre (telephone 020 3080 7080, or fax 020 3118 9814, or email aic@mhra.gsi.gov.uk, or online at www.mhra.gov.uk, or by writing to the address given in section 10). 5 What are the consequences and risks? It is important to be aware of some of the short-term effects of breast implant surgery and the longer-term risks. Breast Augmentation Dubai - Some short-term effects • You are likely to have swelling at first, with hardness and discomfort. Bruising, twinges and pains may continue for the first few weeks, although any symptoms that are causing concern, or cannot be explained, should be reported immediately to your surgeon or GP. Warning symptoms include: excessive swelling, deflated breast, offensive wound discharge, excessive pain or heat in breasts. • Changes in breast sensation are common; most are temporary, some are permanent. • It can take several months for breasts to look more natural. • As with any surgical operation, you may need to take some time off. Risks Capsular contracture The human body puts a wall of scar tissue (fibrous capsule) around any implanted foreign material and breast implants are no exception. Scar tissue shrinks, but the extent of the shrinkage varies from person to person and even from breast to breast. This shrinkage, or capsular contracture, is noticeable as an apparent hardening of the breast. Capsular contracture is the most common complication with breast implants although modern implants, which have a textured silicone shell, have a lower incidence of capsular contracture. Capsular contracture is also the most common reason for further surgery. Recent evidence in the UK suggests that with the passage of time, in up to one in ten women who have had breast implants, the fibrous capsules can contract causing the implant to deform, become hard and, in some cases, painful. The implant may have to be removed along with the capsule and replaced, if appropriate, with another implant. Rupture rates and life expectancy of implants Rupture means the development of a split or hole in the silicone shell of a breast implant. Rupture was common with early, thin-walled implants. There is little information on the overall rupture rate of breast implants although modern implants, available in the UK since the early 1990s, appear to rupture less. Their life expectancy is, as yet, unknown. It is difficult to establish the rate of rupture because imaging techniques can fail to detect ruptures or can incorrectly identify intact implants as ruptured. Information for women considering breast implants Breast Augmentation Dubai Rupture does not necessarily create a medical problem; different fillers will react differently. In the majority of cases of silicone gel filled implants, the silicone gel will remain within the capsule that the body forms and can be removed if the ruptured implant is removed. Occasionally, the silicone can spread outside the capsule into the breast and create a series of lumps known as siliconomas. These may give rise to local symptoms such as tenderness. In a small number of cases the gel has been found in the breast tissue, the muscles under the breast, the armpit or (rarely) around the nerves to the arm. If any symptoms such as excessive pain, burning sensation, lumps or aching occur and cause concern, it is advisable to contact your surgeon or GP. Scarring The scars resulting from the insertion of breast implants are normally satisfactory. However, in a small number of women, (up to 1 in 20) as with any surgical procedure, scars will be red, or highly coloured, thick, painful and will take several years before they improve. Appearance of the implanted breasts The position of the breast may be unsatisfactory as a result of the implant and the shape of the breast tissue may be unpredictable. It may not always be possible to produce a natural cleavage and the implant may not drop to the side when the woman lies down. The breast will feel relatively firm but for most women the implant will approximate to the normal feel of the breast. The silicone controversy A number of women have reported serious illness following silicone gel breast implant surgery. This has been said to relate mainly to silicone gel leakage and possible migration to other parts of the body. Stated symptoms include: muscle spasm and pain; swollen and painful joints; rashes; changed eye and saliva fluid; hair loss. The Independent Review Group (IRG) set up by the Department of Health to review the safety of silicone gel filled breast implants published its report in 1998. The report is archived on the MHRA’s website (www.mhra.gov.uk). The IRG found no scientific relationship between silicone gel implants and immune reactions. No relationship was shown between silicone gel implants and long-term systemic illness (affecting the whole body), nor with specific connective tissue disease or non-specific systemic illness. The MHRA takes the safety of all breast implants seriously and will continue to evaluate carefully any new scientific evidence. Should the conclusions formerly reached about breast implants change in the light of this continuing evaluation, then further advice will be communicated to the public. Implanted breast size A specific size of implant does not necessarily equate to a certain cup size increase. Augmentation can magnify small differences in breasts, and these may become more obvious after surgery. Creasing and folds The nature of the implant capsule may enhance less desirable characteristics such as creasing, kinking, vertical ripple folds and rippling in the breast. These are seen most frequently in women with very little breast tissue. Information for women considering Breast Augmentation Dubai Breast Augmentation Dubai - Nipple sensation As a result of the surgery to insert the implants under the breast, there may be a loss of or diminished nipple sensation in approximately 1 in 7 women. Nipple sensation may be increased for a period of 3 to 6 months following surgery and this may be painful. Infection, bleeding and fluid collection Infection of cosmetic breast implants is rare, as is bleeding surrounding the implant. Infection and bleeding may, however, be more frequent after surgery for breast reconstruction following mastectomy and may indeed delay further medical management. On the rare occasion where infection occurs, the breast implant may have to be removed. In a very small number of women, fluid builds up around the implant (this is known as seroma). Additional surgery may be needed to remove this fluid. 6 General issues – other questions you may have Pregnancy and breast feeding Implants do not interfere with the ability to breast feed. There is some evidence which suggests that the amount of milk produced by some women with breast implants is reduced. Reduction in milk production may also occur if the implants are inserted into the periareolar area, as this technique tends to cut the milk ducts. There is no evidence of any effect in children of women with silicone gel breast implants. Breast Augmentation Dubai - Breast cancer There is good evidence that there is no increased risk of developing breast cancer for women who have breast implants. Indeed the risk may be less. If a woman who has breast implants develops breast cancer, scientific studies have consistently shown that the risk of cancer recurring is no greater than in women without implants, and that there is no difference in their survival. There have been anecdotal reports of ACLC (a tumour of the immune system) present in the breasts of implanted women. No association has, however, been confirmed. Breast Augmentation Dubai - Mammography The presence of silicone gel-filled breast implants may interfere with standard mammography used to detect breast cancer. In addition, calcium salt deposits around implants can be seen on mammograms and may interfere with findings. However, studies indicate that breast cancer in women with implants is not diagnosed at a later stage compared with women without implants. Women with breast implants should be sure to tell their radiographer that they have implants so that the most appropriate method of screening can be used. Travelling Breast implants are not subjected to strain or rupture when travelling in aircraft. Breast Augmentation Dubai - Breast implants are a long-term commitment Remember that breast implants do not come with a lifetime guarantee. They are likely to need replacing with consequent further surgery and expense. A young woman who has implants may expect to have further operations in her lifetime to maintain the beneficial effects of the implants. The length of time a breast implant lasts is unknown and may vary depending on an individual’s personal factors. Commitment to follow-up Keep to the aftercare schedule provided by your surgeon and ensure that you attend all post- operative consultations. Ensure that you are given and keep full details of your implants: manufacturer, style, catalogue number and batch/lot number. Commitment to breast awareness Women should be aware of what is normal for them about their breasts and should look and feel for any changes during everyday activities such as bathing, showering or dressing. Advice on breast checks can be obtained from your GP. 8 Consent for the operation Consenting to the surgery should be the last stage in a thoroughly researched process, when you have asked questions and feel comfortable with the decisions you are making When asked to sign a consent form, assure yourself that you have had the following: • an explanation of what it means when you sign a consent form • an opportunity to work through the questions included in the checklist at the end of this publication • full details of the surgery and the treatment that you will be receiving when undergoing surgery and afterwards • full details of what you are likely to experience immediately after the operation and as you recover • full details of the most common long-term and short-term side effects of the operation itself and those which might arise from the use of implants • advice that you have the legal right to refuse surgery, even at the last minute, if you change your mind. Breast Augmentation Dubai - Checklist of questions to ask Below is a suggested checklist of some issues recommended to be discussed with the surgeon. There may be others that occur to you during the consultation process. Take the opportunity to make sure that you understand all the medical terms used. If you are considering reconstructive surgery, you will want to discuss the particular aspects of this operation. Breast Augmentation Dubai - The experience of the surgeon • How many successful breast implant operations has he/she done in the past two years? • How many implants has he/she had complications with? • Is he/she on the GMC Specialist Register for Plastic Surgery? • Is he/she a member of a relevant association, e.g. the British Association of Plastic Surgeons, British Association of Aesthetic Plastic Surgeons? The types of implant • Which implants are available and what are the advantages and disadvantages of each? • Ask to see breast implants before the operation. Size • What size do you wish to be? • Be sure to discuss the differences between cup size and implant size. Cosmetic effects of the operation • What will be the position of the implants, the position of the scar and the appearance of the scar? • What are the advantages and disadvantages of the different positions for the incision, through the armpit, (axilla), surrounding the nipple (periareolar), or under the breast (sub- mammary)? • What are the advantages and disadvantages of placing the implant above or under the muscle? The operation • Will a general or local anaesthetic be used? • What is the competence of the anaesthetist? Is it someone the surgeon has worked with regularly? • How long does the surgery take? • What are the side effects of the operation, e.g. bruising? • What kind of response can I expect in the event of an emergency situation? • Will surgical drains be necessary? • Will it be necessary to take medication after surgery, to alleviate pain? • How long is the recovery period? • How long should I be off work? Information for women considering breast implants Breast Augmentation Dubai • Is there a properly equipped recovery unit? • Is it unsafe to have breast implants whilst suffering from an illness? • How long will the stay in hospital be? • When can I drive, lift heavy objects? Immediate post-operative effects • Will there be any bruising, pain, swelling, bleeding or infection? • Will the nipples be sensitive or not? • What is the likely recovery time? Longer term, local effects • Will there be any wrinkles; capsule formation; or bleed from the implant? • Will nipple sensation be affected? • What is the incidence of rupture? • How is screening for rupture carried out? • What does it mean if rupture occurs? • What symptoms may be noted if rupture occurs? • What actions need to be taken under these circumstances? • What is capsular contracture? • Does this always occur and is it painful? • Does it require further surgery? Follow-up • How long is the follow-up? • Is follow-up at your own request or on development of certain symptoms? • How can rupture, leakage or any other complication be detected? • Is the filler retrievable in the case of leakage or rupture? • Is appropriate screening for leakage or rupture available and who will pay the costs? • When a breast implant is removed, will there be breast tissue loss? • Are guidelines or protocols (such as the Clinical Practice Guidelines for Breast Implant Surgery) produced by a reputable/recognised professional body followed? • Will chemotherapy or radiation therapy affect breast implants? Financial implications • What are the financial implications? • What are the costs of the initial consultation; follow-up; possible screening for rupture and possible removal of the implants and re-implantation? • If corrective surgery is necessary, or if an implant fails, will there be further costs? Breast screening • What kind of breast screening is considered the most appropriate for women with Breast Augmentation Dubai? • Is mammography suitable for women with breast Breast Augmentation Dubai? • Will breast screening unit staff be familiar with procedures and techniques required for Breast Augmentation Dubai imaging? • Will a Breast Augmentation Dubai impair the ability to view any changes which may indicate breast cancer? Breast feeding • Do Breast Augmentation Dubai interfere with breast feeding? • Are there any effects on the children of women with Breast Augmentation Dubai? If things go wrong • What measures are available if things go wrong? • What is the hospital’s complaints process? • If I am not satisfied can I go to another organisation? • How do I report problems with my implants?
Once your surgery is completed, you must follow all the instructions given to you in order to heal properly and have a good outcome. The following instructions are your obligation. Use this as a checklist of progress as you heal. Included are normal post-surgical experiences and key health considerations that may be a cause of concern. TYPICAL POST-OPERATIVE SYMPTOMS Typical symptoms of breast augmentation and signs to watch for following surgery with silicone breast implants include the following: Tightness in the chest region and stiffness Tingling, burning or intermittent shooting pain. These are normal experiences as the skin, muscles and tissue stretch to accommodate your breast implants, and as sensory nerves heal. Pain medication and muscle relaxants will help you cope with any discomfort. If you have drains, you may experience additional localised discomfort. Consistent sharp pain should be reported to our office immediately. Hypersensitivity of nipples or lack of sensitivity This is normal and will gradually resolve over time. You may also experience a small amount of fluid or milk seeping through the nipples. If this becomes painful or excessive notify my office immediately. A feeling of heaviness It is normal for your chest to feel heavy as you adjust to your implants. This will subside within 2-4 weeks following surgery. Shiny skin or any itchy feeling Swelling can cause the breast’s skin to appear shiny. As the healing process advances, you may also find a mild to severe itchy feeling of the breasts. If the skin becomes red and hot to the touch, contact our office immediately. Asymmetry, the breasts look different, or heal differently Breasts may look or feel quite different from one another in the days following surgery. This is normal. Although no two breasts in nature or following surgery are perfectly symmetrical, breast massage and time will produce breasts that are similar in shape, position and size. A sloshing sound or sensation This is not the result of your implant, but rather of air that is trapped in the implant pocket and fluid that may naturally accumulate. This is perfectly normal and will resolve within 2-4 weeks. AFTER SURGERY CARE Your greatest discomfort usually occurs the first 24-48 hours after surgery. During this time, take all medications prescribed by me as directed. It is helpful to take pain medication with bland food to avoid nausea, which may occur if taken on an empty stomach. Wear garments as directed after surgery. An additional garment may be picked up at the office. Contact the office before taking any Aspirin, ibuprofen (Motrin/Advil) or Aspirin-like medications. You may take Tylenol, if you are not taking a pain medicine that already contains Tylenol (acetaminophen), such as Percocet (oxycodone) or Norco (hydrocodone). Eat easily digestible foods. These are tolerated well the first 24 hours after surgery. If you are not experiencing nausea, you may resume a normal diet. Drink plenty of non-caffeinated beverages and eat fruit and food high in fiber to avoid constipation. Should constipation occur, discontinue pain medication (if tolerated). For relief, you may try magnesium citrate (purchased at your local pharmacy) or prune juice. It may take up to 24 hours to produce a bowel movement. These treatments may be repeated as needed. AFTER SURGERY ACTIVITY AND HYGIENE INSTRUCTIONS No lifting over 10-15lb. until cleared by myself. When at home, take frequent rest periods – you may walk for short distances, as walking is important to prevent clots from forming in your legs. As you increase your activity, let comfort be your guide. If it hurts, don’t do it. Do not resume jogging, aerobics, sexual or vigorous activity until cleared by myself. No heavy household chores (laundry, vacuuming, sweeping/mopping, etc.) until cleared. You may shower 24 hours after surgery. Do not submerge incisions or drains (if present) under water such as in bath, lake, river, pool or hot tub. If present, leave steri-strips (flesh colored bandages) in place. All other dressings may be removed to shower. Continue to wear the garment, placed on you at the time of surgery, 24/7 except to shower or to launder the garment. Two weeks after surgery, you may discontinue sleeping in the garment and only wear it during the day. While taking pain medicine, have someone assist you with daily activities, particularly personal hygiene. Limit arm usage to routine daily functions such as brushing your teeth, eating, washing and combing your hair. Avoid vigorous arm motion that requires pushing, pulling and/or lifting heavy objects. As you heal and soreness subsides, let pain be your guide for your activity level. If it hurts, don’t do it. Check with me before returning to work, particularly if your job requires heavy lifting or vigorous activity. Avoid sleeping on your abdomen until all soreness has subsided. You may find sleeping propped on 2-3 pillows more comfortable. Avoid sunbathing for 4-6 weeks or until cleared by myself. Do not wear an underwire bra for 6 weeks. At that point, you may wear a bra of your choice. However you will need to wear a good supportive bra for exercise or vigorous activity. Preferably a sports-type bra that has cups versus one that just compresses the breasts. Do not smoke for 6 weeks as smoking delays the healing process. WOUND CARE You may have several layers of dressings. After 24 hours, you may remove all dressings except the flesh-colored bandages (steri-strips) or clear “tape” (Prineo). Leave either of these dressings in place until your follow up with your surgeon. If either of these dressings comes off, please contact my office for further instructions. Do not put anything on your incisions except soap and water unless instructed. Please notify me if: - You have a fever greater than 101 that lasts more than 24 hours. - You develop excessive swelling, redness or warmth of incisions. - You experience severe pain not responding to pain medication. - You develop thick, odorous drainage or bleeding that does not subside. - You experience shortness of breath. - One breast appears twice the size or more than the other. AFTERCARE: BREAST AUGMENTATION SUMMARY Dressings On day two from surgery remove all gauze in the bra and throw it away. Shower, and then pat the incisions (steri-strips or skin glue) with a clean cloth. Replace soft bra. You will not need gauze unless you have some slight drainage from the incision sites and want to keep this from getting on your clothes. Bathing You may shower two days after surgery (48 hours after surgery). Do not bathe, swim, hot tub, lake swim, or use a whirlpool until incisions are fully closed. I will determine when you are cleared for these activities based on your physical exam. You may feel lightheaded on your first or second shower, therefore a shower assistant is mandatory. Sitting on a chair in the shower is also helpful if you feel more comfortable. Medications Complete your course of antibiotics. Arnica may reduce bruising and you should take a complete course. Take prescribed pain medication only as directed and consider Extra Strength Tylenol in place of narcotics. Take medications with food to reduce nausea. Resume pre-operative medications unless otherwise directed by your operating physician or personal physician. Swelling Initially, there will be quite a bit of swelling. This swelling over the first couple of days. You will notice that your implants/breasts seem high on your chest. This is often very normal. On day 5 you will start massaging your breasts. This will assist with the implants settling and the capsule to form flexibly. Do not apply heat or ice to any treatment areas. Your ability to sense if your skin is getting too cold or hot is not normal and you may burn yourself. Massage Start gentle massage of the breasts at day 5. I or my office staff will demonstrate this technique for you at your post-operative visit. Lymphatic massage has also been shown to help people with fluid retention following surgery. Do not lie on your stomach. Diet Start with a bland soft diet and increase this slowly. Slowly resume a balanced healthy diet. This is often difficult following surgery as you are not feeling at your best and are limited in the amount of physical activity you can do. Limit the amount of salt to take in as this will affect your swelling. Drink plenty of fluids. Avoid alcohol. Clothing Avoid tight fitting bras that dig into your skin or incision. Wear a soft bra that gives moderate support and opens from the front. This makes it easier to take it on and off. Smoking It is well known that nicotine impairs healing and increases your risk of infection. Your scars and final outcome are negatively affected by smoking/nicotine as well. Driving Do not drive or operate any heavy machinery for 24 hours following surgery and/or until you are not taking pain pills. You will need someone with you mandatorily for 24 hours following surgery. Glossary 2 1. How To Use This Educational Brochure 10 2. General Information About Breast Augmentation With Breast Implants 11 2.1 What Gives The Breast Its Shape? 11 2.2 What Is A Silicone Gel Breast Implant? 12 2.3 How Do Breast Implants Work In Breast Augmentation? 12 3. Deciding Whether To Have Breast Augmentation Surgery With Implants 12 3.1 Am I Eligible For Augmentation With Silicone Gel Breast Implants? 13 3.2 Contraindications 13 3.3 Precautions 14 3.4 Warnings 15 3.5 WhatAreTheAlternativesToImplantationWithSilicone Gel-Filled Breast Implants? 17 4. Risks Associated With Breast Implants 18 4.1 What Are The Potential Complications? 22 4.2 What Are Other Reported Conditions? 30 5. Benefits Associated With Breast Implants 36 6. Preparing For Breast Augmentation With Silicone Gel Breast Implants 37 6.1 Should I Have Breast Augmentation? 37 6.2 Breast Augmentation With Implants – Understanding The Procedure 38 6.3 Choosing The Right Implant For You 42 6.4 Other Procedures At The Time Of The Breast Augmentation 45 6.5 Choosing A Surgeon 45 7. Caring For Yourself After Breast Implant Surgery 46 7.1 Postoperative Care In The Hours And Days After Surgery 46 7.2 Postoperative Care In The First Weeks After Surgery 47 7.3 Caring For Yourself In The Months And Years After Surgery 47 7.4 Monitoring Your Implants For Rupture 50 8. Sientra’s Clinical Study Results 51 8.1 Overview Of The Study 52 8.2 What Are The 3-Year Follow-Up Rates? 53 8.3 What Are The Benefits? 53 8.4 What Were The 3-Year Complication Rates? 54 8.5 What Are The Main Reasons For Reoperation? 56 8.6 What Are The Main Reasons For Implant Removal? 59 8.7 What Are Other Clinical Data Findings? 60 9. What To Do If You Have A Problem 63 10. Where To Find More Information 64 11. Sientra’s Implant Tracking Program 65 11.1 Breast Implant Tracking 66 11.2 Device Identification Card 66 12. Important Contact Information 67 13. Warranty Information 68 14. Acknowledgement Of Informed Decision 69 15. Device Tracking And Limited Warranty Enrollment Form 71 16. Device Identification Card 72 17. References 73 18. Index 79 2 Glossary Abdomen Anaplastic Large Cell Lymphoma (ALCL) Areola Asymmetry Atrophy Autoimmune Disease The part of the body between the upper chest (breasts) and the pelvis (hips); often called the stomach. ALCL is not breast cancer; it is a rare type of non-Hodgkin’s lymphoma (cancer of the immune system). The pigmented or darker colored area of skin surrounding the nipple. Uneven appearance between a woman’s left and right breasts in terms of their size, shape, or breast level. Thinning or diminishing of tissue or muscle. An autoimmune disease is a disease in which the body’s immune system attacks its own cells or tissues by mistake, causing damage and dysfunction. Autoimmune diseases can affect connective tissue in the body (the tissue that binds together body tissues and organs). Autoimmune diseases can affect many parts of the body, like nerves, muscles, glands and the digestive system. The ability to exist along with living tissues or systems without causing harm. The removal and examination of tissue, cells, or fluid from a living body. A psychological condition characterized by excessive worry about an imagined or minor physical flaw to the point that it can interfere with normal daily activities. A series of questions asking about a person’s feelings about his or her body. Biocompatible Biopsy Body Dysmorphic Disorder (BDD) Body Esteem Scale Breast Augmentation A surgical procedure to increase breast size and to treat such conditions as sagging or drooping of the breast (ptosis) or breasts of different size, shape, or placement (asymmetry). The first time a breast implant is placed to increase breast size or treat such conditions as ptosis or asymmetry, it is referred to as “primary augmentation.” Any time there is another surgery to replace the implant, it is referred to as “revision- augmentation.” Any surgically implanted artificial device intended to replace missing breast tissue or to enhance a breast. A lump in the breast. A surgical procedure to replace breast tissue or reconstruct a breast after tissue was taken out because of cancer or injury. Breast reconstruction also includes the surgical correction of a breast that has failed to develop properly due to a severe abnormality or congenital defect. The first time a breast implant is placed to replace breast tissue is referred to as “primary reconstruction.” Any time there is another surgery to replace the implant, it is referred to as “revision- reconstruction.” The process of a soft tissue hardening when the mineral calcium builds up in a certain place. Tightening of the scar tissue (also called a capsule) that normally forms around the breast implant during the healing process after surgery. In some women, the scar tissue (capsule) squeezes the implant. When this occurs, it is called capsular contracture. This results in firmness or hardening of the breast. Capsular contracture is classified by a scale named Baker Grade. Breast Implant Breast Mass Breast Reconstruction Calcification/ Calcium Deposits Capsular Contracture 3 4 Capsule Capsulotomy (Closed) Capsulotomy (Open) Chest Wall Congenital Anomaly Connective Tissue Disease/Disorder (CTD) Contraindication CORE Clinical Study Scar tissue that forms around the breast implant. An attempt to break the scar tissue capsule around the implant by pressing or pushing on the outside of the breast. This method does not require surgery but may rupture the implant and is contraindicated (meaning that the procedure is improper and should not be performed). A surgery to create an incision or opening in the capsule (scar tissue). The system of structures outside the lungs that move as a part of breathing, including bones (the rib cage) and muscles (diaphragm and abdomen). An abnormal body part that existed at birth. Also called a congenital malformation or congenital deformity. A disease, group of diseases, or conditions affecting connective tissue, such as muscles, ligaments, skin, etc. and/or the immune system. Connective tissue diseases (“CTDs”) that involve the immune system include autoimmune diseases such as rheumatoid arthritis, lupus, and scleroderma. A use that is improper and should not be followed. Failure to follow contraindications identified in the labeling could cause serious harm. The major clinical study that supports the approval of a medical product (such as breast implants). For Sientra’s breast implants, the CORE study includes augmentation, reconstruction, and revision (revision-augmentation and revision- reconstruction) patients. Information on the safety and effectiveness of the implants are collected every year for 10 years after study participants get their implants. Unusually slow progress in the healing of a wound; surgical incision site fails to heal normally or takes longer to heal. Delayed Wound Healing Displacement Extrusion Fibrocystic Breast Disease Fibromyalgia Fibrous Tissues Gel Bleed/Gel Diffusion Granuloma Groin Hematoma Hypertrophic Scarring Infection Inflammation/Irritation Movement of the implant from the usual or proper place. Skin breakdown with the implant pressing through the skin or surgical incision. Common, benign (noncancerous) changes in the tissues of the breast. The term “disease” is misleading, and many doctors prefer the term “change.” The condition is so commonly found in breasts, it is believed to be a variation of normal. Other related terms include “mammary dysplasia,” “benign breast disease,” and “diffuse cystic mastopathy.” A chronic condition characterized by widespread pain in muscles and joints. It may include fatigue, difficulty sleeping, and morning stiffness. Connective tissue composed mostly of fibers (for example, tendons). When silicone gel leaks or “bleeds” or “diffuses” through the implant shell. Noncancerous lumps that can form around foreign material, such as silicone. Like any lump, it should be evaluated to distinguish it from a lump that might be cancerous. The fold where the lower abdomen meets the inner part of the thigh. A collection of blood inside the body, for example in skin tissue or other body space. An enlarged scar that remains after a wound heals. The growth in the human body of microorganisms such as bacteria, viruses or fungi. An infection can occur as a result of any surgery. The response of the body to infection or injury resulting in swelling, redness, warmth and/or pain. 5 6 Inframammary Fold Inframammary Incision Lactation Local Complications Lymph Nodes The crease under the breast where the breast and chest meet. An incision made in the fold below the breast. The production and secretion of milk by the breast glands. Complications that occur in the breast or chest area. Lymph nodes are glands that play an important part in the body’s defense against infection. They produce lymph, which travels throughout the body in the lymph system, and filters impurities from the body. Common areas where the lymph nodes can be felt with the fingers include: groin, armpit, neck, under the jaw and chin, behind the ears, and on the back of the head. Enlarged lymph node(s). When the implant is placed incorrectly during the initial surgery or when the implant has moved/ shifted from its original position. Shifting can be caused by many factors, such as gravity, trauma, poor initial placement, and capsular contracture. Pertaining to the breast. A type of x-ray examination of the breasts used for detection of cancer. Plastic surgery of the breast. Surgical procedure to raise and reshape sagging breasts. Movementofsiliconematerialoutsidethebreast implant to other areas of the body. MRI uses a magnetic field to create a 3-dimensional picture of a body part or organ. MRI is the imaging method that currently has the best ability to detect rupture of silicone gel breast implants. Lymphadenopathy Malposition Mammary Mammography Mammoplasty Mastopexy Migration/GelMigration MRI (Magnetic Resonance Imaging) Necrosis Palpability/Visibility Pectoralis Periareolar Periumbilical Plastic Surgery Platinum Postoperative Precautions Prosthesis Ptosis Redness/Bruising Removal Reoperation Risks Death of cells or tissues. Palpability is when the implant can be felt through the skin. Visibility is when the implant can be seen through the skin. Major muscle of the chest. The areola is the pigmented or darker colored area of skin surrounding the nipple. Periareolar refers to the area just around the areola. Around the belly button. Surgery intended to enhance or improve the appearance of the body. A metallic element used to help make both silicone elastomer (the rubbery material of the breast implant shell) and silicone gel. After surgery. Information that warns the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Any artificial device used to replace or represent a body part. Sagging or drooping of the breast. Bleeding at the surgical site that causes discoloration and varies in degree and length of time. This is expected following breast implant surgery or other breast procedures. Removal of the implant, with or without replacement using another implant. Any additional surgery performed to the breast or chest area after the first breast implantation. The chance or likelihood that an undesirable effect will occur. 7 8 Rosenberg Self-Esteem Scale Rupture Saline Scar Revision Scarring Seroma SF-36 Scale Sientra Clinical Study A questionnaire that measures overall self-esteem. A hole or tear in the shell of the implant that allows silicone gel filler material to leak from the shell. Saltwater (A solution made of water and a small amount of salt). A surgical procedure to improve the appearance of a scar. Formation of tissue at an incision site; all wounds heal by the formation of a scar. Similar to a bruise, a seroma occurs when the watery portion of the blood collects around a surgical incision or around a breast implant. The Short Form 36 Health Scale; a questionnaire intended to measure physical, mental, and social health. The clinical Study that supports the approval of a medical product (such as breast implants). For Sientra’s breast implants, the Study includes augmentation, reconstruction, and revision (revision-augmentation and revision-reconstruction) patients. Information on the safety and effectiveness of the implants are collected every year for 10 years after Study participants get their implants. A breast implant rupture without symptoms or a visible change. Silent rupture cannot be felt by the woman or detected by a doctor through physical examination. Silent rupture can only be discovered through appropriate imaging techniques such as MRI. Silicone is a man-made material that can be found in several forms such as oil, gel, or rubber (elastomer). The exact make-up of silicone will be different depending on its use. Silent Rupture Silicone Silicone Elastomer Silicones - Low Molecular Weight (“Low Molecular Weight [LMW] Silicones”) SubglandularPlacement Submuscular Placement Surgical Incision Symptom Symptomatic Symptomatic Rupture Systemic Toxic Shock Syndrome (TSS) Transaxillary Warnings Wrinkling/Rippling A type of silicone that has elastic properties similar to rubber. Small silicone molecules that may be present in gel bleed/gel diffusion. Whentheimplantisplacedunderandwithinthe breast glands (breast tissue) but on top of the chest muscles. When the implant is placed underneath the chest muscles. A cut made to body tissue during surgery. Any perceptible change in the body or its functions that indicates disease or a phase of a disease. Experiencing symptoms; any evidence or sign of disease or disorder. A breast implant rupture that is associated with symptoms (such as lumps, persistent pain, swelling, hardening, or change in implant shape). Pertaining to or affecting the body as a whole. A rare, but life-threatening bacterial infection that may occur after surgery. Symptoms include sudden fever, vomiting, diarrhea, fainting, dizziness, and sunburn-like rash. A doctor should be seen immediately for diagnosis and treatment if TSS is suspected. Under the arm. A statement that alerts the reader about a situation which, if not avoided, could result in serious injury or death. Wrinkling of the implant that can be felt or seen through the skin. 9 10 1. How To Use This Educational Brochure Sientra, the company that sells these Silicone Gel Breast Implants, has designed this educational brochure to help you understand breast augmentation and to help you talk with your doctor(s) about breast augmentation. Sientra sponsored a large clinical study of these breast implants (also referred to in this brochure as the “Study”) that gathered data about these breast implants. The Study collected data from the primary augmentation and revision-augmentation cohorts of the CORE study, as well as pooled data from Sientra’s CORE and Continued Access studies for the primary reconstruction and revision-reconstruction cohorts. There are 1,788 patients participating in the Study. A total of 1,115 patients had primary augmentation and 362 patients had revision-augmentation. Of the 229 patients who had primary reconstruction, 156 patients were from the CORE study and 73 were from the Continued Access study. Of the 82 patients who had revision-reconstruction with Sientra Silicone Gel Breast Implants, 50 were from the CORE study and 32 were from the Continued Access study. Results from the Study are presented in Section 8 of this brochure. After you receive this information, give yourself time to read and think about the information. Because breast implants will require monitoring and care for the rest of your life, you should wait 1-2 weeks after reviewing and considering this information before deciding whether to have the surgery. If you are having revision-augmentation surgery, your surgeon may advise you to have the surgery sooner. If you decide to have the surgery, you will be asked to sign a statement before the surgery. The statement says you have read and understood the information in this brochure and that you have been informed of the benefits and risks of breast implants. This statement is called the “Acknowledgement of Informed Decision,” and there is a copy of it at the end of this brochure. Make sure all of your questions have been answered and you understand the information in this brochure, before you sign the “Acknowledgement of Informed Decision.” 2. General Information About Breast Augmentation With Breast Implants The information in this section provides some general information about breast augmentation with breast implants. 2.1 What Gives The Breast Its Shape? As shown in Figure 1, your breast consists of milk ducts, glands, blood vessels, and nerves that are surrounded by fatty tissue. Glandular tissue is firm and gives the breast its shape. The fatty tissue gives the breast its soft feel. The chest muscle (the pectoralis major muscle) is located underneath all this breast tissue but does not have much effect on the shape or feel of the breast. Figure 1. Anatomy of the Breast Fatty Tissue Rib Pectoralis Muscles Milk Ducts and Glands 11 12 2.2 What Is A Silicone Gel Breast Implant? A silicone gel breast implant is a sac (implant shell) made of silicone elastomer (rubber), which is filled with clear silicone gel. Sientra uses implant grade silicone elastomer and implant grade high-strength silicone gel to manufacture its Implants. Sientra’s Implants are designed to resemble the human breast in shape, weight and feel. Sientra’s Implants are available in a variety of shapes and sizes, with either a smooth or textured surface. You and your surgeon can choose the Sientra round or shaped implant option that best suits your individual needs. Round implants provide volume in the upper breast area (called upper pole area). Shaped implants are intended to match the anatomy of your chest wall. Depending on your needs, shaped implants can also provide more or less volume in the upper pole area. Refer to Section 6.3 - Choosing the Right implant foR You, for more information on the different silicone gel breast Implants available from Sientra. 2.3 How Do Breast Implants Work In Breast Augmentation? Breast implants are used to make the breasts larger or to restore or replace breast tissue. They are surgically implanted beneath your breast tissue, either on top of the chest muscle (subglandular placement) or underneath part or all of the chest muscle (submuscular placement). 3. Deciding Whether To Have Breast Augmentation Surgery With Implants The answers to the questions in this section will help you to decide whether breast augmentation surgery with implants is right for you. 3.1 Am I Eligible For Augmentation With Silicone Gel Breast Implants? Breast implants have been approved for use in augmentation in two cases: • Primary augmentation to increase the size and proportions of the breast(s) in women at least 22 years old. • Revision-augmentation surgery to correct or improve the result of primary augmentation. Revision-augmentation includes replacing an existing breast implant. Women who have lost breast tissue to cancer or injury or want to correct a congenital anomaly may also use Sientra Silicone Gel Breast Implants (also referred to as Implants). This is considered breast reconstruction with implants. A different educational brochure that describes breast reconstruction with Sientra Implants is available for you to read if appropriate to your situation. 3.2 Contraindications A contraindication is a condition or circumstance that, if present, means a procedure should not be done. Contraindications for breast implant surgery are discussed in this section. Silicone Gel Breast Implants are contraindicated in the following circumstances because the risk of undergoing breast augmentation with implants outweighs the benefits: • Women with active infection anywhere in their bodies, • Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, and in • Women who are pregnant or nursing. Surgery in general is not recommended in patients with an active infection, existing cancer or pre-cancer, and existing pregnancy (unless the surgery is to treat the infection, cancer or pregnancy as recommended by your doctor), as it may interfere with the treatment of the infection or the cancer and safety of the pregnancy/nursing. In addition, these conditions may interfere with the healing after surgery. 13 14 Adequate studies have not been performed to demonstrate the safety of breast implant surgery in women with these conditions or under these circumstances; therefore, if you have any of the above conditions or circumstances, breast augmentation surgery with implants should not be performed at this time. Failure to take into consideration these contraindications may increase the risks involved with the surgery and could cause harm. 3.3 Precautions CAUTION: Notify your doctor if you have any of the following conditions as the risks of breast implant surgery may be higher if you have any of these conditions. • An autoimmune disease, • A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease), • Conditions that interfere with wound healing and/or blood clotting, • Reduced blood supply to breast tissue, • Chemotherapy or radiation to the breast following implantation, or • Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. If you have been diagnosed with or treated for depression, an anxiety disorder, or another mental health condition, you should wait until your condition has resolved or stabilized before having breast implant surgery. Discuss any history of mental health disorders with your doctor(s) prior to surgery. Before you have surgery, you should have a detailed conversation with all of your doctors (primary care doctor, surgeon, and any specialists you see) about breast implant surgery in light of your medical history. CAUTION: In order to avoid possible injury or damage to your incision site(s), you should avoid the following for the first month after your surgery: • Sun exposure, • Jerky movements or activities that stretch the skin at your incision site(s), • Participating in sports or other activities that raise your pulse or blood pressure, and • Unnecessary physical or emotional stress. 3.4 Warnings Read this entire brochure before having breast implant surgery so that you will understand the risks and benefits and have realistic expectations of the outcome of your surgery. Breast implants are associated with many short-term and long-term risks. WARNING – Smoking can make it harder for your body to heal. If you smoke, your doctor will probably have told you to stop before your surgery. Do not smoke while you are recovering from breast implant surgery. WARNING – The following is a list of possible complications associated with breast implant surgery. Make sure you read and understand these before deciding whether to have breast implant surgery. Please refer to the following sections in this brochure for more detail on these factors: Section 4 - RisKs assoCiateD With BReast implants, Section 7 - CaRing foR YouRself afteR BReast implant suRgeRY and Section 8 - sientRa’s CliniCal stuDY Results. • Breast implants are not expected to last for the rest of your life, and breast implantation may not be a one-time surgery. It is likely that you will need other surgery related to your breast implants over the course of your life. These additional surgeries can include implant removal with or without replacement, or they can include other surgical procedures. 15 16 • Many of the changes to your breast that may occur as a result of breast implant surgery will be permanent and cannot be undone. If you have your implants removed, your skin may be permanently dimpled, puckered, or wrinkled. • Breast implants may interfere with your ability to produce milk (lactate) for breast-feeding. If you are planning to breast-feed your infant, be prepared to use formula and bottle-feed your baby in the event you have difficulty breast-feeding. • Mammography for detecting breast cancer (or cancer recurrence) may be more difficult with breast implants in place. You will need more views captured than during a routine mammogram. Therefore, the procedure will take more time and you will be exposed to more radiation than during a standard routine screening mammogram. However, the benefits of mammograms outweigh this risk. You must tell the technologist that you have silicone gel breast implants before the procedure. The technologist can then use special techniques to get the best possible views of your breast tissue. • Your implants could rupture without you feeling the rupture or noticing any change in your breasts. In some of these instances even your doctor might not be able to tell that a rupture has occurred. A rupture that has no symptoms is called a “silent” rupture. The best way to diagnose a silent rupture is with an MRI examination. An MRI is similar to using x-ray imaging but an MRI machine uses magnetism and not x-ray radiation. Because silent ruptures can occur and because they are difficult to detect, you should have an MRI 3 years after your breast implant surgery and then every 2 years after that for as long as you have your breast implants. • Routine self-examination of your breasts may be more difficult with implants. However, you should still perform an examination of your breasts every month for cancer screening. Ask your surgeon to help you distinguish the implant from your breast tissue. You should perform an examination of your breasts for the presence of lumps, swelling, hardening, or change in implant shape, which may be signs of rupture of the implant. Report any of these symptoms or persistent pain to your doctor. Your surgeon may recommend an evaluation via MRI to check for rupture. • After undergoing breast augmentation surgery, you may experience changes in your healthcare insurance. Your health insurance premiums may increase; your coverage may be dropped or discontinued; you may not be able to get health insurance coverage in the future; and/ or insurance may not cover treatment of complications associated with your breast implants. Be sure to check with your insurance company about these potential issues and understand the complete extent of your health coverage before having breast augmentation with implants. 3.5 What Are The Alternatives To Implantation With Silicone Gel-Filled Breast Implants? If this is your first (primary) breast augmentation surgery your alternatives may include • Electing to have no surgery, • Wearing a padded bra or external prosthesis, • Having a breast lift surgery (mastopexy) without implant(s), or • Having breast augmentation with saline-filled implants. If you are considering a revision surgery, your alternatives may include • No revision surgery, • Removing your implants without replacing them, • Wearing a padded bra or external prosthesis, or • Having revision breast augmentation with saline-filled implants. 17 18 4. Risks Associated With Breast Implants Undergoing any type of surgery involves risks. There are a number of local complications (problems at or near the breast/surgical incision site) that may occur after you have silicone gel breast implant surgery. The following addresses both general, surgery-related complications and implant- related complications. Tables 1 and 2 present the potential risks associated with breast implant surgery, the likelihood of the risks based on the results from Sientra’s Clinical Study through 3 years, as well as the possible effects of the events for primary and revision-augmentation patients. TABLE 1 Potential Risks Associated with Primary Breast Augmentation Event Reoperation Implant Removal with Replacement Implant Removal without Replacement Capsular Contracture (Baker Grade III/IV) Implant Rupture Likelihood of the Event Occurring* Possible Resulting Effects of the Event • Infection • Scarring • Hematoma or Seroma • Delayed wound healing • Necrosis • Pain or Discomfort • Anesthesia-related complications • Loss of breast tissue • Undesirable cosmetic result • Infection • Scarring • Hematoma or Seroma • Delayed wound healing • Necrosis • Pain or Discomfort • Anesthesia-related complications • Loss of breast tissue • Undesirable cosmetic result • Infection • Scarring • Hematoma or Seroma • Delayed wound healing • Necrosis • Pain or Discomfort • Anesthesia-related complications • Loss of breast tissue • Undesirable cosmetic result • Pain or Discomfort • Breast hardness/firmness • Reoperation • Implant removal • Implant removal • Increased or decreased nipple sensitivity • Breast-feeding difficulties • May affect sexual response • Undesirable cosmetic result • Wrinkling/rippling • Reoperation • Implant removal • Implant Visibility • Asymmetry • Reoperation • Implant removal Asymmetry * Based on the results of Sientra’s Clinical Study within the first 3 years after implant surgery. Key Risks 13 out of 100 patients (13%) 5 out of 100 patients (5%) 1 out of 100 patients (1%) 6 out of 100 patients (6%) Other Risks Occurring in 1% or more of Patients Nipple Sensation Changes Ptosis Implant Malposition 3 out of 100 patients (3%) 3 out of 100 patients (3%) 2 out of 100 patients (2%) 1 out of 100 patients (1%) 1 out of 100 patients (1%) • Undesirable cosmetic result • Reoperation • Implant removal 19 TABLE 2 Potential Risks Associated with Revision-Augmentation Event Reoperation Implant Removal with Replacement Implant Removal without Replacement Capsular Contracture (Baker Grade III/IV) Implant Rupture Likelihood of the Event Occurring* Possible Resulting Effects of the Event • Infection • Scarring • Hematoma or Seroma • Delayed wound healing • Necrosis • Pain or Discomfort • Anesthesia-related complications • Loss of breast tissue • Undesirable cosmetic result • Infection • Scarring • Hematoma or Seroma • Delayed wound healing • Necrosis • Pain or Discomfort • Anesthesia-related complications • Loss of breast tissue • Undesirable cosmetic result • Infection • Scarring • Hematoma or Seroma • Delayed wound healing • Necrosis • Pain or Discomfort • Anesthesia-related complications • Loss of breast tissue • Undesirable cosmetic result • Pain or Discomfort • Breast hardness/firmness • Reoperation • Implant removal • Implant removal Key Risks 20 out of 100 patients (20%) 9 out of 100 patients (9%) 3 out of 100 patients (3%) 5 out of 100 patients (5%) 20 0 out of 100 patients (0%) * Based on the results of Sientra’s Clinical Study within the first 3 years after implant surgery. TABLE 2 (cont.) Potential Risks Associated with Revision-Augmentation Event Implant Malposition Wrinkling/Rippling Asymmetry Nipple Sensation Changes Infection Seroma/Fluid Accumulation Likelihood of the Event Occurring* Possible Resulting Effects of the Event • Implant Visibility • Asymmetry • Reoperation • Implant removal • Discomfort • Undesirable cosmetic result • Reoperation • Implant removal • Undesirable cosmetic result • Reoperation • Implant removal • Increased or decreased nipple sensitivity • Breast-feeding difficulties • May affect sexual response • Redness or rash • Pain or tenderness • Swelling • Fever • Reoperation • Implant removal • Swelling • Pain or Discomfort • Infection • Incision and drainage (reoperation) • Implant removal Other Risks Occurring in 1% or more of Patients 3 out of 100 patients (3%) 2 out of 100 patients (2%) 2 out of 100 patients (2%) 1 out of 100 patients (1%) 1 out of 100 patients (1%) 1 out of 100 patients (1%) * Based on the results of Sientra’s Clinical Study within the first 3 years after implant surgery. For additional information on how often Sientra has reported these events in its studies of the Implants, please read the section of this brochure on the Clinical Study (Section 8). For example, using information from Sientra’s Clinical Study, the risk of a patient experiencing any complication at some point through 3 years after implant surgery was calculated. This risk is 20% for primary augmentation patients and 26% for revision-augmentation patients. This means that 20 out of 100 primary augmentation patients and 26 out of 100 revision- augmentation patients may experience a complication (of some kind) within 3 years after receiving implants. 21 22 4.1 What Are The Potential Complications? INFECTION Infection is a possible consequence of any kind of surgery. It most often happens within days to weeks after the surgery, but you could develop an infection in your breast(s) at any time. Signs that you have an infection include: redness or rash, tenderness or pain, fluid accumulation in or around the breast(s), and fever. If you experience any of these symptoms, call your doctor right away. It is harder to treat an infection with an implant present. If antibiotics do not cure your infection, it is possible that your implant(s) may have to be removed to treat the infection. In rare cases, Toxic Shock Syndrome (TSS) has been noted in women after surgery, including breast implant surgery. TSS is a life-threatening condition. Symptoms of TSS occur suddenly: a high fever, vomiting, diarrhea, a sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and/or drops in blood pressure, which may cause fainting. If you feel any of these symptoms, contact a doctor immediately. HEMATOMA OR SEROMA You may experience a hematoma or a seroma following your surgery. A hematoma is similar to a bruise; hematomas related to breast implants are the collection of blood within the space around the implant. A seroma is a buildup of fluid around the implant. Symptoms from a hematoma or seroma may include swelling, pain, and bruising. If a hematoma or seroma occurs, it will usually be soon after surgery. However, other injuries to the breast can cause hematomas and/or seromas in your breast. The body can absorb small hematomas and seromas on its own, but some will require surgery. When surgery is needed, it often involves draining the blood or fluid and sometimes involves placing a surgical drain in the wound temporarily for proper healing. A small scar can result from surgical draining. Implants may rupture if they are damaged by surgical instruments during the draining procedure. CAPSULAR CONTRACTURE After your breast implant surgery, your breasts will begin to heal and to adapt to the presence of the breast implants. A regular part of this process is that the breast tissue typically forms an internal scar immediately surrounding the implant. In many cases, this tissue forms a capsule that helps hold the implant in place. However, in some women, the scar tissue around the implant tightens and squeezes the implant. When scar tissue squeezes an implant, it is called capsular contracture. Capsular contracture causes the breast to feel abnormally firm or hard and can cause pain. There is a scale for describing the severity of the contracture. It is called the Baker Grading Scale. The grades are: • Grade I – contracture is observed, but the breast feels and looks normal (it is soft); • Grade II – the breast is a little firm, but looks normal • Grade III – the breast is firm and looks abnormal • Grade IV – the breast is hard, painful, and looks abnormal Capsular contracture may be more common if you have had a breast infection or hematoma/seroma. The chances of having contracture typically increase the longer you have your implants. It also seems that women who have additional surgery to replace their implants (revision surgery) are more likely to have capsular contracture than women having their first augmentation or reconstruction. However, whether or not a woman experiences capsular contracture at all and with what degree of severity varies from woman to woman. If you feel severe pain and/or firmness (usually Grades III and IV contracture), you may need surgery to correct the problem. This could mean that the surgeon has to remove the part of your breast tissue that has contracted around the implant (the scar tissue capsule), and you could lose some breast tissue during such a surgery. During such surgery, it is possible that your implant(s) would need to be replaced. Even after having surgery to fix contracture problems once, contracture may happen again. The Clinical Study of Silicone Gel Breast Implants reported a 6% risk of experiencing Baker Grade III or IV capsular contracture for primary augmentation patients through 3 years after receiving implants. For revision-augmentation patients, the risk is 5%. This means that 6 out of 100 23 24 primary augmentation patients and 5 out of 100 revision- augmentation patients may experience Baker Grade III or IV capsular contracture within 3 years after receiving implants. More details on capsular contracture results from the Study are found in Section 8.4. RUPTURE Breast implants are considered to have ruptured when the implant shell develops a tear or hole. Sometimes silicone gel can minimally leak or “bleed/diffuse” through the implant shell even if there is no obvious tear in the shell. This is called “gel bleed” or “gel diffusion.” Implants could rupture any time after your implant surgery, but the longer the Implants are in place, the higher the possibility that the Implants will rupture or the gel will leak. Breast implants may rupture or leak because of any of these reasons: • Damage by surgical instruments at the time of implantation or during any subsequent surgical procedure, • Stress to the implant during implant surgery that weakens it, • Folding or wrinkling of the implant shell, • Excessive force to the chest (for example, during closed capsulotomy, which is contraindicated), • Trauma (like being in a car accident), • Compression during a mammogram, • Severe capsular contracture, or • Normal use over time. Sometimes there are symptoms associated with gel implant rupture that you or your doctor can notice. Sometimes your implants could rupture without you feeling the rupture or noticing any changes in your breasts. In some of these instances even your doctor might not be able to tell that a rupture has occurred. A rupture that has no symptoms is called a “silent” rupture. Sientra has done studies to better understand what causes breast implants to rupture or leak gel. These studies might not have identified all the causes of rupture and these studies are continuing. When silicone gel breast implants rupture, most of the silicone gel usually stays in the implant, and if any silicone does escape through a tear or hole, most of the gel stays within the scar tissue (capsule) around the implant. Sometimes, the gel does not stay there and may move to other areas around the body (gel migration). There have been rare reports of gel moving to nearby tissues such as the chest wall, armpit, or upper abdominal wall, and to more distant locations down the arm or into the groin. One group of researchers found silicone in the livers of women with ruptured silicone gel breast implants.1 Sometimes silicone travels into the lymph nodes. When silicone gel moves into the lymph nodes, they may become enlarged. When silicone gel moves into lymph nodes or other parts of the body, small hardened lumps of silicone (called silicone granulomas) may be felt. These lumps are NOT cancer, but it can be hard to tell them from cancerous lumps just by feeling them. If you feel any lumps in your breasts, around your breasts, in your armpits or anywhere in your body, your doctor should examine them. Your doctor may have to remove a small amount of tissue from the lump(s) (called taking a biopsy) to find out if the lump is cancer. Before having a biopsy, be sure to tell your doctor that you have breast implants. Studies have been done to find out what, if any, effects migrated silicone gel has on the body.1-5 In most cases, no serious problems were reported. Several studies report that some women with migrated silicone gel experienced breast hardness, numbness and/or tingling in their extremities, and some seemed more sensitive to sunlight.1,4,6 In a few cases, migrated gel has caused nerve damage, hard silicone nodules (granulomas) in the body, and/or breakdown of the body tissues around the gel.5 Most doctors and researchers agree that there is NO evidence that ruptured implants or migrated gel causes any disease that affects the whole body (systemic disease) like Connective Tissue Disease (CTD) or cancer. However, one group of researchers2,3 reported that women who had migrated silicone gel had a higher risk of getting a CTD. This is discussed more fully in Section 4.2. 25 26 Studies on breast implants that women have had for a long time suggest that gel bleed may play a role in capsular contracture.7 However, complication rates for silicone gel breast implants are similar to or lower than those for saline- filled breast implants (which do not have silicone gel and, therefore, do not have gel bleed). REOPERATION It is likely that you will need additional surgery (a reoperation) at some point after your first breast implant surgery, either to correct a problem with or replace your breast implants. Common reasons for subsequent surgeries include capsular contracture and a woman deciding to change the size or style of her breast implant(s). Some changes to your breast(s) after having breast implants are irreversible (cannot be changed or fixed). These may include dimpling, puckering, wrinkling, or the appearance that the breast is empty or deflated. Based on the experiences of augmentation patients in the Study, the 3-year risk of reoperation is 13% for primary augmentation patients and 20% for revision-augmentation patients. This means that 13 out of 100 primary augmentation patients and 20 out of 100 revision-augmentation patients who receive Implants may have a reoperation within 3 years after their implant surgery. Reoperation information from the Study is discussed in more detail in Section 8.5. IMPLANT REMOVAL Your Implants may be removed (with or without being replaced) at some point during the course of your life. You and your doctor may decide to remove an implant or implants because of a complication or to improve the cosmetic result. Based on the experiences of augmentation patients in the Study, the 3-year risk of implant removal (including removal with replacement for a size exchange) is 6% for primary augmentation patients and 11% for revision-augmentation patients. This means that 6 out of 100 primary augmentation patients and 11 out of 100 revision-augmentation patients who receive Silicone Gel Breast Implants may need to have one or both implant removed within 3 years after receiving their implants. Implant removal information from the Study is discussed more fully in Section 8.6. PAIN You will probably have some pain after your surgery. The intensity of the pain and the length of time it lasts vary from patient to patient. The pain may persist long after you have healed from surgery. In addition, improper implant size, placement, surgical technique, or capsular contracture may result in pain. Tell your surgeon if you have a lot of pain or if your pain does not go away. CHANGES IN NIPPLE AND BREAST SENSATION Feeling in the nipple and breast can change after implant surgery. Nipples may become more or less sensitive. They may be painfully sensitive or feel nothing at all. These changes are temporary for many women, but for some, sensation may never be what it was before implant surgery. They may affect a woman’s sexual response or ability to breast-feed. COSMETIC CHANGES You may not be satisfied with the way your breasts look or feel after your surgery. Unsatisfactory results such as scarring or asymmetry (note: asymmetry that exists before breast implant surgery may not be entirely correctable), wrinkling of the skin, implant displacement/ migration, incorrect size, unanticipated shape and/or implant palpability/visibility may occur. A surgeon can minimize the chances of these things happening by planning the surgery carefully and using good surgical techniques. You should understand the possible cosmetic results and discuss them carefully with your doctor before the surgery. Your surgeon cannot promise that after implant surgery your breast(s) will look exactly as you wanted them to look. Revision surgery may be the only way to improve a result you do not like. BREAST-FEEDING Breast implant surgery might interfere with your ability to successfully breast-feed. It is possible that you will produce less milk or not be able to produce milk at all. Some women with breast implants have also reported painful breast-feeding.7,8 The Institute of Medicine (IOM) and The American College of Obstetricians and Gynecologists (ACOG) encourage women with breast implants to try breast-feeding. The IOM concluded, “Breast feeding should be encouraged in all 27 28 mothers when possible, including those with silicone breast implants. There is evidence that breast implantation may increase the risk of insufficient lactation, but no evidence that this poses a hazard to the infant beyond the loss of breast feeding itself. The evidence for the advantages of breast feeding to infant and mother is conclusive.”7,9 The Clinical Study collected information from patients who had babies after augmentation with Silicone Gel Breast Implants. Of those patients, 89% (of 150 patients who gave birth) in the primary augmentation group and 92% (of 39 patients who gave birth) in the revision-augmentation group reported no difficulties with lactation. Lactation experiences from the Study are discussed more fully in Section 8.7. IMPLANT ExTRUSION Extrusion is when the breast implant comes through the skin. This can happen if your surgical wound has not healed properly or if the skin over your breast weakens. Radiation therapy has been reported to increase the chances of implant extrusion.10 Additional surgery is needed to fix implant extrusion. This can result in more scarring or loss of breast tissue. An extruding implant may have to be removed and not replaced. NECROSIS/DELAYED WOUND HEALING Necrosis means that of most or all of the cells in a certain part of your body have died. In the case of implanted breasts, it means dead or dying breast tissue or skin. This can mean that the implant may extrude. Necrotic tissue must be surgically removed. The additional surgery may cause more scarring or loss of breast tissue. Your implant may have to be removed with or without being replaced. Some patients may take a long time to heal after breast implant surgery. The longer it takes for your surgical wound to close and heal, the greater the risk for infection, implant extrusion, or necrosis. The normal time for wound healing is different for every patient. Infection, radiation, chemotherapy, smoking, taking steroids, and excessive heat or cold therapy can cause necrosis and delayed wound healing. Be sure to ask your surgeon how long he or she expects healing to take for you. If you do not heal in that timeframe, talk to your surgeon immediately. BREAST ATROPHY/CHEST WALL DEFORMITY The breast implant pressing on the breast tissue may cause the tissue to become thinner. When this happens, you may be able to see and/or feel the breast implant through the skin. This tissue thinning can occur while implants are still in place or following implant removal without replacement. The presence of breast implants can cause deformity that is noticeable, especially in very thin women. Additional surgery may be needed to correct either of these conditions, which may mean more scarring, and removal with or without replacement of your breast implant(s). CALCIUM DEPOSITS Calcium deposits (hard lumps of calcium) may form in your breast(s) and may be painful. Calcium deposits form in women who have not had any breast surgery and in women who have had breast surgeries. They also become more common as women get older. Calcium deposits do not mean you are ill, but they can be mistaken for cancer. It may be difficult to tell if they are calcium deposits or cancer just by feeling them. They can show up on mammograms as possible cancer lumps. If you have hard lumps, your doctor may have to operate in order to perform a biopsy (remove a small piece of the lump for testing) or to remove the lump(s). Tell your doctor about any lumps your feel in or around the breast or anywhere on your body. ENLARGED LYMPH NODES There are a large number of lymph glands in the body, but it is the lymph nodes in the armpit that drain the breast area of fluid. Some patients with breast implants have been found to have enlarged lymph nodes in the arm pit. This is referred to as lymphadenopathy. It has been reported to occur in women with both ruptured and intact silicone gel breast implants. If an enlarged lymph node becomes painful, it may need to be surgically removed. You should report any painful or enlarged lymph nodes to your doctor. 29 30 4.2 What Are Other Reported Conditions? Sientra will continue its Clinical Study of its Silicone Gel Breast Implants through 10 years. Sientra will update the information it publishes about its implants (including this patient brochure) with the results of this Study. Contact your surgeon or Sientra (See Section 12 on ImportAnt ContACt InformAtIon) for updates. Some women with breast implants have reported health problems that they believe are related to their implants, although the connection between their implants and their health problems has not been proven. Examples of such health problems include autoimmune diseases or connective tissue disease, cancer, or neurological problems (problems with the brain or nerves). Studies have not shown that breast implants can cause these conditions. Most studies suggest that there is no connection between breast implants and these medical conditions. However, you should be aware of them. It is possible that there are risks that are not known and could be associated with breast implants in the future. The information discussed in this section is based on studies published in the medical literature that include women with many different types, brands, and models of breast implants for augmentation and/or reconstruction. The following potential long-term health effects of breast implants have been studied in relation to breast implants in general: CANCER At this time, there is no scientific evidence that silicone gel breast implants increase the risk of any kind of cancer in women, but this possibility cannot be completely ruled out. Major research groups agree that silicone gel breast implants do not cause cancer.11-13 BREAST CANCER Patients with breast implants do not seem to have greater risk of developing breast cancer.14-25 The Institute of Medicine (IOM) report (a comprehensive review of studies that looked at the safety of silicone gel breast implants since they were introduced in 1962) showed that breast cancer is no more common in women with implants than those without implants. Some studies have suggested that breast implants may interfere with or delay breast cancer detection by mammography and/or biopsy. However, other studies reported that breast implants neither delayed breast cancer detection nor affected cancer survival.17,25-28 BRAIN CANCER Most studies of brain cancer in women with silicone gel breast implants have found no increased risk.16,18,20,23-25 One study reported a higher rate of brain cancer in women with breast implants, compared to the general population.15 However, rates of brain cancer were not significantly higher in women with breast implants when compared to women who had other non-breast implant plastic surgeries. LYMPHO-HEMATOPOIETIC CANCERS Lympho-hematopoietic cancers are cancers that develop in the lymph nodes or certain blood cells. Lymph nodes and the affected cells are part of the body’s immune system to fight infection. These kinds of cancers include non-Hodgkin’s lymphoma, Hodgkin’s disease, multiple myeloma, and leukemia. Although most studies have found no increased risk of these cancers for women with silicone gel breast implants.16,18,20,23-25 some reports have suggested a possible association between a type of anaplastic large cell lymphoma (ALCL) and breast implants.29 anaplastic large Cell lymphoma Women with breast implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL, in the scar tissue and fluid adjacent to the implant. ALCL is not breast cancer— it is a rare type of non-Hodgkin’s lymphoma (cancer of the immune system). Most patients were diagnosed when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. In the cases reported, ALCL was typically diagnosed years after the implant surgery. 31 32 Your physician should consider the possibility of ALCL if, after your surgical site is fully healed, you see changes in the way the area around the implant looks or feels—including swelling or pain around the implant. If ALCL is suspected, your physician will refer you to an appropriate specialist for evaluation which may involve obtaining fluid and tissue samples from around your breast implant. If ALCL is confirmed, your physician will develop an individualized treatment plan for you. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined treatment. If you have breast implants and have no symptoms, you do not need to do anything additional, but you should continue to routinely monitor your breast implants and follow your routine medical care. Removing the implants is not recommended in women with no symptoms without a diagnosis of ALCL. If you do not currently have breast implants but are considering breast implant surgery, you should discuss the risks and benefits with your health care provider. You may also visit the FDA’s Breast Implants website for additional information. For additional and the most up-to-date information please visit: http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ImplantsandProsthetics/ BreastImplants/ucm239995.htm RESPIRATORY/LUNG CANCER Several studies have found that women with silicone gel breast implants are not at greater risk for lung cancer.16,18,20,23-25 One study found an increased risk of respiratory/lung cancer in women with breast implants15 compared to women who had other kinds of plastic surgery (non-breast implant). However, the risk of lung cancer was not higher than national lung cancer rates for the general population. Other studies of women in Sweden and Denmark have found that women who get breast implants are more likely to be current smokers than women who get breast reduction surgery or other types of cosmetic surgery;30-32 this may increase their risk for lung cancer. REPRODUCTIVE SYSTEM CANCER Reproductive system cancers in women are cancers of the cervix, ovaries, uterus, vulva, vagina, and other female genital organs. Most studies16,18,20,23-25 found that women with silicone gel breast implants have no greater risk of these cancers than women without implants. One study reported an increased incidence of cervical/vulvar cancer in women with breast implants.15 OTHER CANCERS Studies have examined other types of cancer including eye, urinary tract (related to the bladder and urethra), connective tissue (fibrous tissues like tendons, cartilage, and bone that provide structure and support throughout the body), and endocrine system (the parts of the body that make hormones). Studies show that women with silicone gel breast implants have no greater risk of these types of cancers compared to the general population.4,15,16,18,20,23,24,33 CONNECTIVE TISSUE DISEASE (CTD) AND DISORDERS OF THE IMMUNE SYSTEM The body’s immune system protects the body from infection. It is a complicated system and includes a variety of different organs and cell types such as white blood cells and antibodies. Disorders of the body’s immune system (also called autoimmune diseases) can cause CTDs when the patient’s immune system mistakenly attacks parts of its own body, including the connective tissues of the body, like fibrous tissues (tendons,) cartilage, and bones. Autoimmune diseases include lupus (inflammation and tissue damage in different body parts and organs), rheumatoid arthritis (inflamed and deteriorating joints), polymyositis (inflamed, weakened muscles), dermatomyositis (inflamed, weakened muscles and skin); and progressive systemic sclerosis or scleroderma (damaged skin or organs because of excess collagen, the main protein in connective tissue). Other CTDs include • Fibromyalgia (ongoing fatigue, widespread pain in muscles and joints, difficulty sleeping, and morning stiffness), and • Chronic fatigue syndrome (ongoing mental and physical exhaustion, often with muscle and/or joint pain). Some women with breast implants have experienced signs and symptoms that could be related to the immune system 33 34 but that do not fit into a definable disease, like those listed above. These signs and symptoms include: painful or swollen joints, tightness, tingling, numbness, reddened and swollen skin, swollen glands or lymph nodes, unusual or unexplained fatigue, swollen hands and feet, excessive hair loss, memory problems, headaches, and muscle weakness, pain, cramping and/or burning. The scientific evidence strongly supports the conclusion that there is no increased risk of CTDs or autoimmune disorders for women with silicone gel breast implants.2,3,7,33-46 Independent scientific panels and review groups have also concluded that the weight of the evidence shows no relationship between breast implants and CTDs, or at least if a risk cannot be absolutely excluded, it is too small to be measured.7,47,48 EFFECTS ON CHILDREN BORN TO MOTHERS WITH BREAST IMPLANTS It is not known if a small amount of silicone may move through the breast implant shell and pass into breast milk. There is no test for detecting silicone in breast milk that is considered accurate. There has been a study that measured silicon levels (one component of silicone). It did not indicate higher levels of silicon in breast milk from women with silicone gel breast implants when compared to women without implants.49 In addition, questions have been raised about whether silicone gel breast implants could harm babies whose mothers had implants while pregnant. Two studies in humans have found that the risk of birth defects overall is not increased in children born after breast implant surgery.50,51 A third study looked at low birth weight and did not find an elevated risk.52 Overall, there is no evidence that shows that silicone gel breast implants have any harmful effects on the children of implanted women.7,8,50-52 SUICIDE Some studies have reported a higher incidence of suicide in women with breast implants, but it is not clear whether these suicides were associated with having silicone gel breast implants or some other underlying condition that can lead to suicide, depression and/or anxiety.15,26,53-59 One researcher60 believes that some women who want cosmetic surgery suffer from a disorder, called body dysmorphic disorder (BDD), which may cause them to think about suicide or attempt suicide. The strongest predictor for suicide is having been hospitalized for any psychiatric condition. One study found that women with breast implants were admitted to the hospital more often because of psychiatric problems before they even had their implant surgery, compared to women who had breast reduction or to the general population.53 This may be a contributing factor to the reported higher incidence of suicide in women with breast implants. NEUROLOGICAL DISEASE, SIGNS, AND SYMPTOMS Some women with breast implants have complained of neurological symptoms such as difficulties with vision, sensation, muscle strength, walking, balance, thinking, or remembering things. Some have been diagnosed with diseases such as multiple sclerosis (which is an autoimmune disease that affects the nerves). Some of these women believe their symptoms are related to their implants. A scientific expert panel found that there is not enough reliable evidence that neurological problems may be caused by or associated with breast implants.7 Other researchers have found more evidence that silicone gel breast implants do NOT cause neurological diseases or symptoms.7,19,61 There is one published report of an increased risk of multiple sclerosis among women with silicone gel breast implants;37 these researchers did not find any increased risk of other neurological symptoms. POTENTIAL HEALTH CONSEqUENCES OF GEL BLEED Small quantities of low molecular weight (LMW) silicone compounds, as well as platinum (in zero oxidation state), have been found to diffuse (bleed) through an intact implant shell.7,62 The evidence is mixed as to whether there are any clinical consequences associated with gel bleed. For instance, studies on implants implanted for a long duration have suggested that such bleed may be a contributing factor in the development of capsular contracture7 and lymphadenopathy.5 However, evidence against gel bleed being a significant contributing factor to capsular contracture and other local complications is provided by the fact that there are similar or lower complication rates for silicone gel-filled breast 35 36 implants than for saline-filled breast implants. Saline-filled breast implants do not contain silicone gel and, therefore, gel bleed is not an issue for those products. Furthermore, toxicology testing has indicated that the silicone material used in Sientra’s implants does not cause toxic reactions when large amounts are administered to test animals. It should also be noted that studies reported in the literature have demonstrated that the low concentration of platinum contained in breast implants is in the zero oxidation (most biocompatible) state.63-66 Sientra performed a laboratory test to analyze the silicones and platinum (used in the manufacturing process), which may bleed out of intact implants into the body. Over 99% of the LMW silicones and platinum stayed in the implant. The overall body of available evidence supports that the extremely low level of gel bleed is of no clinical consequence. 5. Benefits Associated With Breast Implants Women choose primary breast augmentation surgery to increase the size and proportion of their breast(s). In addition, women choose revision-augmentation surgery (replacement of an existing breast implant) to correct or improve the result of a primary augmentation surgery. According to literature reports, most women who have undergone breast implant surgery have reported high levels of satisfaction with their body image and the shape, feel and size of their implants.67 In Sientra’s Clinical Study, most primary and revision-augmentation patients were pleased with the results of their implant surgery. The results showed that most women who underwent primary or revision- augmentation with the Study Implants felt their breast implants made them feel more feminine and more attractive. In addition, the majority of these women indicated that their breast implants made them feel better about themselves. For more information on the benefits of breast augmentation with Sientra’s Implants based on the results of the Clinical Study, refer to Section 8.3 of this brochure. 6. Preparing For Breast Augmentation With Silicone Gel Breast Implants Deciding to have breast augmentation with implants is an important personal decision that has both benefits and risks. You should decide whether it is the right choice for you after discussing all the options with your plastic surgeon and any other doctors who are treating you. This section will give you the information you need to make an informed choice and help you make a number of decisions that have to be made before your surgery. 6.1 Should I Have Breast Augmentation? Breast augmentation with Silicone Gel Breast Implants is one option that may be available to you if you wish to enhance the appearance of your breasts. A breast revision- augmentation surgery may be appropriate if you have had a breast augmentation with implants but need to complete, improve upon, or correct a part of that first surgery (called the primary augmentation). Whether breast augmentation is right for you depends on many things; some of them are personal. You should take into account your medical condition, general health, lifestyle, how you feel emotionally, and your breast size and shape before surgery, as well as your hopes for breast size and shape after surgery. All of these things will affect the outcome of your surgery. Discuss your goals for breast augmentation with your doctors. You may also wish to consult your family and friends and breast implant support groups, to help you learn about the options and decide. Many women who choose implants as part of their augmentation say their augmented breast(s) help them feel more self-confident, feel better about their bodies, and/or give them a greater feeling of well-being. Other women are not satisfied with their implants because of complications, like capsular contracture, rupture, or pain. 37 6.2 Breast Augmentation With Implants – Understanding The Procedure The surgical procedure for breast augmentation consists of choices you and your surgical team (surgeon(s), nurses, anesthetist, etc.) will make as you plan your surgery. These choices include: • The surgical setting (where the surgery will be performed, for example, in a hospital, surgery center, or doctor’s office), • The type of anesthesia used, • The location of the incisions made to insert the Implants, • How the Implants will be placed in your breasts (subglandular or submuscular), and • Whether your existing skin and/or breast tissue can cover implants. Each of these is discussed in the sections that follow. The type of procedure that is available to you depends on your medical situation, breast shape and size, general health, lifestyle, and goals for the augmentation. Breast augmentation with Silicone Gel Breast Implants can usually be completed in a single surgery. SURGICAL SETTING Breast augmentation surgery can be performed in a hospital, private surgery center, clinic, or in the surgeon’s office. Be sure you are comfortable with the location of the surgery before it happens. If you are considering having surgery in a private surgery center or office, you may want to see the area where the surgery will be performed. ANESTHESIA Breast implant surgery may be performed under general or local anesthesia. All anesthetics carry some risk. Discuss the risks and benefits of the anesthetic your surgeon and anesthetist recommend for you before the surgery. INCISION SITES Figure 2 shows the three incision sites (location of cut through which the breast implant is inserted in your body) usually used for breast augmentation surgery: • Inframammary – the most common incision, made under your breast at the crease where the breast meets the body, • Periareolar – an incision is made around the nipple, and • Transaxillary – the incision is made in the armpit, which gives the surgeon easier access to the chest muscle. 38 Figure 2. Incision sites for breast augmentation surgery Under arm (transaxillary incision) Around nipple (periareolar incision) In breast fold (inframammary incision) You may hear about a fourth incision site – the “periumbilical approach” (incision at your belly button). This way of placing breast implants has not been studied in the Clinical Study and should not be used. It may cause damage to the implant shell. Your surgeon can explain which incision site he or she recommends for you and talk about the pros and cons of each with you. 39 IMPLANT PLACEMENT As shown in Figure 3, breast implants are placed beneath your breast tissue, either on top of the chest muscle (subglandular placement) or underneath part or all of the chest muscle (submuscular placement). Figure 3. Breast implant placement 40 Breast before Breast after augmentation subglandular augmentation Breast after submuscular augmentation Table 3 compares positive and negative aspects (pros and cons) of each method. The “best” placement depends on you and the characteristics of your body, the types of implants you choose, and your surgeon. Talk with your surgeon about his or her reasons for choosing one placement over the other and the advantages and disadvantages of each. TABLE 3 Comparison of Submuscular and Subglandular Placement of Breast Implants Submuscular Placement Subglandular Placement • Surgery time may be longer • Recovery may be longer • May be more painful • Future re-operation may be more difficult • Implants may feel more like a natural part of the breast (be less “palpable”) • Capsular contracture may be less likely7 • It may be easier to image breast with mammography • If you have thin or weakened breast tissue, submuscular positioning may work better • Surgery time may be shorter • Recovery time may be shorter • May be less painful • Future reoperation may be easier • Implants may be more palpable (can feel the implant through breast tissue) • Capsular contracture may be more likely68,69 • It may be harder to image breast with mammography 41 6.3 Choosing The Right Implant For You Sientra Implants are available in several different shapes, profiles (the contour the implant provides to your body), and sizes to help each woman achieve the result that is best for her body. Table 4 lists the styles of Sientra Silicone Gel Breast Implants that are available. TABLE 4 Sientra Silicone Gel Breast Implant Designs Implant Shell Texture Implant Shape Implant Profile Volume Range Smooth Textured Textured Textured Round Moderate High 95 - 695 cc 80 - 700 cc Round Low Shaped Low Inferior Pole Shaped High Superior Pole 60 - 700 cc 95 - 695 cc 170 - 500 cc 120 - 700 cc Moderate/ High Moderate/ High 180 - 550 cc Moderate 115 - 690 cc 42 When you and your doctor decide what you want your breasts to look like after augmentation, your doctor can help you choose the right implant to get the effect you want. Your body type, height, and weight will be factors your surgeon considers to help you achieve the best result. IMPLANT SIzE, SHAPE AND SURFACE Your surgeon will examine your breast tissue and skin to figure out if you will have enough to cover the implant. It is possible that you will not have enough skin and/or breast tissue to cover the implant you desire. In this case, you may be offered several choices. Breast implants that are too big for the amount of breast tissue or skin can cause problems: they can actually speed up the effects of gravity; your breasts may droop or sag earlier with implants that are too large. Implants that are too large can also cause implant extrusion, skin wrinkling, infection, and hematoma. You may be able to feel folds on the implant created by it being squeezed too tightly by the surrounding tissue and skin. If you do not have enough skin, and it is stretched too thin over the implant, you may be able to feel or see the edges of the implant under your skin surface after surgery. As shown in Figure 4, the Implants come with either a smooth shell or a textured shell; you should speak with your surgeon to find out whether he or she recommends smooth or textured implants for you. 43 WP width projection Smooth Round Implant H WP Textured Shaped Implant width projection Figure 4. photographs of smooth and textured Sientra implant styles 44 6.4 Other Procedures At The Time Of The Breast Augmentation Your surgeon may recommend having other cosmetic procedures during the same surgery to get the best results from your breast implants. In some cases, breast implants alone may not give you the results you want. If, in the past, you have lost a lot of weight, been pregnant, or breast-fed, you may have sagging, stretched, or extra skin that is not completely filled out by breast tissue. In this case, your doctor may recommend doing a breast lift (mastopexy) to remove excess skin from the rest of the breast tissue in one or both breasts. During mastopexy, your surgeon will remove a piece of skin from your breast (usually from under the breast or around the nipple). Then he or she will use stitches to close the incision where the skin was removed. This lifts the whole breast or nipple location and tightens the skin over the breast. This might cause more scarring than just having implants placed and may lengthen your recovery time. Mastopexy (to one or both breasts) may be done at the same time as the primary augmentation or may be done at a later, follow-up procedure. It is not always best to do multiple procedures during one surgery. Your doctors can discuss the risks and benefits of this procedure with you. 6.5 Choosing A Surgeon The following are types of questions you should consider when choosing a surgeon: • In which states is he or she licensed to practice surgery? • Has he or she completed residency requirements in plastic surgery from a recognized and accredited academic program? • Is he or she board certified in the United States? If so, which board? • How many breast augmentation surgeries does he or she perform each year? • How many years has he or she been doing breast augmentation surgeries? 45 46 • What is the most common complication he or she encounters with breast augmentation patients? • What is his or her reoperation rate for augmentation patients? And what is the most common type of reoperation that he or she performs in his or her practice? • Will he or she perform all of my surgery in a hospital? (Many surgeons perform breast implant surgery or components of breast augmentation in their own out-patient surgery centers. Hospitals require surgeons to prove that they are properly trained before they can operate in the hospital.) 7. Caring For Yourself After Breast Implant Surgery How you feel after your surgery and the level of care you need in the first few days vary from patient to patient and depend on the extent of your surgery. Your wounds will take several weeks or more to heal completely. Talk with your surgeon after your surgery about how to care for yourself and how long your recovery should take. 7.1 Postoperative Care In The Hours And Days After Surgery The first few hours after your initial augmentation surgery will be spent recovering in the hospital. You may be there for several days or you may be able to go home sooner. During these first days after your surgery, you will need to follow some simple directions to take care of yourself. Your surgeon will give you specific directions about what to do. Follow your surgeon’s directions. If you have had general anesthesia, you will remain in the hospital or surgery center until the anesthesia wears off. You may have drains in your breasts so that fluid or blood will drain out of the wound at the incision site. You will probably leave your surgery wearing a bandage to protect the wounds and support your breasts. Your surgeon will tell you how long to keep your breasts bandaged. Eventually, you will be able to wear a bra for support instead of the bandages. Your doctor will give you instructions about bathing or washing the area during the first few days. He or she may tell you not to take baths for a certain period of time. Call your doctor immediately if you think you may have an infection. If your incision sites or breasts are red, swollen, hot, painful, or are weeping (draining white or yellow fluid) or if you have a fever, chills, aches, nausea, or vomiting, you may have an infection. If you do not have any complications, you will probably be able to go back to most of your usual daily activities in 1 to 2 weeks after surgery. 7.2 Postoperative Care In The First Weeks After Surgery In the weeks after your augmentation, the skin over your breasts may feel tight as it adjusts to your new breast size. After your stitches are removed, your doctor may tell you to massage your incision site(s) with a cream or lotion to keep the skin from drying out; this may make you more comfortable as well. Use the product(s) he or she recommends. Your doctor may have special directions about avoiding exercise or activities that compress or put pressure on your breasts during the first weeks after surgery. Follow your doctor’s directions. 7.3 Caring For Yourself In The Months And Years After Surgery There are some things you should do to make sure your breasts stay healthy and to take care of your implants: mammograms, breast exams, and protecting your implants from certain types of damage. It will be important to monitor your breasts for breast cancer. Also monitor regularly for breast implant rupture. MAMMOGRAMS A mammogram is a special way of x-raying the breast. Whether or not you have breast implants, having a mammogram is considered the best way to detect breast 47 48 cancer. However, there are some special considerations for women with breast implants: • Breast implants can make it harder to see breast cancer on a mammogram. • Breast implants can make it harder for the technologist to perform the mammogram. The machine that does a mammogram squeezes the breast to make it as flat as possible while taking a picture. The pressure from this squeezing could make your implant rupture or cause gel bleed. You must tell the technologist that you have silicone gel breast implants before the procedure. The technologist can then use special techniques to get the best possible views of your breast tissue. He or she can also take steps to reduce the likelihood that your implants will rupture due to the mammogram. It is a good idea to have a mammogram before your breast implant surgery. This establishes a baseline to which future mammograms can be compared. You are also encouraged to have another mammogram 6 months to 1 year after your implant surgery to establish a baseline with the implant present. After that, the recommendations for mammograms are the same as for women without implants; have a mammogram every 1 to 2 years, starting at age 40, or as advised by your doctor. When you go for a mammogram, do the following things to get the most reliable pictures of your breast(s): When you schedule a mammogram, tell the office that you have breast implants. Find a mammographer who is experienced with imaging implanted breasts. (Your doctor should be able to help you find a qualified mammographer.) You may want to request a “diagnostic” mammogram instead of a “screening” mammogram because more pictures are taken for a diagnostic mammogram. Using that language may help the mammogram site to schedule the right kind of procedure for you. Make sure your mammographer knows what type of implants you have and how they are placed (for example, on top of the chest muscle or underneath). Carry your Device Identification Card (that you will receive after surgery) with you and show it to the mammographer. OTHER BREAST ExAMS Perform self-breast exams regularly. Once a month, after your period ends, is a good time to examine your breasts. You can find brochures about how to perform breast self- exams through your doctor, a women’s health clinic, or online. Your doctor can show you how to do a self-breast exam. Ask your doctor to help you learn to tell the difference between your breast implant and breast tissue. This will help you do your self-breast exams without squeezing your implant too much. If you see or feel that something has changed, talk to your doctor promptly. It is important to have regular exams by a doctor as well. It may be hard for you to feel changes in your breast because the implant is there, especially if you have capsular contracture. The doctor will look at your breasts and palpate your breasts like in a self-exam to feel for any changes. If your doctor finds anything, he or she may refer you for a mammogram to help diagnose the change. Your doctor may also ask for an MRI if he/she suspects rupture. PROTECTING YOUR IMPLANTS To protect your implants, you should make sure that any healthcare practitioners (doctors, emergency medical technologists, nurses, massage therapists, acupuncturists, chiropractors, physical therapists, etc.) treating you know that you have Silicone Gel Breast Implants. If they do not know about your implants, they may damage them by accident and your implants could rupture. Carry your Device Identification Card with you and show it to healthcare practitioners before receiving treatment. You should also protect your implants by guarding against any strong or repeated pressure on your breasts. 49 50 THINGS TO CALL YOUR DOCTOR ABOUT RIGHT AWAY Call your doctor immediately if you have • Signs of an infection, • A lump, • Skin around the nipple that has become dimpled or drawn in, • Discharge from the nipple, • Change in the position or shape of your implant, or • Injury to your breast(s). If your implant becomes damaged, it may have to be removed. PHYSICAL LIMITATIONS After you have healed from surgery, you should be able to carry on normal activities including sports. Avoid situations that put a lot of pressure on your breasts or may cause trauma to your breast. Ask your doctor if there are any activities he or she does not recommend. 7.4 Monitoring Your Implants For Rupture Rupture is a rare occurrence with silicone gel breast implants. However, the following information will help you to monitor your implants for evidence of rupture. DETECTING RUPTURE A variety of factors can cause your breast implants to develop a tear or hole in the shell. These tears or holes are usually called ruptures because they can allow silicone gel from inside the implant to exit your implant. If your implant(s) ruptures, you may experience certain symptoms. Any of the following may indicate that your implant has ruptured: hard knots or lumps surrounding the implant or in the armpit, changes in breast size or shape, pain, tingling, swelling, numbness, burning, and/or hardening of the breast. If you feel any of these symptoms, contact your doctor for an exam. If your implant ruptures, it is more likely that you will not experience any symptoms and you will not even know your implant had ruptured. In these situations, even your doctor may not be able to determine that a rupture has occurred. This is referred to as a “silent” rupture. MRI examination (taking pictures of your implants similar with a device similar to an x-ray machine) is the best way to tell if a silent rupture has happened. For this reason it is strongly recommended that you have an MRI the third year after your surgery and then every 2 years after that for as long as you have your breast implants. WHAT TO DO IF YOU SUSPECT AN IMPLANT RUPTURE If you suspect that an implant has ruptured or if you suspect that silicone gel has moved out of your implants, call your doctor right away and schedule an exam. Your doctor may recommend an MRI or other kinds of tests to help diagnose possible rupture. MRI is currently considered the best way to diagnose rupture. WHAT TO DO IF THE IMPLANT RUPTURE IS CONFIRMED If your doctor confirms that you have a ruptured implant or that silicone gel has bled (moved) out of your implant shell, he or she will talk with you about your options. As a precaution, Sientra recommends that ruptured implants be taken out permanently and either replaced with a new implant or not replaced, depending on your preference or medical need. If your implant is taken out, your surgeon may also have to remove some of your breast tissue (the tissue capsule that forms around the breast implant), which will involve additional surgery, with associated risks and costs. In some cases, it may not be possible to replace your implants. 8. Sientra’s Clinical Study Results As part of the marketing approval requirements for the Silicone Gel Breast Implant, Sientra conducted the Clinical Study with patients who received the Implants for augmentation (primary and revision) and reconstruction (primary and revision). The Study collected data from the primary augmentation and revision-augmentation cohorts of the CORE study, as well as pooled date from Sientra’s CORE and Continued Access studies for the primary reconstruction 51 52 and revision-construction cohorts. The results of the Study will provide you with useful information on the experience of other women who have received these Silicone Gel Breast Implants. The results of the Study should not be used to predict your own experience with the Implant, but the information can be used as a general guide about what you may expect. Your own benefits and complications depend on many individual factors. 8.1 Overview Of The Study The Study is a prospective, 10-year, multicenter clinical study conducted to examine the safety and effectiveness of the Sientra Silicone Gel Breast Implants (now referred to as Sientra Implants or Implants) in patients undergoing primary augmentation, primary reconstruction, revision-augmentation, and revision-reconstruction of the breast. There are 1,788 patients participating in the Study. A total of 1,115 patients had primary augmentation and 362 patients had revision-augmentation. Of the 229 patients who had primary reconstruction, 156 patients were from the CORE study and 73 were from the Continued Access study. Of the 82 patients who had revision-reconstruction with Sientra Silicone Gel Breast Implants, 50 were from the CORE study and 32 were from the Continued Access study. Of these patients, 230 primary augmentation patients, 74 revision-augmentation patients, 34 primary reconstruction patients and 7 revision-reconstruction patients are assessed for implant rupture for MRI at years 3, 4, 6, 8, and 10 after receiving implants. Assessment of the safety of the Implants is based on the incidence of complications, including device failures. Effectiveness was assessed based on changes in bra size, chest circumference, and patient satisfaction in terms of quality of life, self esteem (how you feel about yourself overall), and body esteem (how you feel about your body). Several scales and questionnaires about these topics were used to collect information for analysis, including a patient- reported quality-of-life (QOL) outcomes questionnaire, the Short Form Health Survey (SF-36), the Rosenberg Self-Esteem Scale, and the Body Image Scale. The Study will continue to follow patients through 10 years after their breast implant surgery. Results provided here represent the first 3 years of data. This brochure will be updated as more information becomes available. You should also ask your surgeon if he or she has received any updated clinical information. The following sections provide more information about the complications and benefits you may experience following augmentation with Sientra Silicone Gel Breast Implants, based on the experiences of the augmentation patients in the Study. 8.2 What Are The 3-Year Follow-Up Rates? The Study enrolled 1,115 augmentation patients. Of the women expected to be seen at the 3-year follow-up visit, 80% were seen. The Study enrolled 362 revision-augmentation patients. Of the women expected to be seen at the 3-year follow-up visits, 79% were seen. 8.3 What Are The Benefits? The benefits of the Implants were examined by measuring the change in bra size (in terms of cup size and chest circumference) and assessing patient satisfaction and quality- of-life (QOL). Patient satisfaction and QOL were determined using several questionnaires that the patients responded to, including a health survey, a numeric scale that assessed body esteem, and a numeric scale that assessed body image. The information was collected before implantation and at scheduled follow-up visits (1 year and 2 years after their surgery). PRIMARY AUGMENTATION PATIENTS Most primary augmentation patients were pleased with the results of their implant surgery. Many (91%) had increased their bra size by at least one cup size. Over 81% of patients increased by one to two cup sizes. Some increased their bra size more than two cup sizes (10%) and some increased their bra size less than one cup size (6%). Patients reported satisfaction in terms of their quality of life, self esteem (how they feel 53 54 about themselves), body esteem (how they feel about their bodies), and sexual attractiveness. According to their scores on a questionnaire about a variety of general QOL concepts (health, mental, and social well-being), these women felt better about themselves than a sample of average women in the United States. However, compared to their QOL before getting implants, most women experienced unchanged or even slightly decreased QOL on most measures. Other findings of the Study showed that over 90% of women felt their breast implants made them feel more feminine (94%) and more attractive (92%). In addition, the majority of women indicated that their breast implants made them feel better about themselves (85%). REVISION-AUGMENTATION PATIENTS Most revision- augmentation patients were pleased with the results of their additional implant surgery. Bra size changes were not analyzed for revision-augmentation patients. According to their scores on a questionnaire about a variety of general QOL concepts (health, mental and social well-being) these women felt better about themselves than a sample of average women in the United States. However, compared to their QOL before getting implants, most women experienced unchanged or even slightly decreased QOL on most measures. Another finding of the Study showed that most women agreed that their breast implants make them feel more feminine (90%) and more attractive (89%). In addition, the majority of women indicated that their breast implants made them feel better about themselves (82%). 8.4 What Were The 3-Year Complication Rates? The safety of Sientra Silicone Gel Breast Implants was determined by assessing the incidence of complications, including device failures. PRIMARY AUGMENTATION The complications observed in women who had primary augmentation through 3 years are presented in Table 5. The most common reported complication within the first 3 years after augmentation surgery was reoperation (13% or approximately 13 out of 100). TABLE 5 Complication Rates Reported through 3 Years for Primary Augmentation Patients (N=1,115 Patients) Key Complications % Reoperation 12.6% Capsular Contracture (Baker Grade III/IV) 6.0% Implant Removal with Replacement 4.6% Implant Rupture (MRI cohort)1 2.5% Implant Removal without Replacement 1.2% Nipple Sensation Changes 3.2% Ptosis 1.8% Implant Malposition 1.2% Asymmetry 1.1% 1 No ruptures were reported in the non-MRI cohort. 2 The following complications were reported at a risk rate of less than 1%: breast mass/cyst/lump, breast pain, bruising, delayed wound healing, hematoma, hypertrophic/abnormal scarring, implant extrusion, implant visibility, infection, redness, seroma/fluid accumulation, skin sensation changes, swelling, upper pole fullness, wrinkling/rippling, and other complications. REVISION-AUGMENTATION The complications observed in women who had revision-augmentation through 3 years are presented in Table 6. The most common reported complication within the first 3 years after revision- augmentation surgery was reoperation (20% or approximately 20 out of 100). Other Complications Occurring in 1% or more of Patients2 % 55 TABLE 6 Complication Rates Reported through 3 Years for Revision-Augmentation Patients (N=362 Patients) Key Complications % Reoperation 20.3% Implant Removal with Replacement 8.7% Capsular Contracture (Baker Grade III/IV) 5.2% Implant Removal without Replacement 2.9% Implant Rupture (MRI cohort)1 – Implant Malposition 3.2% Wrinkling/Rippling 2.4% Asymmetry 1.8% Nipple Sensation Changes 1.4% Infection 1.2% Seroma/Fluid Accumulation 1.2% 1 No ruptures were reported in the MRI cohort. However, implant rupture was reported at a risk rate of 0.4% in the non-MRI cohort. 2 The following complications were reported at a risk rate of less than 1%: breast pain, bruising, delayed wound healing, hematoma, hypertrophic/ abnormal scarring, implant extrusion, implant palpability, implant visibility, irritation, necrosis, ptosis, redness, skin sensation changes, swelling, and other complications. 8.5 What Are The Main Reasons For Reoperation? Patients may require a reoperation for a number of reasons, including size and/or style change, implant removal (with or without replacement), capsular contracture procedures, incision and drainage, implant repositioning, scar revision, etc. In addition, patients may require more than one surgical procedure. Other Complications Occurring in 1% or more of Patients2 % 56 PRIMARY AUGMENTATION In the Study, 11% of the patients had at least one reoperation through 3 years (a total of 149 reoperations performed in 127 patients). Table 7 provides the main reasons for reoperation. The two most common reasons for reoperation through 3 years in these patients were capsular contracture and the patient requesting a change in the size or style of the implant. TABLE 7 Main Reasons for Reoperation through 3 Years for Primary Augmentation Patients (N=149 Reoperations) Reasons for Reoperation through 3 Years1 % Capsular contracture 22.1% Patient request for size/style change 19.5% Ptosis 12.1% Hematoma/seroma 11.4% Implant malposition 11.4% Scarring/hypertrophic scarring 5.4% Infection 4.0% Asymmetry 3.4% Wrinkling/rippling 2.7% Delayed wound healing 2.0% Mass/lump/cyst 1.3% Nipple-related complications 1.3% Unknown 1.3% Breast cancer 0.7% Upper pole fullness 0.7% Pain 0.7% 1 Some reoperations were performed for multiple reasons; only the primary reason is provided in the table. 57 REVISION-AUGMENTATION In the Study, 19% of the patients had at least one reoperation through 3 years (a total of 84 reoperations performed in 67 revision-augmentation patients). Table 8 provides the main reasons for reoperation. The two most common reasons for reoperation through 3 years were the patients desiring a change in the size or style of their implants and capsular contracture. TABLE 8 Main Reasons for Reoperation through 3 Years for Revision-Augmentation Patients (N=84 Reoperations) Reasons for Reoperation through 3 Years1 % Patient request for size/style change 15.5% Capsular contracture 15.5% Implant malposition 13.1% Wrinkling/rippling 9.5% Unknown 8.3% Asymmetry 6.0% Delayed wound healing 6.0% Ptosis 6.0% Hematoma/seroma 4.8% Infection 3.6% Scarring/hypertrophic scarring 3.6% Pain 2.4% Breast cancer 1.2% Implant extrusion 1.2% Implant palpability/visibility 1.2% Nipple-related complications 1.2% Other2 1.2% 1 Some reoperations were performed for multiple reasons; only the primary reason is provided in the table. 2 Patient reported back pain from the weight of the Implants. 58 8.6 What Are The Main Reasons For Implant Removal? Breast implants may be removed (with or without replacement) in response to a complication or to improve the cosmetic result. PRIMARY AUGMENTATION In the Study, 5% of the patients had at least one removal (a total of 103 implants removed from these 58 patients). Of these 103 implants, 82% were replaced. As Figure 5 shows, the most common reason for implant removal was the patient requesting a different implant size or style. Figure 5. main reasons for Implant removal through 3 Years primary Augmentation (n=103 implants) Patient Request for Size/Style Change Capsular Contracture Infection Implant Malposition Asymmetry Wrinkling/Rippling Unknown Ptosis Hematoma/Seroma Delayed Wound Healing Breast Cancer 58 14 7 6 5 4 3 2 2 1 1 59 REVISION-AUGMENTATION In the Study, 10% of patients had at least one removal (a total of 68 implants removed from these 37 patients). Of these 68 implants, 78% were replaced. Figure 6 shows that the most common reason for implant removal was the patient requesting a different implant size or style. Figure 6. main reasons for Implant removal through 3 Years revision-Augmentation (n=68 implants) Patient Request for Size/Style Change Unknown Wrinkling/Rippling Asymmetry Other Infection Implant Malposition Capsular Contracture Hematoma/Seroma Pain Breast Cancer 27 13 8 4 3 3 3 3 60 8.7 What Are Other Clinical Data Findings? The Study evaluated several possible long-term health effects that have been reported in breast implant patients. These include rupture, cancer, CTD, CTD signs and symptoms, complications with lactation, reproductive complications, and suicide. RUPTURE In the Study, there are 230 primary augmentation patients enrolled in an MRI cohort study who have routine MRI screening of their implants to track rupture; Through 3 years, 97% of these patients (99% of implants) had no evidence of rupture. Through Year 3, there have been two confirmed implant ruptures occurring in one patient and five unconfirmed implant ruptures occurring in five patients. 2 1 1 Overall, the 3-year risk of rupture was 3% per patient. This means that after receiving Silicone Gel Breast Implants, 3 out of 100 women may experience a rupture during the first 3 years. There are 74 revision-augmentation patients enrolled in the MRI cohort who have routine MRI screening of their implants to track rupture. Through 3 years, all of these patients (100%) had no evidence of rupture. However, of the revision- augmentation patients in the Study who were not evaluated by MRI, there was one confirmed (silent) implant rupture occurring in one patient. Overall, the 3-year risk of rupture was 0.4% per patient. This means that 3 years after receiving Implants, 1 out of 250 women may experience a rupture. CANCER Two primary augmentation patients reported breast cancer during the 3 year period following implantation (risk rate 0.2%). Other types of cancers (including basal cell skin cancer and uterine cancer) occurred in 6 (less than 1%) primary augmentation patients. One revision-augmentation patient (0.3%) reported breast cancer and one patient (0.3%) reported lung cancer through 3 years in the Study. No other cases of cancer were reported in revision-augmentation patients. There were no cases of fibrocystic breast disease reported through 3 years in either primary or revision- augmentation patients. There were no reports of ALCL in any patient cohort in the Sientra Study. CONNECTIVE TISSUE DISEASE (CTD) Of the 1,115 primary augmentation patients in the Study, two primary augmentation patients were diagnosed with a CTD in the 3 years after receiving implants; the diagnoses were one case of fibromyalgia and one case of rheumatoid arthritis. Based on these, the 3-year risk rate of fibromyalgia and rheumatoid arthritis are each 0.1% (or 1 in 1,000 patients). Of the 362 revision-augmentation patients in the Study, one revision-augmentation patient was diagnosed with a CTD through 3 years; she was diagnosed with fibromyalgia. Based on this, 0.3% (or 3 in 1,000 patients) of revision-augmentation patients may be diagnosed with fibromyalgia within 3 years of revision-augmentation with Implants. 61 62 CTD SIGNS AND SYMPTOMS The Study collected information on CTD signs and symptoms (that did not result in a diagnosis of a CTD) in augmentation and revision augmentation patients every other year during follow up. Thirteen categories of CTD signs and symptoms were examined in the Study, including symptoms related to skin, muscles, joints, brain and/or nerves, pain, fatigue, fibromyalgia, eyes, ears, nose, and throat (EENT), blood or lymph, constitution (unexplained weight loss or fever, depression, or lupus [a disease in which there is inflammation and tissue damage in different parts of the body]); endocrine/exocrine system; and blood vessels. In Sientra’s Study, self-reported CTD signs and symptoms were collected. Compared to before having implants, significant increases were found in only 2 of the 13 CTD sign/ symptom categories in the pooled primary augmentation and revision-augmentation cohorts: Pain and Fibromyalgia, for which the statistical significance is driven by the occurrence of low back pain. These increases were not found to be related to simply getting older. On the other hand, a significant decrease compared to before having implants was found for 2 of the 13 sign/symptom categories: Endocrine/Exocrine and Constitutional. For the category of Endocrine/Exocrine the significance is driven by the low number of post-implantation reports of Hashimoto’s Thyroiditis, while for the category of Constitutional the significance is driven by a decrease in Depression post- implantation. The Sientra Study was not designed to evaluate the cause and effect associations because there is no comparison group of women without implants, and because other contributing factors, such as medications and lifestyle/exercise, were not studied. Therefore it cannot be determined whether or not these 2 increases (and 2 decreases) were due to the implants. However, you should be aware that you may experience an increase in low back pain after receiving breast implants. LACTATION COMPLICATIONS Lactation complications including difficulties with breast-feeding, breast infection (mastitis), and pain were examined in the Study. There were 150 primary augmentation patients who delivered a baby after receiving their Sientra Implants. Of these patients, 89% reported no difficulties with breast-feeding. Eight percent (8%) reported difficulties related to breast- feeding only after receiving implants, including difficulty producing milk, breast infection, and/or breast pain. There were 39 revision-augmentation patients who delivered a baby after receiving their Sientra Implants; 92% of these women reported no problems with breast-feeding. A total of 5% reported a lactation problem only after implantation, such as lack of milk production, breast infection, or pain, through 3 years. REPRODUCTION COMPLICATIONS Reproduction complications that were examined in the Study include miscarriage, preterm labor (going into labor before a complete pregnancy), and having a stillborn baby. Of the 1,115 patients in the primary augmentation cohort, 15 (1%) reported postoperative pregnancy difficulties through 3 years. Of the 362 patients in the revision-augmentation cohort, four (1%) reported postoperative pregnancy difficulties. SUICIDE There were no reports of suicide in primary augmentation or revision-augmentation patients in the Study through 3 years. 9. What To Do If You Have A Problem If you have a problem with your breast implant(s), tell your doctor about it immediately. Your doctor may need to examine you. (Write your doctor’s contact information here) 63 64 In addition to informing your doctor, you can report a problem to Sientra and/or to the U.S. Food and Drug Administration (FDA). Your doctor or other healthcare provider may do this or you may report it yourself. You can report any serious problem directly to the FDA through its voluntary reporting program called MedWatch. (See http://www.fda.gov/medwatch). There is a special form you must use for voluntary reporting (FDA Form 3500). You can obtain it several ways: • Complete Form 3500 and submit it online at https://www.accessdata.fda.gov/scripts/medwatch/ medwatch-online.htm, • Download Form 3500 from the website (https://www. accessdata.fda.gov/scripts/medwatch/medwatch-online. htm) and print it out, fill it in, and send it to FDA, or • Call FDA to get a reporting package at 1-800-FDA-1088 (1-800-332-1088). If you need to complete a Form 3500, FDA recommends that you take Form 3500 to your doctor, who can help you to complete it. 10. Where To Find More Information Sientra has more information about its Silicone Gel Breast Implants that is available to you. You may request a copy of the package insert given to surgeons that describes how to use the Implant. It also discusses safety information and research performed on implants in general and on Sientra Silicone Gel Breast Implants in particular. Note that this document is intended only for surgeons, so it has a large amount of undefined medical and technical language. You can find more detailed information on the studies (in animals and humans or other laboratory testing) done on these Implants in Sientra’s Summary of Safety and Effectiveness Document (SSED) on the FDA’s website at: http://www.fda.gov/breastimplants. You can find these resources on Sientra’s website at www. sientra.com or through Sientra Customer Service (888) 708-0808. There are several other sources of information about breast implants and breast implant surgery. The U.S. Food and Drug Administration (FDA) has published a breast implant complications booklet titled “Breast Implants: Local Complications and Adverse Outcomes.” It contains descriptions of the risks of having breast implants (similar to this brochure) and links to more information. The booklet is available through the FDA website at: http://www.fda.gov/ breastimplants. Professional organizations for surgeons offer helpful information on their websites about making decisions about plastic/cosmetic surgery and about choosing a surgeon. You can find this information at the following websites: The American Society for Aesthetic Plastic Surgery - http://www.surgery.org American Society of Plastic Surgeons - http://www. plasticsurgery.org In 2000, the Institute of Medicine (IOM) published a comprehensive review of studies that have looked at the safety of silicone gel breast implants. The report is available on the website http://www.iom.edu/Reports/1999/Safety-of- Silicone-Breast-Implants.aspx. Patient groups offer support and information to women who have had problems with their breast implants. Several such websites are listed at: http://www.fda.gov/breastimplants. 11. Sientra’s Implant Tracking Program Each breast implant has a unique serial number that allows Sientra to identify the Implant(s) and locate important information about how and when they were manufactured. Sientra has developed an Implant tracking program to help facilitate contacting you with updated information if needed. 65 66 11.1 Breast Implant Tracking At the time of your implant surgery, you will be asked to participate in Sientra’s Implant tracking program. This will help to ensure that Sientra has a record of your contact information so that Sientra can contact you in the event there is updated information on your breast implant(s) that you need to know about. Federal regulations require Sientra to track its Silicone Gel Breast Implants. Your surgeon will report the serial number(s) of your breast implants to Sientra, along with the date of your surgery, your personal contact information, and contact information about his or her practice. Sientra maintains this information in a confidential manner. Participation in Sientra’s Device Tracking program is mandatory in order to activate the product warranty. Your doctor or his or her staff will fill out the Device Tracking and Limited Warranty Enrollment Form for you and return it to Sientra. A sample copy of the form is attached to this brochure. Sientra’s warranty program is discussed in Section 13. 11.2 Device Identification Card After your surgery, your surgeon will provide you a card that contains important information about your breast implants. This card will have the style, size, and serial number of your implants, along with other information. Carry the card with you and show it to doctors or other healthcare providers when you visit them. It will help them treat you appropriately and protect your implants during any medical treatment you need in the future. If you have your implants replaced, you will get a new Device Identification Card for those implants. Your doctor should keep a copy of the Device Identification Card with your medical records. Please inform Sientra whenever your contact information, e.g., mailing address, email, etc., changes so that we may keep you up to date with important information about your breast implant(s). 12. Important Contact Information Your Silicone Gel Breast Implants are manufactured for and sold by: Sientra, Inc. PO Box 1490, Santa Barbara, CA 93116-1490 U.S. Toll-Free Phone: (888) 708-0808 Phone: (805) 562-3500 Fax: (805) 562-8401 www.sientra.com My surgeon’s name and contact information: 67 68 13. Warranty Information Sientra’s Limited Warranty provides limited replacement and limited financial reimbursement in the event of shell leakage or breakage resulting in implant rupture. Sientra’s standard Limited Warranty program applies to every Silicone Gel Breast Implant recipient who agrees to participate in the Device Tracking program. For more information, please contact Sientra’s Customer Service at (888) 708-0808. 14. Acknowledgement Of Informed Decision I understand that this patient brochure provided by Sientra is intended to provide information regarding the benefits and risks of silicone gel breast implants. I understand that some of this information is about breast implants in general and some is specific to Sientra’s Implants. I understand that choosing to have augmentation breast surgery with implants involves both benefits and risks. I also understand that scientists and doctors have not been able to identify or quantify all of the risks of breast augmentation with implants and that, over time, additional information may become available. I have had adequate time to review and understand the information in this brochure and my questions and concerns have been addressed by my doctor. I have considered alternatives to augmentation surgery, including the use of external prostheses or surgery with saline-filled breast implants, and I am choosing to proceed with silicone gel-filled breast implant surgery. By circling my response for each statement below and signing below, I acknowledge that: Y N Y N Y N Y N Y N Y N I have had adequate time to read and fully understand the information in this brochure, I have had an opportunity to discuss this Information with my surgeon and to ask any questions I may have, I have carefully considered options other than augmentation surgery with breast implants and have decided to proceed with silicone breast implant surgery, I have been advised to wait an adequate amount of time after reviewing and considering this information before scheduling my silicone breast implant surgery, I understand that, in order to activate Sientra’s Limited Warranty, I must participate in Sientra’s Device Tracking program, and I will retain this brochure, and I am aware that I may also ask my surgeon for a copy of this signed acknowledgement. Patient Name (Printed) Patient Signature* Date * A patient must be at least 22 years old for primary and revision breast augmentation with silicone breast implants. By my signature below, I acknowledge that: _ _ • My patient has been given an opportunity to ask any and all questions related to this brochure, or any other issues of concern; • All questions outlined above have been answered “Yes” by my patient; • My patient has had an adequate amount of time before making her final decision, unless an earlier surgery was deemed medically necessary, and • This acknowledgment of informed Decision will be retained in my patient’s permanent record. Implanting Surgeon Name (Printed) Implanting Surgeon Signature Date _ _ 69 70 15. Device Tracking And Limited Warranty Enrollment Form ENROLLMENT FORM SIENTRA SILICONE GEL BREAST IMPLANT DEVICE TRACKING AND LIMITED WARRANTY PLEASE SEND FORM VIA EMAIL: ENROLLMENT@SIENTRA.COM or FAX: 888.906.0101 IMPORTANT *Please Note: Patients must participate in Sientra’s Device Tracking Program in order to activate the Sientra Product Warranty. Please complete section 2 of this form, all fields not marked optional must be completed for warranty activation. 1. DEVICE AND SURGERY INFORMATION PATIENT’S LEFT SIDE Place LEFT Patient Record label here or write in below: PATIENT’S RIGHT SIDE Place RIGHT Patient Record label here or write in below: REF # SIZE / VOLUME REF # SIZE / VOLUME SN SN PRODUCT NAME PRODUCT NAME REASON FOR SURGERY AUGMENTATION RECONSTRUCTION REPLACEMENT REASON FOR SURGERY AUGMENTATION RECONSTRUCTION REPLACEMENT DATE OF IMPLANTATION (mm/dd/yyyy) DATE OF IMPLANTATION (mm/dd/yyyy) 2. PATIENT INFORMATION* Patient Refused to Release Patient Indentifying Information (Non-Patient specific information must still be collected. All fields not marked optional must be complete.) LAST NAME FIRST NAME M.I. TELEPHONE CELL PHONE (OPTIONAL) FAX (OPTIONAL) EMAIL (OPTIONAL) ADDRESS DATE OF BIRTH (mm/dd/yyyy) CITY STATE ZIP CODE COUNTRY 3. IMPLANTING / EXPLANTING PHYSICIAN INFORMATION LAST NAME FIRST NAME TELEPHONE FAX EMAIL ADDRESS CITY STATE ZIP CODE 4. FOLLOW-UP PHYSICIAN INFORMATION If different than above (e.g. primary care provider) N/A LAST NAME FIRST NAME TELEPHONE FAX EMAIL ADDRESS CITY STATE ZIP CODE FORM COMPLETED BY: ________________________________________________________ (SIGNATURE): ________________________________________________________ (DATE): _________________ (TELEPHONE): _______________________________ (FAX): _______________________________ (EMAIL): __________________________________ MDC-0005 R1 71 16. Device Identification Card SIENTRA DEVICE IDENTIFICATION AND LIMITED WARRANTY CARD KEEP FOR YOUR RECORDS PATIENT WARRANTY ENROLLMENT ACTIVATED PATIENT NAME DATE OF SURGERY PHYSICIAN NAME LEFT SIDE REFERENCE NUMBER SERIAL NUMBER IMPLANT SIZE REF SN Smooth Round Textured Round Textured Shaped RIGHT SIDE Augmentation Reconstruction Implant Replacement REF SN REFERENCE NUMBER SERIAL NUMBER IMPLANT SIZE Smooth Round Textured Round Textured Shaped Augmentation Reconstruction Implant Replacement MDC-0007 R1 DEVICE IDENTIFICATION AND LIMITED WARRANTY CARD Plastic Surgeon and Staff: The enclosed card should be provided to the patient to retain for her records. Please follow the instructions below. Remove the attached Device Identification Card and place the patient record labels (supplied with packaging) from each device used on the Device ID Card. If the Patient Record Label is not available, please use a ball point pen to record the serial number and reference number from the package label. Please complete the remaining fields prior to giving to the patient. Completion and submission of the Device Tracking Form (supplied with packaging) is required to activate the patient’s Product Warranty. Please check the box on the front of the card for the patient’s records of warranty enrollment. MDC-0006 R1 72 TOLL FREE: 888.708.0808 info@sientra.com sientra.com DEVICE ID CARD 17. References 1 Gaubitz, M., Jackisch, C., Domschke, W., Heindel, W. & Pfleiderer, B. Silicone breast implants: correlation between implant ruptures, magnetic resonance spectroscopically estimated silicone presence in the liver, antibody status and clinical symptoms. Rheumatology (Oxford) 41, 129-135; discussion 123-124 (2002). 2 Brown, S. L., Duggirala, H. J. & Pennello, G. An association of silicone-gel breast implant rupture and fibromyalgia. Curr Rheumatol Rep 4, 293-298 (2002). 3 Brown, S. L., Pennello, G., Berg, W. A., Soo, M. S. & Middleton, M. S. 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Characteristics of women with cosmetic breast implants compared with women with other types of cosmetic surgery and population-based controls in Denmark. Ann Plast Surg 50, 6-12, (2003). 33 Breiting, V. B. et al. Long-term health status of Danish women with silicone breast implants. Plast Reconstr Surg 114, 217-226; discussion 227-228 (2004). 34 Blackburn, W. D., Jr. & Everson, M. P. Silicone-associated rheumatic disease: an unsupported myth. Plast Reconstr Surg 99, 1362-1367 (1997). 35 Brinton, L. A. et al. Risk of connective tissue disorders among breast implant patients. Am J Epidemiol 160, 619- 627 (2004). 36 Fryzek, J. P. et al. A nationwide study of connective tissue disease and other rheumatic conditions among Danish women with long-term cosmetic breast implantation. Ann Epidemiol 17, 374-379 (2007). 37 Greenland, S. & Finkle, W. D. A retrospective cohort study of implanted medical devices and selected chronic diseases in Medicare claims data. Ann Epidemiol 10, 205- 213 (2000). 38 Hochberg, M. C. & Perlmutter, D. L. The association of augmentation mammoplasty with connective tissue disease, including systematic sclerosis (scleroderma): a meta-analysis. Curr Top Microbiol Immunol 210, 411-417 (1996). 75 76 39 Janowsky, E. C., Kupper, L. L. & Hulka, B. S. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med 342, 781- 790 (2000). 40 Kjoller, K. et al. Connective tissue disease and other rheumatic conditions following cosmetic breast implantation in Denmark. Arch Intern Med 161, 973-979 (2001). 41 Lamm, S. H. Silicone breast implants, breast cancer and specific connective tissue diseases: A systematic review of the data in the epidemiological literature Int. J. Toxicol. 17, 497-527 (1998). 42 Lewin, S. L. & Miller, T. A. A review of epidemiologic studies analyzing the relationship between breast implants and connective tissue diseases. Plast Reconstr Surg 100, 1309-1313 (1997). 43 Silverman, B. G. et al. Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med 124, 744-756 (1996). 44 Vermeulen, R. C. & Scholte, H. R. Rupture of silicone gel breast implants and symptoms of pain and fatigue. J Rheumatol 30, 2263-2267 (2003). 45 Wolfe, F. & Anderson, J. Silicone filled breast implants and the risk of fibromyalgia and rheumatoid arthritis. J Rheumatol 26, 2025-2028 (1999). 46 Wong, O. A critical assessment of the relationship between silicone breast implants and connective tissue diseases. Regul Toxicol Pharmacol 23, 74-85 (1996). 47 Independent Review Group (IRG). Silicone Gel Breast Implants: Report of the IRG (United Kingdom) (1998). 48 Tugwell, P. et al. Do silicone breast implants cause rheumatologic disorders? A systematic review for a court- appointed national science panel. Arthritis Rheum 44, 2477-2484 (2001). 49 Lugowski, S. J. et al. Analysis of silicon in human tissues with special reference to silicone breast implants. J Trace Elem Med Biol 14, 31-42 (2000). 50 Kjoller, K. et al. Health outcomes in offspring of Danish mothers with cosmetic breast implants. Ann Plast Surg 48, 238-245 (2002). 51 Signorello, L. B., Fryzek, J. P., Blot, W. J., McLaughlin, J. K. & Nyren, O. Offspring health risk after cosmetic breast implantation in Sweden. Ann Plast Surg 46, 279-286 (2001). 52 Hemminki, E., Hovi, S. L., Sevon, T. & Asko-Seljavaara, S. Births and perinatal health of infants among women who have had silicone breast implantation in Finland, 1967- 2000. Acta Obstet Gynecol Scand 83, 1135-1140 (2004). 53 Jacobsen, P. H. et al. Mortality and suicide among Danish women with cosmetic breast implants. Arch Intern Med 164, 2450-2455 (2004). 54 Koot, V. C., Peeters, P. H., Granath, F., Grobbee, D. E. & Nyren, O. Total and cause specific mortality among Swedish women with cosmetic breast implants: prospective study. BMJ 326, 527-528 (2003). 55 Le, G. M. et al. Breast implants following mastectomy in women with early-stage breast cancer: prevalence and impact on survival. Breast Cancer Res 7, R184-193 (2005). 56 Lipworth, L. et al. Excess mortality from suicide and other external causes of death among women with cosmetic breast implants. Ann Plast Surg 59, 119-123; discussion 124-125 (2007). 57 McLaughlin, J. K., Lipworth, L. & Tarone, R. E. Suicide among women with cosmetic breast implants: a review of the epidemiologic evidence. J Long Term Eff Med Implants 13, 445-450 (2003). 58 Pukkala, E. et al. Causes of death among Finnish women with cosmetic breast implants, 1971-2001. Ann Plast Surg 51, 339-342; discussion 343-344 (2003). 59 Villeneuve, P. J. et al. Mortality among Canadian women with cosmetic breast implants. Am J Epidemiol 164, 334- 341 (2006). 60 Klesmer, J. Mortality in Swedish women with cosmetic breast implants: body dysmorphic disorder should be considered. BMJ 326, 1266-1267 (2003). 61 Winther, J. F. et al. Neurological disease among women with silicone breast implants in Denmark. Acta Neurol Scand 103, 93-96 (2001). 62 Flassbeck, D. et al. Determination of siloxanes, silicon, and platinum in tissues of women with silicone gel-filled implants. Anal Bioanal Chem 375, 356-362 (2003). 63 Chandra, G., Lo, P. Y., Hitchcock, P. & Lappert, M. F. A convenient and novel route to bis(alkyne)platinum(0) and other platinum(0) complexes from Speier’s hydrosilylation catalyst. Organometallics, 191-192 (1987). 64 Lappert, M. F. & Scott, F. P. A. The reaction pathway from Speier’s to Karstedt’s hydrosilylation catalyst. J. Organomet. Chem. 492, C11-C13 (1995). 77 78 65 Lewis, L. N. et al. Mechanism of Formation of Platinum(0) Complexes Containing Silicon-Vinyl Ligands. Organometallics 14, 2202-2213 (1995). 66 Stein, J. In situ determination of the active catalyst in hydrosilylation reactions using highly reactive Pt(0) catalyst precursors. J. Am. Chem. Soc. 121, 3693-3703 (1999). 67 FDA. FDA Update on the Safety of Silicone Gel-Filled Breast Implants. (June 2011). 68 Henriksen, T. F. et al. Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors. Ann Plast Surg 54, 343-351 (2005). 69 Kulmala, I. et al. Local complications after cosmetic breast implant surgery in Finland. Ann Plast Surg 53, 413-419 (2004). 18. Index Alternatives to Breast Implantation Anaplastic Large Cell Lymphoma (ALCL) Anesthesia Asymmetry Autoimmune Disease Benefits Biopsy Body Dysmorphic Disorder (BDD) Breast Augmentation Breast-Feeding/Lactation Breast Implant Breast Implant Designs Breast Mass Breast Reconstruction Breast Self-Exams Breast Tissue Atrophy Calcium Deposits/Calcification Cancer Capsular Contracture Capsule Capsulotomy Chest Wall Deformity Complications Congenital Anomaly Connective Tissue Disease (CTD) Contraindications CTD Signs and Symptoms Delayed Wound Healing Device Identification Card Device Tracking Effects on Children Fibrocystic Breast Disease Fibromyalgia Fibrous Tissue Food and Drug Administration (FDA) Gel Bleed/Gel Diffusion Gel Migration Granuloma Hematoma Implant Displacement Implant Extrusion Implant Malposition Implant Palpability Implant Removal Implant Rupture Indications Infection Inflammation Inframammary Incision Low Molecular Weight (LMW) Silicone Lymphadenopathy Magnetic Resonance Imaging (MRI) Mammography Mastopexy MedWatch Necrosis Neurological Disease Pain Periareolar Incision Periumbilical Approach Plastic Surgery Platinum Postoperative Care Precautions Ptosis Reoperation Reproduction Complications Revision-Augmentation Risks Saline Scar Revision Scarring Seroma Sientra Clinical Study Silent Rupture Silicone Subglandular Placement Submuscular Placement Suicide Summary of Safety and Effectiveness Document (SSED) Surgical Incision Symptomatic Rupture Systemic Disease Toxic Shock Syndrome (TSS) Transaxillary Incision Warnings Wrinkling Breast Augmentation Dubai
A American Board of Medical Specialties (ABMS): an organization that certifies physicians as specialists. This group comprises 24 member boards, including the American Board of Plastic Surgery. Rigorous membership standards include educational requirements, professional peer evaluation and exams. American Board of Plastic Surgery (ABPS): the medical specialty board that certifies plastic surgeons. analgesic: a pain reliever. anatomical implant: a contoured or teardrop-shaped implant. anesthesia: a numbing agent. areola: the disc of pigmented skin around the nipple; plural: areolae or areolas. arnica montana: an herb used to treat swelling and bruising. American Society of Plastic Surgeons (ASPS): the professional organization of board-certified plastic surgeons. American Society for Aesthetic Plastic Surgery (ASAPS): the sister organization of the ASPS. All board-certified plastic surgeons are members of ASPS, but ASAPS members specialize in cosmetic surgery. asymmetrical: unequal, unmatching. axilla: the armpit or underarm area; plural: axillae. axillary: related to the armpit or underarm region. B band size: measurement of the rib cage denoted in bra sizes. It is measured in inches. Benelli mastopexy: a type of breast lift performed by removing a circle of skin around the areolae complex and pulling in the breast tissue. Also known as a concentric, periareolar, or donut mastopexy. bilateral: both the right and left sides. For example, a bilateral mastectomy is the surgical removal of both breasts. board certified: an important term regarding the credentials of a physician or surgeon. bottoming out: a condition which occurs when the lower poles (halves) of the breast slide under the inframammary crease. breast envelope: the skin and subcutaneous tissue that covers the breast and helps give it shape. breast lift: also called mastopexy or mastoplexy, the surgical procedure used to raise and firm sagging breasts. bromelain: a homeopathic remedy derived from the pineapple stem which may reduce swelling and bruising. C capsular contracture: a complication that occurs when scar tissue forms around the implant, resulting in painful breast stiffness and possible leakage of the fluid inside the implant. capsule: the fibrous tissue around the breast implant. cleavage: the area between the breasts. cohesive: marked by a tendency to stick together. Cooper’s Ligament: the connective tissue that attaches the breast gland to the overlying skin. cutaneous: relating to or affecting the skin. D dissect: to separate tissue in surgery; to place an implant, your surgeon must first create or dissect a pocket within your breast. E endoscopic surgery: surgery performed using an endoscope (a small camera) and special surgical tools. Endoscopic surgery usually involves one or more small incisions and a shorter recovery time than traditional open surgery. epinephrine: a hormone secreted by the adrenal glands during conditions of stress. It raises the blood pressure and breathing rate, and constricts blood vessels. expander implant: a temporary breast implant that is slowly inflated with saline to stretch the tissue in preparation for a permanent breast implant. F fascia: a sheet of connective tissue that covers or binds muscles or organs. fibrous tissue: tissue containing tightly woven strands of collagen protein. fluffing: a condition that occurs when the breast implants drop into a slightly lower, more natural position, after the skin and muscle have completely relaxed during healing. Also called dropping. form stable: Another name for highly cohesive or gummy bear breast implants. Form stable breast implants are filled with viscous gel that won’t migrate in the event of a rupture. G general anesthesia: a type of anesthesia often used for breast augmentation. Under general anesthesia, you are fully asleep. glandular: relating to or involving glands, gland cells, or their products. gummy bear implants: nickname for a type of breast implants filled with highly cohesive silicone gel. This viscous filler has the consistency of a gummy bear, so if the implant ruptures, the gel won’t migrate. H hematoma: a break in a blood vessel, causing a blood clot or localized, blood-filled area. hemorrhage: an abnormal flow of blood from an incision or wound. hypoxia: lack of oxygen to the body. I inferior: lower or closer to the feet. inframammary crease: the crease below the breasts where the breast envelope meets the skin over the rib cage. inframammary incision: an incision in the inframammary crease used to place breast implants. Also called the “crease” or “fold” incision. intercostal arteries: the arteries responsible for the blood supply to the breast. intracapsular rupture: type of implant rupture in which a silicone-filled breast implant breaks, but the silicone is contained within the capsule. intravenous sedation: sedation or anesthesia delivered through an intravenous (IV) line. L lactation: producing milk from the breasts. latissimus dorsi flap reconstruction procedure: a reconstructive procedure that uses the latissimus dorsi (a back muscle) to form a breast mound. lobules: the part of the breast where milk is produced. The lobules are gathered into lobes. There may be as many as 20 lobes per breast. local anesthesia: anesthesia that numbs a small part of the body. lidocaine: a local anesthetic, also called Xylocaine. lumpectomy: surgical removal of breast tumor tissue. lymph node: any of the small glands that make up the lymphatic system, which carries lymph fluid, nutrients and waste material between the body tissues and the bloodstream. The lymphatic system is a major component of the body’s immune system. lymphadenopathy: abnormal enlargement of the lymph nodes. lymphedema: swelling, generally in the arms or legs, that occurs when there is a blockage in the lymphatic system that is preventing lymph fluid from draining well. This tends to occur after certain types of breast cancer surgery. M malposition: incorrect or abnormal position. mamma: breast, organ of lactation; plural: mammae. mammogram: a breast X-ray. mammography: the use of X-rays to form a diagnostic picture of the breast. mastectomy: surgical removal of the breast or breasts and associated tissue. mastopexy: breast lift. micromastia: abnormal smallness of the breasts. myectomy: excision of muscle. N nipple: the bulge of pigmented, erectile tissue in the center of the surface of the breast from which milk can flow. O P pectoralis major: either of two large, fan-shaped chest muscles. These are the muscles that a breast implant is placed beneath in submuscular or subpectoral placement. pectoralis minor: the small chest muscles. These muscles are targeted with a Botox breast lift. periareolar: surrounding the areolae complex of the nipple. pocket: a cavity made in the body by dissection. In breast augmentation, the pocket is the space created for the implant. pole: the upper or lower half of the breast or breast implant. ptosis: sagging. R regional anesthesia: anesthesia that numbs a region of the body. This type of anesthesia is not routinely used for breast augmentation. rectus abdominus fascia: the fascia covering the rectus abdominus muscle of the abdomen. It is used to help cover the breast implant in full submuscular implant coverage. rippling: the appearance of ridges or wrinkles in a breast implant. S saline: salt water. saline-filled implants: a type of breast implant that is filled with sterile saline. sedation: a state of calm or sleep. seroma: a collection of fluid under the skin. serratus muscle: a muscle on either side of the chest that is connected to, and covers, the ribs. It is used in conjunction with the pectoralis major muscle and rectus abdominus fascia in full submuscular breast implant placement. silicone: the second most abundant element on Earth and a staple ingredient in commercial products, from pacifiers and breast implants to non-stick bakeware and adhesives. silicone-filled implants: breast implants filled with silicone gel. sternum: the breast bone between the two breasts. submuscular, full submuscular: implant placement patterns. Full submuscular placement involves placing the implant entirely under the muscle. supine: face up. symmastia: condition characterized by touching, in the center of the chest, of the two breast implants; also called kissing implants and “uniboob.” symmetrical: similar in size and shape. T tachycardia: a rapid heart rate. thoracic: relating to or located within the thorax or chest. thromboembolus: obstruction of a blood vessel by a blood clot; plural, thromboemboli. thrombosis: localized coagulation of blood. transaxillary: though the axilla (armpit). transverse: lying or going across at an angle. transumbilical breast augmentation (TUBA): a procedure in which breast implants are inserted via the belly button. tubular (or tuberous) breasts: a breast shape caused by a small breast base and/or herniated areolae. twilight sedation: a light form of sedation anesthesia that provides full sedation, but you can be roused. U umbilical: relating to the navel or belly button. V vasoconstrictor: a drug that constricts the blood vessels. G C H A P T E R 54 The dual plane approach to breast augmentation Steven Teitelbaum History The breast implant pocket choice has a profound effect on the appearance of the augmented breast. Along with the selection of the device itself, it is the most important preoperative decision. Critical manifestations of this choice may not be apparent for many years, as some effects of the implant on the soft tissue occur gradually yet inexorably. The most commonly described pocket locations are: (1) total submuscular (subserratus and subpectoral); (2) partial retropectoral (behind the pectoralis with its origins from the ribs left intact); (3) subfascial (between the pectoralis muscle fascia and the pectoralis muscle); (4) submammary or subglandular (between the breast and the pectoralis fascia). Total submuscular is more frequently a reconstructive technique, less commonly done for augmentation owing to a more painful and bloody dissection, a tendency for the device to rise superiorly, and diffi culty in predictably creating a deep and well-formed inframammary fold. Subfascial has not been widely adopted due to an absence of satisfactorily controlled or long-term data. With scarcely 0.5 – 1 mm more coverage than a classic submammary dissection, this procedure is only a minor variation of the submammary pocket and does not qualify as a distinct pocket type. Partial retropectoral and submammary are the most popular methods. Proponents of each are quick to point out the distinct advantages of their technique and the disadvantages of the other. These comments are frequently appropriate. But these comments are not equally applicable to all situations. There are indeed breast types for which the benefi ts and drawbacks of one pocket makes it the better choice. Even so, some shortcomings of that preferred pocket frequently remain at issue. The dual plane as fi rst published by John Tebbetts in 2001 is the ideal compromise, in that it allows the implant to be simultaneously retropectoral where the device most needs coverage, and retromammary where it most needs to be in direct apposition to the breast. This allows near-total achievement of the purported benefi ts of both at the same time, while minimizing the trade-offs associated with selecting just one of the two pockets. It is therefore less of a compromise per se, than a way of “ having your cake and eating it, too ” , essentially doing both pockets at once, using each pocket where it exacts its greatest benefi t. While submammary and partial retropectoral are “ pure ” extremes, the dual plane is a continuous spectrum of options, occupying the “ gray-zone ” in between. The operation starts with the creation of a partial retropectoral pocket. The origins are carefully divided along the inframammary fold, which allows the cut edge of the muscle to glide a bit superiorly, so that there is both a small submammary and a large subpectoral area of the pocket, and hence the term dual plane. By disrupting attachments of the muscle to the overlying gland, the muscle can be gradually and incrementally raised, thereby reducing the proportion of subpectoral pocket and increasing the proportion of submammary pocket. The purported advantages of the partial retropectoral pocket are predominantly coverage along the sternum and over the superior border of the implant; the dual plane preserves these. The purported advantages of the submammary pocket are to direct implant pressure upon the lower pole; the dual plane preserves these as well ( Fig. 54.1 ). Criteria for the ideal pocket Our ability to determine the ideal pocket for a given situation rests upon the criteria that we choose to use to make that determination. Rather than vague, subjective decisions that allow certain issues to be overemphasized and others neglected, it is important to attempt to quantify all of the pertinent issues and measure each of the methods against them. Over the last several decades, published reoperation rates in PMA studies have not changed despite the use of different implants, remaining consistently at about 20% at three years. In a study of one device, a single surgeon achieved a 0% 675 Section 11: The breast Go to www.expertconsult.com to see updates to this chapter 0060_ch54_9780702031687.indd 675 4/8/2009 3:33:26 PM G Section 11: The breast Aesthetic Plastic Surgery 676 deforming and even uncorrectable. It is therefore not enough just to tally complications, but also to consider their severity. Dual plane data objectively show that this procedure succeeds in maintaining the advantages of both pockets while mitigating the trade-offs associated with selecting a single pocket. Preservation of future options in the event of an unsatisfactory outcome is important: if Plan A was still a viable option after Plan B, but Plan B would not be after Plan A, then that would suggest an advantage for starting with Plan B. Finally, outcomes need to be assessed at long intervals after surgery. Irrevocable, permanent, progressive, and at times totally uncorrectable changes occur to a breast years after an augmentation. Adequacy of tissue coverage needs to be judged at the longest possible intervals, decades if possible. Such long-term data is meager, but owing to the importance of such lifelong changes on the breast, at this point anecdote and extrapolation of shorter-term results should be considered ( Fig. 54.3 ; Table 54.1 ). breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Pain and recovery In general, there is less pain with the submammary approach, as the submuscular approach subjects the sensitive rib cage to possible trauma and the overlying muscle to stretching. But the largest data ever assembled on postoperative pain showed that 24-hour recovery without the use of any narcotics or pain pumps could be routinely achieved with a dual plane approach. Bloodless surgery and avoidance of creating any rib trauma circumvented the typical pain experienced from the rib cage in submuscular patients. Precise, gentle elevation, bloodless elevation of a pectoralis muscle paralyzed by the anesthesiologist results in a minimum of trauma to the muscle. This author has routinely been using these techniques for many years, and only uses ibuprofen for postoperative pain for routine augmentation mammaplasty in all planes, including the dual plane. Dual plane patients routinely go out to dinner, shower, and wash and brush their own hair the night of surgery. They describe the feeling as “ tight ” , a “ pressure ” , “ soreness ” , or “ like working out hard ” . Fig. 54.1 The three types of dual plane breast augmentation. A , Dual Plane Type I. B , Dual Plane Type II. C Dual Plane type III. A B Complete division along IMF C No division No division No divisionbreast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubaiFig. 54.2 Retromuscular pockets are often criticized for causing high-riding implants. In this case, the dissection was a blunt/blind transaxillary augmentation. The muscle was divided along the IMF on the left, but not the right. This is not a shortcoming of the procedure itself, but from its execution in this particular instance. 3-year reoperation rate in contrast to an average of 13.9% for all the doctors in the study. Taken together, these two fi ndings demonstrate that the outcome in breast augmentation is determined far less by the type of the device than by other factors ( Fig. 54.2 ). In the absence of data, surgeons must turn to the anecdotal. But when data is available, it trumps anecdote. Of all endpoints, the most decisive measurement of outcome is the reoperation rate, as it is an incontrovertible endpoint. “ Satisfi ed ” or “ happy ” patients are imprecise and unquantifi able endpoints, and since we have all seen unhappy patients with beautiful results and thrilled patients despite notable problems, they do not qualify as adequate endpoints with which to entirely judge the quality of an operation. The absolute incidence of reoperation tells only part of the story: the severity of a problem must also be considered. Some may be minor or annoying, while others may be 0060_ch54_9780702031687.indd 676 4/8/2009 3:33:26 PM G Chapter 54 The dual plane approach to breast augmentation 677 Fig. 54.3 A & C , Preoperative. B & D , Postoperative. Anecdotes are anecdotal, but sometimes that is the best that we have. If anyone doubts the importance of muscle coverage, they should be shown a series of patients with tissue so thin, with a saline implant looking like this, 11 years after surgery, free from capsular contracture, visible edges or rippling. Cases like this abound, but there are few examples of submammary or subfascial patients at this interval that look this good. A B C D When these same techniques are applied to the submammary approach, patients typically feel slightly less stiff and sore than do dual plane patients, but both groups still consistently achieve a “ 24-hour ” recovery. Any difference is subtle, noted only for a day or two, and is of no real consequence, particularly relative to advantages of achieving more muscle coverage. Coverage and stretch Soft tissue coverage is the single-most important issue affecting the short and long-term result after a breast augmentation. With adequate coverage, the implant edges are less visible, and the breast looks more natural and less augmented. Any folds or irregularities with the implant shell are more concealed. With more tissue over it, the device is less palpable. With less tissue coverage, the edges of the implant are more visible, the breast looks more augmented, and it is easier to feel the implant ( Fig. 54.4 ). Over the long term, these changes become more profound. Implants put pressure on the breast, and the parenchyma gradually compresses and atrophies. The presence of the implant stretches and thins skin. This occurs with implants in all positions. No study will ever randomize patients of similar tissue types and implant sizes and follow them over enough time for a scientifi c conclusion to be made. But a large amount of clinical observation and logic (see Fig. 54.3 and Fig. 54.5 ) offers us guidance. Examples of submammary patients with severe parenchymal atrophy abound, while retropectoral patients with similar characteristics are rarely seen. And when they are, though the implants may have ostensibly been placed “ behind the muscle ” , secondary surgery frequently reveals that the muscle has been avulsed off both the inframammary fold and sternum, thereby sacrifi cing the critical coverage of which we are speaking ( Fig. 54.6 ). These problems are sometimes noticeable within a year or two, but can often take years more to develop. We must be 0060_ch54_9780702031687.indd 677 4/8/2009 3:33:28 PM G Section 11: The breast Aesthetic Plastic Surgery 678 Table 54.1 Pocket comparisons Issue Advantage PRP Advantage subglandular Dual plane remedies Less pain X Best data to date Better coverage X Large advantage vs. SM; difference relative to PRP dependent upon release and up to determination of surgeon Access to lower pole parenchyma X Yes Expands constricted breasts X Yes Fills ptotic breasts X Yes Avoids muscle animation X Rarely clinically signifi cant Reduces tendency to “ ride high ” X Yes Reduces tendency to “ lateralize ” X Yes Faster recovery X Best data to date Less capsular contracture X Best data to date Better for mammograms X Appears to be Reduce parenchymal atrophy X Best data to date Reduces stretch deformities Best data to date Narrower cleavage X No – but subglandular can only do so at the expense of coverage Fig. 54.4 Tissue coverage is always a priority, particularly superiorly and medially. The implant she holds in her hand mimics what is occurring within her breast. With muscle coverage in the upper pole, such a deformity will rarely if ever occur. Fig. 54.5 This is not a capsular contracture. This is a submammary implant. The breast is soft. The patient chose this at the surgeon ’ s behest in order to avoid animation deformity. But even in repose, the signifi cant deformity is present; there is no substitute for soft tissue coverage. aware of these problems and remind ourselves that we need to create a result that will look good not just for years, but for decades. As someone who sees many secondary problems, I can state categorically that subglandular patients present more frequently, with more severe problems, and with more unsolvable problems than do subpectoral or dual plane patients. Such tissue thinning with submammary patients also is a set up for a problem which is diffi cult to correct, as to do so often requires a switch to the partial retropectoral or dual plane position. But once there is a subglandular pocket, the coverage in the retropectoral pocket is forever impaired. Though one can use sutures to tack the muscle back up to the gland, its caudal cut edge can never be retained as caudally as it might have been were this not to have happened, thereby forever impairing inferior coverage. Marionette pullout sutures have been described to hold down the muscle in this situation, but this also cannot achieve the same degree of 0060_ch54_9780702031687.indd 678 4/8/2009 3:33:31 PM G Chapter 54 The dual plane approach to breast augmentation 679 Fig. 54.6 This patient just had removal of subpectoral implants. The dotted line indicates the caudal border of the pectoralis. Though she had “ retromuscular ” pockets, the implant itself had negligible if any coverage as the muscle was so high it could cover only a bit of the implant, and the pressure of it probably pushed the implant away. Though her muscle was still attached to the sternum, the muscle had been inadvertently detached from the overlying parenchyma, thereby allowing it to window shade up far higher than would be ideal even for a DP III. Fig. 54.7 This patient had a submammary capsulectomy and then had a submuscular pocket dissected. It illustrates the basic principle of the DP approach. With no attachment of the muscle to the overlying parenchyma, this muscle window shades strongly superiorly. The DP approach recognizes the importance of maintaining those attachments when it is important to keep the muscle inferiorly to maintain coverage, and emphasizes the importance of a gradual and incremental release of them to allow controlled vertical elevation of the muscle and exposure of the parenchyma in the lower breast when the situation demands. Fig. 54.8 The most common argument for submammary placement is to deal with the postpartum involution and ptosis patient who does not want mastopexy scars. But this group has the thinnest tissue and is the most prone to stretch and thinning. A , A patient merely two years following such a procedure; note the extreme parenchymal atrophy and skin thinning. B , Note the improvement still noted two years after conversion to a dual plane. A B coverage as if the attachments between the muscle and the overlying gland were never disrupted ( Fig. 54.7 ). In conjunction with the thinning, there is often progressive stretch of the skin envelope, sometimes necessitating mastopexy. Even if this mastopexy would have been inevitable in the future with a partial retropectoral or dual plane pocket, such patients frequently have soft tissue thinning or capsular contractures in addition to the stretched skin. This necessitates a pocket change and possible capsulectomy in addition to the mastopexy, which can be a riskier procedure than if the implant had started out dual plane or partial retropectoral. This combination of secondary revision occurs so frequently that efforts must be made at the time of the original surgery so that this doesn ’ t happen ( Fig. 54.8 ; also see Fig. 54.5 ). If tissue coverage is adequate, it almost doesn ’ t matter what is going on with the implant; a capsular contracture may be less noticeable; suboptimal implant shape may be less problematic; implant folds might be harder to discern. These are powerful reasons to select the partial retropectoral pocket over the submammary pocket. But what should one do if there is glandular ptosis or a constricted lower pole and the tissue is thin? Partial retropectoral is preferred for the tissue coverage issue, but submammary may be necessary to allow better expansion of the lower pole. The dual plane solves this dilemma by allowing the upper and inner portion of the implant to be covered by muscle, while the inferior portion, the part that needs to push directly on the gland to expand and fi ll it, can be allowed to be in direct apposition. Achieving “ adequate ” coverage is an insuffi cient goal. “ Maximum ” coverage must be the goal. There is almost no long-term problem that is not solvable when substantial soft tissue is available, and there are few problems completely correctable when soft tissue is not available. There is some sacrifi ce in coverage with the dual plane relative to partial retropectoral, and if tissue coverage in the lower pole is such that the benefi ts of changing to the dual plane do not outweigh its advantages, then it is suggested to patients to have a partial retropectoral pocket. In any case, the reduction in coverage with the dual 0060_ch54_9780702031687.indd 679 4/8/2009 3:33:33 PM G Section 11: The breast Aesthetic Plastic Surgery 680 plane relative to partial retropectoral is reasoned and controlled. Access to parenchyma The most profound advantage of submammary over partial retropectoral is attributable to the direct pressure the implant can make against the gland. This can make it look less empty, and the pressure can better expand a tight lower pole. If behind the muscle, the muscle essentially protects the preexisting confi guration of the lower pole, inhibiting the implant ’ s ability to push it and fi ll it out. And if weak fi brous connections between the pectoralis muscle and breast gland allow the gland to slipe relative to the muscle, placing the implant against the breast tissue can help reduce the extent of inferior tissue migration. Otherwise, the subpectoral placement still allows the gland to slide inferiorly relative to the muscle ( Figs 54.9 and 54.10 ). Depending upon the degree of release with the dual plane, these advantages of the submammary approach can be almost completely if not completely realized with the dual plane approach. The coverage that is preserved superiorly and medially typically allows for muscle coverage where it is most needed: superiorly and along the medial sternal border. Capsular contracture Capsular contracture still remains the leading cause of reoperation in PMA studies, yet publications using antibiotic irrigation and the dual plane pocket have resulted in some of the lowest reported capsular contracture rates to date. Whether it is specifi cally due to the dual plane per se or other factors, such as the irrigation, is not entirely clear. But it is suffi cient to say that the lowest reported capsular contracture rates are with the dual plane position, and no paper suggests an advantage to partial retropectoral over dual plane. Dual plane is the ideal choice. Mammography Given the cancer prone nature of the breast, optimizing the ability to detect cancer early must remain a priority. Numer- Fig. 54.9 The long term stability of the outcome in this post partum atrophy/ptosis patient with implants in the dual plane position demonstrates the value of proper implant sizing and tissue coverage. pre 5 months 1 yr 2 yrs 3 yrs 5 yrs 0060_ch54_9780702031687.indd 680 4/8/2009 3:33:37 PM G Chapter 54 The dual plane approach to breast augmentation 681 ous authors have suggested an advantage to retropectoral over submammary placement for this regard, but it is unclear whether the advantage is directly due to the anatomic location relative the muscle itself, or due to a lower capsular contracture rate below the muscle. Suffi ce to say, mammogram is impaired when the breast tissue cannot be pulled out and away from the implant and placed between the mammogram plates, such as when the implant is hard, there is a large implant relative to the breast tissue, or any other reason that restricts the pull of the tissue forward. While no studies have specifi cally compared sensitivity of mammogram between these pockets over a long period of time, the low incidence of capsular contractures and the extensive muscular coverage over a dual plane implant suggests that this would not be a problem. In any case, the role of MRI in screening for breast cancer is increasing, even for women without breast implants. And since implants do not affect its sensitivity, this entire issue may soon be moot. Muscle animation breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai The lack of signifi cant implant motion or distortion with contraction of the pectoralis is a signifi cant advantage of the submammary position relative to the partial retropectoral pocket. But it is not enough to look at the problematic subpectoral patients with animation problems: one must also be aware of the submammary patients with signifi cant implant visibility even in repose. The deformity of a thin patient with subglandular implants at rest is typically more profound than a partial retropectoral patient during maximal contracture. With the dual plane approach, the release of the pectoralis along the inframammary fold (IMF) reduces if not totally eliminates the forces that might distract the implant superiorly. While the medial origins along the sternum may compress and slightly lateralize the implant on strong contraction, they rarely cause a signifi cant deformity ( Fig. 54.11 ). Fig. 54.10 The constricted lower pole breast is frequently touted as being a reason for submammary, as it allows scoring of the lower pole. In this case, shown here at 5 years post-surgery, a DP II was done, allowing the muscle to rise to the lower border of the areola. This exposed parenchyma for the entire lower pole of the breast, allowing it to be shaped just as much as it would have been were this to have been a submammary placement, but with maintenance of muscle coverage superiorly and medially, which helps to obscure the borders of the implant. 0060_ch54_9780702031687.indd 681 4/8/2009 3:33:39 PM G Section 11: The breast Aesthetic Plastic Surgery 682 Certainly, there is some motion, but in the Tebbetts series, there was no revision requested for this reason. In my experience, there has been occasional complaint and discussion of revision, but I have not switched my own patient to a submammary pocket for this reason ( Fig. 54.12 ). Usually, the patients with any such problems are very thin, and were therefore the least well suited for a submammary pocket. The key in minimizing animation with the dual plane pocket is to uniformly and accurately take the muscle down along the inframammary fold, stopping evenly on both sides at the point at which the IMF meets the sternum, and never releasing along the sternum. It appears that when the IMF is horizontal and meets the sternum at a discrete point, these issues are less problematic than when the IMF curves sharply superiorly as it moves towards the sternum, oftentimes not actually meeting the sternum until being at or even above the level of the nipple. These patients are also often thin, and they represent a particular challenge, in that there in fact may be no way to avoid some deformity with either approach. Fig. 54.11 A critical step of all dual planes – I, II, and III – is to completely divide the pectoralis major along the inframmary fold, stopping at the sternum, without division along the sternum. Failure to divide the origins along the IMF result in either a high-riding implant, superior malposition with animation, or a blunted IMF. However, if tissue coverage is thin ( < 5 mm), they probably should not be divided, as maintaining coverage is the fi rst priority. Division along the sternum can result in symmastia, excessive edge visibility and uncorrectable deformities. Complete division along IMF No division Fig. 54.12 DP and all retromuscular pockets are criticized for animation deformities. But the patient needs to be considered in repose as well. Here the same patient on the top is seen submammary, relaxed in two different poses. Though there is no animation deformity, the implants are unattractive. In the lower left, she is shown relaxed in the DP position, looking much prettier and more natural. In the lower right, she does demonstrate distortion with contracture, but no doubt even if this is the maximal distortion she can manage, it is still less deformed than she looks in either of the preoperative views in repose. 0060_ch54_9780702031687.indd 682 4/8/2009 3:33:44 PM G Chapter 54 The dual plane approach to breast augmentation 683 No matter which pocket is selected, the patient must be fully informed preoperatively of the trade-offs, and participate in the pocket selection. That way, if she has an animation deformity or implant deformity later, she can be reminded that she preferred accepting that problem to the risks of the other pocket. If a patient is not made aware of these choices preoperatively, then dissatisfaction and request for revision remain avoidable risks for revision. Narrower cleavage Both partial retropectoral and dual plane procedures accept the inner border of the pectoralis major muscle as an absolute limit to the medial placement of the implants. Once submammary, the implant can certainly be more medial. However, this comes at a price: the patients who most request or “ need ” such medialization invariably have the least soft tissue cover, and moving the implant medial to where the internal border of the pectoralis origin on the sternum results in risking symmastia and excessively visible implant edges. It is foolhardy to attempt to create cleavage by excessive medial placement of any implant, as tight skin usually pushes the implant laterally and the thin skin results in distinctly visible edges. So while the submammary does have the potential to place implants more medially, this amounts to more of a liability than an advantage. Physical evaluation Until experienced, most surgeons believe that an operation is all about what happens the day of surgery. In fact, it is the decisions that lead up to surgery that often have the most long-term effects on a result. This is particularly true of breast augmentation, where patient wishes, patient anatomy, and surgeon judgment converge. This topic is more important than pocket choice or any other issue with breast augmentation alone. The following are the most important of these points: Patient education The patient must be informed about the limitations of her tissue, so that her expectations are met. She must anticipate all trade-offs with respect to issues such as tissue coverage, animation, correction of ptosis, etc. When patients participate in these choices and sign off on them, the incidence of revision surgery is reduced and patient satisfaction increases. Determination of ideal implant size A patient is asked to decide whether she wants an implant that fi ts properly within her tissue, or she wants to force a certain size into her breasts without regard for creating an unnatural result in the short term and causing permanent tissue changes in the long term. Informed patients will usually select the latter. In that case, using the base width, skin stretch, and degree of envelope fi ll, the ideal implant size for that patient ’ s breast is determined. Larger will have an upper convexity and look more full, stuffed, or fake. Smaller will have a concave upper pole and look emptier. Determination of need for coverage and for muscle release breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai The dual plane preserves coverage and allowing coverage where it is needed. These two opposing characteristics need to be evaluated in all patients. Coverage It is always a goal to maintain as much coverage as possible, sacrifi cing coverage only when there is a reason to do so. With the exception of patient request (after being fully informed), a dual-plane approach is suggested to all. If coverage is < 2 cm of pinch at the upper pole, then a submammary approach will not even be offered. If pinch < 5 mm at the IMF, serious consideration is given to not releasing the muscle to create the dual plane, choosing instead to use a partial retropectoral pocket. In such situations, the long-term benefi ts of preserving maximal coverage often outweigh animation deformities, widening of the intermammary distance, and the predictability and crispness of the inframammary fold position. Muscle release The breast is examined for lower pole constriction or glandular ptosis that might necessitate controlled release of the muscle from the gland. While one might decide specifi cally preoperatively to perform a dual plane type II or type III, the surgeon should always start by dissection a type I, and then examine and feel the breast, releasing as much as is necessary during the operation. Need for mastopexy Many patients see plastic surgeons for a breast augmentation following lactation or weight loss. For some of these women, mastopexy is the appropriate procedure. Not wanting scars, some of these patients either receive an implant that fi lls, but is larger than they wish, or an implant of the size they want but which creates inadequate fi ll. In either case, and in particular in the case of the larger implants, the result is aesthetically compromised, and the already stretched skin stretches more and deteriorates with time. I have seen many such patients who had received submammary augmentations, and have tried this on my own patients. If followed long enough, the results are frequently unsatisfactory. Neither is the dual plan an answer for these patients; if the nipple (N) is below the fold, if N : IMF distance is > 9.5 cm on maximum stretch, or if substantial parenchyma lays caudal to the inframammary fold, mastopexy must be considered, and augmentation should either not be attempted or only performed on the patient who clearly demonstrates an understanding of the limitations of such a procedure (see Fig. 54.8 ). Anatomy The pectoralis major muscle has origins along the clavicle, sternum, and the 4th – 6th ribs along the IMF, and inserts onto the humerus, causing fl exion and internal rotation. Studies 0060_ch54_9780702031687.indd 683 4/8/2009 3:33:48 PM G Section 11: The breast Aesthetic Plastic Surgery 684 have demonstrated that the pectoralis origins along the IMF can be released without loss of strength or coordination. What is most relevant to the dual plane is the recognition that the deep surface of the pectoralis glides over the chest wall. It is anchored like a trampoline on three sides to the humerus, clavicle, and ribs. Like a trampoline released on one edge, the muscle will retract strongly away from the side of the release. The only thing that holds it in place – in distinct contrast to its deep surface – is that its superfi cial surface is tightly bound to the deep surface of the gland. The superfi cial surface of the muscle gives rise to the Cooper ’ s ligaments and fi brous tissue that ramify throughout the breast. These attachments help hold the caudal edge of the muscle inferiorly, thereby maintaining coverage to the lower pole of the implant. Following careful release of the muscle along the inframammary fold, the surgeon will observe the muscle “ window shade ” , sliding superiorly 1 – 2 cm. However, if there was an inadvertent dissection on the superfi cial surface of the muscle, thereby disrupting some of the fi bers connecting the muscle to the overlying gland, the muscle will window shade far more, sacrifi cing what might be intended coverage of the lower pole. This point is most emphasized when creating a retropectoral pocket following a submammary capsulectomy. Even if the pectoralis origins along the IMF are left intact, the caudal edge of the muscle window shades very high superiorly; if those origins are released, it may move so high that it cannot even cover the implant at all. Understanding this dynamic is critical to the dual plane approach. Technical steps See Table 54.2 ; see also Fig. 54.1 . Though a dual plane dissection can be done from all incisions, the inframammary incision allows the greatest degree of visualization and control of the dual plane pocket. Most specifi cally, it allows preservation of all the attachments between the muscle and the overlying gland, so that if they need to be dissected, it can be done in a specifi c and controlled manner. Dissection from the periareolar incision down to the inframammary fold or the proposed level of transection of the muscle invariably results in some degree of inadvertent disconnection of the muscle from the overlying gland, thereby resulting in unintentional superior elevation of the muscle, creating for example a dual plane type II or III when a type I was the goal. I frequently perform revision surgery on patients who had periareolar augmentation in which the operative note described the procedure as “ partial retropectoral ” and described only division of the muscle along the inframammary fold, yet the caudal edge of the muscle is frequently found well above the upper border of the areola, beyond what is even considered a dual plane III. This may be due to a combination of a bit of release of the muscle along the sternum, but it seems more commonly due to a release of the attachments of the superfi cial surface of the muscle from the gland simply as part of the tunneling process to reach the inframammary fold. Unless a DP II or III is a goal, a surgeon should probably perform dual plane pocket surgery from the inframammary incision until they have gained substantial experience. Many surgeons divide the muscle along the inframammary fold and describe the procedure as “ half over – half under ” , or even “ partial retropectoral ” , which is exactly what is described as a dual plane type I. Whatever the label, these surgeons should always be cognizant that the loss of tissue coverage from a periareolar incision is always a risk unless extremely fastidious dissection is done. Table 54.2 Technical steps Description Indication Goal Partial retropectoral Pectoralis attached to sternum and to IMF IMF pinch < 5 mm Maintain maximum coverage Dual plane type I Same plus complete division of pectoralis along IMF All parenchyma above IMF; gland adherent to muscle; A : IMF on maximum stretch 4 – 6 cm Small sacrifi ce in coverage to increase IMF accuracy; reduce animation deformity; allow implant to sit at bottom of pocket Dual plane type II Same plus pectoralis released from overlying gland and allowed to slide to about the lower border of the areola Most parenchyma above IMF; looser attachments of gland to muscle with some sliding of gland over muscle; stretched lower pole skin with A : IMF under maximum stretch 5.5 – 6.5 cm More sacrifi ce in lower pole muscle coverage in order to reduce risk of mobile parenchyma from sliding off of muscle, better fi ll of loose envelope Dual plane type III Same plus greater release of pectoralis from gland, allowing it to slide to about the upper border of the areola Ptosis with one-third or more of parenchyma below level of anticipated IMF with patient standing; substantial sliding of gland over muscle; more stretched lower pole skin with A : IMF under max stretch 7 – 8 cm or constricted lower pole breasts Most sacrifi ce in lower pole muscle coverage to allow maximal contact of implant against gland; allows for maximal scoring/reshaping of gland to allow maximal expansion 0060_ch54_9780702031687.indd 684 4/8/2009 3:33:48 PM G Chapter 54 The dual plane approach to breast augmentation 685 Likewise, a DP I, involving only the release of the pectoralis along the inframammary fold, can be undertaken from the transaxillary incision. Unlike a blunt and blind transaxillary approach which risks uneven release of the muscle and imprecise level of the inframammary fold, a true DP I transaxillary should be done with a bloodless, endoscopic technique. Creating a DPII or III, however, involves retrograde dissection from the transaxillary incision. This remains on the technical fringe at this time, and should be undertaken by surgeons experienced with endoscopic transaxillary partial retropectoral pocket creation after experience with the dual plane for a variety of situations from the inframammary incision. IMF approach See Fig. 54.13 . The fi rst step is to determine the ideal position of the inframammary fold. It is calculated from the nipple with the tissue placed on maximum stretch. In general, the standard of 7 cm for a base width of 11 cm, 8 cm for a base width of 12 cm, and 9 cm for a base width of 13 cm holds true. If the inframammary fold is already at that height, it does not need to be altered. An incision is made at the proposed inframammary fold. Dissection is carried straight down to the muscle fascia with the electrocautery, taking care not to skive inferiorly. There is a natural tendency of the cut edge of the tissue to pull inferiorly, so the dissection may angle superiorly, but only for the purpose of not undercutting the skin edge and inadvertently lowering the fold more than intended, if at all. The fascia is scored carefully with the cautery, so that the muscle is visible. Place in a double-ended or army-navy retractor with the tip pointed towards the medial border of the areola. With no horizontal dissection yet made, there will be little to hold the tissue up onto the blade of the retractor, so use the ulnar fi ngers of the retractor holding hand to pull the tissue onto the blade. Lift up towards the ceiling. Only the pectoralis will tent up. If the muscle does not tent at this point, it may be that the muscle is tight, or it may be that it is not the pectoralis. To ensure that it is pectoralis, and neither serratus, rectus, nor intercostals, touching it with the cautery will make the pectoralis in the upper chest contract. If still not clear, only then dissect just a couple of millimeters along the muscle surface in a cephalad direction. These are the important fi bers that you want to preserve in order to hold the muscle down after you release along the inframammary fold, so sacrifi ce no more than necessary for the anatomy to be clear. This will allow you to see the fi bers of the muscle, and allow some tissue to lie over the blade of the retractor, thereby allowing the pectoralis to tent up. Again advance the retractor blade to the edge of the muscle, pointing the blade to the medial border of the areola, pulling the breast tissue onto the retractor, and lifting toward the ceiling. Because it is loose on its deep surface, the pectoralis will tent upwards. Holding your hand down onto the abdomen so that the cautery is horizontal, sweep gently the taught pectoralis fi bers that appear vertical in front of you. Use hand switching monopolar forceps, as it allows precise control of blood vessels by squeezing, but so too can it be held together and used as a Bovie pencil. So long as it tents, it is pectoralis. So long as your cautery is horizontal and parallel to the chest wall, the chest is safe. Keep advancing the retractor forward and lifting up after every stroke of the cautery. With each motion of the cautery and repositioning of the retractor, the muscle will tent higher and the plane through the muscle will become more obvious. With this maneuver, you will very quickly get through the muscle, and will see the subpectoral space. Free up areolar tissue that is immediately in front of the incision, and then turn the retractor blade medially along the inframammary fold towards the sternum. Controlling the tension of the retractor blade on the muscles with fi ngers on the outside of the breast, use the cautery to take down the muscle about 1 cm above the proposed inframammary fold. This may serve as a shelf to help support the implant; it prevents over lowering of the fold; and it allows point coagulation of intramuscular blood vessels. Cut through the muscle and the overlying fascia. This should be bloodless and very easy to visualize. In fact, this dissection is so anatomic, that you should expect to be able to do it without needing to place a single four by eight into the pocket. Look beyond the tissue plane immediately in front of you, anticipating and seeing the perforators ahead of time. Continue all the way to the sternum, but do not proceed up the sternum at all. If you are unclear where this point is, mark it with an “ X ” externally on both sides preoperatively. Continue the dissection sweeping superolaterally, and then sweeping inferiorly. This helps to fi nd the plane between the pectoralis major and pectoralis minor, which are more intertwined if the dissection in that area starts inferolaterally instead of superolaterally. Irrigate with antibiotic solution and inspect the pocket. Take note of the long, narrow V -shaped trough where the muscle was released inferomedially and window shaded a bit superiorly. Inspect where the cut edge of the pectoralis is relative to your incision; sometimes it is just a few millimeters beyond it, and sometimes it is already window-shaded several centimeters. This will vary based upon how cleanly you got through the pectoralis and how tight the given patient ’ s connections between the pectoralis and breast tissue are. Place a fi nger in the incision and feel the lower border of the muscle and lift up, taking note of the position of the muscle through the skin as shown by the position of your fi nger. This inspection process is not just important in order to defi ne what you need to do for that specifi c patient, but done repeatedly, it provides the surgeon with a valuable experience about the dynamics of the muscle and the soft tissue. If the intention is to do a dual plane I, by virtue of the muscle release, the dual plane portion of the dissection is complete. The implant can be placed and the incision closed. If the goal is to do a dual plane type II or type III, then now is the time to do a release. This release is gradual and incremental. It cannot be overstated that substantial differences in position of the caudal edge of the pectoralis are created by just several millimeters of dissection. Surgeons ask 0060_ch54_9780702031687.indd 685 4/8/2009 3:33:48 PM G Section 11: The breast Aesthetic Plastic Surgerybreast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubaiFig. 54.13 A & B , After the retropectoral pocket is made, the pectoralis is divided 1 cm above the proposed inframammary fold. Note the use of the ulnar digits on the retractor hand pressing the muscle under tension so that it splits as it is divided. The superior and inferior cut edges are visible. When this is divided up to the sternum, a dual plane I will have been created, as shown in this photo. Depending upon the tension of the tissues, the muscle will window shade up a centimeter or two; in this case the muscle is about half the width of the retractor blade above the IMF. C , To go from a dual plane I to a II or III, the fi brous connections between muscle and the overlying parenchyma must be taken down. Just a few sideways swipes with the cautery is enough to cause signifi cant movement of the muscle. D , After just a few swipes of the cautery freeing up some attachments of the muscle to the gland, the muscle moves cephalad. The fresh yellow fat shows the signifi cant motion of the muscle relative to the last photo. Again, note the use of the ulnar digits against the retractor to create tension at the muscle parenchyma border, thereby making the dissection more precise and facile. E , When converting to a DP I to a II or a III, note how the hand and the retractor are used as a unit to create tension at the muscle/parenchyma interface. F , Here the release is being done more laterally. It can be adjusted on each breast exactly as the conditions necessitate. G , Copious irrigations with “ Adams ” solution (50 mL Betadine, 80 mg gentamicin, 1 g Ancef in 500 mL NS) is used throughout the operation. Note the yellow fat visible just beyond retractor; cut edge of muscle is just visible. H , In this case, the muscle is released to the lower border of the areola, which is a so-called dual plane II. When it is released to about the upper border of the areola, it is termed a DP III. A G H E F C D B 0060_ch54_9780702031687.indd 686 4/8/2009 3:33:49 PM G Chapter 54 The dual plane approach to breast augmentation 687 why they can ’ t dissect between the muscle and the gland before the muscle dissection, and the reason is that such small amounts of dissection result in such signifi cant movement of the muscle, that it is impossible to predict where the muscle will end up before dissecting the pocket and releasing the IMF. With the curved end of a double-ended retractor placed in the incision, abutting to the caudal edge of the muscle, but with only breast tissue within it, use the other fi ngers in the retractor hand to push in on the breast, so that together with the retractor, it is putting tension between the muscle and the overlying gland. Visualize the fascial connections between the muscle and gland, and use the cautery to gradually cut these, using sideways sweeping motions. You will see the muscle quickly pull away from the retractor and slide upwards. Once it does this even for several millimeters, move the retractor medially and laterally and repeat this process where you feel there is restriction by the muscle. Rather than repeating this motion in the same area, keep moving around, as this will give the most control over the fi nal position of the muscle. While illustrations suggest dual plane type I, II, and III as distinct entities, they are part of a continuum of options. Their designations are designed as a guide to enable us to think about a clinical situation and compare notes. But in any given patient, the muscle does not necessarily end exactly at the lower border of the areola (type II) or the upper border of the areola (type III). Rather, the release is made to the extent that is necessary to achieve the exposure of the implant to the gland of the breast. The most important point is not to overdo it. You can always release more, but once it is released, it is diffi cult if not impossible to pull the muscle back down. Put your fi nger back in as you did before, and note the chance in position of the muscle relative to before you did the release. Feel all along its edge, and go back and release more where you feel it is necessary. If you feel bands within the breast that are restricting expansion, such as with a constricted lower pole, or when the IMF had to be lowered with a tight IMF, now would be the time to score the lower pole, much as you might have done with a submammary pocket. Irrigate again with antibiotic solution, recheck for bleeding, and place the chosen implant close per the usual routine. Postoperative care With precise visualization of the pocket, no special bras or straps are necessary to try to push the implant into a pocket. Tape or a Steri-strip over the incision is the only dressing that is used. With bloodless dissection, no special bandages are necessary to create compression, and early motion is not just allowed, it is ordered. Patients move their arms over their head in the recovery room in a gradual jumping jack type of motion. They go home, take a nap, and then are instructed to continue their exercises every hour while awake, take a shower, and leave the house for dinner. They may drive a car when they feel that they can safely make unrestricted movements, which is usually in two to four days. They are encouraged to do all normal daily activities that do not involve particular exertion, such as opening and closing car doors, putting on a seatbelt, lifting a baby, emptying a dishwasher, or making dinner. They may return to the gym after three weeks, though some surgeons allow this after two weeks. With gentle, precise, and bloodless dissection, patients are only given narcotics through their time in the recovery room, and are managed over 95% of the time with ibuprofen alone at home. Complications There is no complication of dual plane that has not been well-described with either the submammary or partial retropectoral operations. The issue with dual plane is not that there are new complications, but that the patient and surgeon understand its limitations. So long as these trade-offs are well understood preoperatively, they are accepted later. For instance, in cases of extreme mobility of the breast over the underlying chest wall, inferior sliding of tissue may still occur with the dual plane approach. It is my impression that in extreme cases of laxity this may occur more with the dual plane than the submammary approach, but this is diffi cult to quantify because even the submammary approach does not always totally solve the problem. Though dual plane can reduce muscle animation relative to partial retropectoral, it cannot eliminate it to the same extent as the submammary pocket. Patients need to be aware of this, and make their decision about the pocket they prefer. 0060_ch54_9780702031687.indd 687 4/8/2009 3:33:53 PM G Pearls & pitfalls Pearls • When you have a choice in breast augmentation, always prioritize coverage. This will make the breast more natural in the short term and reduce the likelihood of diffi cult to correct long-term problems. • Point out all limitations a patient ’ s pre-existing anatomy poses on her result preoperatively. This will help her to let you do what you think is best for her, and will prepare her to accept trade-offs and shortcomings in her result later. • With the dual plane, dissect a partial retropectoral pocket fi rst. The more directly you are able to get behind the muscle, the less it will move superiorly after muscle division. • Do not force yourself to choose which type of dual plane you will do; these are not so much distinct entities as points on a path. You should feel the breast during the dissection and adjust the dissection accordingly. • Demand of yourself to make a gentle and bloodless pocket dissection so that your patients have an easy recovery. Pitfalls • The dual plane is not perfect, and though it maximizes most of the advantages and minimizes most of the disadvantages of either the submammary or partial retropectoral pockets, neither the surgeon nor the patient should think that it is perfect. • It is easy to over-dissect the attachments between the muscle and gland; avoid excessive dissection in that plane before dividing the pectoralis along the IMF, and then only release gradually and incrementally. • Do not release the pectoralis ever along the sternum; it creates deformities that are diffi cult to correct. Summary of steps 1. Partial retropectoral: Pectoralis origins left intact along sternum and IMF. 2. Dual plane type I: Pectoralis origins left intact along sternum, but divided along the IMF. 3. Dual plane type II: Same plus pectoralis released from overlying gland and allowed to slide to about the lower border of the areola. 4. Dual plane type III: Same plus greater release of pectoralis from gland, allowing it to slide to about the upper border of the areola. Further reading Adams WP Jr . The process of breast augmentation: Four sequential steps for optimizing outcomes for patients . Plast Reconstr Surg 2008 ; 122 ( 6 ): 1892 – 1900 . Adams WP Jr , Rios JL , Smith SJ . Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: Six-year prospective clinical study . Plast Reconstr Surg 2006 ; 118 ( 7S ): 46S – 52S . Spear SL , Carter ME , Ganz JC . The correction of capsular contracture by conversion to “ dual-plane ” positioning: Technique and outcomes . Plast Reconstr Surg 2006 ; 118 ( 7S ): 103S – 113S . Tebbetts JB , Adams WP . Five critical decisions in breast augmentation using fi ve measurements in 5 minutes: The high fi ve decision support process . Plast Reconstr Surg 2006 ; 118 ( 7S ): 35S – 45S . Tebbetts JB . Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study . Plast Reconstr Surg 2006 ; 118 ( 6 ): 1453 – 1457 . Teitelbaum S . The Inframammary approach to breast augmentation . Clin Plast Surg 2009 ; 36 ( 1 ): 33 – 43 Section 11: The breast Aesthetic Plastic Surgery 688 0060_ch54_9780702031687.indd 688 4/8/2009 3:33:53 PM Please see inside for Indications and Important Safety Information. ART. SCIENCE. A collection as diverse as your patients, Natrelle® is the #1 plastic surgery portfolio.1,2,*,† Shaping the future with you *Based on surgeon survey data, December 2016 (N = 100). †Based on US market share data through November 2016 (N = 67). ART. SCIENCE. Table of contents Indications and Important Safety Information 2 Natrelle®—the most complete portfolio 8 The Natrelle INSPIRA® Collection 13 Natrelle® 410 Anatomical Gel Breast Implants 23 Natrelle® Saline-Filled Breast Implants 31 Natrelle® 133Plus Tissue Expanders 36 Natrelle® 133 Tissue Expanders 41 Natrelle® tissue expander accessories 46 Natrelle® breast implant accessories 47 ConfidencePlus® warranty program 49 Additional information 50 Lee Natrelle INSPIRA® Style SRM-255 Individual results may vary. To order breast-shaping products, please call Customer Care at 1-800-766-0171. 1 Natrelle® Breast Implants Important Information INDICATIONS Natrelle® Breast Implants are indicated for women for the following: • Breast augmentation for women at least 22 years old for silicone- filled implants. Breast augmentation for women at least 18 years old for saline- filled implants. Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. • Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Breast implant surgery should not be performed in: • Women with active infection anywhere in their body. • Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions. • Women who are currently pregnant or nursing. WARNINGS • Breast implants are not lifetime devices or necessarily a one-time surgery. • Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Use care when using surgical instruments in proximity with the breast implant. For more information, please see the full Directions for Use. PRECAUTIONS Safety and effectiveness have not been established in patients with the following: • Autoimmune diseases (eg, lupus and scleroderma). • A compromised immune system (eg, currently receiving immunosuppressive therapy). • Planned chemotherapy following breast implant placement. • Planned radiation therapy to the breast following breast implant placement. • Conditions or medications that interfere with wound healing and blood clotting. • Reduced blood supply to breast tissue. • Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery. ADVERSE EVENTS Key adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV. Other potential adverse events that may occur with breast implant surgery include: asymmetry, breast pain, breast/skin sensation changes, capsular calcification, delayed wound healing, hematoma, hypertrophic scarring/scarring, implant extrusion, implant malposition, implant palpability/visibility, infection, nipple complications, redness, seroma, swelling, tissue/skin necrosis, wrinkling/rippling. For more information see the full Directions for Use at www.allergan.com/labeling/usa.htm. To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871. Natrelle® Breast Implants are available by prescription only. 3 2 breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Intraoperative Breast Implant Sizers Important Information INDICATIONS The Natrelle ® Silicone Sizer and the Allergan Saline Sizer are indicated for single use only for temporary intra-operative insertion in the surgical pocket to evaluate and assist in determining the final breast implant size/volume. The Natrelle ® Re-sterilizable (410 and Round) Silicone Breast Implant Sizer is used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of a breast implant to use. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS All sizers are contraindicated for use as long-term breast implants or tissue expanders. The Natrelle ® Silicone Sizer and the Allergan Saline Sizer are contraindicated for multiple patient use or multiple sterilizations. WARNINGS Sizers are designed for temporary intra-operative use only and are NOT long-term implants. DO NOT alter, insert or attempt to repair a damaged sizer. DO NOT reuse the Natrelle ® Silicone Sizer or the Allergan Saline Sizer, which are for single use only. The Silicone Sizers may rupture and release silicone gel. Infection, necrosis, hematoma/seroma and pain may occur following any type of surgery. Minute quantities of silicone gel may diffuse through the elastomer envelope. PRECAUTIONS The surgeon must carefully evaluate patient suitability and be knowledgeable about the use of this device. DO NOT expose the sizer to contaminants. Avoid damaging the sizer with surgical instruments (e.g. sharp, blunt or cautery devices). DO NOT attempt to repair damaged products. DO NOT damage the sizer by overhandling, manipulation, or excessive force. Maintain a sterile back-up sizer during surgery. ADVERSE EVENTS Adverse events and/or complications may include sepsis, hemorrhage, thrombosis, bleeding, and/or infection. For more information, please visit www.allergan.com/labeling/usa.htm. To report a problem, please call Allergan at 1-800-433-8871. Intraoperative Breast Implant Sizers are available by prescription only. 4 5 Natrelle® 133Plus and 133 Tissue Expanders With/Without Suture Tabs and With MAGNA-SITE® Injection Sites Important Information INDICATIONS Natrelle® 133Plus and 133 Tissue Expanders are indicated for: • Breast reconstruction following mastectomy. • Treatment of underdeveloped breasts. • Treatment of soft tissue deformities. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Natrelle® 133Plus and 133 Tissue Expanders SHOULD NOT be used in patients: • Who already have implanted devices that would be affected by a magnetic field (eg, pacemakers, drug infusion devices, artificial sensing devices). • Whose tissue at the expansion site is determined to be unsuitable. • Who have an active infection or a residual gross tumor at the expansion site. • Undergoing adjuvant radiation therapy. • Whose physiological condition (eg, sensitive over- or underlying anatomy, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use of certain drugs (including those that interfere with blood clotting or affect tissue viability) poses an unduly high risk of surgical and/or postoperative complications. • Who are psychologically unsuitable. WARNINGS • DO NOT use Natrelle® 133Plus and 133 Tissue Expanders in patients who already have implanted devices that would be affected by a magnetic field (see Contraindications), because the MAGNA-SITE® integrated injection site contains a strong rare-earth, permanent magnet. Diagnostic testing with Magnetic Resonance Imaging (MRI) is contraindicated in patients with Natrelle® 133Plus and 133 Tissue Expanders in place. • DO NOT alter the tissue expander or use adulterated fill. Fill only with sterile saline for injection as described in INSTRUCTIONS FOR USE. DO NOT expose to contaminants. • DO NOT expand if the pressure will compromise wound healing or vasculature of overlying tissue, or beyond patient or tissue tolerance. Stop filling immediately if tissue damage, wound dehiscence, abnormal skin pallor, erythema, edema, pain, or tenderness are observed. • Active infection anywhere may increase risk of periprosthetic infection. Postoperative infections should be treated aggressively. Unresponsive or necrotizing infection may require premature removal. • Natrelle® 133Plus and 133 Tissue Expanders are temporary, single-use only devices, and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 months to 6 months. • When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs. PRECAUTIONS Active infections may need to be treated and resolved before surgery. Allergan relies on the surgeon to know and follow proper surgical procedures and carefully evaluate patient suitability using standard practice and individual experience. Avoid damage to the tissue expander and use a sterile backup in case of damage. Pay careful attention to tissue tolerance and hemostasis during surgery. Expansion should proceed moderately and never beyond patient or tissue tolerance. Avoid contamination in any postoperative procedure. ADVERSE REACTIONS Deflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue flap, and inflammatory reaction. For more information, please visit www.allergan.com/labeling/usa.htm. To report a problem with Natrelle®, please call Allergan at 1-800-433-8871. Natrelle® 133Plus and 133 Tissue Expanders are available by prescription only. 6 7 Artistry becomes reality with the most complete portfolio.3-5 Countless possibilities.6,‡ Inside this catalog, you will find the collection that has it all—the most complete portfolio of cohesive gel breast implants, saline-filled implants, and tissue expanders.3-5 Our science, research, and development—the substantiating factors in the safety of every one of our products—give us the confidence to know that we are providing you and your patients with a high level of satisfaction.7,8 ‡Over 700 breast implant options. Committed to supporting surgeons and patients. Natrelle® is dedicated to offering you a full range of services for your office and your patients. Programs such as the Natrelle® Gel Rewards Program, Brilliant Distinctions® Consumer Loyalty Program, Natrelle® ConfidencePlus®, and ALLERGAN PARTNER PRIVILEGES® are designed to support your practice and patients every step of the way. And they’re only offered from Natrelle® and Allergan. Natrelle® is the #1 plastic surgery portfolio1,2,*,† *Based on surgeon survey data, December 2016 (N = 100). †Based on US market share data through November 2016 (N = 67). ART. SCIENCE. 8 9 ART. SCIENCE. Natrelle® 410 The Natrelle® Cohesive Collection Natrelle INSPIRA® Cohesive Natrelle INSPIRA® Soft Touch Natrelle INSPIRA® Expansion meets breast shaping Create a precise pocket for the breast shape you both envision. Only Natrelle® 133Plus Tissue Expanders include the FOURTÉ™ Expander Fill System. • FOURTÉ™ fills tissue expanders 4X faster than a 21-gauge needle9,*,† Natrelle® 133 Tissue Expanders • 30 years of clinical experience10 *Clinical significance has not been established. † Methodology The FOURTÉ™ Expander Fill System and 21-gauge needle are attached to 60-cc syringes filled with water. The injector starts the injection at maximum effort while the time is tracked. When the plunger reaches the end of the syringe barrel, the time is stopped and recorded. This is repeated 20 times, recorded, and compared. 10 11 Nikki Natrelle INSPIRA® Style SRF-415 Individual results may vary. Natrelle INSPIRA® Collection 12 13 Natrelle INSPIRA® Soft Touch Natrelle INSPIRA® Natrelle INSPIRA Cohesive ® Three unique silicone gels feature cross-linking technology for 3 distinct cohesivities. Highly Cohesive cohesive Cohesivity Level Cohesivity Level Cohesivity Level 1 2 3 Cohesivity Level Cohesivity Level Cohesivity Level 1 2 3 Cohesivity Level Cohesivity Level 1 2 3 55% more cohesive than level 111,† Natrelle INSPIRA® SMOOTH ROUND GEL IMPLANTS STYLES SCX, SSX, & SRX EXTRA-FULL PROFILE Low Low Plus Moderate Full eXtra-Full Smooth Cohesive (SCX) Smooth Soft Touch All Natrelle INSPIRA® Round Gel Breast Implants offer: • Systematic diameter sizing for simplified implant selection • Smooth or BIOCELL® textured surface • 5 projection style options • Matching sizers available Natrelle® offers the widest range of cohesivities for every breast, patient type, and aesthetic vision—whether it’s Three cohesivities. for reconstruction, revision, or augmentation.11 Countless possibilities.6,* *Over 700 breast implant options. † Methodology Breast implant gel was measured for material properties using the BTC-2000 ™. The BTC-2000 ™ applies a controlled vacuum, or negative pressure, to the gel while measuring the dynamic response of material deformation using a synchronized target laser. The gel for each device (n = 8 per group) was tested at 3 sites, all at or near the apex of the implant (anterior side). From those measurements, the gel cohesivity was calculated and the relative change was determined. Natrelle INSPIRA® Collection 14 15 16 Natrelle INSPIRA® SMOOTH ROUND GEL IMPLANTS STYLES SCM, SSM, & SRM MODERATE PROFILE Low Low Plus Moderate Full eXtra-Full Smooth Cohesive (SCM) Smooth Soft Touch (SSM) Smooth INSPIRA (SRM) Volume (cc) Diameter (cm) Projection (cm) SMOOTH ROUND GEL IMPLANTS STYLES SCL, SSL, & SRL LOW PROFILE Low Low Plus Moderate Full eXtra-Full Smooth Cohesive (SCL) Smooth Soft Touch (SSL) Smooth INSPIRA (SRL) Volume (cc) Diameter (cm) Projection (cm) TEXTURED ROUND GEL IMPLANTS 17 18 19 20 Natrelle ® 410 Style FM Individual results may vary. Natrelle ® 410 Anatomical Gel 21 22 23 Natrelle ® 410 ANATOMICAL GEL IMPLANTS STYLE FX FULL HEIGHT/EXTRA-FULL PROJECTION Catalog Number Volume (cc) Width (cm) Height (cm) (cm)breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubaiRe-sterilizable Sizer MX-410165 MSZLX625Cohesivity LevelCohesivity LevelCohesivity Level123 Designed to mirror the curve of a woman’s breast. Natrelle® 410 Anatomical Gel Breast Implants are filled with highly cohesive silicone gel and are designed to maintain their shape over time. Natrelle ® 410 Anatomical Gel Breast Implants have the most high-projection (≥ 6.0 cm) sizes available.3-5 Natrelle® 410 Anatomical Gel Breast Implants offer: • Shaped fullness • Highly cohesive gel • BIOCELL® textured surface • 4 projection style options • Matching sizers available Natrelle ® 410 Anatomical Gel Breast Implants MMLMModerate ProjectionMXFXLXMFFFFMLFFLMLLLFull HeightModerate HeightLow HeightLow ProjectionFull ProjectioneXtra-Full Projection 116 size options3 Offering the highest-projection implant—7.1 cm—in all 3 heights.3-5 Natrelle ® 410 Anatomical Gel 25 26 24 STYLE LF LOW HEIGHT/FULL PROJECTION Catalog Number Volume (cc) Width (cm) Height (cm) Projection (cm) Re-sterilizable Sizer LF-410125 125 9.5 7.6 3.7 MSZLF125 LF-410150 150 10.2 4.4 10.0 15.0 350-370 468-230 10.2 11.9 Paired for precision Natrelle® 133Plus delivers a seamless match between tissue expander and round breast implant. • 100% match (in base width and projection) to Natrelle INSPIRA®12,† • 83% match (in base width and projection) to Natrelle ® 41012,† Only Natrelle ® 133Plus Tissue Expanders include the FOURTÉ™ Expander Fill System • Patented 4-needle design fills tissue expanders 4X faster than a standard 21-gauge needle9,‡,§ • May save up to 9 minutes of expander fill time9,‡,§ Building on the success of the original Natrelle® 133— the #1 surgeon-selected tissue expander.2,* Blue tabs designed for suture accuracy. FOURTÉ™ Expander Fill System Blue orientation line assists in precise placement within the breast pocket. *Based on US market share data through November 2016 (N = 67). Natrelle ® 133Plus Tissue Expanders 36 37 WARNING: The strong rare-earth, permanent magnet contained in the Natrelle ® Style 133Plus Series Tissue Expanders is contraindicated where the magnetic field may affect other polarized devices (eg, pacemakers, drug infusion devices, artificial sensing devices, similar-type products, and MRI procedures). NOTE: All Natrelle ® 133Plus Tissue Expanders include the FOURTÉ™ Expander Fill System. STYLE 133P-FX FULL HEIGHT/ EXTRA PROJECTION Catalog Number Volume (cc) Width 39 Jessica Natrelle ® 133 Style MV, 400 cc Natrelle ® 410 Style FF, 425 cc Individual results may vary. Natrelle ® 133 Tissue Expanders 40 41 Natrelle ® 133 Tissue Expanders Natrelle ® 133 Tissue Expanders offer a precise match with Natrelle ® breast implants. All Natrelle ® 133 Tissue Expanders offer: • 84 options with or without suture tabs3 • BIOCELL® textured surface • 7 style options *Based on US market share data through November 2016 (N = 67). #1 surgeon-selected tissue expander with 30 years of clinical experience.2,10,* Natrelle ® 133 Tissue Expanders 43 WARNING: The strong rare-earth, permanent magnet contained in the Natrelle ® Style 133 Series Tissue Expanders is contraindicated where the magnetic field may affect other polarized devices (eg, pacemakers, drug infusion devices, artificial sensing devices, similar-type products, and MRI procedures). breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai 44 45 FOURTÉ™ Expander Fill System Description Catalog Number Four-pronged 21-gauge, 1¾” butterfly needles, tubing, luer adapter F-4444 Natrelle ® tissue expander accessories Natrelle® breast implant accessories Sizer Templates Description Catalog Number Plastic measuring templates for Styles 133Plus and 133 Tissue Expanders, nonsterile: Styles 133P-FX and 133FX Sizer Template Set 30-00038 Styles 133P-FV and 133FV Sizer Template Set 30-00018 Styles 133P-MX and 133MX Sizer Template Set 30-00039 Styles 133P-MV and 133MV Sizer Template Set 30-00017 Styles 133P-SX and 133SX Sizer Template Set 30-00040 Styles 133P-SV and 133SV Sizer Template Set breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai 30-00035 Styles 133P-LV and 133LV Sizer Template Set 30-00016 MAGNA-FINDER® Xact Port Finders Description Catalog Number Xact2 External locating device with dermal indicator for use with Style 133Plus Tissue Expanders for locating MAGNA-SITE® injection sites (provided nonsterile) 30-00034 Xact External locating device for use with Style 133 Tissue Expanders for locating MAGNA-SITE® injection sites (provided nonsterile) 30-00032 21-G Needle Infusion Set Description Catalog Number 21-gauge, 1¾” butterfly needle, tubing, luer adapter 30-00012 Universal Fill Kit Description Catalog Number 60-cc syringe, 122-cm transfer set with piercing device, 25-cm extension tube, 2-way check valve 30-00033 Diaphragm Valve Fill Tube and Reflux Valve Description Catalog Number Diaphragm valve fill tube and reflux valve 25-00017 BIOCELL® Delivery Assistance Sleeve Description Catalog Number Clear, sterile sleeve 27-000001 The above accessories are not eligible for return for credit. The above accessories are not eligible for return for credit. Accessories 47 46 Warranty program brochure ConfidencePlus® warranty program Get more coverage and confidence with Natrelle ® Gel implants than with any other breast implant warranty— ONLY with Natrelle ® ConfidencePlus ®. • The ONLY warranty with a 10-year FREE breast implant replacement in the event of capsular contracture (Baker Grade III/IV) • The ONLY warranty to cover primary AND revision surgeries in the event of capsular contracture (Baker Grade III/IV) • The ONLY warranty that allows you to choose ANY style and size of Natrelle® Gel breast implant for replacement in the event of capsular contracture (Baker Grade III/IV) or rupture • Lifetime product replacement for all gel implants in the event of rupture • Financial assistance up to $3500 for 10 years in the event of implant rupture For more information about the ConfidencePlus ® warranty program, please visit Natrelle.com/warranty. Accessories Warranty Program 48 49 Additional information CAUTION: United States Federal Law restricts these devices to sale by, or on the order of, a licensed physician. PRODUCT SUPPLIED STERILE: Please see Directions for Use at www.allergan.com/labeling/usa.htm for additional product information including warnings, precautions, adverse reactions, and instructions for use. Natrelle ® Styles 133Plus and 133 Tissue Expander Sizing Templates and MAGNA-FINDER® breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Xact2 and Xact are supplied nonsterile. DIMENSIONS: Dimensions listed are typical and are measured with the implant placed on a flat surface. Not every implant will conform to the dimensions given. Slight variations may occur. RECOMMENDED FILL VOLUMES: Following recommended fill volumes for saline-filled breast implants can decrease t breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai he possibility of shell wrinkling and crease-fold failure.13 Committed to advancing the field of breast aesthetics. We have advanced the medical aesthetics industry through scientific discovery, market innovation, and partnering with the medical communities that we serve. Building on 50 years of scientific research and development, we are taking our passion for innovation and applying it to the consumer realm. That’s why we’ve created the Natrelle ® Portfolio—specially designed to give you and your patients more options to help you achieve the desired results. Additional Information Warranty Program 50 51 ART. SCIENCE. Shaping the future with you Natrelle® is the #1 plastic surgery portfolio.1,2,*,† Natrelle INSPIRA® Collection #1 selected round gel implant collection in the US.1,* Natrelle ® 410 #1 selected anatomically shaped implant in the US.2,† Natrelle® 133 Series #1 selected tissue expander in the US.2,† Natrelle INSPIRA® Cohesive Most cohesive round gel breast implant in the US.11 *Based on surgeon survey data, December 2016 (N = 100). †Based on US market share data through November 2016 (N = 67). To order breast aesthetics products, please call Customer Care at 1-800-766-0171. © 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Natrelle.com NAT64504_v2 03/17 170324 References: 1. Data on file, Allergan, December 2016; Plastic Surgery Monthly Tracker: Breast Implants & Tissue Expanders. 2. Data on file, Allergan, November 2016; Breast Implant + Tissue Expander Share Tracker. 3. More of Everything: Natrelle® Product Catalog. Irvine, CA: Allergan; 2015. 4. Our products: breast implants. Mentor Worldwide LLC website. http://www.mentorwwllc.com/global-us/Breast.aspx. Updated April 2016. Accessed February 14, 2017. 5. Sientra® HSC & HSC + Breast Implant Product Catalog. Santa Barbara, CA: Sientra, Inc., 2015. http://sientra.com/Content/pdfs /MDC-0177%20R2%20HSCHSC%2B%20Breast%20Implants%20Product%20Catalog.pdf. Accessed February 14, 2017. 6. Data on file, Allergan, January 2017; Allergan Plastic Surgery Order Form. 7. Natrelle® Silicone-Filled Breast Implants and Natrelle INSPIRA® Breast Implants: Smooth & BIOCELL® Texture Directions for Use, 2016. 8. Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Directions for Use, 2014. 9. Data on file, Allergan, January 4, 2016; Protocol MM-1225-FR. 10. Data on file, Allergan, July 14, 1986; FDA Section 510(k) marketing approval letter. 11. Data on file, Allergan, February 8, 2017; Study Report MD16075-DV2. 12. Data on file, Allergan, January 6, 2017; Study Report MD16076-DV. 13. Natrelle ® Saline-Filled Breast Implants: Smooth & BIOCELL® Texture Directions for Use, 2014. Additional Information Founded in 1979, Nagor™ is the only British company dedicated to the specialist design, manufacture and supply of high quality breast implants and related medical devices. Nagor’s commitment to quality is demonstrated by ongoing research and development with investment in manufacturing processes, supported by the most demanding quality control management. Nagor’s products are manufactured under a quality management system in accordance with EN ISO 13485 and products intended for sale in Europe are CE certified according to the applicable European medical device regulations. All dimensions and weights are approximate and slight variations may occur between the product catalogue and the product label. 4 5 Introduction to Breast Aesthetics Shapes • Round: Impleo™ • Anatomical: CoGel™ SiloGard™ 360° Barrier Layer All Nagor™ implants are manufactured with high performance silicone elastomer layers to enhance shell integrity and have a unique SiloGard™ 360° barrier layer to minimise gel diffusion. Shell surface • Smooth • Nagotex® mid-textured SiloGel Twist™ 6th generation soft form stable high cohesive silicone gel. GCA comfort guarantee Lifetime product replacement warranty, for details view our brochure. Instructions for use We encourage surgeons to refer to the package insert supplied with every Nagor® product for instructions for use, indications and contraindications. Round Silicone Gel-Filled implants Anatomical Silicone Gel-Filled implants Profile Moderate High Extra High Textured Surface Soft Form Stable High Cohesive Gel 100% Fill IMP-MR IMP-HR IMP-EHR Smooth Surface Soft Form Stable High Cohesive Gel 100% Fill IMP-SMR IMP-SHR IMP-SEHR CoGel® System Low Moderate High Full Height XF1 XF2 XF3 Moderate Height XM1 XM2 XM3 Low Height XL1 XL2 XL3 Breast Aesthetics 6 Nagotex® Mid-textured Surface. Tapered edges for less visibility and palpability. Firm upper pole for shape maintenance. Higher projection for added lift. SiloGard™ 360° Barrier. SiloGel™ form stable high cohesive gel. 7 Orientation marker dots. Gel-filled and Inflatable Sizers available for core sizes. XF1 (F) Full Height (1) Low Projection XM1 (M) Moderate Height (1) Low Projection XL1 (L) Low Height (1) Low Projection XL2 (L) Low Height (2) Moderate Projection XL3 (L) Low Height (3) High Projection XM2 (M) Moderate Height (2) Moderate Projection XM3 (M) Moderate Height (3) High Projection XF2breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai(F) Full Height (2) Moderate Projection XF3 (F) Full Height (3) High Projection Greater Precision for Individualised Augmentation. 7 WIDTH / HEIGHT W H LVC P A PROJECTION / ARC IMPLANT CATALOGUE MENTOR® BREAST IMPLANTS © Mentor Worldwide LLC 2018 062724-161103 F RO N T PA G E F I N I S H E S S H O R T In 2002, we completed a plant in Leiden, The Netherlands. At 6,000 square meters, it is one of the largest of its kind in the world. This plant contains an automated breast implant dipping machine, which produces every implant shell in a consistently uniform manner. To meet an ever-increasing demand for our products, plant produces more than 300,000 breast implants a year, distributed to more than 100 nations. At Mentor all our products are made under strict standards of design and testing. F RO N T PA G E F I N I S H E S S H O R T F RO N T PA G E F I N I S H E S S H O R T Founded in 1969, Mentor Worldwide LLC is a leading manufacturer and supplier of medical products for the global Aesthetic medicine market and Reconstructive surgery. As the world’s leading maker of high-quality breast implants for over 30 years, our experience results in quality products that you can rely on. Headquartered in Irvine, California, Mentor has manufacturing and research operations in the United States and the Netherlands. In 1995, Mentor became the first breast implant manufacturer to achieve CE-marking for its products. Mentor has worked closely with surgeons throughout the world to develop innovative products such as MENTOR® CONTOUR PROFILE™ BECKER™ 35 Expander/ Breast Implant and the MENTOR® CPG™ breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Gel Breast Implants. Mentor’s manufacturing capability is exceptional. We have substantial experience in biomaterials and biopolymers manufacturing. At the same time, our regulatory expertise has enabled the Company to bring products to market in the world’s most stringently regulated health care environments. Mentor is a manufacturer with a strong customer focus. Our sales representatives are skilled in technical product issues, enabling them to act as a valuable information F RO N T PA G E F I N I S H E S S H O R T resource. For questions or additional information, please contact your local Mentor branch, Johnson & Johnson office or distributor. On Jan 23, 2009, Mentor was acquired by Johnson & Johnson, one of the leading providers of suture, mesh, hemostats and other products for a wide range of surgical procedures. By joining forces, we aspire to be the trusted global leader in aesthetic medicine among both consumers and professionals by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. Simply said, our goal is to make life more beautiful. F RO N T PA G E F I N I S H E S S H O R T A More Evolved Implant MemoryGel™ BREAST IMPLANTS About MemoryGel™ Implants MENTOR® MemoryGel™ Breast Implants feature a proprietary cohesive silicone gel formulation used to fill all MENTOR® Silicone Gel-Filled Breast Implants around the world. By varying the components of the gel, Mentor is able to produce a wide selection of products ranging from very soft to very firm. • Strict US and EU manufacturing standards • Highly compliant shell for ease of placement • Lifetime product replacement policy • MENTORPromise Protection Plan, the most comprehensive protection plan available1 • Moderate Plus, Xtra Moderate Plus, High, Xtra High and Ultra High projection • Proprietary silicone gel formula for a natural touch that resembles breast tissue F RO N T PA G E F I N I S H E S S H O R T MemoryGel™ Breast Implants MemoryGel™ Breast Implants Product Scale Product Profile Cohesive I™ Cohesive II™ Cohesive III™ Round Moderate Plus Memory GelTM Xtra Moderate Plus Round High Memory GelTM Xtra High Round Ultra High CPGTM Gel Breast Implant Round BECKERTM 25 Expander/ Breast Implant CONTOUR PROFILETM BECKER™ Expander/ Breast Implant 35 F RO N T PA G E F I N I S H E S S H O R T All MENTOR® Silicone Gel-Filled Breast Implants contain gel that is cohesive, safe and aesthetically pleasing’. Cohesive I™ The standard cohesive level gel used in Mentor® Breast Implants. This is the softest gel and has been preferred by millions of women worldwide. Products are available textured and smooth Moderate Plus, Xtra Moderate Plus, High, Xtra High and Ultra High projection Gel Breast Implants as well as the MENTOR® Becker™ Expander/Breast Implants. Cohesive II™ A slightly firmer gel, for surgeons wanting a firmer feeling implant. This gel is used in textured Moderate Plus, High Profile Gel Breast Implants and MENTOR® Contour Profile™ Becker™ Expander/Breast Implants. Cohesive III™ Mentor’s most cohesive gel, providing shape retention with a pleasing level of firmness for optimal aesthetic results. This gel is used in the Mentor® CPG™ Gel Breast Implants. All Cohesive, all the time.™ Advanced MemoryGel™ Breast Implants. The more evolved implant. F RO N T PA G E F I N I S H E S S H O R T PROVEN TEXTURE YOU CAN TRUST MENTOR® CPG™ Implants are proven to have a low risk of capsular contracture and rotation in primary augmentation patients at 10 years and are covered by the most comprehensive warranty in the market.2 Not a head to head study. Based on the comparison of key complication rates reported in the 10 year Core Studies for MemoryShape®/ CPG™ Gel Breast Implants, NATRELLE™ 410 TruForm™ 3 Gel Breast Implants. *Specification for MemoryGel™ Round Gel implants The third-party trademarks used herein are trademarks of their respective owners. MENTOR®: SILTEX™ Texture3* Allergan®: Biocell Texturing3 Surface Description Manufacturing Technique Pore Size Width (μm) Pore Size Depth/ Height (μm) Edge(μm) Distribution Depression or Nodules Gentle patterned surface Aggressive, open-pored surface with cuboid-shape depressions and a stilted edge Negative contact imprint off polyurethane texturing foam Shell is pressed onto bed of finely granular salt: lost salt technique 70-150 600-800 40-100 (height) 100-150 (depth) 0 100-150 Regular Irregular Nodules Depressions F RO N T PA G E F I N I S H E S S H O R T PROVEN PERFORMANCE Reliable implants continuously delivering world class clinical results. The lowest reported risk of key complications in primary breast augmentation for MENTOR® CPG™ Gel Breast Implants at 10 years2 Primary Augmentation MENTOR®CPG Breast Implant Core Study, Long Term 10 years4 Allergan® Natrelle® Breast Implant Core Study, Long Term 10 years5,6 Capsular Contracture (Baker III/IV) Suspected or Confirmed Rupture (MRI Cohort) Device Removal (with or without replacement) Rotation 3.6% 6.6% 9.2% 1.3% 9.2% 17.7% 19.6% 4.7% Kaplan-Meier estimated risk of first occurrence. Data presented in table is not based on a head to head comparison of the Mentor® CPG™ Gel Breast Implant and the Allergan® Natrelle® 410 Breast Implant Core Studies. F RO N T PA G E F I N I S H E S S H O R T 8080 PERSON YEARS OF FOLLOW UP DATA 43 SITES 955 SUBJECTS Multi-center Core Study F RO N T PA G E F I N I S H E S S H O R T PROVEN PEACE of MIND To our Mentor customers and patients, we pledge our commitment to excellence. That is why we back our MemoryGelTM Breast Implants with the most comprehensive plan in the industry. Mentor Warranties & Product Replacement Policy † In the event of a confirmed rupture or deflation (leaking) of any MENTOR® Breast Implant due to wear or delamination requiring surgical intervention, regardless of the age of the implant, Mentor will provide a free replacement of a MENTOR® Breast Implant of any size in the same or similar style as the originally implanted product. α When a replacement surgery of a MENTOR® Gel-Filled Breast Implant is required due to confirmed rupture occurs within ten (10) years from the date of implantation, provided that eligibility is proven and confirmed by Mentor based on its assessment and evaluation, Mentor will pay uninsured, out-of-pocket costs for operating room, anesthesia and/or surgical expenses directly related to revision surgery up to a maximum aggregate amount of €1000. Operating room and anesthesia charges shall be given payment priority. In such cases, the request for financial assistance under the MentorPromise Protection Plan must be made to your surgeon. Financial assistance does not imply a loan to you. β In the events of capsular contracture (Baker III/IV), double capsule or late-stage seroma in augmentation surgery of a MENTOR® Gel-Filled Breast Implant, Mentor will provide a replacement of a MENTOR® Gel-Filled Breast Implant, free of charge for the period of ten (10) years from the date of implantation, provided that eligibility is proven and confirmed by Mentor based on its evaluation of explanted product and assessment of all required documentation. Mentor will provide a replacement MENTOR® Product of any size in the same or similar style as the originally implanted product. For further information about MENTOR® CPG™ Breast Implants or any other MENTOR® Products, talk to your Mentor sales representative today or visit mentorwwllc.eu $ 10 YEAR FREE AND AUTOMATIC ENROLLMENT MENTORPromise Protection Plan Overview FREE CONTRALATERAL IMPLANT at your surgeon’s request FREE PRODUCT REPLACEMENT IN THE EVENTS OF CAPSULAR CONTRACTURE (Baker III/IV), DOUBLE CAPSULE AND LATE STAGE SEROMAβ UP TO €1000 FINANCIAL ASSISTANCE COVERAGE FOR RUPTUREα FREE LIFETIME PRODUCT REPLACEMENT FOR RUPTURE† F RO N T PA G E F I N I S H E S S H O R T Uncover the unique SILTEXTM Texture of MENTOR® CPGTM Gel Breast Implants today. Talk to your Mentor Sales Representative or visit mentorwwllc.eu for more information. A closer look at MENTOR® patented SILTEX™ Texture SEM images of SILTEXTM Texture Anterior View Radius View Posterior View Cross Section View SILTEX™ Texture providing you and your patients with peace of mind. F RO N T PA G E F I N I S H E S S H O R T RIGHT FROM THE START. MADE TO MATCH Expansion matters. Texture you can trust. Natural shape Presenting the: CPX™4 Breast Tissue Expander and CPG ™ Gel Breast Implants, giving you greater control over the desired shape in two stage breast reconstruction: 1. MENTOR® is the only company to offer a breast tissue expander with proven directional lower pole expansion7 2. CPG Implants can help achieve a smooth transition from tissue to implant8 3. Unsurpassed Peace of Mind F RO N T PA G E F I N I S H E S S H O R T γ The third-party trademarks used hereibreast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai are trademarks of their respective owners CPX™4 Breast Tissue Expander Post operatively adjustable device PATIENT COMFORT Incorporates two principle innovations that were designed to enhance patient comfort while maintaining the same expansion profile9 TEXTURED SURFACE The patented SILTEXTM Texture has a surface substantially free of pores and interstices The manufacturing process for the SILTEXTM Texture on MENTOR® Breast Tissue Expanders does not require the use of salt or sugar crystals. EASY TO DETECT The CENTERSCOPE® Magnetic Detection Device locates the magnetic injection dome for absolute ease and acuracy. The injection dome contains a rare earth magnet that is 48% stronger than previous expanders9 NATURAL SHAPE The Combination of the Buffer- ZoneTM Self-Sealing Patch and the posterior Dacron® Patch provides directionally focused expansion to maximize lower pole expansion to mimic the shape of a natural breast γ F RO N T PA G E F I N I S H E S S H O R T F RO N T PA G E F I N I S H E S S H O R T MENTOR® MemoryGel™ Xtra Breast Implants She’s confident in what she wants - An innovation in breast implants from the brand you trust. Soft, Natural Feelδ10 Xtra Fullness11 Xtra Firmness11 Xtra Projection11 δ In-person consumer survey with 452 respondents. F RO N T PA G E F I N I S H E S S H O R T F RO N T PA G E F I N I S H E S S H O R T Round Expanders Other CPG Siltex™ Round Breast Implants, Cohesive ITM Smooth Round Breast Implants, Cohesive ITM Siltex™ and Smooth MemoryGel™ Xtra Breast Implants Siltex™ Round Breast Implants, Cohesive IITM CONTOUR PROFILE™ Tissue Expanders BECKER™ Expander/Breast Implants Other Expanders Accessories Saline products Sizers CPG™ Gel Breast Implants, Cohesive III™ F RO N T PA G E F I N I S H E S S H O R T Round SILTEX™ Round Breast Implants, Moderate Plus Profile, Cohesive ITM Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε Round Gel Breast Implants, Cohesive I™ - 2 - ε Resterilizable up to 10 times. Round Round Gel Breast Implants, Cohesive I™ SILTEX™ Round Breast Implants, High Profile, Cohesive I™ Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε ε Resterilizable up to 10 times. Round Round Gel Breast Implants, Cohesive I™ SILTEX™ Round Breast Implants, Ultra High Profile, Cohesive I™ Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε - 4 - ε Resterilizable up to 10 times. Round Round Gel Breast Implants, Cohesive I™ - 5 - Round Round Gel Breast Implants, Cohesive I™ Smooth Round Breast Implants, Moderate Plus Profile, Cohesive I™ Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε ε Resterilizable up to 10 times. Round Round Gel Breast Implants, Cohesive I™ Smooth Round Breast Implants, High Profile, Cohesive I™ Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε ε Resterilizable up to 10 times. Round Round Gel Breast Implants, Cohesive I™ Smooth Round Breast Implants, Ultra High Profile, Cohesive I™ Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε ε Resterilizable up to 10 times. Round - 9 - Round Gel Breast Implants, Cohesive I™ Round SILTEX™ Round Moderate Plus Profile Xtra Gel Breast Implants Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε - 10 - MemoryGelTM Xtra Breast Implants ε Resterilizable up to 10 times. Round - 11 - MemoryGelTM Xtra Breast Implants SILTEX™ Round High Profile Xtra Gel Breast Implant Vol cc Diameter cm Proj cm Catalog # breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Resterilizable Gel Sizerε 150 8,4 4,2 THPX-150 RSZTHPX150 175 9,0 4,4 THPX-175 RSZTHPX175 200 9,4 4,5 THPX-200 RSZTHPX200 230 9,8 4,8 THPX-230 RSZTHPX230 255 10,1 4,9 THPX-255 RSZTHPX255 285 10,5 5,1 THPX-285 RSZTHPX285 325 10,8 5,4 THPX-325 RSZTHPX325 340 11,1 5,4 THPX-340 RSZTHPX340 365 11,4 5,5 THPX-365 RSZTHPX365 405 11,6 5,9 THPX-405 RSZTHPX405 425 11,9 5,8 THPX-425 RSZTHPX425 455 12,1 6,0 THPX-455 RSZTHPX455 470 12,3 5,9 THPX-470 RSZTHPX470 515 12,6 6,2 THPX-515 RSZTHPX515 570 13,2 6,3 THPX-570 RSZTHPX570 620 13,4 6,5 THPX-620 RSZTHPX620 680 14,0 6,6 THPX-680 RSZTHPX680 725 14,5 6,7 THPX-725 RSZTHPX725 765 14,7 6,7 THPX-765 RSZTHPX765 ε Resterilizable up to 10 times. Round - 12 - MemoryGelTM Xtra Breast Implants Smooth Round Moderate Plus Profile Xtra Gel Breast Implant Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε ε Resterilizable up to 10 times. Round MemoryGelTM Xtra Breast Implants Smooth Round High Profile Xtra Gel Breast Implant Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε ε Resterilizable up to 10 times. Round Round Gel Breast Implants, Cohesive II™ SILTEX™ Round Breast Implants, Moderate Plus Profile, Cohesive II™ Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε ε Resterilizable up to 10 times. Round Round Gel Breast Implants, Cohesive II™ SILTEX™ Round Breast Implants, High Profile, Cohesive II™ Vol cc Diameter cm Proj cm Catalog # Resterilizable Gel Sizerε ε Resterilizable up to 10 times. Round - 16 - CPG MENTOR® CPG™ Gel Breast Implants, Cohesive III™ Diagrams not to scale, for reference only. LOWER POLE ARC (LPA) = Length measured along the lower pole of the implant running from the bottom of the implant (Point B) upto the midway point (Point A) including a 0,5 cm of tissue thickness. MIDWAY POINT HEIGHT LOWER POLE ARC MEASUREMENT ASSUMES 0,5 CM OF TISSUE THICKNESS 50% 50% 0,5 cm MENTOR® CPG™ BREAST IMPLANT NAMING LEGEND Cohesive Level Implant Height Implant Projection III 3 Tall 3 Medium 2 Low 1 High 3 Moderate Plus 2 Moderate 1 KEY: DIGIT 1 = COHESIVE LEVEL DIGIT 2 = HEIGHT OF IMPLANT DIGIT 3 = PROJECTION OF IMPLANT UNDERSTANDING THE LOWER POLE ARC - 17 - CPG CPG™ Gel Breast Implants, Cohesive III™ Vol cc Width cm Height cm Projection cm Lower Pole Arc A-B cm Catalog # Resterilizable Gel Sizerε CPG™ Implants 331, Cohesive III™, Tall Height, Moderate Projection Vol cc Width cm Height cm Projection cm Lower Pole Arc A-B cm Catalog # Resterilizable Gel Sizerε CPG™ Implants 321, Cohesive III™, Medium Height, Moderate Projection ε Resterilizable up to 10 times. - 18 - CPG CPG™ Gel Breast Implants, Cohesive III™ Vol cc Width cm Height cm Projection cm Lower Pole Arc A-B cm Catalog # Resterilizable Gel Sizerε CPG™ Implants 311, Cohesive III™, Low Height, Moderate Projection - 19 - ε Resterilizable up to 10 times. CPG CPG™ Gel Breast Implants, Cohesive III™ CPG™ Implants 322, Cohesive III™, Medium Height, Moderate Plus Projection Vol cc Width cm Height cm Projection cm Lower Pole Arc A-B cm Catalog # Resterilizable Gel Sizerε - 20 - Vol cc Width cm Height cm Projection cm Lower Pole Arc A-B cm Catalog # Resterilizable Gel Sizerε CPG™ Implants 332, Cohesive III™, Tall Height, Moderate Plus Projection ε Resterilizable up to 10 times. CPG Vol cc Width cm Height cm Projection cm Lower Pole Arc A-B cm Catalog # Resterilizable Gel Sizerε CPG™ Implants 312, Cohesive III™, Low Height, Moderate Plus Projection CPG™ Gel Breast Implants, Cohesive III™ - 21 - ε Resterilizable up to 10 times. CPG CPG™ Gel Breast Implants, Cohesive III™ - 22 - Vol cc Width cm Height cm Projection cm Lower Pole Arc A-B cm Catalog # Resterilizable Gel Sizerε CPG™ Implants 323, Cohesive III™, Medium Height, High Projection Vol cc Width cm Height cm Projection cm Lower breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai CPG Vol cc Width cm Height cm Projection cm Lower Pole Arc A-B cm Catalog # Resterilizable Gel Sizerε CPG™ Implants 313, Cohesive III™, Low Height, High Projection CPG™ Gel Breast Implants, Cohesive III™ - 23 - ε Resterilizable up to 10 times. CPG MENTOR® CONTOUR PROFILE™ Breast Tissue Expanders / CPG™ Gel Breast Implants Sizing Guide / Two-Stage Breast Reconstruction STAGE 1 Selection of the CPX4™Expander Styles 9100 – Low Height Volume cc Width cm Height cm Proj. cm Catalog # CPG™ Implant 311 Cohesive III™, Low Height, Moderate Projection Volume cc Width cm Height cm Proj. cm Catalog # 180 11,0 9,8 3,7 334-1101 210 11,5 10,3 3,9 334-1151 270 12,5 11,2 4,2 334-1251 300 13,0 11,6 4,4 334-1301 375 14,0 12,5 4,7 334-1401 460 15,0 13,4 5,1 334-1501 510 15,5 13,8 5,2 334-1551 560 16,0 14,3 5,4 334-1601 615 16,5 14,7 5,6 334-1651 CPG™ Implant 311 Cohesive III™, Low Height, Moderate Projection Volume cc Width cm Height cm Proj. cm Catalog # Styles 9200 – Medium Height Volume cc breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai cm Catalog # - 24 - CPG *PLEASE NOTE: The CONTOUR PROFILE™ Tissue Expander Injection Dome is not MRI compatible. For detailed indications, contraindications, warning and precautions associated with the use of this device, please refer to the Product Insert Data Sheet. Individual implant dimensions may vary slightly in products of this type. Not all units conform exactly to the dimensions noted. CPG™ Implant 312 Cohesive III™, Low Height, Moderate Plus Projection Volume cc Width cm Height cm Proj. cm Catalog # CPG™ Implant 313 Cohesive III™, Low Height, High Projection Volume cc Width cm Height cm Proj. cm Catalog # Selection of CPG™ Gel Breast Implant to use as a long-term implant after expansion is complete. STAGE 2 - 25 - CPG™ Implant 312 Cohesive III™, Low Height, Moderate Plus Projection Volume cc Width cm Height cm Proj. cm Catalog # CPG™ Implant 313 Cohesive III™, Low Height, High Projection Volume cc Width cm Height cm breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Height cm Proj. cm Catalog # Styles 9300 – Tall Height Volume cc Width cm Height cm Proj. cm Catalog # 250 10,1 10,7 5,6 354-9321 350 11,3 11,8 6,0 354-9322 450 12,3 12,9 6,5 354-9323 550 13,2 13,8 6,9 354-9324 650 14,0 14,6 7,3 354-9325 750 14,6 15,3 7,6 354-9326 850 15,4 15,9 7,9 354-9327 CPG™ Implant 321 Cohesive III™, Medium Height, Moderate Projection Volume cc Width cm Height cm Proj. cm Catalog # CPG™ Implant 331 Cohesive III™, Tall Height, Moderate Projection Volume cc Width cm Height cm Proj. cm Catalog # MENTOR® CONTOUR PROFILE™ Breast Tissue Expanders / CPG™ Gel Breast Implants Sizing Guide / Two-Stage Breast Reconstruction STAGE 1 Selection of the CPX4™Expander CPG CPG™ Implant 322 Cohesive III™, Medium Height, Moderate Plus Projection Volume cc Width cm Height cm Proj. cm Catalog # CPG™ Implant 323 Cohesive III™, Medium Height, High Projection Volume cc Width cm Height cm Proj. cm Catalog # CPG™ Implant 332 Cohesive III™, Tall Height, Moderate Plus Projection Volume cc Width cm Height cm Proj. cm Catalog # CPG™ Implant 333 Cohesive III™, Tall Height, High Projection Volume cc Width cm Height cm Proj. cm Catalog # - 27 - *PLEASE NOTE: The CONTOUR PROFILE™ Tissue Expander Injection Dome is not MRI compatible. For detailed indications, contraindications, warning and precautions associated with the use of this device, please refer to the Product Insert Data Sheet. Individual implant dimensions may vary slightly in products of this type. Not all units conform exactly to the dimensions noted. Selection of CPG™ Gel Breast Implant to use as a long-term implant after expansion is complete. STAGE 2 CPG - 28 - Expanders CPX Breast Tissue Expander BufferZone™ Self-sealing patch and posterior Dacron® Patch. • Protecting the chest wall whilst driving lower pole expansion to mimic the shape of the natural breast. Improved stronger magnet.ζ • Easier to locate injection dome for larger patients. Enhanced smooth, flat injection dome and shell pliability.ζ • Helps ease insertion and removal through incision. Better more pliant proprietary BufferZone™ Patch.ζ • Enhanced patient comfort. Patented SILTEX Texture. • Prevents the pooling or sequestration of body fluids. Implant matching. • Matching range of definitive implants to be used after tissue expansion. ζ Compared with the MENTOR® CPX2™ and CPX3™ Breast Tissue Expanders. BufferZone™ Self-sealing patch and posterior Dacron® Patch. • Protecting the chest wall whilst driving lower pole expansion to mimic the shape of the natural breast. Improved stronger magnet.* • Easier to locate injection dome for larger patients. Enhanced smooth, flat injection dome and shell pliability.* • Helps ease insertion and removal through incision. Better more pliant proprietary BufferZone™ Patch.* • Enhanced patient comfort. ® Texture. • Prevents the pooling or sequestration of body fluids. • Matching range of definitive implants to be used after tissue expansion. Patented SILTEX Implant matching. *Compared with the MENTOR® CPX2™ and CPX3™ Breast Tissue Expanders. Mentor CPX4 Breast Tissue Expander Expanders - 29 - 27 Expanders CONTOUR PROFILE™ Tissue Expanders CPX™4 Breast Tissue Expander, Low Height, Style 8100 η Volume cc Width cm Height cm Projection cm Catalog # 250 11,4 8,1 6,1 354-8121 350 12,7 9,4 6,5 354-8122 450 14,0 10,2 7,1 354-8123 550 15,0 10,9 7,4 354-8124 650 15,7 11,2 7,9 354-8125 750 16,5 11,9 8,1 354-8126 CPX™4 Breast Tissue Expander, Medium Height, Style 8200 η Volume cc Width cm Height cm Projection cm Catalog # CPX™4 Breast Tissue Expander, Tall Height, Style 8300η Volume cc Width cm Height cm Projection cm Catalog # η Includes CENTERSCOPETM Magnetic Detection Device PLEASE NOTE: Contour Profile™ Tissue Expanders are not MRI compatible Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above - 30 - Expanders η Includes CENTERSCOPETM Magnetic Detection Device PLEASE NOTE: Contour Profile™ Tissue Expanders are not MRI compatible Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above MENTOR® CPX™4 Breast Tissue Expander with Suture Tabs Low Height, Style 9100η Volume cc Width cm Height cm Projection cm Catalog # 250 11,4 8,1 6,1 354-9121 350 12,7 9,4 6,5 354-9122 450 14,0 10,2 7,1 354-9123 550 15,0 10,9 7,4 354-9124 650 15,7 11,2 7,9 354-9125 750 16,5 11,9 8,1 354-9126 MENTOR® CPX™4 Breast Tissue Expander with Suture Tabs Medium Height, Style 9200η Volume cc Width cm Height cm Projection cm Catalog # 275 10,7 9,3 6,2 354-9221 350 11,7 10,0 6,6 354-9222 450 12,7 10,8 7,0 354-9223 550 13,5 11,7 7,4 354-9224 650 14,6 12,6 7,6 354-9225 800 15,6 13,3 8,0 354-9226 MENTOR® CPX™4 Breast Tissue Expander with Suture Tabs Tall Height, Style 9300η Volume cc Width cm Height cm Projection cm Catalog # 250 10,1 10,7 5,6 354-9321 350 11,3 11,8 6,0 354-9322 450 12,3 12,9 6,5 354-9323 550 13,2 13,8 6,9 354-9324 650 14,0 14,6 7,3 354-9325 750 14,6 15,3 7,6 354-9326 850 15,4 15,9 7,9 354-9327 CONTOUR PROFILE™ Tissue Expanders - 31 - Expanders MENTOR® BECKER™ Expander/ Breast Implants SILTEX™ ROUND BECKER™ 25 EXPANDER/IMPLANTS, COHESIVE I™ (25% Silicone Gel, Cohesive I™, in outer lumen, 75% Saline in inner lumen) temporary overexpansion volumes Volume cc Gel Volume cc Max Saline cc Total Gel- Saline cc Total Saline cc Total Gel- Saline cc Diameter cm Proj. cm Cat.# 150 40 185 225 85-150 125-190 10,7 2,4 354-1500 200 50 250 300 125-200 175-250 11,6 2,7 354-2000 250 60 315 375 165-255 225-315 12,1 3,0 354-2500 300 75 375 450 200-300 275-375 12,9 3,0 354-3000 350 90 435 525 235-350 325-440 14,1 3,0 354-3500 400 100 500 600 275-400 375-500 13,9 3,4 354-4000 500 125 625 750 350-500 475-625 14,7 3,7 354-5000 600 150 750 900 425-600 575-750 15,6 4,2 354-6000 700 175 875 1050 500-700 675-875 16,8 4,3 354-7000 800 200 1000 1200 575-800 775-1000 17,2 4,6 354-8000 Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above - 32 - Expanders SILTEX™ CONTOUR PROFILE™ BECKER™ 35 Expander/Implants, Cohesive II™ (35% Silicone Gel, Cohesive II™, in outer lumen, 65% Saline in inner lumen) temporary overexpansion volumes Volume cc Gel Volume cc Max Saline cc Total Gel- Saline cc Total Saline cc Total Gel- Saline cc Width cm Height cm Proj. cm Cat.# MENTOR® BECKER™ Expander/ Breast Implants Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above - 33 - Expanders - 34 - Smooth Round Tissue Expanders Device Volume cc Diameter cm Projection cm Catalog # 400 11,3 5,9 350-4305M 550 13,4 5,8 350-4307M 700 14,6 6,7 350-4304M 850 15,0 7,2 350-4308M 1000 15,5 7,8 350-4306M Smooth Elliptical Tissue Expanders temporary overexpansion Device Volume cc Length cm Width cm Nominal Projection cm Proj. cm Max. Volume cc Catalog # 25 6,0 4,0 2,3 4,5 75 350-5301M breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Projection cm Catalog # Smooth Crescent Tissue Expanders Device Volume cc Length cm Width cm Projection cm Catalog # Other Tissue Expanders Expanders - 36 - Accessories Injection Port Detector Description CENTERSCOPE™ Magnetic Detection Device Injection Dome Description Dome Pack Set Can be used with SPECTRUM™ Shaped Adjustable Saline Breast Implant, Round BECKER™ Expander/Breast Implant, and Smooth Tissue Expanders 350-DOMPK Catalog # Catalog # 350-4402 Expanders - 37 - Other Round Saline Breast Implants Smooth Round Breast Implants, Moderate Profile NOMINAL FILL MAXIMUM FILL Volume cc Diameter cm Projection cm Volume cc Diameter cm Projection cm Catalog # Sterile Saline Sizerι 125 9,5 3,0 150 9,1 3,4 350-1610 351-125SZ 150 10,0 3,1 175 9,6 3,7 350-1615 175 10,6 3,3 200 10,0 3,9 350-1620 351-175SZ 200 11,0 3,4 225 10,4 3,9 350-1625 225 11,5 3,5 250 10,9 4,0 350-1630 351-225SZ 250 11,9 3,6 275 11,2 4,1 350-1635 275 12,3 3,7 300 11,7 4,2 350-1640 351-275SZ 300 12,6 3,7 325 12,1 4,3 350-1645 325 13,0 3,8 375 12,3 4,5 350-1650 351-325SZ 350 13,3 3,9 400 12,6 4,7 350-1655 375 13,6 4,0 425 12,8 4,8 350-1660 351-375SZ 425 14,2 4,1 475 13,5 4,9 350-1670 351-425SZ 475 14,8 4,2 525 14,2 4,9 350-1680 351-475SZ 525 15,0 4,2 575 14,5 5,1 350-1685 575 15,0 4,5 625 14,8 5,1 350-1690 625 15,2 4,6 700 14,9 5,6 350-1695 700 15,6 4,9 775 14,9 5,8 350-1697 Saline Breast Implants - 38 - ι Single Use Only Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Other Saline Breast Implants Smooth Round Breast Implants, Moderate Plus Profile NOMINAL FILL MAXIMUM FILL Volume cc Diameter cm Projection cm Volume cc Diameter cm Projection cm Catalog # Sterile Saline Sizerι - 39 - ι Single Use Only Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Other Smooth Round Breast Implants, High Profile NOMINAL FILL MAXIMUM FILL Volume cc Diameter cm Projection cm Volume cc Diameter cm Projection cm Catalog # Sterile Saline Sizerι Saline Breast Implants - 40 - Other Saline Breast Implants - 41 - SPECTRUM™ Adjustable Saline Breast Implants Smooth Round SPECTRUM™ Implants NOMINAL FILL MAXIMUM FILL Temp. Volume cc Min. Volume cc Final Volume cc Diameter cm Projection cm Final Volume cc Diameter cm Projection cm Catalog # SILTEX™ CONTOUR PROFILE™ SPECTRUM™ Implants NOMINAL FILL MAXIMUM FILL Temp. Volume cc Min. Volume cc Final Volume cc Width cm Height cmbreast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubaiProj. cm Final Volume cc Width cm Height cm Proj. cm Catalog # 275 235 275 11,5 9,5 5,1 330 11,1 9,4 6,3 354-2511 350 300 350 12,3 10,5 5,3 420 11,9 10,1 6,9 354-2512 450 380 450 13,2 11,0 6,1 540 12,7 11,0 7,5 354-2513 550 470 550 14,0 11,9 6,4 660 13,7 11,9 7,9 354-2514 650 550 650 15,0 12,7 6,6 780 14,5 12,5 8,2 354-2515 Other Sterile Resterilizable Gel Breast Implants Sizersε - 42 - Other Sterile Resterilizable Gel Breast Implants Sizersε ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Round Gel Breast Implant Sizers, Moderate Plus Profileε Volume cc Diameter cm Projection cm Catalog # 125 8,9 2,8 RSZ-1251 150 9,5 2,9 RSZ-1501 175 10,0 3,1 RSZ-1751 200 10,5 3,2 RSZ-2001 225 10,9 3,3 RSZ-2251 250 11,3 3,4 RSZ-2501 275 11,7 3,5 RSZ-2751 300 12,0 3,6 RSZ-3001 325 12,3 3,8 RSZ-3251 350 12,5 3,9 RSZ-3501 375 12,8 4,0 RSZ-3751 400 13,1 4,0 RSZ-4001 450 13,6 4,2 RSZ-4501 500 14,1 4,3 RSZ-5001 550 14,6 4,5 RSZ-5501 600 15,0 4,6 RSZ-6001 700 15,8 4,9 RSZ-7001 800 16,5 5,1 RSZ-8001 - 43 - Other - 44 - Sterile Resterilizable Gel Breast Implants Sizersε Round Gel Breast Implant Sizers, High Profile Volume cc breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai cm Projection cm Catalog # 125 8,3 3,5 RSZ-1254 150 8,8 3,7 RSZ-1504 175 9,3 3,9 RSZ-1754 200 9,7 4,0 RSZ-2004 225 10,1 4,2 RSZ-2254 250 10,5 4,3 RSZ-2504 275 10,8 4,4 RSZ-2754 300 11,1 4,5 RSZ-3004 325 11,4 4,6 RSZ-3254 350 11,7 4,8 RSZ-3504 375 12,0 4,8 RSZ-3754 400 12,2 5,0 RSZ-4004 425 12,5 5,0 RSZ-4254 450 12,8 5,1 RSZ-4504 500 13,2 5,3 RSZ-5004 550 13,6 5,5 RSZ-5504 600 14,0 5,6 RSZ-6004 650 14,4 5,7 RSZ-6504 700 14,8 5,8 RSZ-7004 800 15,5 6,0 RSZ-8004 ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Other - 45 - Sterile Resterilizable Gel Breast Implants Sizersε Round Gel Breast Implant Sizers, Ultra High Profile Volume cc Diameter cm Projection cm Catalog # 135 7,8 4,1 RSZ-5135 160 8,2 4,3 RSZ-5160 185 8,4 4,4 RSZ-5185 215 8,7 4,5 RSZ-5215 240 9,0 4,7 RSZ-5240 270 9,3 4,8 RSZ-5270 295 9,7 5,0 RSZ-5295 320 9,8 5,1 RSZ-5320 350 10,1 5,2 RSZ-5350 375 10,4 5,3 RSZ-5375 400 10,6 5,4 RSZ-5400 430 10,9 5,6 RSZ-5430 455 11,2 5,7 RSZ-5455 480 11,4 5,8 RSZ-5480 535 12,0 6,1 RSZ-5535 590 12,5 6,3 RSZ-5590 ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Other ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Round Moderate Plus Profile Xtra Sterile Resterilizable Gel Breast Implant Sizers (for textured implants) Volume cc Diameter cm Projection cm Catalog # 130 8,9 3,1 RSZMPX130 160 9,5 3,3 RSZMPX160 190 10,0 3,4 RSZMPX190 215 10,4 3,6 RSZMPX215 240 10,8 3,7 RSZMPX240 270 11,4 3,8 RSZMPX270 295 11,5 4,0 RSZMPX295 325 11,9 4,1 RSZMPX325 350 12,3 4,1 RSZMPX350 370 12,6 4,1 RSZMPX370 405 12,7 4,4 RSZMPX405 440 13,1 4,5 RSZMPX440 490 13,6 4,7 RSZMPX490 545 14,0 4,9 RSZMPX545 605 14,5 5,1 RSZMPX605 645 14,9 5,1 RSZMPX645 755 15,7 5,4 RSZMPX755 Sterile Resterilizable Gel Breast Implants Sizersε - 46 - Other Sterile Resterilizable Gel Breast Implants Sizersε ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Round Moderate Plus Profile Xtra Sterile Resterilizable Gel Breast Implant Sizers (for smooth implants) Volume cc Diameter cm Projection cm Catalog # 130 8,9 3,1 RSZMPX130 160 9,5 3,3 RSZMPX160 190 10,0 3,4 RSZMPX190 215 10,4 3,6 RSZMPX215 240 10,8 3,7 RSZMPX240 270 11,4 3,8 RSZMPX270 295 11,5 4,0 RSZMPX295 325 11,9 4,1 RSZMPX325 350 12,3 4,1 RSZMPX350 370 12,6 4,1 RSZMPX370 405 12,7 4,4 RSZMPX405 440 13,1 4,5 RSZMPX440 490 13,6 4,7 RSZMPX490 545 14,0 4,9 RSZMPX545 605 14,5 5,1 RSZMPX605 645 14,9 5,1 RSZMPX645 755 15,7 5,4 RSZMPX755 - 47 - Other - 48 - ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizers (for textured implants) Volume cc Diameter breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai cm Catalog # 150 8,3 4,1 RSZTHPX150 180 8,8 4,4 RSZTHPX175 200 9,2 4,5 RSZTHPX200 235 9,5 4,9 RSZTHPX230 260 9,9 5,0 RSZ-HPX255 285 10,3 5,0 RSZ-HPX285 335 10,7 5,4 RSZTHPX325 355 11,0 5,5 RSZTHPX340 380 11,3 5,5 RSZ-HPX365 415 11,5 5,8 RSZTHPX405 450 11,9 5,9 RSZTHPX425 465 12,1 5,8 RSZTHPX455 490 12,5 5,8 RSZTHPX470 535 12,7 6,0 RSZTHPX515 595 13,1 6,3 RSZTHPX570 650 13,5 6,5 RSZTHPX620 700 14,1 6,5 RSZTHPX680 755 14,4 6,7 RSZTHPX725 790 14,8 6,7 RSZTHPX765 Sterile Resterilizable Gel Breast Implants Sizersε Other - 49 - Sterile Resterilizable Gel Breast Implants Sizersε ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizers (for smooth implants) Volume cc Diameter cm Projection cm Catalog # 150 8,3 4,1 RSZSHPX150 180 8,8 4,4 RSZSHPX180 200 9,2 4,5 RSZSHPX200 235 9,5 4,9 RSZSHPX235 260 9,9 5,0 RSZSHPX260 285 10,3 5,0 RSZSHPX285 335 10,7 5,4 RSZSHPX335 355 11,0 5,5 RSZSHPX355 380 11,3 5,5 RSZSHPX380 415 11,5 5,8 RSZSHPX415 450 11,9 5,9 RSZSHPX450 465 12,1 5,8 RSZSHPX465 490 12,5 5,8 RSZSHPX490 535 12,7 6,0 RSZSHPX535 595 13,1 6,3 RSZSHPX595 650 13,5 6,5 RSZSHPX650 700 14,1 6,5 RSZSHPX700 755 14,4 6,7 RSZSHPX755 790 14,8 6,7 RSZSHPX790 Other - 50 - Sterile Resterilizable Gel Breast Implants Sizersε CPG™ GEL BREAST IMPLANT SIZERS CPG™ Implant Sizers 331, Cohesive III™, Tall Height, Moderate Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 125 9,0 9,2 3,2 7,3 RSZ-0903 150 9,5 9,7 3,3 7,7 RSZ-0953 175 10,0 10,2 3,4 8,1 RSZ-1003 200 10,5 10,7 3,5 8,4 RSZ-1053 230 11,0 11,3 3,6 8,8 RSZ-1103 265 11,5 11,8 3,7 9,1 RSZ-1153 300 12,0 12,3 3,9 9,5 RSZ-1203 340 12,5 12,8 4,0 9,9 RSZ-1253 380 13,0 13,3 4,1 10,2 RSZ-1303 425 13,5 13,8 4,3 10,6 RSZ-1353 475 14,0 14,3 4,5 11,0 RSZ-1403 530 14,5 14,8 4,6 11,3 RSZ-1453 585 15,0 15,3 4,0 11,7 RSZ-1503 645 15,5 15,9 5,0 12,1 RSZ-1553 CPG™ Implant Sizers 321, Cohesive III™, Medium Height, Moderate Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 120 9,0 8,5 3,3 7,0 RSZ-0908 135 9,5 8,9 3,5 7,3 RSZ-0958 155 10,0 9,4 3,7 7,7 RSZ-1008 180 10,5 9,9 3,8 8,0 RSZ-1058 215 11,0 10,3 3,9 8,2 RSZ-1108 245 11,5 10,8 4,0 8,6 RSZ-1158 280 12,0 11,3 4,2 8,9 RSZ-1208 315 12,5 11,8 4,4 9,2 RSZ-1258 355 13,0 12,2 4,6 9,6 RSZ-1308 395 13,5 12,7 4,7 9,9 RSZ-1358 440 14,0 13,2 4,9 10,3 RSZ-1408 480 14,5 13,6 5,0 10,5 RSZ-1458 530 15,0 14,1 5,2 10,9 RSZ-1508 640 16,0 15,0 5,6 11,5 RSZ-1608 775 17,0 16,0 5,9 12,2 RSZ-1708 ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Other - 51 - Sterile Resterilizable Gel Breast Implants Sizersε CPG™ Implant Sizers 311, Cohesive III™, Low Height, Moderate Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 120 9,5 8,5 3,2 6,9 RSZ-0095 140 10,0 8,9 3,4 7,2 RSZ-0100 160 10,5 9,4 3,6 7,5 RSZ-0105 180 11,0 9,8 3,7 7,9 RSZ-0110 210 11,5 10,3 3,9 8,2 RSZ-0115 235 12,0 10,7 4,1 8,5 RSZ-0120 270 12,5 11,2 4,2 8,8 RSZ-0125 300 13,0 11,6 4,4 9,2 RSZ-0130 335 13,5 12,0 4,6 9,5 RSZ-0135 375 14,0 12,5 4,7 9,8 RSZ-0140 415 14,5 12,9 4,9 10,1 RSZ-0145 460 15,0 13,4 5,1 10,5 RSZ-0150 510 15,5 13,8 5,2 10,8 RSZ-0155 560 16,0 14,3 5,4 11,1 RSZ-0160 615 16,5 14,7 5,6 11,4 RSZ-0165 ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Other - 52 - Sterile Resterilizable Gel Breast Implants Sizersε CPG™ GEL BREAST IMPLANT SIZERS CPG™ Implant Sizers 332, Cohesive III™, Tall Height, Moderate Plus Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 145 9,0 9,4 3,8 8,1 RSZ-0909 175 9,5 9,9 4,0 8,5 RSZ-0959 205 10,0 10,4 4,2 8,9 RSZ-1009 235 10,5 10,9 4,4 9,3 RSZ-1059 270 11,0 11,5 4,7 9,7 RSZ-1109 305 11,5 12,0 4,9 10,1 RSZ-1159 350 12,0 12,5 5,1 10,5 RSZ-1209 395 12,5 13,0 5,3 10,9 RSZ-1259 455 13,0 13,5 5,5 11,3 RSZ-1309 495 13,5 14,1 5,7 11,7 RSZ-1359 555 14,0 14,6 5,9 12,1 RSZ-1409 615 14,5 15,1 6,1 12,6 RSZ-1459 680 15,0 15,6 6,3 13,0 RSZ-1509 CPG™ Implant Sizers 322, Cohesive III™, Medium Height, Moderate Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 140 9,0 8,5 3,8 7,6 RSZ-0905 165 9,5 8,9 4,0 8,0 RSZ-0955 195 10,0 9,4 4,2 8,4 RSZ-1005 225 10,5 9,9 4,4 8,8 RSZ-1055 255 11,0 10,3 4,7 9,2 RSZ-1105 295 11,5 10,8 4,9 9,5 RSZ-1155 330 12,0 11,3 5,1 9,9 RSZ-1205 375 12,5 11,8 5,3 10,3 RSZ-1255 420 13,0 12,2 5,5 10,7 RSZ-1305 475 13,5 12,7 5,7 11,1 RSZ-1355 525 14,0 13,2 5,9 11,4 RSZ-1405 585 14,5 13,6 6,1 11,8 RSZ-1455 650 15,0 14,1 6,3 12,2 RSZ-1505 ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Other - 53 - Sterile Resterilizable Gel Breast Implants Sizersε CPG™ Implant Sizers 312, Cohesive III™, Low Height, Moderate Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 125 9,0 8,0 3,8 7,2 RSZ-0907 145 9,5 8,4 4,0 7,5 RSZ-0957 170 10,0 8,8 4,2 7,9 RSZ-1007 195 10,5 9,3 4,4 8,3 RSZ-1057 225 11,0 9,7 4,7 8,6 RSZ-1107 255 11,5 10,2 4,9 9,0 RSZ-1157 290 12,0 10,6 5,1 9,3 RSZ-1207 330 12,5 11,1 5,3 9,7 RSZ-1257 370 13,0 11,5 5,5 10,0 RSZ-1307 415 13,5 11,9 5,7 10,4 RSZ-1357 465 14,0 12,4 5,9 10,8 RSZ-1407 515 14,5 12,8 6,1 11,1 RSZ-1457 570 15,0 13,3 6,3 11,5 RSZ-1507 690 16,0 14,2 6,8 12,2 RSZ-1607 ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Other - 54 - CPG™ Implant Sizers 323, Cohesive III™, Medium Height, High Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 165 9,0 8,5 4,6 8,1 RSZ-0902 195 9,5 8,9 4,8 8,5 RSZ-0952 225 10,0 9,4 5,1 8,9 RSZ-1002 260 10,5 9,9 5,3 9,3 RSZ-1052 300 11,0 10,3 5,6 9,7 RSZ-1102 345 11,5 10,8 5,8 10,1 RSZ-1152 390 12,0 11,3 6,0 10,5 RSZ-1202 440 12,5 11,8 6,2 10,9 RSZ-1252 495 13,0 12,2 6,5 11,3 RSZ-1302 555 13,5 12,7 6,7 11,8 RSZ-1352 620 14,0 13,2 6,9 12,2 RSZ-1402 685 14,5 13,6 7,1 12,6 RSZ-1452 CPG™ Implant Sizers 333, Cohesive III™, Tall Height, High Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 180 9,0 9,4 4,6 8,4 RSZ-4090 215 9,5 9,9 4,8 8,8 RSZ-4095 250 10,0 10,4 5,1 9,3 RSZ-4100 290 10,5 10,9 5,3 9,7 RSZ-4105 330 11,0 11,5 5,6 10,1 RSZ-4110 380 11,5 12,0 5,8 10,5 RSZ-4115 430 12,0 12,5 6,0 11,0 RSZ-4120 485 12,5 13,0 6,2 11,4 RSZ-4125 545 13,0 13,5 6,5 11,8 RSZ-4130 610 13,5 14,1 6,7 12,2 RSZ-4135 680 14,0 14,6 6,9 12,7 RSZ-4140 755 14,5 15,1 7,1 13,1 RSZ-4145 ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Sterile Resterilizable Gel Breast Implants Sizersε CPG™ GEL BREAST IMPLANT SIZERS Other - 55 - CPG™ Implant Sizers 313, Cohesive III™, Low Height, High Projection Volume cc Width cm Height cm Projection cm Lower Pole Arc A-B (cm) Catalog # 130 9,0 8,1 4,4 7,6 RSZ-0906 155 9,5 8,6 4,5 7,8 RSZ-0956 180 10,0 9,0 4,6 8,3 RSZ-1006 210 10,5 9,5 4,8 8,7 RSZ-1056 240 11,0 9,9 4,9 9,1 RSZ-1106 270 11,5 10,3 5,0 9,5 RSZ-1156 310 12,0 10,8 5,2 9,9 RSZ-1206 350 12,5 11,2 5,4 10,2 RSZ-1256 395 13,0 11,7 5,6 10,6 RSZ-1306 440 13,5 12,2 5,8 11,0 RSZ-1356 490 14,0 12,6 6,1 11,4 RSZ-1406 545 14,5 13,1 6,3 11,7 RSZ-1456 605 15,0 13,5 6,6 12,1 RSZ-1506 ε Resterilizable up to 10 times. Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above Sterile Resterilizable Gel Breast Implants Sizersε Other Sterile Saline Breast Implant Sizers Round Saline Breast Implant Sizers, Moderate Profile NOMINAL FILL MAXIMUM FILL Volume cc Diameter cm Projection cm Volume cc Diameter cm Projection cm Catalog # 125 9,5 3,0 150 9,1 3,4 351-125SZ 175 10,6 3,3 200 10,0 3,9 351-175SZ 225 11,5 3,5 250 10,9 4,0 351-225SZ 275 12,3 3,7 300 11,7 4,2 351-275SZ 325 13,0 3,8 375 12,3 4,5 351-325SZ 375 13,6 4,0 425 12,8 4,8 351-375SZ 425 14,2 4,1 475 13,5 4,9 351-425SZ 475 14,8 4,2 525 14,2 4,9 351-475SZ Round Saline Breast Implant Sizers, Moderate Plus Profile NOMINAL FILL MAXIMUM FILL Volume cc Diameter cm Projection cmbreast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubaiVolume cc Diameter cm Projection cm Catalog # 175 9,5 3,5 210 9,3 4,2 351-2175SZ 200 10,0 3,7 240 9,7 4,4 351-2200SZ 225 10,4 3,8 270 10,1 4,6 351-2225SZ 250 10,8 4,0 300 10,5 4,7 351-2250SZ 275 11,0 4,1 330 10,8 4,9 351-2275SZ 300 11,5 4,3 360 11,2 5,0 351-2300SZ 325 11,9 4,4 390 11,5 5,2 351-2325SZ 350 12,1 4,5 420 11,7 5,3 351-2350SZ 375 12,3 4,6 450 12,0 5,4 351-2375SZ 400 12,6 4,7 480 12,3 5,5 351-2400SZ 425 12,9 4,8 510 12,5 5,6 351-2425SZ 450 13,0 4,9 540 12,8 5,7 351-2450SZ 475 13,3 5,0 570 13,0 5,8 351-2475SZ 500 13,6 5,1 600 13,2 5,9 351-2500SZ 550 14,0 5,3 660 13,7 6,1 351-2550SZ 600 14,5 5,5 720 14,1 6,3 351-2600SZ 650 14,8 5,6 780 14,4 6,5 351-2650SZ 700 15,2 5,8 840 14,8 6,6 351-2700SZ 750 15,6 5,9 900 15,1 6,8 351-2750SZ 800 16,1 6,0 960 15,5 7,0 351-2800SZ Other - 57 - Sterile Saline Breast Implant Sizers CONTOUR PROFILE™ Saline Breast Implant Sizers, High Profile Volume cc Width cm Height cm Projection cm Catalog # 275 + 25 11,5 9,5 5,1 351-0711SZ 350 + 50 12,3 10,5 5,3 351-0712SZ 450 + 50 13,2 11,0 6,1 351-0713SZ 550 + 50 14,0 11,9 6,4 351-0714SZ 650 + 75 15,0 12,7 6,6 351-0715SZ Round Saline Breast Implant Sizers, High Profile NOMINAL FILL MAXIMUM FILL Volume cc Diameter cm Projection cm Volume cc Diameter cm Projection cm Catalog # 190 9,3 4,1 225 9,1 5,1 351-3190SZ 230 10,0 4,3 275 9,8 5,5 351-3230SZ 270 10,4 4,6 325 10,2 5,8 351-3270SZ 290 10,8 4,7 350 10,5 5,9 351-3290SZ 310 11,0 4,8 375 10,7 6,0 351-3310SZ 330 11,3 4,8 400 11,0 6,2 351-3330SZ 380 11,7 5,2 450 11,4 6,4 351-3380SZ 420 12,0 5,4 500 11,7 6,7 351-3420SZ 500 12,8 5,6 600 12,4 7,1 351-3500SZ 630 13,8 5,9 750 13,4 7,4 351-3630SZ Note: Individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the dimensions noted above - 58 - References 1. Based on warranty comparisons of the following breast implants: Allergan Natrelle: http://www.natrelle.co.uk/breast-enhancement/Pages/ warranty.aspx, EuroSilicone & Nagor: http://nagor.com/pdf/Warranty_ PDF_Nagor.pdf, Arion: http:// www.laboratoires-arion.com images/ arion/ ARION_GUARANTEE_PROGRAM_ANG.pdf, Polytech: http://www.polytechhealth. info/ images/pdf/IoE_ Information_engl_2015- 01.pdf, Motiva: https:// motivaimplants.com/productwarranty/Sebbin: Garantie des IMPLANTS MAMMAIRES and La garantie premium, Accessed March 20 2017. 2. Mentor Worldwide, LLC. MemoryShape® Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015 Mentor Worldwide LLC. Data on File. MemoryGel® Core Gel Clinical Study Final Report, April 2013. Maxwell, G. Patrick; Van Natta, Bruce W.; Bengtson, Bradley P.; and Murphy, Diane K., «Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study» (2015). Public Health Resources. Health Canada: Summary Basis of Decision (SBD) for Natrelle™ Highly Cohesive Silicone-Filled Breast Implants. Application No. 88573. License No.72262. Date Issued: 2014/01/17. Health Canada: Summary Basis of Decision (SBD) for Natrelle™ Silicone-Filled Breast Implants-Smooth Shell With Barrier and Narelle(TM) Silicone Filled Breast Implants - Textured Shell with Barrier Layer. Application No. 61865 and 60524 License No License No 72264 and 72263. Date Issued: 2012/09/25. 3. Danino, A. M., Basmacioglu, P., Saito, S., Rocher, F., Blanchet-Bardon, C., Revol, M., & Servant, J. M. (2001). Comparison of the capsular response to the Biocell RTV and Mentor 1600 Siltex breast implant surface texturing: a scanning electron microscopic study. Plastic and reconstructive surgery, 108(7), 2047-2052. - 59 - 4. Mentor Worldwide, LLC. MemoryShape® Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015 5. Health Canada: Summary Basis of Decision (SBD) for Natrelle™ Highly Cohesive Silicone-Filled Breast Implants. Application No. 88573. License No.72262. Date Issued: 2014/01/17. 6. Maxwell, G. Patrick, et al. «Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study.» Aesthetic Surgery Journal 35.2 (2015): 145-155. 7. Hoffman_CP529_530Interim_Report_for_CP529_DOF_PR_20131007 (PDF pg. 2) 8. Mentor Worldwide LLC, Data on File, HS820.050331.02F Validation Case Study Report: Market Acceptance of the Contour Profile Gel Product Family - TX.820.081125.01 9. As compared to the CONTOUR PROFILE® Tissue Expanders at 5 mm. Data on file at Mentor Worldwide LLC. 10. Mentor Consumer Preference Market Research Report – July 2017. 11. Product Dimensions for MemoryGel™ and MemoryGel™ Xtra Breast Implants Mentor R&D Benchtop Testing (Pinch Test) - July 2017. Important Safety Information MENTOR® Breast Implants are indicated for breast augmentation, in women who are at least 18 years old, or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast(s) who have not received adequate treatment for those conditions or who are pregnant or nursing. There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation is not necessarily a one-time surgery. The most common complications with MENTOR® MemoryGel™ Breast Implants include re-operation, implant removal, capsular contracture, asymmetry, and breast pain. A lower risk of complication is implant rupture, which is most often silent. The health consequences of a ruptured silicone gel-filled breast implant have not been fully established. Screenings such as mammography, MRI, or ultrasound are recommended after initial implant surgery to assist in detecting implant rupture. The most common complications with MENTOR® Saline-Filled Implants include re-operation, implant removal, capsular contracture, wrinkling, deflation, asymmetry, and breast pain. MENTOR® CPX™4 Breast Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. These expanders are intended for temporary subcutaneous or submuscular implantation.* CONTOUR PROFILE™ Tissue Expanders are devices that contain magnetic injection domes and are NOT MRI compatible. Do not use the CONTOUR PROFILE™ Tissue Expander in patients where an MRI may be needed. DO NOT use the CONTOUR PROFILE™ Tissue Expander in patients that have a previously - 60 - implanted device that could be affected by a magnetic field. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas or where severe surgical reduction of the area has previously been performed. Your patient needs to be informed and understand the risks and benefits of breast implants, and provided with an opportunity to consult with you prior to deciding on surgery. For detailed indications, contraindications, warning and precautions associated with the use of all MENTOR® Implantable Devices, please refer to the Product Insert Data Sheet provided with each product, or review the Important Safety Information provided at www.mentorwwllc.eu. - 61 - Mentor Worldwide LLC 33 Technology Drive Irvine, CA 92618, USA Tel: +1 8006368678 www.mentorwwlc.eu FAQ: Breast Augmentation What is a breast augmentation? A breast augmentation involves putting breast implants in your chest to enhance your natural breast tissue and make your breasts fuller and larger. What type of implants are there? Dr. Coon uses silicone implants made by Mentor. There are different profiles available. You will be able to see the implants during your consultation and you and the surgeon will determine what profile is best for your body. Can I try on the implants to know what size I want? During your consultation, you will be able to “try on” some implant samples to inform the surgical team with approximate sizes. Please bring a cami tank top to aid in this process. Where are the implants placed? There are two locations that an implant can be placed, either above or below the muscle. You and your surgeon will talk about what the best surgical option is for your body. What determines the size of the implants? This is a conversation you and your surgeon will have to determine what size is best for your body frame. It is important to keep in mind that skin stretching may limit the size of the implant. Where is the incision? There will be a small surgical incision made underneath the breast where we insert the implant. This incision is typically hidden under the natural fold of the breast and is hardly noticeable. How long is the surgery? On average, the surgery takes 2-4 hours. Will I be in a lot of pain after surgery? You may experience some discomfort for a few days after surgery, but generally 4-5 days after surgery you will be able to return to your normal activities. Will I have surgical drains? No, this procedure does not require you to go home with any drains. What dressings will I go home with after surgery? You will go home with steri strips over the incision line and a large clear band aid, called tegaderm. This dressing will be removed 2 week after surgery during your post-operative visit with clinical staff. FAQ: Breast Augmentation Can I shower after surgery? You may begin showering the day after surgery. Do not scrub at your incision line or remove the dressing placed in the operating room. What bra can I wear after surgery? After surgery you will be given a special bra that you must continue to wear for 3 weeks. This bra will be provided by the hospital and placed on you in the operating room. After 3 weeks, you may begin wearing a sports bra or a soft cloth bra – you should NOT wear an underwire bra for at least 6 weeks after surgery. What limitations do I have after surgery? For 4 weeks after surgery, you should not lift your hands over your head. You should also not push, pull, or lift anything greater than 5 pounds during these 4 weeks. Am I required to do implant exercises after surgery? Yes, you should begin performing implant exercises twice a day starting 5 days after surgery. You should continue these exercises for 3 months after your surgery date. Each breast should be gently pushed up, to the left, and to the right and held for a few seconds. These exercise helps to prevent capsular contractions, which is a pocket around the breast that keep the implant from freely moving. There are more details available in your post-op instructions, which you will receive prior to your surgery. When can I begin scar therapy? You can begin scar therapy approximately 8 weeks after surgery. You can start simply with scar massage, which involves using shea or cocoa butter and gently massaging the scar. If you feel like you need additional scar care, you can use creams, such as Mederma, or silicone-based gels. Remember, it can take up to 18 months for a scar to fully mature and fade. Is there any long term follow-up need after surgery? It is recommended by the FDA that patients with silicone implants should receive a MRI 3 years post-operatively and every 2 years after. Despite recent news, there is no apparent association between silicone gel-filled breast implants and connective tissue disease or breast cancer. G C H A P T E R 54 The dual plane approach to breast augmentation Steven Teitelbaum History The breast implant pocket choice has a profound effect on the appearance of the augmented breast. Along with the selection of the device itself, it is the most important preoperative decision. Critical manifestations of this choice may not be apparent for many years, as some effects of the implant on the soft tissue occur gradually yet inexorably. The most commonly described pocket locations are: (1) total submuscular (subserratus and subpectoral); (2) partial retropectoral (behind the pectoralis with its origins from the ribs left intact); (3) subfascial (between the pectoralis muscle fascia and the pectoralis muscle); (4) submammary or subglandular (between the breast and the pectoralis fascia). Total submuscular is more frequently a reconstructive technique, less commonly done for augmentation owing to a more painful and bloody dissection, a tendency for the device to rise superiorly, and diffi culty in predictably creating a deep and well-formed inframammary fold. Subfascial has not been widely adopted due to an absence of satisfactorily controlled or long-term data. With scarcely 0.5 – 1 mm more coverage than a classic submammary dissection, this procedure is only a minor variation of the submammary pocket and does not qualify as a distinct pocket type. Partial retropectoral and submammary are the most popular methods. Proponents of each are quick to point out the distinct advantages of their technique and the disadvantages of the other. These comments are frequently appropriate. But these comments are not equally applicable to all situations. There are indeed breast types for which the benefi ts and drawbacks of one pocket makes it the better choice. Even so, some shortcomings of that preferred pocket frequently remain at issue. The dual plane as fi rst published by John Tebbetts in 2001 is the ideal compromise, in that it allows the implant to be simultaneously retropectoral where the device most needs coverage, and retromammary where it most needs to be in direct apposition to the breast. This allows near-total achievement of the purported benefi ts of both at the same time, while minimizing the trade-offs associated with selecting just one of the two pockets. It is therefore less of a compromise per se, than a way of “ having your cake and eating it, too ” , essentially doing both pockets at once, using each pocket where it exacts its greatest benefi t. While submammary and partial retropectoral are “ pure ” extremes, the dual plane is a continuous spectrum of options, occupying the “ gray-zone ” in between. The operation starts with the creation of a partial retropectoral pocket. The origins are carefully divided along the inframammary fold, which allows the cut edge of the muscle to glide a bit superiorly, so that there is both a small submammary and a large subpectoral area of the pocket, and hence the term dual plane. By disrupting attachments of the muscle to the overlying gland, the muscle can be gradually and incrementally raised, thereby reducing the proportion of subpectoral pocket and increasing the proportion of submammary pocket. The purported advantages of the partial retropectoral pocket are predominantly coverage along the sternum and over the superior border of the implant; the dual plane preserves these. The purported advantages of the submammary pocket are to direct implant pressure upon the lower pole; the dual plane preserves these as well ( Fig. 54.1 ). Criteria for the ideal pocket Our ability to determine the ideal pocket for a given situation rests upon the criteria that we choose to use to make that determination. Rather than vague, subjective decisions that allow certain issues to be overemphasized and others neglected, it is important to attempt to quantify all of the pertinent issues and measure each of the methods against them. Over the last several decades, published reoperation rates in PMA studies have not changed despite the use of different implants, remaining consistently at about 20% at three years. In a study of one device, a single surgeon achieved a 0% 675 Section 11: The breast Go to www.expertconsult.com to see updates to this chapter 0060_ch54_9780702031687.indd 675 4/8/2009 3:33:26 PM G Se breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai ction 11: The breast Aesthetic Plastic Surgery 676 deforming and even uncorrectable. It is therefore not enough just to tally complications, but also to consider their severity. Dual plane data objectively show that this procedure succeeds in maintaining the advantages of both pockets while mitigating the trade-offs associated with selecting a single pocket. Preservation of future options in the event of an unsatisfactory outcome is important: if Plan A was still a viable option after Plan B, but Plan B would not be after Plan A, then that would suggest an advantage for starting with Plan B. Finally, outcomes need to be assessed at long intervals after surgery. Irrevocable, permanent, progressive, and at times totally uncorrectable changes occur to a breast years after an augmentation. Adequacy of tissue coverage needs to be judged at the longest possible intervals, decades if possible. Such long-term data is meager, but owing to the importance of such lifelong changes on the breast, at this point anecdote and extrapolation of shorter-term results should be considered ( Fig. 54.3 ; Table 54.1 ). Pain and recovery In general, there is less pain with the submammary approach, as the submuscular approach subjects the sensitive rib cage to possible trauma and the overlying muscle to stretching. But the largest data ever assembled on postoperative pain showed that 24-hour recovery without the use of any narcotics or pain pumps could be routinely achieved with a dual plane approach. Bloodless surgery and avoidance of creating any rib trauma circumvented the typical pain experienced from the rib cage in submuscular patients. Precise, gentle elevation, bloodless elevation of a pectoralis muscle paralyzed by the anesthesiologist results in a minimum of trauma to the muscle. This author has routinely been using these techniques for many years, and only uses ibuprofen for postoperative pain for routine augmentation mammaplasty in all planes, including the dual plane. Dual plane patients routinely go out to dinner, shower, and wash and brush their own hair the night of surgery. They describe the feeling as “ tight ” , a “ pressure ” , “ soreness ” , or “ like working out hard ” . Fig. 54.1 The three types of dual plane breast augmentation. A , Dual Plane Type I. B , Dual Plane Type II. C Dual Plane type III. A B Complete division along IMF C No division No division No division Fig. 54.2 Retromuscular pockets are often criticized for causing high-riding implants. In this case, the dissection was a blunt/blind transaxillary augmentation. The muscle was divided along the IMF on the left, but not the right. This is not a shortcoming of the procedure itself, but from its execution in this particular instance. 3-year reoperation rate in contrast to an average of 13.9% for all the doctors in the study. Taken together, these two fi ndings demonstrate that the outcome in breast augmentation is determined far less by the type of the device than by other factors ( Fig. 54.2 ). In the absence of data, surgeons must turn to the anecdotal. But when data is available, it trumps anecdote. Of all endpoints, the most decisive measurement of outcome is the reoperation rate, as it is an incontrovertible endpoint. “ Satisfi ed ” or “ happy ” patients are imprecise and unquantifi able endpoints, and since we have all seen unhappy patients with beautiful results and thrilled patients despite notable problems, they do not qualify as adequate endpoints with which to entirely judge the quality of an operation. The absolute incidence of reoperation tells only part of the story: the severity of a problem must also be considered. Some may be minor or annoying, while others may be 0060_ch54_9780702031687.indd 676 4/8/2009 3:33:26 PM G Chapter 54 The dual plane approach to breast augmentation 677 Fig. 54.3 A & C , Preoperative. B & D , Postoperative. Anecdotes are anecdotal, but sometimes that is the best that we have. If anyone doubts the importance of muscle coverage, they should be shown a series of patients with tissue so thin, with a saline implant looking like this, 11 years after surgery, free from capsular contracture, visible edges or rippling. Cases like this abound, but there are few examples of submammary or subfascial patients at this interval that look this good. A B C D When these same techniques are applied to the submammary approach, patients typically feel slightly less stiff and sore than do dual plane patients, but both groups still consistently achieve a “ 24-hour ” recovery. Any difference is subtle, noted only for a day or two, and is of no real consequence, particularly relative to advantages of achieving more muscle coverage. Coverage and stretch Soft tissue coverage is the single-most important issue affecting the short and long-term result after a breast augmentation. With adequate coverage, the implant edges are less visible, and the breast looks more natural and less augmented. Any folds or irregularities with the implant shell are more concealed. With more tissue over it, the device is less palpable. With less tissue coverage, the edges of the implant are more visible, the breast looks more augmented, and it is easier to feel the implant ( Fig. 54.4 ). Over the long term, these changes become more profound. Implants put pressure on the breast, and the parenchyma gradually compresses and atrophies. The presence of the implant stretches and thins skin. This occurs with implants in all positions. No study will ever randomize patients of similar tissue types and implant sizes and follow them over enough time for a scientifi c conclusion to be made. But a large amount of clinical observation and logic (see Fig. 54.3 and Fig. 54.5 ) offers us guidance. Examples of submammary patients with severe parenchymal atrophy abound, while retropectoral patients with similar characteristics are rarely seen. And when they are, though the implants may have ostensibly been placed “ behind the muscle ” , secondary surgery frequently reveals that the muscle has been avulsed off both the inframammary fold and sternum, thereby sacrifi cing the critical coverage of which we are speaking ( Fig. 54.6 ). These problems are sometimes noticeable within a year or two, but can often take years more to develop. We must be 0060_ch54_9780702031687.indd 677 4/8/2009 3:33:28 PM G Section 11: The breast Aesthetic Plastic Surgery 678 Table 54.1 Pocket comparisons breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Issue Advantage PRP Advantage subglandular Dual plane remedies Less pain X Best data to date Better coverage X Large advantage vs. SM; difference relative to PRP dependent upon release and up to determination of surgeon Access to lower pole parenchyma X Yes Expands constricted breasts X Yes Fills ptotic breasts X Yes Avoids muscle animation X Rarely clinically signifi cant Reduces tendency to “ ride high ” X Yes Reduces tendency to “ lateralize ” X Yes Faster recovery X Best data to date Less capsular contracture X Best data to date Better for mammograms X Appears to be Reduce parenchymal atrophy X Best data to date Reduces stretch deformities Best data to date Narrower cleavage X No – but subglandular can only do so at the expense of coverage Fig. 54.4 Tissue coverage is always a priority, particularly superiorly and medially. The implant she holds in her hand mimics what is occurring within her breast. With muscle coverage in the upper pole, such a deformity will rarely if ever occur. Fig. 54.5 This is not a capsular contracture. This is a submammary implant. The breast is soft. The patient chose this at the surgeon ’ s behest in order to avoid animation deformity. But even in repose, the signifi cant deformity is present; there is no substitute for soft tissue coverage. aware of these problems and remind ourselves that we need to create a result that will look good not just for years, but for decades. As someone who sees many secondary problems, I can state categorically that subglandular patients present more frequently, with more severe problems, and with more unsolvable problems than do subpectoral or dual plane patients. Such tissue thinning with submammary patients also is a set up for a problem which is diffi cult to correct, as to do so often requires a switch to the partial retropectoral or dual plane position. But once there is a subglandular pocket, the coverage in the retropectoral pocket is forever impaired. Though one can use sutures to tack the muscle back up to the gland, its caudal cut edge can never be retained as caudally as it might have been were this not to have happened, thereby forever impairing inferior coverage. Marionette pullout sutures have been described to hold down the muscle in this situation, but this also cannot achieve the same degree of 0060_ch54_9780702031687.indd 678 4/8/2009 3:33:31 PM G Chapter 54 The dual plane approach to breast augmentation 679 Fig. 54.6 This patient just had removal of subpectoral implants. The dotted line indicates the caudal border of the pectoralis. Though she had “ retromuscular ” pockets, the implant itself had negligible if any coverage as the muscle was so high it could cover only a bit of the implant, and the pressure of it probably pushed the implant away. Though her muscle was still attached to the sternum, the muscle had been inadvertently detached from the overlying parenchyma, thereby allowing it to window shade up far higher than would be ideal even for a DP III. Fig. 54.7 This patient had a submammary capsulectomy and then had a submuscular pocket dissected. It illustrates the basic principle of the DP approach. With no attachment of the muscle to the overlying parenchyma, this muscle window shades strongly superiorly. The DP approach recognizes the importance of maintaining those attachments when it is important to keep the muscle inferiorly to maintain coverage, and emphasizes the importance of a gradual and incremental release of them to allow controlled vertical elevation of the muscle and exposure of the parenchyma in the lower breast when the situation demands. Fig. 54.8 The most common argument for submammary placement is to deal with the postpartum involution and ptosis patient who does not want mastopexy scars. But this group has the thinnest tissue and is the most prone to stretch and thinning. A , A patient merely two years following such a procedure; note the extreme parenchymal atrophy and skin thinning. B , Note the improvement still noted two years after conversion to a dual plane. A B coverage as if the attachments between the muscle and the overlying gland were never disrupted ( Fig. 54.7 ). In conjunction with the thinning, there is often progressive stretch of the skin envelope, sometimes necessitating mastopexy. Even if this mastopexy would have been inevitable in the future with a partial retropectoral or dual plane pocket, such patients frequently have soft tissue thinning or capsular contractures in addition to the stretched skin. This necessitates a pocket change and possible capsulectomy in addition to the mastopexy, which can be a riskier procedure than if the implant had started out dual plane or partial retropectoral. This combination of secondary revision occurs so frequently that efforts must be made at the time of the original surgery so that this doesn ’ t happen ( Fig. 54.8 ; also see Fig. 54.5 ). If tissue coverage is adequate, it almost doesn ’ t matter what is going on with the implant; a capsular contracture may be less noticeable; suboptimal implant shape may be less problematic; implant folds might be harder to discern. These are powerful reasons to select the partial retropectoral pocket over the submammary pocket. But what should one do if there is glandular ptosis or a constricted lower pole and the tissue is thin? Partial retropectoral is preferred for the tissue coverage issue, but submammary may be necessary to allow better expansion of the lower pole. The dual plane solves this dilemma by allowing the upper and inner portion of the implant to be covered by muscle, while the inferior portion, the part that needs to push directly on the gland to expand and fi ll it, can be allowed to be in direct apposition. Achieving “ adequate ” coverage is an insuffi cient goal. “ Maximum ” coverage must be the goal. There is almost no long-term problem that is not solvable when substantial soft tissue is available, and there are few problems completely correctable when soft tissue is not available. There is some sacrifi ce in coverage with the dual plane relative to partial retropectoral, and if tissue coverage in the lower pole is such that the benefi ts of changing to the dual plane do not outweigh its advantages, then it is suggested to patients to have a partial retropectoral pocket. In any case, the reduction in coverage with the dual 0060_ch54_9780702031687.indd 679 4/8/2009 3:33:33 PM G Section 11: The breast Aesthetic Plastic Surgery 680 plane relative to partial retropectoral is reasoned and controlled. Access to parenchyma The most profound advantage of submammary over partial retropectoral is attributable to the direct pressure the implant can make against the gland. This can make it look less empty, and the pressure can better expand a tight lower pole. If behind the muscle, the muscle essentially protects the preexisting confi guration of the lower pole, inhibiting the implant ’ s ability to push it and fi ll it out. And if weak fi brous connections between the pectoralis muscle and breast gland allow the gland to slipe relative to the muscle, placing the implant against the breast tissue can help reduce the extent of inferior tissue migration. Otherwise, the subpectoral placement still allows the gland to slide inferiorly relative to the muscle ( Figs 54.9 and 54.10 ). Depending upon the degree of release with the dual plane, these advantages of the submammary approach can be almost completely if not completely realized with the dual plane approach. The coverage that is preserved superiorly and medially typically allows for muscle coverage where it is most needed: superiorly and along the medial sternal border. Capsular contracture Capsular contracture still remains the leading cause of reoperation in PMA studies, yet publications using antibiotic irrigation and the dual plane pocket have resulted in some of the lowest reported capsular contracture rates to date. Whether it is specifi cally due to the dual plane per se or other factors, such as the irrigation, is not entirely clear. But it is suffi cient to say that the lowest reported capsular contracture rates are with the dual plane position, and no paper suggests an advantage to partial retropectoral over dual plane. Dual plane is the ideal choice. Mammography Given the cancer prone nature of the breast, optimizing the ability to detect cancer early must remain a priority. Numer- Fig. 54.9 The long term stability of the outcome in this post partum atrophy/ptosis patient with implants in the dual plane position demonstrates the value of proper implant sizing and tissue coverage. pre 5 months 1 yr 2 yrs 3 yrs 5 yrs 0060_ch54_9780702031687.indd 680 4/8/2009 3:33:37 PM G Chapter 54 The dual plane approach to breast augmentation 681 ous authors have suggested an advantage to retropectoral over submammary placement for this regard, but it is unclear whether the advantage is directly due to the anatomic location relative the muscle itself, or due to a lower capsular contracture rate below the muscle. Suffi ce to say, mammogram is impaired when the breast tissue cannot be pulled out and away from the implant and placed between the mammogram plates, such as when the implant is hard, there is a large implant relative to the breast tissue, or any other reason that restricts the pull of the tissue forward. While no studies have specifi cally compared sensitivity of mammogram between these pockets over a long period of time, the low incidence of capsular contractures and the extensive muscular coverage over a dual plane implant suggests that this would not be a problem. In any case, the role of MRI in screening for breast cancer is increasing, even for women without breast implants. And since implants do not affect its sensitivity, this entire issue may soon be moot. Muscle animation The lack of signifi cant implant motion or distortion with contraction of the pectoralis is a signifi cant advantage of the submammary position relative to the partial retropectoral pocket. But it is not enough to look at the problematic subpectoral patients with animation problems: one must also be aware of the submammary patients with signifi cant implant visibility even in repose. The deformity of a thin patient with subglandular implants at rest is typically more profound than a partial retropectoral patient during maximal contracture. With the dual plane approach, the release of the pectoralis along the inframammary fold (IMF) reduces if not totally eliminates the forces that might distract the implant superiorly. While the medial origins along the sternum may compress and slightly lateralize the implant on strong contraction, they rarely cause a signifi cant deformity ( Fig. 54.11 ). Fig. 54.10 The constricted lower pole breast is frequently touted as being a reason for submammary, as it allows scoring of the lower pole. In this case, shown here at 5 years post-surgery, a DP II was done, allowing the muscle to rise to the lower border of the areola. This exposed parenchyma for the entire lower pole of the breast, allowing it to be shaped just as much as it would have been were this to have been a submammary placement, but with maintenance of muscle coverage superiorly and medially, which helps to obscure the borders of the implant. 0060_ch54_9780702031687.indd 681 4/8/2009 3:33:39 PM G Section 11: The breast Aesthetic Plastic Surgery 682 Certainly, there is some motion, but in the Tebbetts series, there was no revision requested for this reason. In my experience, there has been occasional complaint and discussion of revision, but I have not switched my own patient to a submammary pocket for this reason ( Fig. 54.12 ). Usually, the patients with any such problems are very thin, and were therefore the least well suited for a submammary pocket. The key in minimizing animation with the dual plane pocket is to uniformly and accurately take the muscle down along the inframammary fold, stopping evenly on both sides at the point at which the IMF meets the sternum, and never releasing along the sternum. It appears that when the IMF is horizontal and meets the sternum at a discrete point, these issues are less problematic than when the IMF curves sharply superiorly as it moves towards the sternum, oftentimes not actually meeting the sternum until being at or even above the level of the nipple. These patients are also often thin, and they represent a particular challenge, in that there in fact may be no way to avoid some deformity with either approach. Fig. 54.11 A critical step of all dual planes – I, II, and III – is to completely divide the pectoralis major along the inframmary fold, stopping at the sternum, without division along the sternum. Failure to divide the origins along the IMF result in either a high-riding implant, superior malposition with animation, or a blunted IMF. However, if tissue coverage is thin ( < 5 mm), they probably should not be divided, as maintaining coverage is the fi rst priority. Division along the sternum can result in symmastia, excessive edge visibility and uncorrectable deformities. Complete division along IMF No division Fig. 54.12 DP and all retromuscular pockets are criticized for animation deformities. But the patient needs to be considered in repose as well. Here the same patient on the top is seen submammary, relaxed in two different poses. Though there is no animation deformity, the implants are unattractive. In the lower left, she is shown relaxed in the DP position, looking much prettier and more natural. In the lower right, she does demonstrate distortion with contracture, but no doubt even if this is the maximal distortion she can manage, it is still less deformed than she looks in either of the preoperative views in repose. 0060_ch54_9780702031687.indd 682 4/8/2009 3:33:44 PM G Chapter 54 The dual plane approach to breast augmentation 683 No matter which pocket is selected, the patient must be fully informed preoperatively of the trade-offs, and participate in the pocket selection. That way, if she has an animation deformity or implant deformity later, she can be reminded that she preferred accepting that problem to the risks of the other pocket. If a patient is not made aware of these choices preoperatively, then dissatisfaction and request for revision remain avoidable risks for revision. Narrower cleavage Both partial retropectoral and dual plane procedures accept the inner border of the pectoralis major muscle as an absolute limit to the medial placement of the implants. Once submammary, the implant can certainly be more medial. However, this comes at a price: the patients who most request or “ need ” such medialization invariably have the least soft tissue cover, and moving the implant medial to where the internal border of the pectoralis origin on the sternum results in risking symmastia and excessively visible implant edges. It is foolhardy to attempt to create cleavage by excessive medial placement of any implant, as tight skin usually pushes the implant laterally and the thin skin results in distinctly visible edges. So while the submammary does have the potential to place implants more medially, this amounts to more of a liability than an advantage. Physical evaluation Until experienced, most surgeons believe that an operation is all about what happens the day of surgery. In fact, it is the decisions that lead up to surgery that often have the most long-term effects on a result. This is particularly true of breast augmentation, where patient wishes, patient anatomy, and surgeon judgment converge. This topic is more important than pocket choice or any other issue with breast augmentation alone. The following are the most important of these points: Patient education The patient must be informed about the limitations of her tissue, so that her expectations are met. She must anticipate all trade-offs with respect to issues such as tissue coverage, animation, correction of ptosis, etc. When patients participate in these choices and sign off on them, the incidence of revision surgery is reduced and patient satisfaction increases. Determination of ideal implant size A patient is asked to decide whether she wants an implant that fi ts properly within her tissue, or she wants to force a certain size into her breasts without regard for creating an unnatural result in the short term and causing permanent tissue changes in the long term. Informed patients will usually select the latter. In that case, using the base width, skin stretch, and degree of envelope fi ll, the ideal implant size for that patient ’ s breast is determined. Larger will have an upper convexity and look more full, stuffed, or fake. Smaller will have a concave upper pole and look emptier. breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai Determination of need for coverage and for muscle release The dual plane preserves coverage and allowing coverage where it is needed. These two opposing characteristics need to be evaluated in all patients. Coverage It is always a goal to maintain as much coverage as possible, sacrifi cing coverage only when there is a reason to do so. With the exception of patient request (after being fully informed), a dual-plane approach is suggested to all. If coverage is < 2 cm of pinch at the upper pole, then a submammary approach will not even be offered. If pinch < 5 mm at the IMF, serious consideration is given to not releasing the muscle to create the dual plane, choosing instead to use a partial retropectoral pocket. In such situations, the long-term benefi ts of preserving maximal coverage often outweigh animation deformities, widening of the intermammary distance, and the predictability and crispness of the inframammary fold position. Muscle release The breast is examined for lower pole constriction or glandular ptosis that might necessitate controlled release of the muscle from the gland. While one might decide specifi cally preoperatively to perform a dual plane type II or type III, the surgeon should always start by dissection a type I, and then examine and feel the breast, releasing as much as is necessary during the operation. Need for mastopexy Many patients see plastic surgeons for a breast augmentation following lactation or weight loss. For some of these women, mastopexy is the appropriate procedure. Not wanting scars, some of these patients either receive an implant that fi lls, but is larger than they wish, or an implant of the size they want but which creates inadequate fi ll. In either case, and in particular in the case of the larger implants, the result is aesthetically compromised, and the already stretched skin stretches more and deteriorates with time. I have seen many such patients who had received submammary augmentations, and have tried this on my own patients. If followed long enough, the results are frequently unsatisfactory. Neither is the dual plan an answer for these patients; if the nipple (N) is below the fold, if N : IMF distance is > 9.5 cm on maximum stretch, or if substantial parenchyma lays caudal to the inframammary fold, mastopexy must be considered, and augmentation should either not be attempted or only performed on the patient who clearly demonstrates an understanding of the limitations of such a procedure (see Fig. 54.8 ). Anatomy The pectoralis major muscle has origins along the clavicle, sternum, and the 4th – 6th ribs along the IMF, and inserts onto the humerus, causing fl exion and internal rotation. Studies 0060_ch54_9780702031687.indd 683 4/8/2009 3:33:48 PM G Section 11: The breast Aesthetic Plastic Surgery 684 have demonstrated that the pectoralis origins along the IMF can be released without loss of strength or coordination. What is most relevant to the dual plane is the recognition that the deep surface of the pectoralis glides over the chest wall. It is anchored like a trampoline on three sides to the humerus, clavicle, and ribs. Like a trampoline released on one edge, the muscle will retract strongly away from the side of the release. The only thing that holds it in place – in distinct contrast to its deep surface – is that its superfi cial surface is tightly bound to the deep surface of the gland. The superfi cial surface of the muscle gives rise to the Cooper ’ s ligaments and fi brous tissue that ramify throughout the breast. These attachments help hold the caudal edge of the muscle inferiorly, thereby maintaining coverage to the lower pole of the implant. Following careful release of the muscle along the inframammary fold, the surgeon will observe the muscle “ window shade ” , sliding superiorly 1 – 2 cm. However, if there was an inadvertent dissection on the superfi cial surface of the muscle, thereby disrupting some of the fi bers connecting the muscle to the overlying gland, the muscle will window shade far more, sacrifi cing what might be intended coverage of the lower pole. This point is most emphasized when creating a retropectoral pocket following a submammary capsulectomy. Even if the pectoralis origins along the IMF are left intact, the caudal edge of the muscle window shades very high superiorly; if those origins are released, it may move so high that it cannot even cover the implant at all. Understanding this dynamic is critical to the dual plane approach. Technical steps See Table 54.2 ; see also Fig. 54.1 . Though a dual plane dissection can be done from all incisions, the inframammary incision allows the greatest degree of visualization and control of the dual plane pocket. Most specifi cally, it allows preservation of all the attachments between the muscle and the overlying gland, so that if they need to be dissected, it can be done in a specifi c and controlled manner. Dissection from the periareolar incision down to the inframammary fold or the proposed level of transection of the muscle invariably results in some degree of inadvertent disconnection of the muscle from the overlying gland, thereby resulting in unintentional superior elevation of the muscle, creating for example a dual plane type II or III when a type I was the goal. I frequently perform revision surgery on patients who had periareolar augmentation in which the operative note described the procedure as “ partial retropectoral ” and described only division of the muscle along the inframammary fold, yet the caudal edge of the muscle is frequently found well above the upper border of the areola, beyond what is even considered a dual plane III. This may be due to a combination of a bit of release of the muscle along the sternum, but it seems more commonly due to a release of the attachments of the superfi cial surface of the muscle from the gland simply as part of the tunneling process to reach the inframammary fold. Unless a DP II or III is a goal, a surgeon should probably perform dual plane pocket surgery from the inframammary incision until they have gained substantial experience. Many surgeons divide the muscle along the inframammary fold and describe the procedure as “ half over – half under ” , or even “ partial retropectoral ” , which is exactly what is described as a dual plane type I. Whatever the label, these surgeons should always be cognizant that the loss of tissue coverage from a periareolar incision is always a risk unless extremely fastidious dissection is done. Table 54.2 Technical steps Description Indication Goal Partial retropectoral Pectoralis attached to sternum and to IMF IMF pinch < 5 mm Maintain maximum coverage Dual plane type I Same plus complete division of pectoralis along IMF All parenchyma above IMF; gland adherent to muscle; A : IMF on maximum stretch 4 – 6 cm Small sacrifi ce in coverage to increase IMF accuracy; reduce animation deformity; allow implant to sit at bottom of pocket Dual plane type II Same plus pectoralis released from overlying gland and allowed to slide to about the lower border of the areola Most parenchyma above IMF; looser attachments of gland to muscle with some sliding of gland over muscle; stretched lower pole skin with A : IMF under maximum stretch 5.5 – 6.5 cm More sacrifi ce in lower pole muscle coverage in order to reduce risk of mobile breast augmentation dubai breast enlargement dubai breast implants dubai breast surgery dubai non surgical breast augmentation dubai breast surgery in uae boob job dubai parenchyma from sliding off of muscle, better fi ll of loose envelope Dual plane type III Same plus greater release of pectoralis from gland, allowing it to slide to about the upper border of the areola Ptosis with one-third or more of parenchyma below level of anticipated IMF with patient standing; substantial sliding of gland over muscle; more stretched lower pole skin with A : IMF under max stretch 7 – 8 cm or constricted lower pole breasts Most sacrifi ce in lower pole muscle coverage to allow maximal contact of implant against gland; allows for maximal scoring/reshaping of gland to allow maximal expansion 0060_ch54_9780702031687.indd 684 4/8/2009 3:33:48 PM G Chapter 54 The dual plane approach to breast augmentation 685 Likewise, a DP I, involving only the release of the pectoralis along the inframammary fold, can be undertaken from the transaxillary incision. Unlike a blunt and blind transaxillary approach which risks uneven release of the muscle and imprecise level of the inframammary fold, a true DP I transaxillary should be done with a bloodless, endoscopic technique. Creating a DPII or III, however, involves retrograde dissection from the transaxillary incision. This remains on the technical fringe at this time, and should be undertaken by surgeons experienced with endoscopic transaxillary partial retropectoral pocket creation after experience with the dual plane for a variety of situations from the inframammary incision. IMF approach See Fig. 54.13 . The fi rst step is to determine the ideal position of the inframammary fold. It is calculated from the nipple with the tissue placed on maximum stretch. In general, the standard of 7 cm for a base width of 11 cm, 8 cm for a base width of 12 cm, and 9 cm for a base width of 13 cm holds true. If the inframammary fold is already at that height, it does not need to be altered. An incision is made at the proposed inframammary fold. Dissection is carried straight down to the muscle fascia with the electrocautery, taking care not to skive inferiorly. There is a natural tendency of the cut edge of the tissue to pull inferiorly, so the dissection may angle superiorly, but only for the purpose of not undercutting the skin edge and inadvertently lowering the fold more than intended, if at all. The fascia is scored carefully with the cautery, so that the muscle is visible. Place in a double-ended or army-navy retractor with the tip pointed towards the medial border of the areola. With no horizontal dissection yet made, there will be little to hold the tissue up onto the blade of the retractor, so use the ulnar fi ngers of the retractor holding hand to pull the tissue onto the blade. Lift up towards the ceiling. Only the pectoralis will tent up. If the muscle does not tent at this point, it may be that the muscle is tight, or it may be that it is not the pectoralis. To ensure that it is pectoralis, and neither serratus, rectus, nor intercostals, touching it with the cautery will make the pectoralis in the upper chest contract. If still not clear, only then dissect just a couple of millimeters along the muscle surface in a cephalad direction. These are the important fi bers that you want to preserve in order to hold the muscle down after you release along the inframammary fold, so sacrifi ce no more than necessary for the anatomy to be clear. This will allow you to see the fi bers of the muscle, and allow some tissue to lie over the blade of the retractor, thereby allowing the pectoralis to tent up. Again advance the retractor blade to the edge of the muscle, pointing the blade to the medial border of the areola, pulling the breast tissue onto the retractor, and lifting toward the ceiling. Because it is loose on its deep surface, the pectoralis will tent upwards. Holding your hand down onto the abdomen so that the cautery is horizontal, sweep gently the taught pectoralis fi bers that appear vertical in front of you. Use hand switching monopolar forceps, as it allows precise control of blood vessels by squeezing, but so too can it be held together and used as a Bovie pencil. So long as it tents, it is pectoralis. So long as your cautery is horizontal and parallel to the chest wall, the chest is safe. Keep advancing the retractor forward and lifting up after every stroke of the cautery. With each motion of the cautery and repositioning of the retractor, the muscle will tent higher and the plane through the muscle will become more obvious. With this maneuver, you will very quickly get through the muscle, and will see the subpectoral space. Free up areolar tissue that is immediately in front of the incision, and then turn the retractor blade medially along the inframammary fold towards the sternum. Controlling the tension of the retractor blade on the muscles with fi ngers on the outside of the breast, use the cautery to take down the muscle about 1 cm above the proposed inframammary fold. This may serve as a shelf to help support the implant; it prevents over lowering of the fold; and it allows point coagulation of intramuscular blood vessels. Cut through the muscle and the overlying fascia. This should be bloodless and very easy to visualize. In fact, this dissection is so anatomic, that you should expect to be able to do it without needing to place a single four by eight into the pocket. Look beyond the tissue plane immediately in front of you, anticipating and seeing the perforators ahead of time. Continue all the way to the sternum, but do not proceed up the sternum at all. If you are unclear where this point is, mark it with an “ X ” externally on both sides preoperatively. Continue the dissection sweeping superolaterally, and then sweeping inferiorly. This helps to fi nd the plane between the pectoralis major and pectoralis minor, which are more intertwined if the dissection in that area starts inferolaterally instead of superolaterally. Irrigate with antibiotic solution and inspect the pocket. Take note of the long, narrow V -shaped trough where the muscle was released inferomedially and window shaded a bit superiorly. Inspect where the cut edge of the pectoralis is relative to your incision; sometimes it is just a few millimeters beyond it, and sometimes it is already window-shaded several centimeters. This will vary based upon how cleanly you got through the pectoralis and how tight the given patient ’ s connections between the pectoralis and breast tissue are. Place a fi nger in the incision and feel the lower border of the muscle and lift up, taking note of the position of the muscle through the skin as shown by the position of your fi nger. This inspection process is not just important in order to defi ne what you need to do for that specifi c patient, but done repeatedly, it provides the surgeon with a valuable experience about the dynamics of the muscle and the soft tissue. If the intention is to do a dual plane I, by virtue of the muscle release, the dual plane portion of the dissection is complete. The implant can be placed and the incision closed. If the goal is to do a dual plane type II or type III, then now is the time to do a release. This release is gradual and incremental. It cannot be overstated that substantial differences in position of the caudal edge of the pectoralis are created by just several millimeters of dissection. Surgeons ask 0060_ch54_9780702031687.indd 685 4/8/2009 3:33:48 PM G Section 11: The breast Aesthetic Plastic Surgery Fig. 54.13 A & B , After the retropectoral pocket is made, the pectoralis is divided 1 cm above the proposed inframammary fold. Note the use of the ulnar digits on the retractor hand pressing the muscle under tension so that it splits as it is divided. The superior and inferior cut edges are visible. When this is divided up to the sternum, a dual plane I will have been created, as shown in this photo. Depending upon the tension of the tissues, the muscle will window shade up a centimeter or two; in this case the muscle is about half the width of the retractor blade above the IMF. C , To go from a dual plane I to a II or III, the fi brous connections between muscle and the overlying parenchyma must be taken down. Just a few sideways swipes with the cautery is enough to cause signifi cant movement of the muscle. D , After just a few swipes of the cautery freeing up some attachments of the muscle to the gland, the muscle moves cephalad. The fresh yellow fat shows the signifi cant motion of the muscle relative to the last photo. Again, note the use of the ulnar digits against the retractor to create tension at the muscle parenchyma border, thereby making the dissection more precise and facile. E , When converting to a DP I to a II or a III, note how the hand and the retractor are used as a unit to create tension at the muscle/parenchyma interface. F , Here the release is being done more laterally. It can be adjusted on each breast exactly as the conditions necessitate. G , Copious irrigations with “ Adams ” solution (50 mL Betadine, 80 mg gentamicin, 1 g Ancef in 500 mL NS) is used throughout the operation. Note the yellow fat visible just beyond retractor; cut edge of muscle is just visible. H , In this case, the muscle is released to the lower border of the areola, which is a so-called dual plane II. When it is released to about the upper border of the areola, it is termed a DP III. A G H E F C D B 0060_ch54_9780702031687.indd 686 4/8/2009 3:33:49 PM G Chapter 54 The dual plane approach to breast augmentation 687 why they can ’ t dissect between the muscle and the gland before the muscle dissection, and the reason is that such small amounts of dissection result in such signifi cant movement of the muscle, that it is impossible to predict where the muscle will end up before dissecting the pocket and releasing the IMF. With the curved end of a double-ended retractor placed in the incision, abutting to the caudal edge of the muscle, but with only breast tissue within it, use the other fi ngers in the retractor hand to push in on the breast, so that together with the retractor, it is putting tension between the muscle and the overlying gland. Visualize the fascial connections between the muscle and gland, and use the cautery to gradually cut these, using sideways sweeping motions. You will see the muscle quickly pull away from the retractor and slide upwards. Once it does this even for several millimeters, move the retractor medially and laterally and repeat this process where you feel there is restriction by the muscle. Rather than repeating this motion in the same area, keep moving around, as this will give the most control over the fi nal position of the muscle. While illustrations suggest dual plane type I, II, and III as distinct entities, they are part of a continuum of options. Their designations are designed as a guide to enable us to think about a clinical situation and compare notes. But in any given patient, the muscle does not necessarily end exactly at the lower border of the areola (type II) or the upper border of the areola (type III). Rather, the release is made to the extent that is necessary to achieve the exposure of the implant to the gland of the breast. The most important point is not to overdo it. You can always release more, but once it is released, it is diffi cult if not impossible to pull the muscle back down. Put your fi nger back in as you did before, and note the chance in position of the muscle relative to before you did the release. Feel all along its edge, and go back and release more where you feel it is necessary. If you feel bands within the breast that are restricting expansion, such as with a constricted lower pole, or when the IMF had to be lowered with a tight IMF, now would be the time to score the lower pole, much as you might have done with a submammary pocket. Irrigate again with antibiotic solution, recheck for bleeding, and place the chosen implant close per the usual routine. Postoperative care With precise visualization of the pocket, no special bras or straps are necessary to try to push the implant into a pocket. Tape or a Steri-strip over the incision is the only dressing that is used. With bloodless dissection, no special bandages are necessary to create compression, and early motion is not just allowed, it is ordered. Patients move their arms over their head in the recovery room in a gradual jumping jack type of motion. They go home, take a nap, and then are instructed to continue their exercises every hour while awake, take a shower, and leave the house for dinner. They may drive a car when they feel that they can safely make unrestricted movements, which is usually in two to four days. They are encouraged to do all normal daily activities that do not involve particular exertion, such as opening and closing car doors, putting on a seatbelt, lifting a baby, emptying a dishwasher, or making dinner. They may return to the gym after three weeks, though some surgeons allow this after two weeks. With gentle, precise, and bloodless dissection, patients are only given narcotics through their time in the recovery room, and are managed over 95% of the time with ibuprofen alone at home. Complications There is no complication of dual plane that has not been well-described with either the submammary or partial retropectoral operations. The issue with dual plane is not that there are new complications, but that the patient and surgeon understand its limitations. So long as these trade-offs are well understood preoperatively, they are accepted later. For instance, in cases of extreme mobility of the breast over the underlying chest wall, inferior sliding of tissue may still occur with the dual plane approach. It is my impression that in extreme cases of laxity this may occur more with the dual plane than the submammary approach, but this is diffi cult to quantify because even the submammary approach does not always totally solve the problem. Though dual plane can reduce muscle animation relative to partial retropectoral, it cannot eliminate it to the same extent as the submammary pocket. Patients need to be aware of this, and make their decision about the pocket they prefer. 0060_ch54_9780702031687.indd 687 4/8/2009 3:33:53 PM G Pearls & pitfalls Pearls • When you have a choice in breast augmentation, always prioritize coverage. This will make the breast more natural in the short term and reduce the likelihood of diffi cult to correct long-term problems. • Point out all limitations a patient ’ s pre-existing anatomy poses on her result preoperatively. This will help her to let you do what you think is best for her, and will prepare her to accept trade-offs and shortcomings in her result later. • With the dual plane, dissect a partial retropectoral pocket fi rst. The more directly you are able to get behind the muscle, the less it will move superiorly after muscle division. • Do not force yourself to choose which type of dual plane you will do; these are not so much distinct entities as points on a path. You should feel the breast during the dissection and adjust the dissection accordingly. • Demand of yourself to make a gentle and bloodless pocket dissection so that your patients have an easy recovery. Pitfalls • The dual plane is not perfect, and though it maximizes most of the advantages and minimizes most of the disadvantages of either the submammary or partial retropectoral pockets, neither the surgeon nor the patient should think that it is perfect. • It is easy to over-dissect the attachments between the muscle and gland; avoid excessive dissection in that plane before dividing the pectoralis along the IMF, and then only release gradually and incrementally. • Do not release the pectoralis ever along the sternum; it creates deformities that are diffi cult to correct. Summary of steps 1. Partial retropectoral: Pectoralis origins left intact along sternum and IMF. 2. Dual plane type I: Pectoralis origins left intact along sternum, but divided along the IMF. 3. Dual plane type II: Same plus pectoralis released from overlying gland and allowed to slide to about the lower border of the areola. 4. Dual plane type III: Same plus greater release of pectoralis from gland, allowing it to slide to about the upper border of the areola. Further reading Adams WP Jr . The process of breast augmentation: Four sequential steps for optimizing outcomes for patients . Plast Reconstr Surg 2008 ; 122 ( 6 ): 1892 – 1900 . Adams WP Jr , Rios JL , Smith SJ . Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: Six-year prospective clinical study . Plast Reconstr Surg 2006 ; 118 ( 7S ): 46S – 52S . Spear SL , Carter ME , Ganz JC . The correction of capsular contracture by conversion to “ dual-plane ” positioning: Technique and outcomes . Plast Reconstr Surg 2006 ; 118 ( 7S ): 103S – 113S . Tebbetts JB , Adams WP . Five critical decisions in breast augmentation using fi ve measurements in 5 minutes: The high fi ve decision support process . Plast Reconstr Surg 2006 ; 118 ( 7S ): 35S – 45S . Tebbetts JB . Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study . Plast Reconstr Surg 2006 ; 118 ( 6 ): 1453 – 1457 . Teitelbaum S . The Inframammary approach to breast augmentation . Clin Plast Surg 2009 ; 36 ( 1 ): 33 – 43 Section 11: The breast Aesthetic Plastic Surgery 688 0060_ch54_9780702031687.indd 688 4/8/2009 3:33:53 PM
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