Breast Augmentation Dubai With Sientra Silicone Gel Breast Implants

Breast Augmentation Dubai | 1 March 2018

Breast Augmentation Dubai – 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.

Abdomen Anaplastic Large Cell Lymphoma (ALCL) Areola Asymmetry Atrophy Autoimmune Disease Biocompatible Biopsy Body Dysmorphic Disorder (BDD) Body Esteem Scale 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.


Breast Augmentation Dubai

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 A surgical procedure to replace breast tissue or

Calcification/ Calcium Deposits Capsular Contracture

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.


Breast Augmentation Dubai – Displacement Extrusion Fibrocystic Breast Disease Fibromyalgia Fibrous Tissues

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.


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.


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.


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.”


About Breast Augmentation With Breast Implants
The information in this section provides some general information about breast augmentation with breast implants

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.


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.


Breast Augmentation Dubai? 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).


• 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.
Breast Augmentation Dubai
• 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
NFECTION 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 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 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:
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.
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.
Breast Augmentation Dubai
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
error: Content is protected !!