BREAST AUGMENTATION - SPECIFIC SURGICAL RISKS

DESCRIPTION                   

q      Augmentation mammaplasty is a surgical operation performed to enlarge the breasts for a number of reasons: To enhance the body contour of a woman, who for personal reasons feels that her breast size is too small. To correct a loss in breast volume after pregnancy.  To balance breast size, when there exists a significant difference between the size of the breasts.  As a reconstructive technique for various conditions.

q     The shape and size of the breasts prior to surgery will influence both the recommended treatment and the final results.  If the breasts are not the same size or shape before surgery, it is unlikely that they will be completely symmetrical afterward.

q      Silicone gel-filled implants are available for some conditions within a study protocol supervised by the United States Food and Drug Administration (FDA).  Saline-filled breast implants are still widely available for cosmetic breast augmentation. The FDA is currently reviewing the safety of saline-filled breast implants.  All breast implants are subject to device tracking according to federal law.

q      Breast enlargement is accomplished by inserting a breast implant either behind the breast tissue or under the chest muscles.  Incisions are made to keep scars as inconspicuous as possible, usually under the breast, around the lower part of the areola, or in the armpit.  The method of inserting and positioning breast implants will depend on your preferences, your anatomy and your surgeon’s recommendation.

q     Every surgical procedure involves a certain amount of risk and it is important that you understand the risks involved with augmentation mammaplasty.  Additional information may be obtained from the FDA, package-insert sheets supplied by the implant manufacturer, or other information pamphlets required by individual state laws.  

RISKS

q      INFECTION:  Infection is unusual after this type of surgery.  Should an infection occur, treatment including possible removal of the implant, antibiotics or additional surgery may be necessary.  It is extremely rare that an infection would occur around an implant from a bacterial infection elsewhere in the body.

q      CAPSULAR CONTRACTURE:  Scar tissue, which forms internally around the breast implant, can tighten and make the breast round, firm, and possibly painful.  Excessive firmness of the breasts can occur soon after surgery or years later.  Although the occurrence of symptomatic capsular contracture is not predictable, it generally occurs in less than 20 percent of patients.  The incidence of symptomatic capsular contracture can be expected to increase over time.  Capsular contracture may occur on one side, both sides or not at all.  Treatment for capsular contracture may require surgery, implant replacement, or implant removal.  External pressure (closed capsulotomy) may break up scarring, but can potentially rupture the implant.

q      CHANGE IN NIPPLE AND SKIN SENSATION:  Breasts are usually sore after surgery.  Some change in nipple sensation is not unusual right after surgery.  After several months, most patients have normal sensation.  Partial or permanent loss of nipple and skin sensation may occur.

q     IMPLANTS:  Breast implants, similar to other medical devices, can fail.  Implants can break or leak.  When a saline-filled implant deflates, its salt water filling will be absorbed by the body.  Rupture can occur as a result of an injury, from no apparent cause, or during mammography.  It is possible to damage an implant at the time of surgery.  Damaged or broken implants cannot be repaired.  Ruptured or deflated implants require replacement or removal.  Breast implants do not have an indefinite lifespan and will eventually require replacement surgery.

q      DEGRADATION OF BREAST IMPLANTS:  It is possible that small pieces of the implant material may separate from the outer surface of breast implants.  This is of unknown significance.

q      IMPLANT EXTRUSION:  Lack of adequate tissue coverage or infection may result in exposure and extrusion of the implant.  Skin breakdown has been reported with the use of steroid drugs or after radiation therapy to breast tissue.  If tissue breakdown occurs and the implant becomes exposed, implant removal may be necessary.

q      MAMMOGRAPHY:  Pre-operative mammography is recommended prior to surgery. Post-operative mammography is performed according to American Cancer Society guidelines, but a baseline is recommended 6 months after surgery is completed.  Breast implants may make mammography more difficult and may obscure the detection of breast cancer.  Implant rupture can occur from breast compression during mammography.  Inform your radiologist of the presence of breast implants so that appropriate mammogram studies may be obtained.  Ultrasound, specialized mammography and MRI studies may be of benefit to evaluate breast lumps and the condition of the implant(s).

q      SKIN WRINKLING AND RIPPLING:  Visible and palpable wrinkling of implants can occur.  Some wrinkling is normal and expected.  This may be more pronounced in patients who have saline-filled implants or thin breast tissue.

q      PREGNANCY AND BREAST FEEDING:  There is insufficient evidence regarding the absolute safety of breast implants in relation to fertility, pregnancy or breast feeding.  While there is no convincing evidence of any special danger of breast implants for pregnant women or their children, studies are continuing to look for possible problems.

q      CALCIFICATION:  Calcium deposits can form in the tissue surrounding the implant and may cause pain, firmness, and be visible on mammography.  Should this occur, additional surgery may be necessary to correct his problem.

q      IMMUNE SYSTEM DISEASES AND UNKNOWN DISORDERS:  Some women with breast implants have reported symptoms similar to those of known diseases of the immune system, such as systemic lupus erythematosis, rheumatoid arthritis, scleroderma, and other arthritis-like conditions.  These symptoms include joint pain or swelling, fever, fatigue, thyroid problems, breast pain and musculoskeletal pain.  A connection between implanted silicone and connective-tissue disorders has not been identified.  To date, there is no scientific evidence that women with either silicone gel-filled or saline-filled breast implants have an increased risk of these diseases.  The effects of breast implants in individuals with pre-existing connective-tissue disorders is unknown. 

Unlike silicone gel-filled implants, the saline-filled implants contain salt water.  Any risk related to silicone gel would not be associated with saline-filled implants.  However, gel-filled and saline-filled devices have a silicone rubber envelope.  Reliable medical laboratory tests to determine antibodies to silicone do not exist.  It has not been proved that there is a relationship between silicone antibodies and disease in women with breast implants.  

q      SURFACE CONTAMINATION OF IMPLANTS:  Skin oil, lint from surgical drapes, or talc may become deposited on the surface of the implant at the time of insertion.  The consequences of this is unknown.

q     CHEST WALL DEFORMITY:  Chest wall deformity has been reported secondary to the use of tissue expanders and breast implants.  The consequences of chest wall deformity is of unknown significance.

q     UNUSUAL ACTIVITIES AND OCCUPATIONS:  Activities and occupations which have the potential for trauma to the breast could potentially break or damage breast implants.

q      BREAST DISEASE:  Current medical information does not demonstrate an increased risk of breast disease or breast cancer in women who have breast implant surgery for either cosmetic or reconstructive purposes.  Breast disease can occur independently of breast implants.  It is recommended that all women perform periodic self examination of their breasts, have mammography according to American Cancer Society guidelines, and to seek professional care should they notice a breast lump.

q      OTHER:  You may be disappointed with the results of surgery.  Asymmetry in implant placement, breast shape and size may occur after surgery.  Unsatisfactory displacement or poor surgical scar location may occur.  It may be necessary to perform additional surgery to improve your results.

q      REMOVAL/REPLACEMENT OF BREAST IMPLANTS:  Future removal or replacement of breast implants and the surrounding scar tissue envelope involves a surgical procedure with risks and potential complications.

ALTERNATIVES

q      Augmentation mammaplasty is an elective surgical operation.  Alternative treatment would consist of not undergoing the surgical procedure, the use of external breast prostheses or padding, or the transfer of other body tissues to enlarge breast size.