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Last updated: 02/17/2009
Some women have reported various types of autoimmune-related connective tissue disorders, which they attribute to their implants—usually involving silicone gel implants. Lawsuits have been filed against the manufacturers of these implants. Food and...
Drug Administration (FDA) guidelines, issued in 1992, now greatly restrict their use, primarily to women who need to replace an existing silicone gel-filled implant. In addition, recipients must sign a consent form that details the potential risks of silicone gel-filled implants and become enrolled in a long-range study. Saline is now the filling of choice for breast implants. Saline-filled implants are permitted for all uses, although manufacturers must continue to collect data on possible risks.
The FDA issued a status report on Breast Implant Safety in 1995, and revised it in March 1997. It noted that studies to date have not shown a serious increase in the risk of recognized autoimmune diseases in women with silicone gel-filled breast implants. It also addressed concerns about other complications and emphasized the need for further study of this issue.
There are a number of risks common to any surgical procedure, such as bleeding, infection, anesthesia reaction, or unexpected scarring. Hematoma (accumulation of blood at the surgical site), or seroma (collection of fluid at the surgical site) can delay healing if they are not drained. Any breast reconstruction also poses a risk of asymmetry and the possible need for an unplanned surgical revision. Persistent pain is another potential complication of all types of breast reconstruction.
Implants have some unique problems that may develop. A thick scar, called a capsule, forms around the implant as part of the body's normal reaction to a foreign substance. Capsular contracture occurs when the scar becomes firm or hardened. This may cause pain accompanied by changes in the texture or appearance of the breast. Implants can rupture and leak, deflate, or become displaced. The chances of capsular contracture or rupture increase with the age of the implant. These complications can usually be remedied with outpatient surgery to loosen the capsule and remove or replace the implant as needed. There is some evidence that using implants with textured surfaces may decrease the incidence of these problems. An implant tends to remain firm indefinitely. It will not grow larger or smaller as a woman's weight changes. Asymmetry can develop if a woman gains or loses a large amount of weight.
The autologous procedures all carry a risk of flap failure, which is a loss of blood supply to the tissue forming the new breast. If a large portion of the flap develops inadequate blood supply, another reconstructive technique may be necessary. Tummy tuck flap procedures can result in decreased muscle tone and weakness in the abdomen, or lead to an abdominal hernia. Arm weakness may occur after latissimus dorsi flap surgery.
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Breast reconstruction is the rebuilding of a breast, usually in women. It involves using autologous tissue or prosthetic material to construct a natural-looking breast. Often this includes the reformation of a natural-looking areola and nipple. This procedure involves the use of implants or relocated flaps of the patient's own tissue.
The primary part of the procedure can often be carried out immediately following the mastectomy. As with many other surgeries, patients with significant medical comorbidities (high blood pressure, obesity, diabetes) and smokers are higher-risk candidates. Surgeons may choose to perform delayed reconstruction to decrease this risk. Patients expected to receive external beam radiation as part of their adjuvant treatment are also commonly considered for delayed autologous reconstruction due to significantly higher complication rates with tissue expander-implant techniques in those patients.
Breast reconstruction is a large undertaking that usually takes multiple operations. Sometimes these follow-up surgeries are spread out over weeks or months. If an implant is used, the individual runs the same risks and complications as those who use them for breast augmentation but has higher rates of capsular contracture (tightening or hardening of the scar tissue around the implant) and revisional surgeries.
In 1998, the Women's Health and Cancer Rights Act was passed mandating insurance coverage for breast reconstruction in the United States. Prior to this, many insurance carriers did not cover breast reconstructive surgery as they considered it cosmetic in nature. The act mandates insurance coverage for the surgery of the affected breast and also the contralateral side for purposes of symmetry1, 2
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