FDA Lifts Ban on Silicone Gel-Filled Breast Implants
November 21, 2006 - Fourteen years after they were removed from the market over safety concerns, the U.S. Food and Drug Administration is once again allowing the use of silicone gel-filled breast implants.
The FDA's latest decision was announced November 17, 2006. The government agency approved silicone gel-filled implants for breast augmentation in women 22 years old and older and for women of all ages undergoing breast reconstruction surgery. According to the FDA's comments, 22 is the age by which most women's breasts have developed fully. Follow-up studies for the safety and effectiveness of the implants is a condition of the approval.
The original ban
In 1992, then-FDA Commissioner Dr. David Kessler removed silicone gel-filled breast implants from the open market due to safety concerns, including how often the implants rupture in a woman's body.
Following the ban, the implants were available only to women in clinical trials who needed them after surgery, especially surgery for breast cancer. Since that time, most studies have not linked the silicone-gel implants to serious or chronic diseases such as breast cancer or auto-immune diseases. However, questions still remain about whether leaking silicone could lead to diseases, as some women have claimed.
Factors to be considered
As reported by the FDA press release, the following factors should be considered:
• "breast implants are not lifetime devices and a woman will likely need additional surgeries on [a breast or breasts with implants] at least once over her lifetime;
• many of the changes to a woman's breast following implantation are irreversible;
• rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured;
• a woman will need regular screening - magnetic resonance imaging (MRI) - over her lifetime to determine if silent rupture has occurred. The implant labeling states that a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter. The cost of MRI screening over a woman's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. The labeling also states that if implant rupture is noted on an MRI, the implant should be removed and replaced, if needed."
Additional complications
In addition to the factors listed by the FDA, the local complication of capsular contraction (a hardening or thickening of the tissue around the implant that could result in discomfort or changes in the shape of the implant) is possible. Mammograms are also more difficult to perform on women with implants. This challenge can be overcome by having mammograms done in facilities with technologists trained in the use of special detection procedures.
Approximately 20 percent of patients with breast implants receive them because of a breast cancer diagnosis or other medical need.
Reconstruction of a breast removed by mastectomy, reconstruction of the non-diseased breast to restore symmetry and treatment of any ensuing physical complications are all possibilities in the cancer treatment process. Some women and plastic surgeons choose silicone implants instead of saline implants because they feel silicone provides better symmetry, a more natural appearance and added comfort. Other women may elect to use a prosthesis rather than undergoing reconstructive surgery.
The Komen Foundation Perspective
The Susan G. Komen Breast Cancer Foundation continues to support the availability of silicone breast implants as an option for women considering reconstructive surgery due to mastectomy. Patients should be informed of risks associated with silicone breast implants and discuss these risks with a plastic surgeon in order to select the choice that is best for them.
While the overwhelming body of evidence does not support the existence of a link between silicone breast implants and major diseases of the body, such as systemic diseases and cancers, mastectomy patients considering silicone breast implants should be educated about the higher risk of some complications. This will allow patients to make informed decisions about whether silicone breast implants are right for them.
No conclusive evidence exists showing that implants have hindered or delayed breast cancer detection. Because mammograms are more difficult to perform on women with implants, women with breast implants should notify their physician and mammography facility before a mammogram is done.
The Komen Foundation supports ongoing data collection, analysis and reporting based on the long-term follow-up of all women who receive silicone implants for breast reconstruction.
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