FDA Issues Updated Safety Data on Silicone Gel–filled Breast Implants

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The FDA has released a report updating the clinical and scientific information for silicone gel–filled breast implants, including preliminary safety data from studies conducted by the manufacturers (Allergan and ­Mentor) as a condition of their November 2006 approval. While the report confirms that silicone gel–filled breast implants are safe and effective when used as intended, women should fully understand the risks prior to considering silicone gel–filled breast implants for breast augmentation or reconstruction.

Based on the report, women should know that breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. The most frequently observed complications and outcomes are capsular contracture, reoperation, and implant removal. Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease.

The report includes preliminary safety data from post­approval studies conducted by the manufacturers, a summary and analysis of adverse events received over the years by the FDA, and a comprehensive review of publications that discuss the safety and effectiveness of silicone gel–filled breast implants. The report is part of the FDA’s ongoing effort to ensure that women who have or who may be considering breast implants are informed of all possible complications and outcomes. The agency has also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants (www.fda.gov/breastimplants). ■




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