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FDA Updates Silicone Gel-Filled Breast Implant Data

Report notes that implants are safe if used as intended, offers guidance for patients

WEDNESDAY, June 22 (HealthDay News) -- The U.S. Food and Drug Administration has released a report that updates clinical and scientific information on silicone gel-filled breast implants.

The report includes preliminary safety data from studies conducted by silicone gel-filled breast implant manufacturers (Allergan and Mentor) as part of their approval in November 2006, requiring both companies to conduct six post-approval studies to outline the long-term efficacy and safety of these implants. The aim of the report is to make sure that women are completely aware of implant risks prior to considering breast augmentation or reconstruction surgery. It confirms that silicone gel-filled breast implants are safe and effective when used as indicated.

Key points from the report that women should be aware of include the fact that the risk of complications increases the longer a woman has implants. The most frequently observed complications and outcomes include capsular contracture, reoperation, and implant removal. In addition, preliminary data do not indicate that implants are associated with breast cancer, reproductive problems, or connective tissue disease. The FDA is recommending that women with silicone gel-filled breast implants routinely follow up with their health care provider, be aware of the potential for longer term complications, and pay attention to any changes or symptoms.

"The FDA will continue to monitor and collect safety and performance information on silicone gel-filled breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms," Jeffrey Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health, said in a statement. "Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems."

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