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On November 17, 2006, the FDA approved silicone gel implants. Now that the products have been determined to be safe and effective, the FDA will continue to monitor them by requiring each breast implant manufacturer (Mentor and Inamed) to conduct a large postapproval study following which will follow about 40,000 women for 10 years after receiving breast implants. The FDA often requires postmarket studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events.
The FDA’s decision to approve these implants was based on a thorough review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, the FDA conducted inspections of each company’s manufacturing facilities to determine that they comply with the FDA’s Good Manufacturing Practices. Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported being satisfied with their implants.
Silicone gel-filled breast implants were first introduced in the United States in 1962 by Cronin and Gerow. Implant failure, complications, and illness soon followed and in 1988 the USFDA announced that all breast implants would be relabeled as class III medical devices.
In 1992, the FDA approved adjunct study protocol for silicone gel-filled breast implants for reconstruction and revision patients. Three years later in 1995, the major manufacturer of silicone and other implants, Dow Corning Corp. faced 19,000 lawsuits for defective breast implants, forcing the company to file bankruptcy.
Finally, in November 2006, the FDA approved a new type of silicone gel-filled breast implant made by two manufacturers for cosmetic breast augmentation and breast reconstruction. The approval was given with a requirement to complete a ten year study on women who have already received the implants and a study involving the safety of implants in 40,000 women. The study was conducted to ensure that the breast implants were not defective.
The FDA warns that having implants carries certain risks and that women with implants should be given brochures explaining the risks of breast implants and to have periodic MRI exams to monitor any signs of breast implant defects which can cause rupture or leakage in patients.
FDA has approved new silicone gel-filled breast implant
The Approval is conditioned on post-approval safety studies
The U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.