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FDA panel supports silicone implants’ return to market

Ambulatory Safety Monitor, April 21, 2005

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An advisory panel for the Food and Drug Administration (FDA) voted 7-2 in favor of allowing silicone-gel breast implants to return as an option for American women, a move which may overturn a 13-year ban on most uses of the devices.

The panel made the unexpected turnaround after Mentor Corp., a manufacturer of the implants, persuaded the advisers that its newer silicone implants are safer and more durable than older versions, according to the Associated Press (AP).

The panel's recommendation does not necessarily mean the FDA will overturn the ban, since 15 months ago the FDA overruled a recommendation to bring back gel implants, according to the AP. However, the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery (ASAPS) applauded the recommendation and are optimistic that the FDA will allow the safer silicone implants to return to the U.S. market.

"By doing so, Mentor can move forward to reintroduce silicone implants as an option for American women. Organized plastic surgery is enthusiastic about working with the manufacturer to ensure women's health and safety," said ASAPS President-Elect Mark Jewell, MD, in a statement issued on the ASAPS Web site.

To view the ASAPS press release, click here.

To view the AP's story, click here.

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