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FDA takes step toward silicone immplant approval

Article-FDA takes step toward silicone immplant approval

National report — The U.S. Food and Drug Administration (FDA) recently issued an "approvable with conditions" letter to Mentor Corp. for its silicone breast implants — a move applauded by the American Society for Aesthetic Plastic Surgery (ASAPS) and American Society of Plastic Surgeons (ASPS).

"We are pleased the FDA supports its advisory panel's decision to allow women the choice of silicone breast implants, provided the manufacturer meets certain conditions," says Richard D'Amico, M.D., chair of the ASAPS/ASPS Breast Implant Task Force.

The letter states conditions that Mentor Corp. must meet in order to receive FDA approval to market and sell silicone breast implants in the United States. These include continuation of long-term studies and an independent annual review of safety data, according to news reports.

Josh Levine, president and CEO, Mentor Corp., tells Cosmetic Surgery Times, "For more than a decade, choices for women seeking breast augmentation and reconstruction have been limited. If ultimately approved by the FDA, Mentor's Memory Gel breast implants will be a significant additional option for these women."

The July 28 decision was another step toward approval following the FDA advisory panel hearing held April 12-13. The panel voted 7-2 for an "approval with conditions" of Mentor's application.

Patrick McMenamin, M.D., a cosmetic surgeon based in Sacramento, Calif., and a Cosmetic Surgery Times medical adviser, called the move by the FDA a "thoughtful" one, and adds, "Women are incredibly informed about silicone implants, and they do not need others to make these decisions for them."

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