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Mentor receives 'approvable letter' for silicone breast implants

Ambulatory Surgery Reimbursement Update, August 2, 2005

The two largest plastic surgery membership organizations are applauding the Food and Drug Administration's (FDA) "approvable letter" to Mentor Corporation regarding its silicone breast implants.

The letter outlines the conditions the manufacturer must meet to receive FDA approval to begin marketing and selling the implants.

In a statement issued by the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), the societies voiced their support of this step in the process to eventually allow patients to once again choose silicone breast implants as an option for breast augmentation.

"We are pleased that the FDA has carefully evaluated the testimony of physicians, patients, advocacy groups and industry, and following the recommendation of its scientific advisory panel, is moving forward toward allowing our patients access to silicone gel breast implants," said Alan Gold, MD, vice-chair of the ASPS/ASAPS Breast Implant Task Force.

The letter comes 13 years after the FDA restricted access to silicone implants amidst concerns about patient safety.

To read the FDA's statement on the letter, click here.

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