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Plastic Surgery Societies Applaud FDA "Approvable with Conditions" Letter to Mentor Corporation for Silicone Breast Implants ARLINGTON HEIGHTS, Ill. - The FDA's "approvable letter" with conditions to Mentor Corporation regarding its silicone breast implants is applauded by the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), the two largest plastic surgery membership organizations. The approvable letter stipulates a number of conditions that Mentor must satisfy in order to receive FDA approval to market and sell silicone breast implants in the United States. This letter comes 13 years after the FDA restricted access to silicone implants because of safety concerns. Today's FDA decision follows the April 12-13 FDA advisory panel hearing in which the panel issued a 7-2 "approval with conditions" vote for Mentor's application for approval of its silicone breast implants. Also at the April hearing, the advisory panel issued a 5-4 "non-approvable" vote for Inamed's PMA. The panel encouraged Inamed Medical to address its remaining concerns and submit a revised application for approval. To date, the FDA has not announced a decision regarding Inamed's PMA. ASPS and ASAPS will continue to offer assistance to the manufacturers for the conditions set forth by the FDA related to physician and patient education. At the forefront of their ongoing education campaign is a joint Web site www.breastimplantsafety.org. This authoritative Web site offers objective and science-based information for both saline and silicone breast implants. An increasing number of women are choosing breast augmentation to enhance their appearance. According to the societies, between 264,000 and 335,000 women chose breast augmentation in 2004. More than 62,000 women had breast reconstruction in 2004, according to ASPS. Breast reconstruction has been proven in numerous studies to have many psychological and physical benefits for women who have undergone a mastectomy. This news page is adapted from August 2005 Plastic Surgery Today, a newsletter from the American Society of Plastic Surgeons (ASPS) offering news, advice, and information about cosmetic and reconstructive plastic surgery.
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