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Plastic Surgery Societies Applaud FDA "Approvable with Conditions" Letter to Inamed Medical Corporation for Silicone Breast Implants NEW YORK, NY - The FDA's "approvable letter" with conditions to Inamed Medical 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 Inamed Medical 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 an FDA advisory panel hearing on silicone implants held in April where implant manufacturers presented data regarding these medical devices. Inamed Medical is the second manufacturer to receive an approvable letter from the FDA. Mentor Corporation received a letter in July 2005. 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. Read more about Silicone Implants
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