Plastic Surgery Societies Applaud FDA “Approvable with Conditions” Letter to Mentor Corporation for Silicone Breast Implants
ARLINGTON HEIGHTS, IL – 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.
“We are pleased that the FDA supports its advisory panel's decision to allow women the choice of silicone breast implants provided the manufacturer meets certain conditions,” said Richard D'Amico, MD, chair of the ASPS/ASAPS Breast Implant Task Force. “Organized plastic surgery is enthusiastic about working with the manufacturer to ensure American women's health and safety. We are committed to helping women make informed choices about their health care based on all the available and accurate information about these devices.”
“As plastic surgeons, we fully appreciate and are ever mindful of our critical role as patient advocates, and strive to ensure patient safety while advancing the art and science of our profession,” said Alan Gold, MD, vice-chair of the ASPS/ASAPS Breast Implant Task Force. “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. We believe the FDA has been appropriately diligent in its review of the evidence regarding the safety and efficacy of these devices.”
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 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.
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. With more than 5,800 member surgeons, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises 94 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the society represents physicians certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada.www.plasticsurgery.org .
The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of board-certified plastic surgeons specializing in cosmetic plastic surgery. Since 1967, ASAPS has been an authoritative source in cosmetic surgery education and research. ASAPS' 2,200 plastic surgeons are elected to membership and are certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. www.surgery.org.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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