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The FDA advisory panel voted to recommend to the FDA that Mentor's silicone breast implants be approved with conditions 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. This recommendation comes 13 years after the FDA restricted access to the siliconeimplants because of safety concerns.
"We are pleased that the panel based its decision on scientific evidence, not on special interests, emotion or anecdotes," said James Wells, M.D., ASPS past president. "The comments by Josh Levine, Mentor's CEO, during his summationconfirm Mentor's long-term commitment to safety. This should go a long way to assure the FDA and the public that the panel's recommendation is prudent and sound."
ASPS and ASAPS are optimistic that the FDA will follow the panel's recommendation. "By doing so, Mentor can move forward to reintroduce silicone implants as an option for American women. Organized plastic surgery is enthusiastic about working with the manufacturer to ensure women's health and safety," said ASAPS President-Elect Mark Jewell, M.D. "Plastic surgeons are committed to help women make informed choices abouth their health care based on all the available and accurate information about these devices."
Both societies are prepared to work with the FDA and Mentor to fulfill the conditions which include physician education, patient education, a registry, and a commitment from the manufacturers for continued data collection. Prior to the decision, ASPS and ASAPS have taken a leadership role in physician education, patient informed consent, and development of a registry.
The two societies believe continued data collection and study of the procedure and device are essential, and they are committed to being active participants in post-market monitoring of the implants.
An increasing number of women are choosing breast augmentation to ehance their appearance. According to ASAPS, nearly 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.
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Dr. Grotting
