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Plastic Surgery Societies Applaud FDA Panel Recommendation That Mentor’s Silicone Breast Implants Be Approved With ConditionsUpdated April 8, 2005
AITHERSBURG, MD – The FDA advisory panel’s 7-2 vote today 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 silicone implants 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, MD, ASPS past president. “The comments by Josh Levine, Mentor’s CEO, during his summation confirm 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, MD. “Plastic surgeons are committed to helping women make informed choices about 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 today’s decision, ASPS and ASAPS have taken a leadership role in physician education, patient informed consent, and development of a registry.
On April 12, the FDA advisory panel issued in a 5-4 vote a “non-approvable” recommendation to Inamed’s application for approval of its silicone breast implants. The panel encouraged Inamed to address its remaining concerns and then request panel re-review of its application for approval. “We are hopeful that a similar favorable recommendation will be issued in the near future to Inamed if it can satisfy the FDA’s remaining concerns,” said Dr. Jewell.
To that end, 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.
In addition, ASPS and ASAPS will continue to offer assistance to the manufacturers with additional conditions set forth by the FDA related to physician and patient education. At the forefront of their ongoing education campaign is the recently launched joint Web site www.breastimplantsafety.org. This will be the authoritative Web site for both saline and silicone breast implants and offer objective and science-based information.
An increasing number of women are choosing breast augmentation to enhance 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.
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. With more than 5,000 members, 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 the 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.