Plastic Surgery Societies Disappointed, not Surprised by ‘Non-Approvable' Recommendation for Inamed Silicone Implants
Manufacturer Fails to Address Rupture Rate Concerns
GAITHERSBURG, MD. –An FDA advisory panel's 5-to-4 decision today to deny American women the choice of Inamed silicone breast implants is disappointing but not entirely surprising, said the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS). Multiple scientific studies conducted over the past 35 years support the safety of the medical device, but the manufacturer failed to satisfy all of the panel's safety concerns. In issuing its decision, those panel members who voted “non-approvable” suggested that the manufacturer continue their studies to include additional years of rupture rate data and then resubmit its pre-market application.”
“Inamed did an excellent job of satisfying the majority of the FDA's concerns,” said James Wells, MD, ASPS past president. “Unfortunately, the concern over long term data regarding implant ruptures led the panel to issue a ‘not approvable' recommendation.”
Patient safety and satisfaction are the primary concern of all board certified plastic surgeons. ASPS and ASAPS do not support a flawed medical device. The two societies feel strongly that women deserve the right to make informed personal choices about their health care based on all the available and accurate information about breast augmentation and breast reconstruction. “We hope that today's decision will not be the final word and that the manufacturer will do what it takes to address the panel's concern, said Dr. Wells.
“It was our hope that the FDA would make its decision based on the best interests of patients using the wealth of scientific evidence presented. Unfortunately, Inamed did not show long-term rupture rate data. The good news is that the scientific evidence continues to demonstrate that there is not a link between silicone implants and systemic disease,” said Mark Jewell, MD, ASAPS president-elect. “Now, Inamed will need to more thoroughly address the panel's particular concerns if it hopes to see its implants unrestricted return to the market.”
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.
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 non-surgical 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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