Plastic Surgery Societies Disappointed, Not Surprised by 'Non-Approvable' Recommendation for Inamed Silicone Implants Manufacturer Fails to Address Rupture Rate Concerns



    GAITHERSBURG, Md., April 12 /PRNewswire/ -- 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. http://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.
 http://www.surgery.org.
 
 

SOURCE American Society for Aesthetic Plastic Surgery

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