AESTHETIC PLASTIC SURGEONS SAY FDA DECISION ON SILICONE GEL IMPLANTS IS 'TOO LITTLE, TOO LATE'
AESTHETIC PLASTIC SURGEONS SAY FDA DECISION ON SILICONE GEL IMPLANTS IS 'TOO LITTLE, TOO LATE' ARLINGTON HEIGHTS, Ill., April 16 /PRNewswire/ -- The Food and Drug Administration's decision to allow the use of silicone gel-filled breast implants for reconstructive surgery in breast-cancer patients, but to tightly restrict their use for cosmetic purposes, received both praise and criticism today from the president of the 900-member American Society for Aesthetic Plastic Surgery (ASAPS), Edward S. Truppman, MD, of Miami. "Allowing continued wide access to gel implants for breast reconstruction is the only compassionate and humane decision that FDA Commissioner Kessler could make, and we certainly applaud this action," said Truppman. "We are grateful that the commissioner recognizes the urgent need of some patients who are in the middle of reconstruction, or who need implant replacement, and has made provisions for these individuals to have immediate access to the devices. We further support the concept of a patient registry and the strictest standards of informed consent. "But today's FDA announcement does nothing to address the broader scientific issues and to repair the damage that has been done to hundreds of thousands of women who are stunned and confused by the agency's decision to label implants for cosmetic purposes as 'investigational,' or experimental, devices -- which could affect some patients' health insurance coverage. There is no scientifically valid reason why the use of gel implants for aesthetic breast augmentation should be severely restricted and women denied their right of informed choice. "Kessler has acted contrary to the recommendations of much of organized medicine, including the Council on Scientific Affairs of the American Medical Association, which stated that 'the considerable public anxiety concerning the safety of breast implants is not warranted based on current scientific evidence' and recommended implants' continued availability, pending further study. "As a result of the 'witch-hunt' atmosphere that has characterized the entire FDA review process concerning silicone breast implants, scores of American women, most of whom have never had any significant problems with their implants, are in a state of panic. Some of these women are now undergoing additional surgery to remove their implants and, in some cases, are faced with severe psychological disturbance as a result of their altered body image. "The members of ASAPS are deeply concerned about the physical and psychological well-being of our patients. We are dedicated to providing compassionate counseling and medically appropriate care for breast- implant patients with regard for each individual's personal and financial circumstances. He also have pledged support for scientific research to help resolve any remaining questions about the safety and efficacy of breast implants." -0- 4/16/92 /NOTE TO EDITORS: The American Society for Aesthetic Plastic Surgery (ASAPS) is the largest plastic surgery organization dedicated exclusively to the field of aesthetic (cosmetic) plastic surgery. ASAPS' approximately 900 members are certified by the American Board of Plastic Surgery./ /CONTACT: Nancy Kobus or Elizabeth Sadati of American Society for Aesthetic Plastic Surgery, 708-228-9274/ CO: American Society for Aesthetic Plastic Surgery Inc. ST: Illinois IN: HEA SU:
SM-OS -- NY092 -- 9427 04/16/92 15:32 EDT
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|Date:||Apr 16, 1992|
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