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AESTHETIC PLASTIC SURGEONS SAY FDA PANEL RECOMMENDATIONS WILL LEAVE WOMEN CONFUSED AND CONCERNED

 AESTHETIC PLASTIC SURGEONS SAY FDA PANEL RECOMMENDATIONS WILL LEAVE
 WOMEN CONFUSED AND CONCERNED
 ARLINGTON HEIGHTS, Ill., Feb. 21 /PRNewswire/ -- The FDA advisory panel's recommendation to allow wide use of silicone gel-filled implants for breast reconstruction but to severely restrict use for breast augmentation will leave the estimated 2 million women who currently have the devices confused and concerned, said Edward Truppman, MD, president of the American Society for Aesthetic Plastic Surgery (ASAPS).
 "The FDA proceedings have sent a mixed message to American women," said Dr. Truppman. "On one hand, the advisory panel reached a consensus that current scientific evidence does not show a cause-and-effect relationship between breast implants and serious diseases such as autoimmune disorders or cancer, nor do implants pose unreasonable difficulties in the early detection of breast cancer. This should be of tremendous comfort to women who already have breast implants.
 "On the other hand, however, the panel wants to severely restrict access to women who may want these devices in the future for aesthetic breast augmentation, implying that the risks of breast implants for this group of women may be significant. In light of the failure to prove any serious health risk associated with breast implants, the panel's conclusion is neither logical nor scientific."
 Dr. Truppman emphasized that ASAPS fully supports the recommendation to conduct retrospective studies and prospective clinical trials of breast-implant patients and to develop a workable plan for a breast- implant registry. However, wide access to breast implants for all women who need and want them, within appropriate medical protocols, should not be denied.
 "While we are grateful that the panel's recommendation does recognize the breast cancer patient's urgent need for continued wide availability of silicone gel-filled implants, discrimination against women seeking these devices for cosmetic purposes is unjustified and is clearly based upon a value judgment by some panel members that the desire to enhance one's personal body image is somehow trivial," said Dr. Truppman. "This paternalistic attitude is a slap in the face to hundreds of thousands of American women who have elected aesthetic surgery."
 According to Dr. Truppman, the panel's recommendations have potentially serious public health consequences. "As a result of the FDA proceedings, it is practically assured that health insurance coverage for any condition of the breast, or even general health coverage, will be denied to women who have implants -- including breast cancer patients who are already at high risk to develop cancer in their other breast.
 "In addition, severely restricting the availability of implants for augmentation, which represents an estimated 80 percent of the breast implants currently in use, may make it sufficiently unprofitable for companies to continue producing these devices. In that case, despite the panel's recommendation that breast cancer patients should have wide access to silicone gel-filled implants, these products may be unavailable in the future."
 While commending the panel for its efforts to achieve a compromise solution, Dr. Truppman expressed regret that the process appeared to be seriously flawed. "We are especially concerned that some members of the panel who were committed to taking a purely scientific approach to their evaluation of breast implants felt frustrated to the point of publicly questioning the objectivity of their panel colleagues. This raises doubts about whether the panel was able to effectively carry out its mandate."
 The FDA will announce its final decision on the availability of silicone gel-filled breast implants within 60 days, or by April 20, according to FDA Commissioner David Kessler.
 "We are hopeful that plastic surgeons can work with the FDA to develop protocols, and establish criteria for appropriate size and duration of clinical trials, allowing the widest possible access to breast implants for all women who need them -- both for reconstruction and augmentation. We are pleased that FDA Commissioner Kessler has expressed a willingness to discuss the issues with us and consider our ideas. It may be possible that the panel's recommendations can be further developed to adequately serve the needs and best interests of our patients and the American public."
 The 900 ASAPS members generally perform the highest percentage of aesthetic surgery among board-certified plastic surgeons.
 The American Society of Aesthetic Plastic Surgery (ASAPS) is a not- for-profit organization representing approximately 900 surgeons who are certified by the American Board of Plastic Surgery and concentrate their practices in aesthetic surgery.
 -0- 2/21/92
 /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: MTC SU:


SH-KW -- NY044 -- 1456 02/21/92 14:51 EST
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Date:Feb 21, 1992
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