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CALIFORNIA SOCIETY OF PLASTIC SURGEONS CALLS FDA PANEL FINDING ON BREAST IMPLANTS A CONFUSED, MIXED MESSAGE

 CALIFORNIA SOCIETY OF PLASTIC SURGEONS CALLS FDA PANEL FINDING
 ON BREAST IMPLANTS A CONFUSED, MIXED MESSAGE
 LOS ANGELES, Feb. 24 /PRNewswire/ -- The California Society of Plastic Surgeons Inc. (CSPS) says the advisory panel to the Food and Drug Administration (FDA) has made recommendations which create confusion and doubt in the minds of the 1 million to 2 million women who have had silicone gel breast implants as well as women who desire them for reconstructive or cosmetic reasons, according to CSPS President John O. Strong, M.D.
 "As professionals whose first concern is for the welfare of our patients, our members feel a very mixed message has been given to women by the advisory panel," Strong said.
 "The panel concluded from testimony given during the hearings last week that there is no cause-and-effect relationship between autoimmune disease and the implants, yet it wants to restrict their use to limited research studies for augmentation and a broader protocol for reconstruction. While we support further research, we feel the panel's approach is illogical.
 "Even some nonvoting members of the panel argued that there should be no distinction between augmentation and reconstruction, calling such action judgmental and paternalistic.
 "A woman wanting breast augmentation under the panel's recommendation may have to invest an inordinate amount of time and effort to become part of a controlled study. Some will not be able to make the investment, thus putting augmentation out of many women's reach. Similarly, women seeking reconstructive surgery will have to be participants in a government-controlled study which has the potential of being so restrictive that some who need it may be denied access to the study.
 "Not the least of concerns for women wanting either breast augmentation or reconstruction is the question of how the FDA's actions will be viewed by insurers. It is highly possible that coverage of all such implants will be denied if they are considered 'experimental' by virtue of imposed government studies. It is further possible that manufacturers of these devices will find them unprofitable and discontinue making them, again denying women a choice.
 "We support the FDA's suggestions of registry of breast implant patients, written informed consent and further research into silicone gel breast implants; however, testimony given by experts during the hearings did not support a ban on them.
 "FDA Commissioner David Kessler has promised a final decision within 60 days. We strongly urge him to review the situation carefully, call for further research of the products and obtain expert advice before making that final decision," concluded Strong.
 -0- 2/24/92
 /CONTACT: Norma Collier or Robert M. Garrick of Collier Communications, 213-381-1614, for the California Society of Plastic Surgeons/ CO: California Society of Plastic Surgeons ST: California IN: MTC ST:


EH-CH -- LA023 -- 2058 02/24/92 16:41 EST
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Publication:PR Newswire
Date:Feb 24, 1992
Words:463
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