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CALIFORNIA SOCIETY OF PLASTIC SURGEONS INC. CRITICIZES FDA'S HANDLING OF BREAST IMPLANT ISSUE

 CALIFORNIA SOCIETY OF PLASTIC SURGEONS INC.
 CRITICIZES FDA'S HANDLING OF BREAST IMPLANT ISSUE
 LOS ANGELES, Feb. 10 /PRNewswire/ -- The following is being released by Collier Communications on behalf of the California Society of Plastic Surgeons Inc.:
 The California Society of Plastic Surgeons Inc. (CSPS) strongly objects to the Food and Drug Administration's handling of the silicone gel breast implant issue and moratorium, saying it is biased in favor of contingency fee trial lawyers who potentially can realize millions of dollars by suing manufacturers and surgeons on behalf of "helpless" women who have had such implants, according to John O. Strong, M.D., president of the society.
 Further, it contends that the FDA's advisory panel is tainted by the presence of two members who routinely testify as professional expert witnesses against one of the implant manufacturers in breast implant product liability cases; and by two other members who oppose implants without any scientific basis in fact. One of these members so misunderstands the role of the FDA that she said, "The federal government now has the power to deliver a profoundly important message to the American public involving basic values, concepts of beauty and public health." CSPS, among others, wonders when it became the federal government's role to make moral judgments about such an issue.
 CSPS is convinced the FDA panel is completely biased against silicone breast implants and is discouraging and preventing persons in favor of them from appearing at its hearing. On the contrary, consultants to the panel have been selected not on the basis of their expertise and impartiality, but on the basis that their views coincide with those of the FDA.
 With less than two weeks before its hearings, the FDA has failed to make the data on which it relies public, has not identified its consultants formally and has not made available an agenda for the meeting nor the specific issue on which it will ask the panel's advice.
 CSPS further contends that the issue of silicone gel breast implants should be taken out of the hands of the FDA, where it feels commissioner/lawyer David Kessler has acted with complete irresponsibility, and placed in a more responsible domain such as The National Institutes for Health.
 CSPS also finds it appalling that the Ralph Nader organization, Sidney Wolfe's Public Citizen Health Research Group, is selling how-to kits on suing implant manufacturers to lawyers for $750 each.
 CSPS cites the hundreds of products used by the public daily which contain silicone, as well as the myriad of medical products containing it, such as testicular, chin, calf, hand, joint and pectoral implants; hydrocephalus shunts; Norplant contraceptive implant; pacemakers; catheters, needles, sutures and syringes just to name a few.
 If the FDA considers silicone gel breast implants illegal, what is the medical community to think of all these other products? Are we open to litigation if we use them? It is estimated that there are hundreds of thousands of people who, as children, received silicone hydrocephalus drains to relieve water on the brain. Are these people in danger? Does the FDA know that silicon compounds are present in large amounts in drinking water and food additives in the United States? Does it know that the amount ingested by the average person each day absolutely dwarfs any amount that could leak out of a breast implant?
 We are in a deep recession in the United States, yet two silicone manufacturers have been tried by the media and put out of business by this flagrant, unscientific attack on breast implants. Cessation of medical grade silicone manufacture could close down another 50 companies. Considering all the medical products containing silicone, is the next step in this scenario that we will have no medical grade silicone manufacturers in the United States and will soon be importing it from Japan? Also, silicone gel breast implants will be available in many other countries, such as Great Britain, whose chief medical officer does not agree with the FDA.
 We knows the less scrupulous are gearing up for a black market offshore outside normal quality control by the government and the medical profession. Also, we can expect a resurgence of abhorrent procedures such as injection in the breast of questionable materials in gullible women with usually disastrous outcomes.
 Finally, CSPS feels that all plastic surgeons' reputations have been damaged by this biased, unfair and unscientific attack which has been given wide coverage by the media. We feel the only possible way to prove the validity of silicone gel breast implants lies with the scientific and medical communities, but that the issue has been taken out of our hands and placed in the hands of politicians and lawyers who have other axes to grind.
 -0- 2/10/92
 /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 Inc. ST: California IN: MTC SU:


DM-JL -- LA008 -- 8345 02/10/92 13:48 EST
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Date:Feb 10, 1992
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