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CALIFORNIA PLASTIC SURGEON LAUDS UNITED KINGDOM DOCTOR'S STANCE ON BREAST IMPLANTS

 CALIFORNIA PLASTIC SURGEON LAUDS UNITED KINGDOM
 DOCTOR'S STANCE ON BREAST IMPLANTS
 BONSALL, Calif., Feb. 5 /PRNewswire/ -- A statement issued by Dr. Kenneth C. Calman, chief medical officer of United Kingdom, to all that country's doctors, cited the lack of data issued by the United States Department of Food and Drug Administration (FDA) in requesting a moratorium on the use of silicone gel breast implants, and said, "the (UK) Department of Health has no basis for advising a general change in practice in the United Kingdom."
 Jack Fisher, M.D., chief of plastic surgery at the University of California, San Diego and vice president of the California Society of Plastic Surgeons Inc., has reviewed the recent statement issued by Calman and lauds that action. "It appears that level heads prevail in the U.K., while FDA-stimulated confusion in the United States abounds over the subject of silicone gel breast implants. For three years I led a panel of plastic surgeons and selected consultants in examining all valid evidence pertinent to the silicone-risk issue for the benefit of members of the largest plastic surgery society in the United States. Our conclusions did not find evidence that would support FDA's moratorium.
 "Yet, many voices are being heard in the United States warning of the 'danger' of silicone gel breast implants. Most of these voices have no scientific background nor data to support their views and are practicing what one distinguished colleague of mine termed 'junk science.'
 "The real issues are these:
 "Silicone vs. silicon vs. silica: Don't confuse these words. They are different. The silicon in silicone is chemically bound and is less reactive than most other implantable materials.
 "Silicone in our environment: It is everywhere as a lubricant, as an antifoaming agent, in oral medications, in hairspray and other cosmetics, inside syringes and needles. It is preferred biomaterial for artificial joints, as covering for cardiac pacemakers and for the new implant birth control pill (FDA approved). Anyone with chronic disease requiring injected drugs such as insulin for a diabetic sends thousands of microdroplets of silicone into the body with no recognized adverse effect.
 "Cancer: Silicone has never caused breast cancer in any human or any animal, not even mice.
 "Mammography: Breast implants can impede cancer diagnosis, but not to a degree that alarms the American College of Radiology. Special techniques can assist the radiologist.
 "Contraction, firmness: All implants stimulate a fibrous reaction. This is not peculiar to breast implants. The frequency of a firm breast after silicone implantation varies according to the implant and each person's definition of firmness.
 "Rupture, bleed: A genuine rupture with distant silicone is rare. 'Bleed' means microdroplets of silicone passing through the hardened shell. This can be seen and measured only in a dry environment. Inside the body, an aqueous environment, 'bleed' is barely detectable. Little clinical significance has been shown. Newer implants are designed to reduce 'bleed.'
 "When an implant 'fails': Manufacturers refer to 'failure of the shell' meaning the outer surface becomes sticky. Frequency is unknown. When it exists, the silicone usually remains with the fibrous capsule.
 "Immunity to silicone: Reports of immunity to silicone are wrong. Silicone by itself has not stimulated immunity. Body proteins can attach themselves to implanted silicone, and reactions to silicone- protein complexes have been measured. But these can be found in people without breast implants also. Remember, silicone is everywhere in our environment.
 "Autoimmune Disease: We know of some patients with breast implants plus symptoms of arthritis or a confirmed connective tissue disease like scleroderma. But most reports are not confirmed by any laboratory test evidence. The best analysis, done in San Diego in 1988, finds only coincidental occurrence.
 "Birth Defects: There is no evidence that silicone causes birth defects. The FDA agrees.
 "The disinformation campaign regarding silicone gel breast implants is being carried on by people outside the scientific community, including some members of the FDA's review panel and lawyers who are eager to sue breast implant manufacturers. Many of them are so eager, they are purchasing a $750 how-to-sue kit from a Ralph Nader organization.
 "I wrote to FDA Commissioner David Kessler sometime ago and have not received a reply to my request for his 'new information' to be brought to the medical community. I personally have no faith in his ability to deal responsibly with this issue.
 "If the public wants the real truth regarding these implants, as do 2 million American women who have had them, as does the U.K.'s Department of Health, as do all board-certified plastic surgeons in the United States, the silicone issue must be removed from the jurisdiction of the FDA and assigned to a more scientifically responsible organization, The National Institutes of Health," concluded Fisher.
 -0- 2/5/92
 /CONTACT: Norma Collier of the California Society of Plastic Surgeons Inc., 213-381-1614; or Consumer Information Service, 800-722-2777/ CO: California Society of Plastic Surgeons Inc. ST: California IN: SU:


AL-CH -- LA021 -- 7420 02/05/92 17:52 EST
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Publication:PR Newswire
Date:Feb 5, 1992
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