Fw: Platinum

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----- Original Message ----- From: Myrl Jeffcoat

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Sent: Monday, August 20, 2001 9:36 PM

Subject: Platinum

Thank you Barbara Hasenour for sending this Platinum article our way. Webelieve it was circulated before, but some of us are revisiting some of thechemicals contained in our implants.Myrl------Published Saturday, December 23, 2000Government hasn't pursued suggestions to test silicone breast implantsGreg Gordon / Star TribuneWASHINGTON, D.C. --A government scientist proposed a study four years ago toexplore whether silicone gel breast implants could have leaked toxic formsof platinum into women's bodies, as some health professionals feared.But the proposal by Biagini, a research toxicologist at the NationalInstitute for Occupational Safety and Health who is a leading platinumexpert, went nowhere.Now, the Food and Drug Administration (FDA) says it needs more data todetermine whether platinum may be a culprit in the illnesses of some of theha1f-million women who have sued implant manufacturers.The issue underscores a handicap routinely confronting the FDA: It lacks themoney to perform research that might settle many of the scientific questionson which its regulatory decisions hinge. III an interview this month, FDACommissioner Jane Henney acknowledged the problem and said Congress shouldconsider "at least doubling" her agency's $1.3 billion budget The annualbudget for laboratory research at the FDA's National Center forToxicological Research in Jefferson, Ark, has been in the $40 million to $50million range.To the frustration of some scientists and a number of women who think theirsilicone breast implants made them ill, no government studies are underwayinto the possible effects of platinum, small amounts of which ~re usedduring manufacturing.Potent allergenIn certain reactive forms, platinum is one of the most potent allergensknown to humans. Scientists have yet to establish what level of exposurecauses sensitization, but once a person is sensitized, exposure to thetiniest amounts of the substance can cause allergic reactions ranging fromasthma-Iike breathing problems to hives, skin rashes and joint pain. Somestudies suggest platinum may also cause neurological problems, such asnumbness in fingers and toes.Silicone implant manufacturers, including former makers Dow Corning Corp.and Maplewood-based JM Co., stress that two national science panels have Buta Houston researcher, Ernest Lykissa, says he has detected elevated levelsof reactive platinum in the hair, fingernails and body fluids of a number ofwomen who had the implants for years and blame them for a variety ofailments.Lykissa's findings have aroused the interest of Langone, an FDAmolecular biology official who is monitoring the platinum issue. But Langonesaid the agency needs more extensive studies to determine whether reactiveforms of platinum are in the implant, how much leaches out and what, if any,health effects it may produce.Only two companies currently make silicone gel breast implants in the UnitedStates --for use limited to reconstructive surgery: lnamed Corp. and MentorCorp. Mentor says it uses reactive platinum in making a catalyst, whileInamed declines to say whether it uses platinum. Both companies more widelysell saline-filled breast implants. FDA officials say they use a tincatalyst for those products, but agency literature says they also maycontain platinum .Platinum leakingSeveral researchers and health professionals have urged the FDA and theNational Institutes of Health to conduct studies into the platinum inimplants since 1993. . a supervisory research chemist at the Centers for DiseaseControl and Prevention, reported in the mid-1990s that he had found platinumleaking from 15 of 20 implants he tested after they were removed from ~men'sbodies. said he proposed further study, but got no response.Biagini, the toxicologist, wrote the FDA suggesting a study in which gelfrom silicone implants would be applied to the skin of platinum refineryworkers known to have been sensitized to the substance and to women withimplants. A pattern of skin reactions would be a strong signal of aproblem, he contended. He also got no response.Later, Biagini said, he wrote to a federal judge in Alabama overseeingbreast implant litigation, offering his assistance if a court-appointedscience panel wanted to investigate the platinum issue. He said he receivedno reply.