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WASHINGTON -- Researchers have found a new reason for possible concern about the safety of silicone gel breast implants: high and potentially hazardous levels of the metal platinum in some women who had silicone implants in their bodies for many years.
With the Food and Drug Administration poised to allow silicone implants back on the market for unrestricted sale, two researchers reported this week in a journal of the American Chemical Society that they found high levels of platinum salts in the urine, hair, and breast milk of 16 women with silicone gel implants.
The platinum, they concluded, was in a form that made it a potential source of severe allergic or toxic reactions. Their findings were immediately challenged by chemists associated with implant makers and are at odds with the longtime conclusions of the FDA, which has determined that the platinum used to make silicone gel implants is inactive and unable to cause harm.
While the possibility some silicone implants might release a harmful form of platinum has been debated since the1990s, the metal has not been at the center of the long and contentious debate over the safety of the implants. And the possible health problems that could come from platinum -- severe allergies, asthma, nerve damage and reduced immune responses -- have not been the focus of the many lawsuits against makers.
The FDA last year deemed two applications to sell silicone gel implants to be "approvable," although the agency has yet to give the final go-ahead to Mentor Corp. and Inamed Corp., which is now a division of Allergan, Inc.
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