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Reading the tea leaves with the FDA on breast implants & platinum toxicity

Posted Jun 18 2009 1:03am

In April, the Washington Post featured a story on a report that new, highly reactive species of Platinum free radicals were found in patients with silicone implants. This story was immeadiately seized upon by groups who have been fighting against liberalized reintroduction of silicone breast implants in the United States. In fact, the study referred to, was in part funded by one of these groups.

The Washington Post feature was not particularly partisan, but it did seem to highlight a single study out of context to the body of literture on platinum chemistry, which to that point was pretty dismissive of associations to toxicity. The article did however, get picked up in some scattered newspapers.

Just this past week the FDA updated their information page on breast implants and platinum and they made some interesting statements. Of the study referred to in the Post, they characterized it as have so many flaws as making it of "limited value". Irregular tests performed in the study and control groups makes interpretation difficult, and they point out that several members of the control group had higher levels of platinum then those with the implants.

They conclude that in vivo properties of platinum "do not represent a significant risk to women with silicone breast implants" which is consistant with their previous position, the 1999 Institute of Medicine report, the United Kingdom medical device committee, and a number of other reviews.

The publication of such a strongly worded position on the FDA site makes it seem likely to me that concern over platinum is unlikely to figure much in the timetable for the reintroduction of silicone implants.
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