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Main | Before It Was Real (9/11) »

Silicone Returns
By Amos Kenigsberg

In case the folks at the FDA thought they were done with all the recent controversy and bad press -- Plan B, Vioxx, pot, etc. -- a brouhaha over silicone implants is lurking, ready to pounce on the hapless agency, as well described in this piece in the New York Observer.

In addition to the political points raised by the Observer, there's still debate over the possible health implications of the implants, such as whether they cause cancer or lupus. Although major reviews of silicone-implant safety have found no statistically significant risks for such problems, it's interesting to see that Susan Wood, who quit the agency over its delay on Plan B, says that silicone implants should not be approved (for purely cosmetic surgery) because there's not enough evidence to conclude they're safe --  "it's a data-quality issue."

Meanwhile, there seems to be agreement that the implants can rupture -- sometimes oozing silicone out through a woman's nipples, ears, or eyes.

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