Fw: NYTimes: Slanted Opinion on FDA Breast Implant Decision

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----- Original Message ----- From: ilena rose

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Sent: Monday, October 20, 2003 8:17 AM

Subject: NYTimes: Slanted Opinion on FDA Breast Implant Decision

http://www.nytimes.com/2003/10/20/opinion/20MON2.html?ei=5062 & en=7bc027d43d43341a & ex=1067227200 & partner=GOOGLE & pagewanted=print & position=

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October 20, 2003New Look at Silicone Breast Implants A key advisory committee to the Food and Drug Administration recommended last week that silicone breast implants be allowed back on the market more than a decade after they were largely banished over safety concerns. The decision was a close call, with nine panelists favoring reinstatement and six opposed because of worries about possible long-term dangers. Nevertheless, the verdict adds to a growing impression that the implants, once blamed for a range of serious illnesses in women, are relatively safe, or at least fit for resurrection under appropriate safeguards.

The silicone breast implants had already been on the American market for 13 years when a 1976 law gave the F.D.A. authority to regulate them and other medical devices. At first the agency focused on devices it deemed riskier, but as complaints against the implants mounted, the F.D.A. called for evidence of their safety and effectiveness. The manufacturers proved woefully unable to supply it, so in 1992 the agency blocked general use of the silicone implants and restricted them to clinical studies, breast reconstruction in cancer patients and other limited purposes. Meanwhile, a barrage of lawsuits drove the main manufacturer into bankruptcy and led to payouts and settlements worth billions of dollars for the presumed victims. Saline implants, though deemed inferior in look and feel, took over the market.

As the 1990's ended, however, an array of studies and expert panels largely exonerated the silicone implants as the cause of cancer, immunological diseases, neurological problems or anything more serious than localized pain, scarring and inflammation in the breast. The original alarms began to look overblown.

Now Inamed, a maker of both saline and silicone implants, has presented new data, based on the first three years of a 10-year study, contending that the silicone implants are safe to use and have fewer complications than the saline implants that have already gained approval to remain on the market. Even so, a surprisingly high percentage of silicone implant patients — from 21 percent to 46 percent of various patient categories — need further surgery within two years because of complications or to achieve a better cosmetic result.

The issue now is whether silicone implants should be kept off the market until the manufacturer can provide additional years of data on the long-term health effects or be allowed back on provided the manufacturer continues to follow the women for the full 10-year period to monitor long-term consequences. Those who scorn cosmetic surgery may see no good reason to give the implants another chance, but great numbers of women want them. It makes sense for the F.D.A. to give women access provided they are amply warned that definitive proof of long-term safety is not yet in hand and that vast numbers of patients are apt to need follow-up surgery.

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For other opinions of this FDA Panel's decision, you are welcome to visit:

www.BreastImplantAwareness.org

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