Fw: Statement on FDA panels approval of silicone implants

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----- Original Message ----- From: Tit 4 Tat

K's Monthly

Sent: Thursday, October 16, 2003 10:32 AM

Subject: Statement on FDA panels approval of silicone implants

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Statement Regarding the FDA Advisory Panel's Recommendation to Lift the Ban on Silicone Breast Implants

October 16 ‹ On October 8th I rallied outside the Federal Health and Human Services building with many women who survived years of ill health attributed to their silicone breast implants. I was there to support them and to stand up for the next generation of American women to stop the FDA's fast track approval of Inamed Corp's silicone breast implants. Breast cancer survivors have been able to, and still can, get silicone implants for breast reconstruction.Yesterday, an FDA advisory panel voted 9-6 to accept the implant manufacturer's request to make this product available to women who want it for cosmetic breast enlargement. Apparently all plastic surgeons on the panel voted in favor of lifting the 11-year ban. Kaching! A final FDA decision has yet to be made, but history shows advisory panels' recommendations are usually heeded. More details on the fallout from this vote will be forthcoming. Some highlights:

"Informed consent" to the patient must be provided through a detailed brochure explaining the implant's known risks. You can be sure we'll be watching to ensure that brochure truly "informs," and details the risks, with images and statistics. But who's going to monitor this program, the plastic surgeons? And, FDA, once you're at it, why not require this for saline implants as well? Ironically, many women testified they didn't like their saline implants and wanted silicone instead.

Women must have annual exams to check for leakage or rupture. Nice on paper, but we assume Inamed isn't required to pay for those. What if the woman doesn't have the cash for the exam? Who will monitor to see if she even gets examined? Will these exams need to be expensive MRI's?

Inamed must track the silicone-implanted women's health for 10 years after the implants are installed. Hey, wait a minute! Shouldn't the have FDA demanded this be done in clinical trials BEFORE recommending approval?All of which reinforces our point beautifully: NO SILICONE, NO SALINE, NO SIR! NOW, MORE THAN EVER. Spread the love. Reject the hype. Love the body you have. And, this fight for women's well-being isn't over, you can bet on that.Check our library's Headlights for more stories on this issue. Khttp://www.tit4tat.net