7 janvier, 2007 15:48
FDA's breast implant warning is inadequate
Sacramento Bee - Sacramento,CA,USA
That's the message the federal Food and Drug Administration sent to women when it lifted a
14-year ban on silicone breast implants for cosmetic purposes. ...
Published 12:00 am PST Sunday, January 7, 2007
Story appeared in FORUM section, Page E6
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Editorial: FDA's breast implant warning is inadequate
Published 12:00 am PST Sunday, January 7, 2007
Buyer beware! That's the message the federal Food and Drug Administration sent to women when it lifted a 14-year ban on silicone breast implants for cosmetic purposes. Instead of the usual "test now, approve later" process, the FDA decided to follow an "approve now, test later" policy. Not a good precedent.
In 1992, the FDA placed a moratorium on silicone implants, saying there was "inadequate information" about their safety and effectiveness. FDA made an exception for cancer patients and women with broken implants. In 2004, the FDA affirmed the moratorium, saying more research was necessary.
But the FDA finally succumbed to pressure from manufacturers and plastic surgeons, ending the moratorium last Monday.
Instead of providing a seal of safety, the FDA is warning women who choose silicone implants they will need additional surgery. All breast implants eventually break; the FDA recommends replacing them every 10 years. Women who live 25 years after getting silicone implants will need to remove them twice and possibly more. The FDA also recommends that women have an MRI every two years to detect leakage, rupture or hardening.
What the FDA fails to make clear is that the patients, not the manufacturers, will bear the cost. A breast MRI costs about $2,000, and insurance rarely covers replacement surgery.
The FDA requires the manufacturers to do a 10-year study of 80,000 women who receive silicone implants, but Congress will have to make sure this is enforced.
FDA approval should be a "seal of safety" protecting Americans from untested and unsafe products, not a "put it on the market and see what happens" seal of experimentation.
