U.S. experts convene two-day meeting to revisit breast implant safety in light of new concerns
An expert panel assembled by the Food and Drug Administration opened a two-day meeting Monday to discuss the latest evidence about the risks of illness and complications with the devices, which have been sold since the mid-1960s.
The FDA and other regulators around the world have been grappling with how to manage a recently confirmed link to a rare cancer and thousands of unconfirmed claims that the implants can contribute to other chronic ailments. Last year, European Union regulators declined to renew approval for textured implants sold by Allergan, citing links to the cancer. That led the company to pull the products from the European market.
Thousands of women have also blamed their implants for a host of chronic ailments, including rheumatoid arthritis, chronic fatigue and muscle pain. The panel will hear from dozens of women; many of them have called on the agency to place new warnings and restrictions on the implants. Also scheduled to appear were researchers who theorize that the silicone from implants can trigger or exacerbate immune system disorders in certain patients. Those arguments have long been dismissed by manufacturers, plastic surgeons and FDA regulators. But earlier this month the FDA appeared to signal a shift in its thinking.
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