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Wrinkle Fillers Need New Warnings, US Panel Says (Update1)
Posted on Tuesday, November 18 @ 14:31:33 CST by Raulken

Scienze By Catherine Larkin Nov. 18 (Bloomberg) -- Wrinkle fillers made by companies including Medicis Pharmaceutical Corp. and Allergan Inc. should carry warnings about scarring, tissue damage and other serious complications that may take months to appear,...

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Leila Rosalia receives free lip filling injections in Rio de Janeiro, Thursday, Nov. 13, 2008. An FDA panel has urged the U.S. government to further warn the public on the risks of cosmetic filler injections. (Ricardo Moraes/AP Photo)
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Hundreds of thousands of baby boomer women who think they've found an antidote to aging in cosmetic facial fillers must be better informed of possible risks, government health advisers said Tuesday.

A panel of independent advisers urged the Food and Drug Administration to revise the labeling to include the possibility of long lasting reactions such as bumps under the skin, blotches and scars.

"It is almost a no-brainer," said Dr. Michael Bigby, a Harvard Medical School dermatologist. "The current label is not adequate." The gel-like fillers, which have become hugely popular in the last few years, are injected into the face to smooth away wrinkles.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But Tuesday's FDA hearing raised questions about unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. The hearing was a first step as the FDA considers whether to regulate fillers more closely.

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