Archive for Wednesday, November 19, 2008

Cosmetic filler review urged

November 19, 2008

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— Cosmetic surgery patients who think facial fillers are a magical antidote to aging 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 information for consumers and doctors — called the product label — to include the risk of long-lasting reactions such as bumps under the skin, blotches and scars.

“This is almost a no-brainer,” said panel member Dr. Michael Bigby, a Harvard Medical School dermatologist. “The current label is not adequate.” The panel unanimously agreed on the need for more safety studies.

The gel-like fillers have become immensely popular with baby boomers. Injected into the face, they smooth away wrinkles. Most patients get a couple of touchups a year, at a cost that can easily exceed $1,000 each.

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. It was a first step as the FDA considers whether to regulate fillers more closely.

Plastic surgeons pledged to help find a new consensus on how to track safety, improve training and provide clearer information to consumers.

Different from Botox, which is derived from a toxin that acts on facial muscles, wrinkle fillers are like the biological equivalent of a bit of spackle, except they’re injected. They include such products as Juvederm, made by Allergan Inc., and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested nor approved for, not just erasing wrinkles. These include plumping the lips, cheeks and breasts.

The FDA also has questions how darker-skinned patients fare with the treatments. More black, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to blotches and other complications.

Plastic surgeons performed some

1.5 million cosmetic surgery procedures with fillers last year alone.

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