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Label On Fillers Not Enough

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The Washington Post

Published: November 19, 2008

WASHINGTON - 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 Michael Bigby, a Harvard Medical School dermatologist. "The current label is not adequate." The panel of doctors and other experts 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.

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, and Restylane, from Medicis Aesthetics Holdings.

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