FDA panel: Facial fillers can turn ugly

Washington —- 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.

Plastic surgeons pledged to help the government 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 into the face. They include such products as Juvederm, made by Allergan, and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested and approved for, such as plumping the lips, which are extremely sensitive.

There also are questions about a lack of clinical evidence on how darker-skinned patients fare with the beauty treatments. More black, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to unsightly blotches and other complications from fillers.

FDA scientists will present the advisory panel with data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September.

The overwhelming majority were women, and the most common age group was 50- to 60-year-olds. Plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

Although no deaths were reported to the FDA, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.