Wrinkle Fillers Need Better Label Warnings: FDA Panel

Nov. 19 -- TUESDAY, Nov. 18 (HealthDay News) -- American women who turn to cosmetic treatments called dermal fillers to ease wrinkles must be better informed about the health risks these products pose, an advisory panel to the U.S. Food and Drug Administration recommended Tuesday.

The panel of independent experts urged the agency to revise product labeling to warn of potential reactions to the fillers, including bumps, blotching and scarring.

While side effects are relatively rare, the FDA has also received reports of allergic reactions, including some that were life-threatening, such as anaphylactic shock, the agency said.

"The labeling should be modified to reflect what we're learning further about the products" in various post-marketing studies and elsewhere, panel member Mary McGrath, a professor of surgery at the University of California, San Francisco, told Bloomberg News.

According to The American Society for Aesthetic Plastic Surgery, almost 1,449,000 procedures involving fillers were performed in the United States last year.

The FDA is not bound to follow the recommendations of its advisory panels, although it typically does so.

As part of their review, the group reviewed a variety of reports to see if stronger warning labels were needed for the injectable products. Some fillers are made from natural substances, while others come from synthetic materials. Brand names for some of these products include Restylane, Juvederm, Artefill, and Perlane.

The FDA has also asked the panel to make recommendations on testing the dermal fillers, post-approval follow-up and informing consumers about potential risks. The meeting was spurred by reports of 823 injuries caused by dermal fillers that included allergic reactions, swelling, sores, pain, blisters and cysts.

Overall, 638 patients needed additional medical treatment. Nineteen patients were seen in emergency rooms with life-threatening allergic reactions, such as difficulty breathing. Twelve patients had to be admitted to hospitals due to infections, the FDA said.