FDA Wants Stronger Warning for Dermal Fillers

Product labels on popular cosmetic wrinkle fillers should be strengthened to warn consumers about scarring and other problems that can crop up weeks or years after receiving the treatments, a Food and Drug Administration panel said November 18, 2008.

The panel said current product labels on fillers approved to plump certain facial lines are inadequate and only discuss immediate and temporary side effects, such as swelling. While an FDA review of reported adverse events associated with dermal fillers showed many expected side effects like temporary swelling and redness, the agency said “there are a number of adverse events that are serious and unexpected.”

The agency is considering whether to boost warnings on product labels and require manufacturers to conduct longer and larger studies to be submitted as part of product approval applications. The FDA says it expects more pre-market applications to be submitted for approval of products to fill wrinkles because of growing consumer demand for those products, along with applications for new uses like treating lips, the chin and other parts of the body.

Any regulatory changes would affect such manufacturers as Allergan Inc., which makes several such products, including Juvederm; Sanofi Aventis SA, which makes Sculptra; Medicis, the maker of Restylane and Perlane; Artes Medical Inc., which makes Artefill and BioForm Medical Inc., which sells Radiesse.

All of the products use some type of material, or filler, that’s injected into facial wrinkles in order to smooth out the appearance of the wrinkles.

The FDA said about 1.5 million wrinkle filler procedures were conducted last year. But some products are being used outside of approved indications, such as being injected into lips. There’s concern that a growing number of procedures are being conducted in non-medical facilities like medical spas.

The FDA conducted a review of adverse events filed to the agency that were associated with dermal fillers over the past five years. The review looked at 930 reports. Of those, 823 were classified as injuries, including infection, bleeding, lumps or bumps in the face and, in rarer cases, facial disfigurement.

The report found that 684 of the reports required medical intervention, including nearly 100 patients who needed a surgical procedure. About 20 were treated in an emergency room for allergic reactions.

The review looked at dermal fillers as a whole and did not single out specific products.