FDA: "serious and unexpected" problems with facial fillers

WASHINGTON, D.C.; November 14, 2008

The agency has received a total of 930 reports of health problems over the past six years. Many included known complications such as minor swelling. The FDA did not identify which products had reports of more serious problems.

According to a staff report released today, "While many of reported adverse events, such as minor swelling and erythema, are expected problems and are specified in the labeling of the products, there are a numbers of adverse events that are serious and unexpected such as facial, lip, and eye palsy, disfigurement, retina vascular occlusion, as well as rare but life-threatening events such as severe allergic reactions and anaphylactic shock."

The FDA staff said the reports had several limitations such as failing to say when the problems started.

Dermal fillers include Allergan Inc's Juvederm, Restylane and Perlane from Medicis, and Bioform Medical's Radiesse.

The maker of Restylane and Perlane says the company has not received any reports of life-threatening reactions, or anything more serious than what's on the product label.

A panel of experts meets next Tuesday to review whether to increase the warning label for these products.

The report was posted on the FDA website at this site.<|a>