Safety check: FDA panel: Dermal filler warnings necessary for public

January 1, 2009

Washington - Dermatologists and manufacturers say dermal fillers are safe and effective, despite a recent recommendation by a Food and Drug Administration (FDA) advisory panel that labeling be revised to include stronger warnings about possible complications.

Key Points

Yet doctors and pharmaceutical companies agree, in part, that label changes may be beneficial if they stress the importance of employing properly trained healthcare professionals to ensure safe injections.

"The FDA did not address the root cause of the problem, which is the training and skill level of the injector," says Kenneth Beer, M.D., director of the Palm Beach Esthetic Institute in West Palm Beach, Fla., and clinical instructor at the University of Miami.

The FDA panel's concern is that current product labels may be inadequate, because they indicate only immediate and temporary side effects, such as swelling.

In its assessment - which reviewed the products as a category, rather than specific products - the panel noted 930 side effects connected to the use of wrinkle fillers, with most occurring over the past 10 years.

Of those, 823 were classified as injuries, including bleeding, infection, lumps or bumps in the face, and in some rare cases, facial disfigurement.

Of the reported side effects, 684 required medical intervention, and 100 patients required a surgical procedure. Twenty of these patients were treated in the emergency room for allergic reactions.

A majority of the reported adverse events involved injections in sites other than the nasolabial fold, according to the FDA.

"I have no idea what a 'serious adverse event' is in the mind of the FDA," said Michael E. Bigby, M.D., department of dermatology, Harvard Medical School, Boston, and a consultant to the panel during the hearing.

"(The FDA) needs to establish this. Clearly, if you're talking about events that occur less than 5 percent of the time, none of these studies are appropriate."

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