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Panel: Toughen Dermal Filler Warnings

FDA Panel Wants Stronger Warning Labels on Treatment for Wrinkles

Panel Recommendations continued...

The panel didn't agree on whether the label should list adverse events for all fillers in that class, or only for the adverse events associated with a specific type of filler.

The panel also discussed how clinical studies on the dermal fillers should be done in the future and concludes that "there is no one-size-fits-all study," DeLancey says.

"Certain products seem to have more reactivity than others," she tells WebMD. The panel wants to set up a consensus panel to develop guidelines on how clinical studies should be done and formulate guidance for the industry. "A lot of the panel members say they want manufacturers to do more rigorous premarket studies."

Industry Response

Stronger labels are not needed, says Jonah Shacknai, CEO of Medicis in Scottsdale, Ariz., which makes the fillers Restylane and Perlane.

"We have not seen an adverse effect not reflected on our labels," he tells WebMD. In all, Medicis fillers have been used in more than 10 million treatments, he says.

Caroline VanHove, a spokeswoman for Allergan, which makes Juvederm filler, says the product "has a highly favorable safety profile" and that it's important to differentiate between the short-term and long-term fillers because they have different safety profiles.

Plastic Surgeons' Views

Serious adverse events associated with the fillers are extremely rare, says Toby Mayer, MD, a facial plastic surgeon in Beverly Hills, Calif.

Blaming the product, he adds, is misguided. "I think it's pilot error -- it's the surgeon or dermatologist or whomever is putting it in," he says. Adverse events are more likely to occur, Mayer says, when the fillers are used by inexperienced physicians or others. Often, he tells WebMD, an inexperienced user will not place the material where it's meant to be put: deeper into the skin.

But another plastic surgeon, Karol Gutowski, MD, chief of plastic surgery at NorthShore University Health System in Chicago, welcomed most of the recommendations. Telling consumers about side effects that might appear months after the injection is an especially good idea, he tells WebMD.

"Some of these [dermal fillers] can last only two or three months, but some injectables last three to five years. Some of us are concerned about the long-acting ones."

If the labels end up telling consumers how long the product has been on the market, he says, it should specify whether that is the U.S. market or overseas. Sometimes products have been used successfully overseas for years but are new to the U.S. market.

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