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Panel: Toughen Dermal Filler Warnings

FDA Panel Wants Stronger Warning Labels on Treatment for Wrinkles

WebMD Health News

Nov. 18, 2008 -- Dermal fillers injected to soften facial wrinkles should carry stronger and more specific warning labels about potential adverse effects, according to an FDA advisory panel.

The panel met today in Gaithersburg, Md., to discuss many questions about the popular fillers, including such brand names as Restylane and Juvederm.

Panel members "agree that the labeling should be revised to include the more serious adverse events and how long the product has been on the market and how long it might take events to appear," says Siobhan DeLancey, an FDA spokeswoman who was at the meeting.

While the existing labels do list numerous potential side effects, they do not always list when the events might occur, and an FDA evaluation of the fillers has found that some events may show up months after the injections, she says.

The panel will make its final recommendations to the FDA, which is not bound to follow them but often does.

Industry representatives and some plastic surgeons say the stronger labels are not needed, while another expert welcomed the recommendations.

Types of Adverse Events

About 1.5 million dermal filler treatments are done a year in the U.S., according to statistics kept by the American Society of Aesthetic Plastic Surgery.

Over the past six years, the FDA has received 930 reports of adverse effects from the numerous dermal fillers approved, most of them in the last 10 years. No deaths were reported, but among the adverse effects were:

  • Allergic reactions
  • Swelling
  • Inflammatory reactions resulting in nodule formation, cold sores, arthritis flare-ups, and other problems
  • Infection
  • Bruising, bleeding, scars
  • Blisters and cysts
  • Lumps and bumps
  • Numbness, including palsy
  • Migration, such as the filler material moving to another site on the face

Most of the reported adverse events, according to FDA findings, involved injections in sites other than the nasolabial fold, the indication for which many fillers have approval.

A number of the reports of adverse events involved injections by untrained personnel, the FDA also found.

Panel Recommendations

Besides recommending stronger labels, the panel is advising the FDA to ask manufacturers to note that some events may occur months or years after the injection, DeLancey says.

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."

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