Derm concerns prompt FDA to review postmarket data on facial fillers

Jan 01, 2008, 5:00am

National report - Prompted by dermatologists' concern over the safety of a recently approved permanent dermal filler, the FDA has formed a team to study postmarket experience with all newer dermal fillers, focusing mainly on the permanent variety.

Key Points

National report - Prompted by dermatologists' concerns about the safety of the recently approved permanent dermal filler ArteFill (polymethylmethacrylate/PMMA, collagen, Artes Medical), a Food and Drug Administration (FDA) team continues to study postmarket experience with all newer dermal fillers - focusing mainly on the permanent variety.

Meanwhile, California-based Artes has agreed to perform a 1,000-patient, five-year post-approval study to examine the significance of delayed granuloma formation in patients treated with ArteFill.

"It's probably the second five-year study done on any filler. The first one was ArteFill's initial study. And it will be the first such study to have 1,000 patients," says Rhoda S. Narins, M.D., clinical professor of dermatology, NYU Medical School; director, Dermatology Surgery and Laser Center, New York; and an investigator in the post-market study.

For now, Dr. Narins says, "People have been slow to use this product because they're waiting to see whether patients have problems."

The FDA's actions stem from charges by some dermatologists that the agency didn't adequately scrutinize ArteFill before approving the product for use in the nasolabial folds in October 2006. However, the product's supporters say when ArteFill is used properly, these concerns are unfounded.

'Grave concern'

The letter also requested a prompt hearing to re-examine the product's safety, because it "may pose immediate, debilitating and disfiguring health risks to the American people."

Other signers of the letter were Daniel C. Baker, M.D.; Andrew Blitzer, M.D., D.D.S.; Bernard Ackerman, M.D.; Mitchel P. Goldman, M.D.; Richard Glogau, M.D.; David C. Rish, M.D.; and Howard K. Steinman, M.D.

Dr. Klein tells Dermatology Times, "I could not be silent and see harmful products brought forward in this manner."

He is a Beverly Hills, Calif.-based dermatologist in private practice and professor of medicine and dermatology, David Geffen School of Medicine, University of California, Los Angeles.

He says that when Artecoll's inventor and Artes co-founder Gottfried Lemperle, M.D., pitched him the product before its U.S. approval, "I had a problem putting Plexiglas (PMMA, Altuglas International) in the face." In fact, ArteFill consists of PMMA microspheres suspended in purified bovine collagen (with 0.3 percent lidocaine), according to Artes Medical.

But when doctors in America and Canada began promoting Artecoll for areas including the lip, Dr. Klein says he initially gave the product the benefit of the doubt.

"Then I learned that these doctors were given huge amounts of stock to recommend this product," he says.

At that point, he says, he became concerned because he'd heard, when lecturing in areas including Europe and South America, that the agent was associated with a number of problems, including a lawsuit in which a San Diego patient claimed to have been disfigured by Dr. Lemperle, a German dermatologist never licensed to practice in America.

The lawsuit was dismissed in June 2006, and the material used was not ArteFill or the Artecoll used in the FDA clinical trial, says John Lippman, spokesman for Artes Medical, which terminated Dr. Lemperle's employment in May 2006.