The ArteFill advantage: Longevity

San Diego - ArteFill (Artes Medical), the latest federally approved facial filler, offers dermatologists a long lasting alternative, and, although it has come late to the party, it is the only product now approved that has a potential to remain in the face for years, experts say.

"Nobody expects the competing hyaluronic acid fillers to last a year or longer, but ArteFill recently published data documenting its safety and effectiveness for up to five years," dermatologist Mark Rubin, M.D., of Beverly Hills, Calif., tells Dermatology Times.

Steven R. Cohen, M.D., F.A.C.S., the first author of the study that contains the five-year data, says that ArteFill, indicated for correction of nasolabial folds, has "the potential for persistence measured in years, not months."

Adverse reactions low

The injectable facial filler was approved for sale in the United States in October.

It is composed of a proprietary combination of microspheres of polymethylmethacrylate suspended in a carrier gel containing purified bovine collagen.

Because bovine collagen has the potential of causing allergic reactions, patients should be skin-tested before the filler is used. However, the potential for adverse effects and complications, compared to other fillers using bovine materials, appears low, Dr. Cohen says.

A follow-up of a subgroup of 69 patients who initially received ArteFill four to five years ago revealed only five patients reporting six late adverse reactions.

Four of the adverse events were mild cases of lumpiness, and two events, classified as severe, were reported by one patient in the Miami arm of the study.

Those two adverse reactions involved "nodular, minimally inflammatory to noninflammatory reactions - red streaks - in both nasolabial folds," Dr. Cohen says.

The New York Times reports that pharmaceutical company sales from fillers in the United States have been estimated to be $250 million last year, up from $100 million in 2003. What effect will ArteFill have on those sales?

"The entire market is growing and no one knows what percentage ArteFill will take," Dr. Rubin says. "The biggest differentiating factor between it and other fillers is its longevity."

Longevity raises questions

The product appears to have a definite niche.

Dr. Cohen, a clinical associate professor of plastic surgery at University of California, San Diego, believes it will probably be offered primarily to patients who have previously used other fillers that haven't lasted as long.

"In my own practice, I don't plan to use ArteFill as a first-line filler," he says. "I do plan to offer it to patients who have had repeated injections of fillers and who are tired of having them injected on a regular basis."

Still, the longevity of the filler can trouble some. In the past, there have been reports of physicians using non-Food and Drug Administration (FDA) approved materials as facial fillers. After years of use, some of their patients reported dissatisfaction with the permanent results since the still youthful-looking wrinkles didn't match their aging faces.

"There are some people - both physicians and patients - who are interested in a product that can be used safely once or twice in their lifetimes, and there are others who have concerns about that idea," Dr. Rubin says. "I can understand both viewpoints. Physicians should discuss both the pros and any perceived cons to a product that promises such longevity."

Dr. Cohen points out that almost all of the patients who had the procedure done five, some now even six years ago - who between them had 272 wrinkles treated - were satisfied with the procedure because, "It made them look younger."