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National report - The Food and Drug Administration's (FDA) recent approval of the soft tissue filler Artefill (Artes Medical) marks a big milestone as the first permanent filler ever approved in the United States for wrinkle correction, and that distinction, alone, should give Artefill a unique marketing advantage.
"Artefill has a niche all to itself, and if it is injected by experts and complications are avoided, it will become a very popular product," says Rhoda Narins, M.D., clinical professor of dermatology at the New York University Medical School and director of the Dermatology Surgery and Laser Center in New York.
Artefill is made of injectable polymethylmethacrylate (PMMA) microspheres with a diameter of 30 microns to 50 microns. The microspheres are delivered in a bovine collagen base with 0.3 percent lidocaine, and, after about three months, the vehicle is largely replaced by endogenous collagen, while the original 20 percent PMMA microspheres are preserved.
While the FDA approval for wrinkles gave Artefill a tremendous boost, many doctors and patients alike may still be skittish about the idea of a permanent filler, hence Artefill's initial fans will likely be those who are already comfortable with permanent fillers.
"Many of us already use a permanent filler - silicone, which, when used properly, has few to no side effects, and I think we will be the first ones to adopt Artefill," Dr. Narins tells Dermatology Times.
"If few side effects are reported, then Artefill will become more popular."
Sizing up side effects
The side effects that have generated most concern have been lumps and bumps reported in the lips and with superficial injection.
The FDA panel has suggested that use of Artefill in the lips could therefore be contraindicated.
Some of the best indications, however, would be nasolabial folds and marionette lines, and if lip correction is desired, a more suitable filler, such as Restylane (Q-Med) or Juvederm (Allergan Medical), could be used in combination with Artefill, Dr. Narins says.
"As people get used to Artefill, they may also want to use it for volume filling," she adds.
The critical factor for safety with Artefill use will be training.
The product is highly technique-dependent, and, in most cases, deep dermal injection is important.
"You really need training because the big fear with permanent fillers is, of course, that you can have permanent problems," Dr. Narins says.
Artes Medical says it plans to offer a comprehensive training program to dermatologists, plastic surgeons and cosmetic surgeons with the intention of teaching users how to administer consistent and high-quality treatments.
The training should be worthwhile because demand for Artefill is expected to be high among patients who are comfortable with a permanent correction and don't want to have to keep returning to doctors for repeat treatments.
"Of course there are many patients who don't want a permanent filler because they're afraid of it and their doctors are afraid of it," Dr. Narins says.
Disclosures: Dr. Narins is on the advisory boards for Artes Medical, Bioform, Merz, Colbar and Medicis, and she is also an investigator for several of these companies.