Permanent fillers ... remain a tough sell as doctors increasingly consider the ever-changing structure of the face as it ages.
In the area of temporary fillers, human collagen fillers Cosmoderm and Cosmoplast (Inamed), though enjoying widespread use after their recent FDA approval, may face new competition from the porcine collagen product Evolence (ColBar LifeScience) already in use in Europe.
"The product is generally non-allergenic to humans, and if there are no side effects, I can see porcine collagen eventually replacing all of the other collagen products if it lasts longer," says Rhoda Narins, M.D., a clinical professor of dermatology at New York University and principal investigator on the Evolence clinical trial.
Hyaluronic acid fillers
The hyaluronic filler market should soon also include newcomer Juvederm (Inamed), which is expecting an FDA approval sometime next year. With results said to last six to nine months, Juvederm could offer competition to Restylane, which has about the same longevity, and, like Restylane, the product would not require a skin test.
Juvederm has already been up against Restylane in Europe, and Restylane still remains the prime hyaluronic acid filler in that market, Dr. Narins says.
In the realm of permanent fillers, liquid silicone has held on to a small but committed following of dermatologists for uses such as scars and facial lipoatrophy, despite concerns of granulomas, the lack of FDA approval and a stigma that it has not been able to shake since the disasters from misuse during the 1970s.
"I've used silicone and have never seen a problem with it," Dr. Narins says. "But it is very technique-dependent and must be administered slowly over a period of time using a microdroplet technique."
The off-label silicone debate could become moot, however, when the highly anticipated product Artefill (Artes Medical) receives FDA approval as a permanent filler, in a decision that is expected as soon as March.
Artefill, which received approval from an FDA advisory panel in 2003, is a bovine collagen suspended in polymethylmethacrylate microspheres that stimulates the natural production of collagen to encapsulate each individual microsphere. The product is a combination of partly denatured 3.5 percent collagen (80 percent of total volume) and 0.3 percent lidocaine, according to the manufacturer.
"(Artefill) is expected to have fewer immediate side effects such as bruising," Dr. Narins says. "I think this will be a great substance if people want permanent correction."
Skin testing is necessary with Artefill, and there are concerns about Artefill's potential to cause granulomas.
Permanent fillers of any sort, however, remain a tough sell as doctors increasingly consider the ever-changing structure of the face as it ages, and the chance that a permanent filler that once appeared fine may look very out of place several decades or even years later.