But other physicians look on ArteFill as one more valued tool to banish wrinkles. "If it is placed properly, there are no granulomas," said Dr. Marian Northington, an assistant professor of dermatology at the University of Alabama at Birmingham. She noted that other fillers entail risks for bumpy skin scars, too.
She and Ellenbogen offered up differing views on ArteFill after the injection became the hot topic at the recent annual meeting of the American Academy of Dermatology, in San Diego.
Banishing wrinkles with so-called "soft tissue fillers" such as Restylane or collagen can be a high-maintenance, expensive proposition. Even the longest lasting fillers typically dissipate after six months to a year or so, warranting another trip to the cosmetic surgeon or dermatologist.
But proponents say ArteFill is different. The compound is made up of microspheres of polymethylmethacrylate (PMMA), the most commonly used artificial implant material used in the body, according to the manufacturer of the filler, Artes Medical of San Diego. PMMA is suspended in a gel containing bovine collagen along with 0.3 percent lidocaine, added to help with numbing during injection.
Artes is asking for FDA approval only for the correction of facial wrinkles called nasolabial folds, also known as "smile lines." The company claims that, unlike other products, PMMA is resistant to natural human enzymes that typically break down fillers. Macrophages, the body's natural "scavenger cells," also leave PMMA alone, the company said. All of this means the tiny microspheres are not absorbed or degraded by the body over time.
The company is not making comments or giving interviews as it awaits FDA approval for ArteFill, according to spokesperson Christine LaMontagne.
Doctors attending the AAD were clearly divided when it came to ArteFill. Some said they'd use it liberally, while others said they won't touch the stuff because the risk of bad results isn't worth it.
Most doctors said they don't believe the permanent filler will completely replace other options, such as Restylane, a filler made of hyaluronic acid that may last up to one year, or collagen, which can last about six months, according to the American Society of Plastic Surgeons. All fillers are injected into wrinkled areas and require a physician skilled in working with the compounds.
Last year, Americans underwent more than 1.5 million soft tissue filler procedures, according to the American Society of Plastic Surgeons. At least some of these people may be tempted to switch to ArteFill.
"There is a certain percentage of people who are going to want permanence," said Dr. Douglas Hamilton, a dermatologist in Woodland Hills and Beverly Hills, Calif., who participated in the studies of ArteFill and is on the Artes Medical advisory board, for which he receives compensation. But, he added, "it's hard to say how many."
First-timers should consider a more temporary filler first, said Northington. Hamilton agreed, saying, "That's not a bad rule of thumb."
While Artes is asking for approval only for nasolabial folds, some doctors think it could be useful for plumping lips, too. But Northington contended that, "Restylane is always going to be better for the lips."
According to information posted on the Artes Web site, a clinical trial in the United States was completed in 2001 which formed the basis for the "approvable" letter from the FDA, the step that comes before approval. Wrinkle correction endured and improved at the one year mark; five year results are expected this year. Because it contains bovine collagen, patients will need to undergo allergy testing before receiving ArteFill.
ArteFill is expected to cost about 50 percent more than the older filler, Restylane, which is typically about $500 or $600 per syringe or cc, Northington speculated.
More information
To learn more about fillers, visit American Society of Plastic Surgeons . |
