LAS VEGAS Time after time, Dr. Martin Braun encounters new patients in his Vancouver, B.C.-based practice who have undergone previous cosmetic filler treatments in Europe as well as Asia, but who have no idea what product was used.
Determining product history can be a daunting task because there are more than 100 cosmetic fillers currently being used in the European Union (EU), Dr. Braun said at the annual meeting of the International Society for Dermatologic Surgery.
"Frequently, we have to contact the physician, and I'm introduced to a new filler," he said. "Considering today's sense of a global village, I think it's important for physicians in North America to be familiar with some of these products." Filler products approved for use in the EU are designated with a so-called CE mark, which does not indicate conformity to a standard but rather conformity to the legal requirements of EU directives.
"There may not have been any human trials done on the filler," Dr. Braun said. "It could be something as simple as a certified quality system to ISO 9000 and that's it." (ISO is the International Organization for Standardization.)
He highlighted the following products to keep on the radar:
▸ Evolence (ColBar LifeScience Ltd.). Approved in Canada in 2006 and in the United States in 2008, this product contains 35 mg/mL of porcine collagen (telopeptides removed) cross-linked with D-ribose (nontoxic). No skin testing is required and studies have shown that results last up to 12 months.
However, using it for lip augmentation has resulted in several cases of nodule formation, Dr. Braun said. Of 20 patients he treated in 2006, 16 developed multiple lip nodules that have persisted in one-quarter of the cases for nearly 2 years. "Be very cautious with this product in and around the lips," Dr. Braun said.
He did not evaluate Evolence Breeze, which is said to be less problematic in the lips.
▸ Radiesse (BioForm Medical). Data from clinical studies suggest that this Food and Drug Administration-approved product lasts a few more months than do hyaluronic acid (HA) fillers. "It's the filler of choice for me for very deep nasolabial folds in men, as it appears to lift better than many hyaluronic acid fillers," Dr. Braun commented. "The one disadvantage is that 70% of that Radiesse syringe contains a gel carrier that disappears in 34 months. You have to warn the patient[s] of this because they will see a huge decrease in their filling after 34 months and have to be injected again." In his experience, Radiesse tends to bruise more than other fillers, feels indurated for the first few weeks, and can't be dissolved with anything.
▸ Juvéderm (Allergan Inc.). Developed from Streptococcus equi fermentation, this FDA-approved product "is very similar to Restylane [Medicis Aesthetics Inc.], but it's not as stiff," Dr. Braun said. "So if you want a skin-stiffening agent to perform the fern injection techniques, Restylane will likely do a better job for you." Juvéderm with lidocaine just became available in Canada but is not yet available in the United States. Dr. Braun predicted that this will become his filler of choice for patients who do not wish to have a proper dental block performed.
▸ Sculptra (Sanofi-Aventis). This product is FDA approved for HIV-associated facial lipoatrophy, but in Canada, it's approved for dermal contouring of the face in all patients. Dr. Braun said he uses Sculptra (poly-L-lactic acid) filler in patients with marked hollowing of the buccal fat pads and temporal fat pads and in those with thin skin, because after it's injected "the skin gets a nice glow, similar to [what] you obtain with IPL [intense pulsed light] photorejuvenation."
▸ Atléan (Stiefel Laboratories Inc.). Purchased by Stiefel in 2008, this product contains hyaluronic acid mixed with tricalcium phosphate. "The idea is that the tricalcium phosphate stimulates new collagen formation which is long lasting, like that associated with calcium hydroxyapatite," Dr. Braun said. In split-face injections, Dr. Braun had to use 5 cc of Atléan for 4 cc of Radiesse to get a similar correction. "So Radiesse will have a competitor here," he said. "And unlike Sculptra (where the water absorbs in 2 days), the immediate volumization achieved with Atléan will endure due to the HA component."
Atléan is not approved for use in the United States.
▸ Laresse (FzioMed Inc.). This polyethylene oxide product is marketed as being nonanimal, nonbacterial, nonpermanent, nontoxic, and nonparticulate"everything we would want in a filler," Dr. Braun said.
However, when he injected it into the glabellar folds of two patients, induration developed that lasted more than 3 weeks. "I don't think it has a future, because when you inject it, you get an induration."