New Wrinkle Filler Gets FDA Panel Nod
Restylane Already Available Outside U.S.; Full Approval Expected
Making Botox Better
Rohrich says the new fillers aren't, as some have claimed, the "new Botox." They're better than that, he says.
"You can used them in combination with Botox," he says. "We'll use Botox to relax the muscles underneath wrinkles. Then we'll fill in the area with Restylane or Hylaform."
Bottom Line: Technique
Rohrich and Perron warn that the new products aren't a substitute for a skilled doctor.
"The biggest factor in all these things is technique," Perron says. "You can have the best products in bad hands, and you will have problems. Difficult products in the right hands can yield wonderful results. Basically it is technique. You probably will see a few problems as doctors get used to using the new fillers -- there is a learning cure. But experienced injectors, who have used collagen before, will not have problems."
And where will people be getting the new filler injected?
"The number one use will be to plump up the lips," Rohrich says. "Also a big use will be to plump up those little creases that run from the sides of the nose to the lips and get deeper with age. And we'll use it on a lot of forehead and frown lines, too."
Editor's note: After this article was published, the FDA advisory committee voted 6-3 to recommend full approval of Hylaform. That approval comes with important restrictions.
Because Hylaform clinical trials excluded people allergic to birds -- Hylaform is made from rooster combs -- doctors must find out whether patients have bird allergies. They can do this either by skin testing or by confirming the patient has no history of such allergies.
The panel also recommended that the Hylaform label state that the product's safety and efficacy data is based on only one injection. Multiple injections will be needed to maintain the Hylaform's cosmetic effect. It's not clear what effect this recommendation will have.
According to Genzyme, the product's manufacturer, more than half a million doses of Hylaform have been safely used in Europe since its approval there in 1995.
