Nov. 20, 2003 -- Restylane, a new wrinkle filler, should get U.S. approval, an FDA advisory panel recommends.
That's music to the ears of Rod J. Rohrich, MD, president of the American Society of Plastic Surgeons and chairman of the department of plastic surgery at University of Texas Southwest Medical Center in Dallas.
"It is like youth in a syringe," Rohrich tells WebMD. "It's a synthetic version of a natural lubricating substance in our bodies. Using biotechnology, they harness this material in a syringe. You can plump up the areas where you age that make you look sad. Because as we age, our skin doesn't just sag -- it loses volume. This restores that volume."
The panel's 6-3 vote comes with some conditions, an FDA spokesperson tells WebMD. The manufacturer has already agreed to some of these conditions. And as the FDA usually follows its panels' advice, full approval is expected in two or three months.
The panel is also considering Hylaform, another new wrinkle filler already in use outside the U.S. Like Restylane, Hylaform is a hyaluronic acid gel. Restylane is fully synthetic; Hylaform comes from the combs of specially bred roosters.
Restylane Can't Say It's Better -- Yet
The panel's biggest restriction on Restylane is its refusal to allow the manufacturer to label the drug as superior to the collagen injections plastic surgeons now use to fill wrinkles. That decision was based on the clinical trial information the manufacturer submitted to the FDA.
However, plastic surgeons are considerably more enthusiastic about both Restylane and Hylaform, Rohrich says. He notes that both products have an excellent safety record over eight to nine years in some 60 countries.
"There has not been a substantial new filler in the U.S. in more than a decade," Rohrich tells WebMD. "This new set of fillers will be almost revolutionary. They last two to three times longer than the collagen-based fillers we now use."
The panel's Restylane approval came with other restrictions:
- Post-approval studies must be done to see whether Restylane works in people of color. Nearly all the people who took part in Restylane clinical trials were white.
- Pending FDA consideration of these postmarketing studies, the label must carry a warning that there is limited data on its use in people of color.
- Doctors must be educated in the use of Restylane before they can inject patients with it. Rohrich says the American Society of Plastic Surgeons is already planning to offer such training.
Fewer Allergic Reactions
Before getting a collagen injection, a patient must undergo skin tests to make sure there won't be an allergic reaction. This test isn't needed with the new hyaluronic acid gel fillers, says plastic surgeon Wayne Perron, MD, past president of the Canadian Society for Aesthetic Plastic Surgery. Restylane and Hylaform have been available in Canada for years.
"With collagen, there's been some concern over years about allergic reactions," Perron tells WebMD. "But collagen is still a good product, it won't go away. But it has to be refrigerated or it will spoil. Restylane doesn't need refrigeration. We use it more because of these advantages. Hylaform we have used very little, but they are all good products."
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.