Nov. 18, 2008 -- Dermal fillers injected to soften facial wrinkles should carry stronger and more specific warning labels about potential adverse effects, according to an FDA advisory panel.
The panel met today in Gaithersburg, Md., to discuss many questions about the popular fillers, including such brand names as Restylane and Juvederm.
Panel members "agree that the labeling should be revised to include the more serious adverse events and how long the product has been on the market and how long it might take events to appear," says Siobhan DeLancey, an FDA spokeswoman who was at the meeting.
While the existing labels do list numerous potential side effects, they do not always list when the events might occur, and an FDA evaluation of the fillers has found that some events may show up months after the injections, she says.
The panel will make its final recommendations to the FDA, which is not bound to follow them but often does.
Industry representatives and some plastic surgeons say the stronger labels are not needed, while another expert welcomed the recommendations.
Types of Adverse Events
About 1.5 million dermal filler treatments are done a year in the U.S., according to statistics kept by the American Society of Aesthetic Plastic Surgery.
Over the past six years, the FDA has received 930 reports of adverse effects from the numerous dermal fillers approved, most of them in the last 10 years. No deaths were reported, but among the adverse effects were:
- Allergic reactions
- Inflammatory reactions resulting in nodule formation, cold sores, arthritis flare-ups, and other problems
- Bruising, bleeding, scars
- Blisters and cysts
- Lumps and bumps
- Numbness, including palsy
- Migration, such as the filler material moving to another site on the face
Most of the reported adverse events, according to FDA findings, involved injections in sites other than the nasolabial fold, the indication for which many fillers have approval.
A number of the reports of adverse events involved injections by untrained personnel, the FDA also found.
Besides recommending stronger labels, the panel is advising the FDA to ask manufacturers to note that some events may occur months or years after the injection, DeLancey says.
The panel didn't agree on whether the label should list adverse events for all fillers in that class, or only for the adverse events associated with a specific type of filler.
The panel also discussed how clinical studies on the dermal fillers should be done in the future and concludes that "there is no one-size-fits-all study," DeLancey says.
"Certain products seem to have more reactivity than others," she tells WebMD. The panel wants to set up a consensus panel to develop guidelines on how clinical studies should be done and formulate guidance for the industry. "A lot of the panel members say they want manufacturers to do more rigorous premarket studies."
Stronger labels are not needed, says Jonah Shacknai, CEO of Medicis in Scottsdale, Ariz., which makes the fillers Restylane and Perlane.
"We have not seen an adverse effect not reflected on our labels," he tells WebMD. In all, Medicis fillers have been used in more than 10 million treatments, he says.
Caroline VanHove, a spokeswoman for Allergan, which makes Juvederm filler, says the product "has a highly favorable safety profile" and that it's important to differentiate between the short-term and long-term fillers because they have different safety profiles.
Plastic Surgeons' Views
Serious adverse events associated with the fillers are extremely rare, says Toby Mayer, MD, a facial plastic surgeon in Beverly Hills, Calif.
Blaming the product, he adds, is misguided. "I think it's pilot error -- it's the surgeon or dermatologist or whomever is putting it in," he says. Adverse events are more likely to occur, Mayer says, when the fillers are used by inexperienced physicians or others. Often, he tells WebMD, an inexperienced user will not place the material where it's meant to be put: deeper into the skin.
But another plastic surgeon, Karol Gutowski, MD, chief of plastic surgery at NorthShore University Health System in Chicago, welcomed most of the recommendations. Telling consumers about side effects that might appear months after the injection is an especially good idea, he tells WebMD.
"Some of these [dermal fillers] can last only two or three months, but some injectables last three to five years. Some of us are concerned about the long-acting ones."
If the labels end up telling consumers how long the product has been on the market, he says, it should specify whether that is the U.S. market or overseas. Sometimes products have been used successfully overseas for years but are new to the U.S. market.