Filler Safety Questioned
From Medical Esthetics Magazine, January / February 2009
As we were preparing this issue, newspapers around the country were printing frightening articles about serious adverse outcomes associated with cosmetic fillers. These were based on a report from the Food and Drug Administration Center for Devices and Radiological Health Plastic Surgery Devices Panel. The panel recommended that the FDA require physicians to communicate the risk of long-lasting reactions from these fillers to consumers. The report was based on 930 unique adverse events, which occurred between 2003 and September 2008; 638 patients required some kind of follow-up treatment, of which 94 required some kind of surgical intervention and 19 went to the emergency room with life-threatening allergic reactions. The data was not specific enough to allow the panel to draw any conclusions about individual fillers or to determine whether the adverse events were attributable to the products themselves or occurred as the result of their improper use.
“To me this presentation is not good science,” says Toby Mayer, MD, FACS, Beverly Hills, California. “We do several thousand filler procedures each year using Juvéderm and Radiesse in our practice and we have never had any serious problems. As soon as we heard about this report, we checked with our product reps, and they both told me they have had no reports of any serious complications. I think when you see problems of this type, they are probably the result of pilot error – either a poorly trained injector putting the filler in the wrong plane or someone using fillers off-label.”
FDA scientists agree that fillers have a good risk profile: Plastic surgeons performed more than a million filler procedures in 2007; only 160 adverse events were reported and most of these were swelling and redness. Nevertheless, they are concerned that fillers are being used for unintended purposes, such as for plumping lips, and on dark skin types where there is not enough data to support their safety.
“The companies we work with are diligent about asking for reports of any problems,” says Dr. Mayer. “In my opinion this data will change nothing that a good plastic surgeon or dermatologist will do when it comes to filler procedures.”
Will these negative press reports keep patients away? “Fortunately, our filler patients are extremely motivated. They may ask us some questions, which we can answer honestly,” says Dr. Mayer, “but they will continue their treatments.”
— Linda W. Lewis – Executive Editor/Associate Publisher