As Demand Rises, FDA Reviews Injectable Filler Labeling, Complications

Posted on November 25, 2008 | by

On Tuesday, November 18, members of the Food and Drug Administration will meet with a panel of outside experts to review the various complications that have resulted from cosmetic dermal filler injections.

Products like Juvéderm, Restylane, Radiesse and others that continue to flood the market will be a focus.  Over the last six years, the FDA has received roughly 900 reports about complications related to injectable wrinkle-fillers.  Is this a reason to be concerned?

It might sound alarming, but the complications and side effects associated with fillers are still extremely rare.  Demand for wrinkle reducers like Botox and fillers like Juvéderm has exploded in recent years, leading many improperly trained persons to administer them in non-medical settings.

The majority of industry professionals will attribute most of the reported complications to situations like these.  There are also well known, labeled problems that can occur on an infrequent basis, like minor swelling or allergic reactions, with the latter being a subject of greater FDA interest.

According to a recent MSNBC news article, Allergan spokeswoman Caroline Van Hove said “no serious problems were seen in clinical trials of Juvéderm, and the most common complaint since its approval was swelling in 0.4 percent of patients.”  Also, Food and Drug Administration officials noted that the “reports had several limitations such as failing to say when the problems started.”

Safety and proper training is of the utmost importance with almost any cosmetic procedure, so we recommend that all patients seek a knowledgeable plastic surgeon with the right qualifications.

For more information on the FDA panel discussion, the briefing is located here.