On November 18, 2008, the US Food and Drug Administration convened a panel of outside experts to review the various complications that have been associated with cosmetic dermal fillers like Juvederm, Restylane, Radiesse and others that continue to flood the market. They discussed the possibility of labeling changes, because over the last six years, the FDA has received about 900 reports about complications related to injectable wrinkle-fillers. Is this a reason to worry?
It might sound alarming, but the complications and side effects associated with these products are still extremely rare. Demand for fillers and Botox has exploded in recent years, leading many inadequately trained persons to administer them in non-medical settings.
The vast majority of industry professionals will attribute the reported complications to issues like these. There are also well known complications that occur, 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 Juvederm, 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 physician with the right qualifications.
For more information on the FDA panel discussion, the briefing is located here.
