On November 18, Food and Drug Administration officials will meet with a panel of outside experts to discuss possible changes in the labeling of cosmetic dermal fillers like Juvederm, Restylane, Radiesse and others that continue to flood the market. Within the last six years, the FDA has received 930 reports about complications related to injectable wrinkle-fillers.
While it may sound alarming, the complications and side effects associated with these products are still very rare. There are known issues that occur like minor swelling, and then there are serious allergic reactions, with the latter being a subject of greater FDA interest.
Allergan spokeswoman Caroline Van Hove told MSNBC that “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.”
The majority of industry professionals will attribute most of the reported complications to unqualified persons administering filler injections, since consumer demand for them has recently risen so dramatically. 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.