FDA Discussion Will Focus on Dermal Filler Safety, Efficacy
Officials from the Food and Drug Administration met in November with a group of outside experts to review complications that have been reported in association with cosmetic dermal filler injections.
Over the last six years, there have been roughly 900 reports of wrinkle filler issues. Juvederm, Restylane, Radiesse and other new offerings are products that fall under this category. The group will discuss the possibility of labeling changes and the seriousness of the reported issues. Is this a reason to be concerned about dermal filler safety? Yes and No.
It may sound alarming to those outside the surgery profession, but the complications and side effects associated with these products are still extremely rare. Demand for fillers and wrinkle reducers like Botox has risen dramatically, leading many untrained persons to believe that they can administer them in non-medical settings. The majority of industry professionals will attribute most of the reported complications to issues like these.
There are also well known problems that occur on a very 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 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 when considering any surgical or 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.