Over the past six years, the Food and Drug Administration has received over 900 reports related to injectable wrinkle filler complications. Now that consumer demand for the treatments has risen to an all time high, FDA officials have decided to meet on November 18 with a panel of outside experts to discuss new labeling possibilities.
The products in question include fillers like Juvederm, Radiesse, and Restylane. While it may sound alarming, the complications and side effects associated with these products are extremely rare. There are well known complications like minor swelling and then there are severe allergic reactions, with the latter being a subject of FDA interest.
According to a recent NBC 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.”
Food and Drug Administration officials noted that the “reports had several limitations such as failing to say when the problems started.”
Most industry professionals will attribute a large number of the reported complications to a steep rise in the popularity of these treatments and unqualified persons administering the injections. Safety and proper training is of the utmost importance with almost any cosmetic procedure, so we recommend that all patients seek plastic and cosmetic surgeons with the right qualifications.
For more information on the FDA panel discussion, the briefing is located here.
