FDA Panel Reviews Filler Safety: Reason to Worry?

Over the last six years, the United States FDA has received about 900 reports concerning injectable wrinkle-filler complications.  Now as consumer demand for fillers has reached an all-time high, officials have decided to organize a discussion with a panel of outside experts to go over possible changes in labeling of the products.

Those in question are fillers like Radiesse, Juvederm, Restylane, Perlane and others that continue to enter the market.  While it may sound alarming, the complications and side effects associated with these products are extremely rare.  There are well known issues like minor swelling and then there are serious allergic reactions, with the latter being a subject of 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.”  The majority of industry professionals will attribute most reported complications to 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 a trained and knowledgeable Illinois plastic surgeon with the right qualifications.

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