Government Panel Convenes To Discuss Safety of Injectables

FDA officials will meet this Tuesday with a panel of outside experts to review information on dermal filler complications that have been reported over the last six years.  There have been roughly 900 reports of complications; issues like serious allergic reaction and even anaphylactic shock are among the statistics documented.

Although the FDA did not identify which products had reports of serious problems, Juvederm, Restylane, Radiesse and other new offerings that have flooded the market will be topics of discussion.  Labeling changes are one possible result. Is this a reason to be concerned about dermal filler safety?  Yes and No.

It may sound alarming to those outside the cosmetic surgery profession, but complications and side effects associated with these products are still extremely rare.  Demand for wrinkle reducers like Botox and cosmetic dermal fillers has risen dramatically in recent years, leading many inadequately-trained persons to believe that they can administer the drugs in non-medical settings.  The majority of industry professionals will attribute most of the complications to situations like these.

There are also well known, labeled problems that occur on a very infrequent basis. Minor swelling or allergic reactions occur sometimes, with the latter being a subject of greater interest to the FDA review.  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.”

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 cosmetic surgeon with the right qualifications.