Officials from the United States Food and Drug Administration met with a group of outside experts to review the various complications that have arisen from cosmetic dermal filler injections. Juvederm, Restylane, Radiesse and other new offerings are products that fall under this category.
The panel discussed the possibility of labeling changes and the seriousness of the reported complications related to injectable wrinkle-fillers that have occurred over the last six years. Is this a reason to be concerned about dermal filler safety? Yes and no.
It might sound alarming, 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 in the last decade, leading many inadequately trained persons to 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.
On December 1st, 2008, Mentor corporation (MNT), the well-known breast implant and aesthetic specialties supplier was purchased by Johnson & Johnson for a price of 1.1 billion. Market analysts claim the move was probably due to the recent economic strain that had the company aggressively marketing its popular silicone implants.
