FDA: Dermal Fillers for Wrinkles Linked to Serious Side Effects
According to the Food and Drug Administration, Plans are underway to review the labeling of certain wrinkle-filler products, also known as dermal fillers, as some people suffered ``serious and unexpected'' side effects such as the inability to control facial muscles, disfigurement and rare life-threatening allergic reactions; majority of the reports involved minor swelling.
From January 2003 to Sept. 20 of this year, the FDA received 930 reports of side effects due to the products made by various companies though they did not name the products that were linked. Among top-selling fillers are Medicis Pharmaceutical Corp.'s Restylane and Perlane, Allergan Inc.'s Juvederm and Medical’s Radiesse.
Dermal fillers are made from animal collagen or chemicals and are injected into the skin to make it look younger or to reduce scarring. According to dermanetwork.org, Dermal fillers are, “being used more and more to help reverse the changes associated with aging. Because the goal is to return the dermis to its original youthful state, dermal fillers can give a more natural appearance than surgical face lifts. Dermal fillers are being used to reduce or eliminate wrinkles, raise scar depressions, enhance lips, and replace soft-tissue volume loss.”
Bloomberg reported last year alone about 1.36 million women and 84,000 men received wrinkle- fillers. According to the American Society for Aesthetic Plastic Surgery, non-surgical cosmetic procedures increased more than eightfold between 1997 and 2007.
According to the FDA, it expects more applications to sell dermal fillers for wrinkles and possibly for contouring the face and body and the agency said it wants to determine whether improvements are needed in the way the products are studied and labeled.
Medicis’s spokesman Jonah Shacknai, the company's chairman and chief executive officer, in a telephone interview said, Medicis has an ``outstanding'' safety record with its dermal fillers, which have been used more than 10 million times worldwide. We applaud the FDA's inquiry into the safety of dermal fillers.''
Caroline Van Hove, a spokeswoman for Allergan said, Allergan’s product has a ``very strong safety profile. We have a very low adverse event reporting rate,'' she said in a telephone interview.
The FDA has a meeting scheduled on Nov. 18 with agency advisers in Gaithersburg, Maryland, to discuss the safety of the products and whether new warnings are needed. The FDA usually follows the recommendations of its panels, though it isn't required to do so.