Juvederm, Restylane and Other Wrinkle Fillers Raise Safety ConcernsNov 14, 2008 | Parker Waichman LLP Juvederm, Restylane, and other wrinkle treatments known as dermal fillers have been linked to serious side effects, including severe allergic reactions and anaphylactic shock. On Tuesday, the Food & Drug Administration (FDA) will convene a meeting of independent advisors to discuss possible changes to the labeling of Juvederm, Restylane and other dermal fillers.
Derma Fillers are injectable substances used to restore or enhance fullness to the lips or to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. Some such as Restylane are among the most popular non-invasive cosmetic surgery procedures on the market today. The types of materials approved for dermal fillers vary from biologic to synthetic materials and absorbable to nonabsorbable compounds.
According to the FDA, the first dermal fillers were approved nearly 20 years ago, with the majority of the currently marketed dermal fillers approved in the last 10 years. While dermal fillers are approved for the treatment of moderate to severe facial wrinkles, the FDA said that they are increasingly being used to augment and contour tissues.
According to an FDA report released today, over the past six years, the agency has received 930 reports of adverse events associated with dermal fillers. In addition to allergic reactions and anaphylactic shock, dermal fillers have been linked to other problems ranging from mild swelling to facial, lip and eye palsy, retina vascular occlusion, infection and disfigurement. The FDA report did not say which dermal fillers had been involved in the most serious reactions.
The FDA said that a number of side effect reports indicated that the patient received a series of injections but did not specify the time intervals between the injections, and did not mention which one in the course of injections triggered the adverse events. Some reports indicated that the patient received multiple brands of dermal implants but did not mention which adverse events occurred at which brand’s injection site. Many reports did not specify the injection site, and many of the reports did not specify how long after an injection a reaction occurred.
According to the FDA, 638 reports indicated that patients required treatment with medication, including steroids, antihistamines and oral antibiotics. Ninety-four reports indicated surgical intervention, 44 of which were among the patients who received drug therapy as well. Surgical procedures ranged from opening an abscess for drainage of pus, excision of nodules, to biopsy of the lesions, the FDA said.
Nineteen reports indicated patients’ were admitted to an emergency room for immediate medical attention due to severe hypersensitivity reactions such as swollen tongue, difficulty breathing and anaphylactic shock. Twelve patients required hospitalization for extended IV antibiotic therapy and close monitoring. Three patients were monitored for an extended period of time in the clinic. One-hundred thirty-five reports did not specify treatment of adverse events.
In the report, the FDA said it expects to receive more applications to sell dermal fillers for wrinkles and possibly for contouring the face and body. As a result, the agency said it wants to determine whether improvements are needed in the way the products are studied and labeled.