FDA to Review Labeling due to Adverse Event Reports
Complaints about Wrinkle-Filler Products Spark FDA Review
Problems Include Facial Palsy and DisfigurementThe FDA has announced that it plans to review the labeling of certain wrinkle-filler products, also known as dermal fillers, because it has received 930 reports of serious problems associated with the products during the past 6 years.
Problems include rare but life-threatening events such as severe allergic reactions and anaphylactic shock, and more commonly facial palsy and disfigurement. Many reports involved minor swelling.
While the FDA would not name the products cited in the reports, commonly used dermal fillers include Restylane and Perlane from Medicis, Bioform Medical's Radiesse, and Allergan Inc's Juvederm.
NOV-14-08: FDA receives 930 reports of wrinkle-filler issues [MSNBC: FDA TO REVIEW WRINKLE FILLERS]
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