Revanesse® Important Safety Information

Updates on Labeling

The US FDA has requested all dermal filler manufacturers to update the Postmarketing Surveillance section of the physician labeling and the patient labeling with the following information:

Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.