Concerns About Off-Label Use of Wrinkle Fillers

Jamie Sheller

Attorney
(866) 735-1102 Ext 475

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While dermal wrinkle fillers, like Juvaderm and Restylane, have been approved by the FDA for facial wrinkles, the surge in a particular off-label use has caused some concern. Cosmetic doctors are using the dermal fillers for under-eye indentations, a use for which the fillers are not approved. For the under-eye procedure, the wrinkle filler is injected around the eye socket. However, doctors at a plastic surgery conference reported more patients having under-eye mounds, discoloration and persistent hard nodules after under-eye procedures with wrinkle fillers.

Recently, an FDA panel held a meeting to review the safety of wrinkle fillers. At the meeting, the panel heard from manufacturers and medical societies about these products, which include Juvaderm, Restylane, Radiesse and ArteFill. Though dermal wrinkle fillers are only approved for facial wrinkles, doctors are free to use them as they see fit for their patients. One concern is that patients don't always know that a particular treatment is off-label. Manufacturers are prohibited from marketing their products for an unapproved use. However, some wrinkle filler manufacturers provided grants to finance a web site created by several medical societies, which covers both approved and unapproved uses of dermal fillers.