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FDA approves premarket application for Allergan’s Juvederm Ultra XC in lip augmentation

October 15, 2015

By Jennifer Garvin

Silver Spring, Md. — The Food and Drug Administration Sept. 30 approved a supplemental premarket application for a new indication for Allergan’s Juvederm Ultra XC.

The supplemental approval for Juvederm Ultra XC, an injectable hyaluronic acid/lidocaine gel combination, is for injection into the lips and perioral area for lip augmentation in adults 21 years of age and older. Three other soft tissue fillers — Restylane Silk, Restylane Gel and Restylane-L — already have FDA approval for this indication.

Dentists using dermal fillers is not a new development. In July, the ADA Professional Product Review featured an in-depth interview with three clinicians with particular knowledge on the subject and covered how dentists determine if dermal fillers are right for their practices and which patients should not be considered for treatment.

The FDA recommends the following practices for using the fillers:
  • Do not inject soft tissue fillers if you do not have appropriate training or experience.
  • Familiarize yourself with the anatomy at and around the site of injection.
  • Thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
  • Know the signs and symptoms associated with injection into the blood vessels and have an updated plan detailing how you plan to treat the patient if this should occur.
In May, FDA issued a safety alert regarding the risk of serious patient injury with the unintentional injection of soft tissue filler into blood vessels in the face. According to the alert, some patients have suffered serious adverse effects including blocked blood vessels and restricted blood supply to tissues, sometimes resulting in embolization.

For a list of all soft tissue fillers approved by the FDA’s Center for Devices and Radiological Health, visit the FDA website.