FDAnews Device Daily Bulletin

FDA PUBLISHES INFORMATION ON RECENTLY APPROVED FACIAL IMPLANTS

July 3, 2006
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The FDA has issued updated information Juvederm 24HV, Juvederm 30 and Juvederm 30HV gel implants, which were approved on June 2.

The devices, made by Santa Barbara, Calif.-based Inamed, are injected into the middle layer of skin to temporarily correct moderate to severe facial wrinkles and folds, the agency said.

The implants should not be used in patients with severe allergies and a history of anaphylaxis or in patients with allergies to bacterial proteins, the FDA cautioned.

The device approval letter can be viewed at www.fda.gov/cdrh/pdf5/p050047a.pdf (http://www.fda.gov/cdrh/pdf5/p050047a.pdf).