FDA approves Radiesse for hand augmentation

The FDA has approved Radiesse for hand augmentation to improve volume loss in the dorsum of hands, according to a press release from Merz North America.

Radiesse, an opaque dermal filler composed of calcium hydroxyapatite microspheres suspended in a water-based gel carrier, temporarily adds volume to hands, according to the release. It also is indicated for subdermal correction to moderate to severe facial wrinkles and folds.

Mitchel Goldman

“Merz is proud to be able to provide patients and physicians with the first and only dermal filler approved by the FDA for use in hands,” Jim Hartman, vice president and head of U.S. Aesthetics/OTC for Merz North America, said in the release.

The FDA approval was based on a randomized, controlled trial in which masked evaluators reported that Radiesse improved appearance at 3 months in both hands in 75% of treated patients, the release stated. Improvement in hand appearance at 3 months was reported by 98% of patients in the trial. Adverse events reported were injection site reactions including swelling, redness, pain and bruising, which were mostly mild to moderate, lasted about 1 week and required no treatment, according to the release.

“Hands have been a real unmet need in cosmetic surgery,” Mitchel Goldman, MD, founder and medical director of Cosmetic Laser Dermatology, San Diego, who was a researcher in the clinical trial, said in a separate press release. Goldman also testified before the FDA hearings as part of the approval process for Radiesse.

“This is a real problem for many people concerned about maintaining a vibrant appearance,” Goldman said in the release. “Addressing our patients’ aging hands goes beyond simple vanity. Often the first interaction we have when meeting someone for the first time is a handshake. ... Age discrimination is very real in the workplace, so it’s a matter of making the best possible first impression as a professional.”

Reference: www.MerzUSA.com; www.clderm.com