The US Food and Drug Administration (FDA) has approved the injectable dermal filler Radiesse (Merz North America, Inc) for hand augmentation to correct volume loss in the dorsum of the hands, the company announced June 4.
Earlier this year, as reported by Medscape Medical News, the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 9 to 4 that the benefits of Radiesse outweigh its risks. A majority of panelists also voted that it is safe and effective.
“Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to 1 year,” the company said.
Radiesse is an opaque dermal filler composed of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel carrier. It was first approved in the United States in 2001, and has since had subsequent approvals, including for correction of nasolabial folds in 2006. It has been used off-label for hand augmentation — and is approved in 52 countries for that indication.
Data to support FDA approval for hand augmentation came from a multicenter, randomized controlled study of 114 patients. Most were white women with an average age of 53 years. Eighty-five patients were randomly assigned to immediate treatment, and 29 to delayed treatment and were considered controls. The control group crossed over to treatment at 12 weeks.
The effectiveness of Radiesse was measured by the Merz Hand Grading Scale (MHGS) — validated by the company in another study — and the Global Aesthetic Improvement Scale (GAIS), which the patients used to self-assess results.
According to the MHGS, 75% of Radiesse patients experienced at least a one-point improvement at 3 months compared with 3% of those in the control group. The mean change in the MHGS from baseline was 1.1 point for those given Radiesse compared with 0.1 in the control group.
In addition, 98% of treated patients reported improvement in the appearance of their hands at 3 months. Improved aesthetic outcomes as measured on the GAIS after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met, the company said.
Most adverse events were injection site reactions such as swelling, redness, pain, and bruising, which were usually mild to moderate, short in duration (lasting about 1 week), and required no treatment. No severe device-related adverse events were reported that required treatment, according to the company.
Radiesse is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.
ARTICLE ORIGINALLY PUBLISHED ON MEDSCAPE: http://www.medscape.com/viewarticle/846031