FDA Panel Votes to Approve Radiesse for Hand Augmentation

Alicia Ault

February 27, 2015

A US Food and Drug Administration (FDA) advisory committee has recommended that the injectable filler Radiesse (Merz North America, Inc) be approved for hand augmentation.

The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 9 to 4 that the benefits of Radiesse outweigh its risk. A majority of panelists also voted that it was safe and effective.

However, the panel expressed some concern about long-term safety, and asked the FDA to require postmarketing studies that would assess radiographic evidence of implant stability and also of impact on hand function.

Radiesse, a synthetic calcium hydroxylapatite, was first approved in the US in 2001, and has had a handful of 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. The manufacturer, Merz North America, argued that FDA approval would ensure proper training and use.

Panel member Glenn B. Pfeffer, MD, agreed. "With FDA oversight of this product, it will be safer for the public," said Dr Pfeffer, director of the foot and ankle program at Cedars-Sinai in Los Angeles, California.

Some advisory committee members questioned whether there was truly a patient need for hand augmentation. A phalanx of dermatologists and plastic surgeons — many flown in by Merz — testified during the public hearing portion of the meeting that their patients were asking for hand treatment and that it had become an increasingly common off-label procedure.

Study Results

Merz submitted data from one pivotal randomized controlled study of 114 patients at six US sites. Seventy-seven percent were Caucasian, and most were women, with an average age of 53.

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. All patients were eligible for retreatment at 24 weeks. There were live hand evaluations at baseline, 12, 24, 36, and 48 weeks. Photographs were also taken, but the live evaluations were given the most weight.

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, which the patients used to self-assess results.

According to Merz, 75% of Radiesse patients had at least a one point improvement at three 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.

The FDA reviewers, however, noted that efficacy results varied widely by study site — from 63% at the low end to 95% at the high end. That made them question whether it was due to the treatment method, or the perception of the evaluator at that site.

The agency also said that adverse events appeared to be higher with injection into the hands than into the face, and that side effects rose as the volume of Radiesse used increased. All patients reported adverse events, with the most common being swelling, bruising, pain, and itching. Almost half of patients reported some problem with hand function, though it was short-lived for most.

The panel was mostly convinced about safety, at least in the short term. "I felt that the wealth of experience suggested that it is safe," said Hobart W. Harris, MD, chief of general surgery at the University of California, San Francisco Medical Center.

The FDA does not have to, but usually follows its panels' advice.

None of the panelists reported any conflicts that would have required a waiver from the FDA.

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