In the study, 13 patients developed lumps, bumps and nodules, most were mild and none were severe and they resolved without intervention or sequelae. At the end of the study, no patients had a persistent granuloma. In three studies of 234 patients evaluating Radiesse in the hands, no granulomas have been reported, according to the company.
There were 8 severe recurrent adverse events in 7 patients: 5 reports of swelling, 1 report pf pain, 1 report of difficulty in performing activities, and 1 report of bruising.
FDA reviewers agreed that the clinical study appeared to meet the primary effectiveness endpoint, but pointed out that the amount of improvement varied between study sites. Among other issues they raised was the increased rate, severity, and duration of adverse events associated with treatment, particularly pain and swelling, which seemed to be higher and lasted longer than when Radiesse was used for the two facial indications. In addition, they indicated that the results of hand function tests were difficult to interpret.
Panelist Dr. Murad Alam, professor of dermatology, otolaryngology, and surgery, Northwestern University, Chicago, said there were some significant issues with the pivotal study, “but they do not undermine the overall conclusions” that treatment appeared to be safe and effective. The significant off-label use and experience elsewhere “was sufficient to sway me,” he added.
One of the panelists voting no on the risk-benefit question, Dr. Clayton Peimer, an orthopedic surgeon at Michigan State University, said he simply did not have enough information to support approval. He added that there were still unanswered questions, such as what would happen if the filler ends up next to synovial tissue, or if it was used in patients with systemic sclerosis, or calcinosis cutis. “I respect that board-certified plastic surgeons, dermatologists, and hand surgeons are using this safely” in the hands, he said, but added that he was concerned that FDA approval could lead to widespread use by cosmetologists and mid-level practitioners.
FDA usually follows the recommendations of its advisory panels. The panelists had no disclosures.
If approved, Merz has plans for a postapproval, open-label study that would follow at least 100 patients after they receive hand augmentation with Radiesse for three years after their initial treatment, monitoring for adverse events and satisfaction with treatment.