FDA Panel: No Answers to MoM Hip Dilemma (MedPageToday)
Two days of public hearings yielded little in the way of solid information for an FDA advisory panel to use in promulgating new policy recommendations for use of metal-on-metal (MoM) hip implants.
The FDA's Orthopaedic Surgery and Rehabilitation Devices panel, meeting Wednesday and Thursday, had been tasked with providing recommendations on how to manage patients who have received such devices and whether they should be used at all in new patients.
Where Are the Data?
Toward the end of the 2-day meeting, Scott Evans, PhD, a Harvard University biostatistician, said that, although the group had been presented with reams of data, "the issue is that it's from observational studies and registries that are not optimally designed to answer the very, very difficult questions we've been trying to hassle with today."
At another point, Raj Rao, MD, of the Medical College of Wisconsin in Milwaukee, protested that an FDA question about populations who should not receive MoM implants was "unfair" because the agency had offered no data comparing such devices with metal-on-polyethylene or other alternative designs.
The discussions, which did ...
