FDA Panel Questions Knee Device ...WSJ Online
An FDA panel of outside experts found that there isn't enough scientific evidence to come to a firm conclusion about the benefits of a knee device approved by the FDA in 2008. The panel's statement highlights the agency's dilemma as it weighs whether it has authority to revoke a device's approval.
The chairman of the panel, orthopedic surgeon John Kelly of the University of Pennsylvania, cited inadequate and low-quality evidence about the effectiveness of the Menaflex implant made by ReGen Biologics Inc., and not enough information about the device's safety.
"There is evidence of reasonable efficacy, but we have concerns about inadequacies of scientific proof," Dr. Kelly said toward the end of a daylong meeting. He said it was the panel's opinion that the device "is reasonably safe, but it fails to pass scientific muster." In particular, the panel questioned a study produced by the Hackensack, N.J., company because of its design, lack of some data, and its potential for bias.
Earlier in the day, ReGen defended the quality of its research, saying it had done more testing and provided more data than makers of similar devices.
The de...
