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 device is used to fix torn meniscus tissue in the knee. A ReGen consultant, Stephen Badylak of the University of Pittsburgh, said the regrown tissue had proven effective in increasing mobility and stability in Menaflex patients.
After the meeting, Jeffrey Shuren, the FDA device division director, told reporters that the FDA had several options, including doing nothing, applying special controls, or reclassifying Menaflex as a high-risk device, which could require a new application. Menaflex is currently classed as a lower-risk product.
Representatives of the medical-device industry expressed concern at the hearing about tighter regulation over Menaflex, which the FDA has been re-evaluating since last year. ReGen has said the product is safe and effective.
Susan Krasny of Stryker Corp., chairwoman of the Orthopedic Surgical Manufacturers Association, said that if the FDA could overturn an approval without a major safety issue involved, it would create uncertainty in the medical community.
The agency said last year that the process it used to approve Menaflex in December 2008 was flawed. The then-director of the FDA device division approved the product over the objections of a half-dozen FDA scientists and managers.
Menaflex was approved under an abbreviated process called 510(k) that applies to products similar to devices already on the market.
The company has challenged the legitimacy of the new FDA review, saying new questions about safety and efficacy were irrelevant to the requirements to clear a 510(k) review. ReGen also says the questions written by the FDA staff for the panel to consider were slanted to elicit responses unfavorable to ReGen.
The industry laid its concerns on the table early in the day, when the device makers’ representative to the panel, Robert Durgin of Biomet Inc. of Warsaw, Ind., interrupted to question the FDA about the panel’s purpose and its intentions.
Both Dr. Kelly and FDA officials said the panel was there to address scientific questions, not regulatory issues.