No Firm Conclusions on ReGen Knee Device From FDA Panel

A Food & Drug Administration (FDA) panel convened yesterday to discuss ReGen Biologic’s <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Menaflex knee device found there wasn’t enough scientific evidence to come to a firm conclusion about its benefits. The FDA will now have to decide what, if anything, to do about the controversial device.

Menaflex is meant to repair a torn meniscus, which basically acts as a shock absorber for the knee. The device was approved in December 2008 through a process known as 510(K), which doesn’t require human clinical trials, and is meant for devices that are substantially similar to products already on the market.

As we’ve reported previously, ReGen’s 510(K) application for Menaflex was rejected by FDA scientists on three occasions, with the agency’s staff asserting it wasn’t eligible for the process. But agency managers ultimately overruled the scientists and approved Menaflex in December 2008.

A report issued by the FDA’s Center for Devices last fall found that agency officials repeatedly deviated from procedures in approving Menaflex. According to the report, the FDA’s Congressional Liaison said the political pressure put on the agency was “the most extreme he had seen, and the agency’s acquiescence to the company’s demands for access to the commissioner and other officials in the commissioner’s office as unprecedented.” The document also criticized former FDA Commissioner Andrew von Eschenbach for pressuring other FDA officials to act quickly. The agency decided to convene yesterday’s panel following release of that report.

According to The Wall Street Journal, the panel’s chairman, John Kelly of the University of Pennsylvania, pointed to inadequate and low-quality evidence about the effectiveness of the Menaflex implant, as well as a lack of information about its safety. He said it was the panel’s opinion that the device “is reasonably safe, but it fails to pass scientific muster.” The panel singled out one ReGen-produced study in particular for its design, lack of some data, and its potential for bias, the Journal said.

After the meeting, Jeffrey Shuren, the FDA device division director, told reporters that the FDA had several options in dealing with Menaflex, the Journal said. Those include doing nothing, applying special controls, or reclassifying Menaflex as a high-risk device, which could require a new application. According to The Wall Street Journal, Menaflex is currently classed as a lower-risk product.

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