FDA Panel to Revisit Approval of ReGen’s Menaflex Knee Device

The Food & Drug Administration (FDA) is reconsidering its approval of ReGen Biologics Inc.’s <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Menaflex knee device. The FDA will convene a panel of outside experts tomorrow to make a recommendation to the agency’s Center for Devices about whether Menaflex should remain on the market.

Menaflex is meant to repair a torn meniscus, which basically acts as a shock absorber for the knee. Menaflex was approved 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 several New Jersey Democrats – Sens. Frank Lautenberg and Robert Menendez, and Reps. Steve Rothman and Frank Pallone Jr. – contacted the FDA in 2007 and 2008 to encourage it to speed its review of the ReGen device. 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 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.

According to The Wall Street Journal, the FDA continues to have serious concerns about the Menaflex device. In documents released Friday, the FDA said ReGen hasn’t provided adequate data to show that Menaflex is safe, and the company didn’t completely follow FDA guidelines. “Overall, the FDA believes that [ReGen] did not provide adequate pre-clinical mechanical testing data to clearly demonstrate safety against mechanical failure,” the agency said.

In early testing, ReGen compared Menaflex to surgical meshes used to repair injuries to other parts of the body, the Journal said. The FDA is concerned about such comparisons because, for example, the weight stress on the shoulder is less than that on a person’s knee. The FDA said it also found it difficult to analyze some of ReGen’s data because it wasn’t presented according to recognized guidelines and didn’t follow certain study protocols.

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