ReGen Biologics has sharply declined an FDA offer of a hearing regarding the agency's attempts to rescind approval of the Menaflex collagen meniscus implant. Menaflex is a resorbable surgical mesh used in meniscus surgeries to reinforce damaged or weakened meniscal soft tissues. It was cleared in December 2008 after a three-year review under the 510(k) process; however, this clearance came even though the device often failed and required second operations, as Mass Device notes.
Last October, the FDA announced that the implant shouldn't have been cleared for marketing. That determination came several months after an FDA panel determined there isn't enough scientific evidence to come to a firm conclusion about Menaflex's benefits.
But company Chair and CEO Gerald Bisbee, Jr., hasn't been sitting quietly by. In a statement, he maintains the company's experience with the FDA over the past six years makes it clear the hearing would be futile. "The safety and effectiveness issues surrounding the clearance of our device were settled years ago at a November 14, 2008 Advisory Panel meeting. The independent experts on that Panel were completely in Menaflex's favor," he said. "The only issues that require remediation are the blatantly arbitrary and unfair processes of the FDA, and those aren't on the table in a Part 16 review. Enough is enough."
Bisbee questions the FDA's reasoning behind re-reviewing the device. In early 2010, following a change in top management at the FDA, CDRH Director Jeffery Shuren justified the re-review by citing a September 2009 FDA report,"Review of the ReGen Menaflex: Departures from Process, Procedures and Practices Leave the Basis for a Review Decision in Question." In the report, the agency goes as far as to admit that there were "multiple departures" from standard procedures during the 17-year review history of the device. The agency also admitted that it was unable to counter accusations that lobbying on behalf of ReGen had affected its decision. Four New Jersey congressmen and former commissioner Andrew von Eschenbach reportedly had lobbied on behalf of the device.
ReGen sent a letter to FDA Commissioner Margaret Hamburg that it said provided a detailed analysis stating the report "...contains inaccuracies, misrepresentations, speculation and bias, and omits material information...The extent and depth of these irregularities raise the question of whether the preliminary report was intended to discuss the results of the agency's internal investigation or instead provide support for a foregone conclusion, i.e., a re-examination of the Menaflex device 510(k) clearance." Bisbee maintains Hamburg has yet to respond to a request in this letter to correct or retract the errors in the report as required by law.
In a last slap at the FDA, ReGen says by opting out of the hearing, it has put the agency on notice that it will seek an unbiased review of Menaflex's approval status under U.S. law. "We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage," says Bisbee. "After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA's administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients."
- get ReGen's release
- see the Mass Device report