Knee Device Approval to be Rescinded

The US Food and Drug Administration (FDA) just announced that <"">ReGen Biologic’s Menaflex Collagen Scaffold, an orthopedic device used in the knee, should not have been cleared for marketing in the United States. The announcement follows a re-evaluation of the scientific evidence undertaken after a September 2009 agency report identified problems in the agency’s review of the device.

To correct this error, the agency will begin the process to rescind the product’s marketing clearance. Before beginning this process, the FDA has asked the product’s manufacturer, ReGen Biologics Inc., to meet with it to discuss appropriate marketing and what data it would need to provide a reasonable assurance of safety and efficacy.

The Menaflex Collagen Scaffold was cleared for marketing by the FDA in December 2008 for the repair and reinforcement of the meniscal tissue in the knee. The meniscus is a C-shaped disk of fibrocartilage that acts as a cushion between the ends of bones in the joint and also helps lubricate the joint.

The device 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—so-called predicate devices. 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 September 2009 report recommended a scientific re-evaluation of the device because the administrative record did not supply a basis for the FDA’s December 2008 decision to clear that was adequate to dispel questions about the role of outside pressures on the review process. This re-evaluation, initiated in the fall of 2009, included a team of scientists at the agency not involved in previous reviews. Another advisory committee meeting was also held in March 2010.

The FDA now concludes that the Menaflex device is meant for different purposes and is technologically dissimilar from predicate devices. These differences can affect the safety and efficacy of the Menaflex device. For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace surgically removed tissue. Because of these differences, the Menaflex device should not have been cleared by the agency.

It’s unlikely that explanting—surgically removing—the device will generally be appropriate or necessary because it is resorbed and replaced with new tissue; however, patients implanted with the Menaflex device should talk to their health care professional about what, if any, steps should be taken.

A rescission is an FDA action to revoke a marketing clearance later determined to be erroneous and, after implementing a rescission, the FDA prohibits the manufacturer from further US marketing until the agency approves or clears a new marketing application, or grants a classification petition. After the FDA issues a rescission notice, a manufacturer has the option of requesting a regulatory hearing with the FDA or can choose to voluntarily withdraw their marketing clearance. The device will remain on the market until the agency rescinds its clearance.

We previously wrote that 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.

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