The Food and Drug Administration has taken the unprecedented step of rescinding approval of a patch used in knee surgeries after admitting it had succumbed to political pressure in approving it.

The patch, called Menaflex Collagen Scaffold and marketed by New Jersey-based ReGen Biologics, received FDA approval in 2008 for repairing and reinforcing the meniscal tissue in the knee. However, in a surprising mea culpa, the FDA announced that the device “should not have been cleared for marketing in the United States” and that the agency would start the process of revoking its marketing clearance.

The controversy over FDA approval of Menaflex and other medical devices erupted early last year, when a group of scientists complained to Congress and the Obama administration that they had been pressured by their superiors to approve potentially unsafe devices. Menaflex was approved in 2008 over objections from FDA scientific reviewers, after the agency was pressured to green-light the device by a group of New Jersey lawmakers, including Democratic Senators Frank R. Lautenberg and Robert Menendez.

A report released by the FDA a year ago found that despite the repeated and unanimous recommendations from the agency’s scientific reviewers not to approve Menaflex, they had been inappropriately overruled by agency managers and then-commissioner Dr. Andrew C. von Eschenbach.

The New York Times reports that the controversy marks a number of firsts for the FDA: the first time it has admitted to approving a drug or device mistakenly; the first time it has rescinded such an approval based on anything other than new information about the product; the first time it has admitted that politics influenced a regulatory decisions; and the first time it has accused a former commissioner of questionable conduct.

In a statement to the Times, the chairman and chief executive of ReGen, Gerald E. Bisbee Jr., noted that the product “has been approved and in use successfully in Europe for nearly 10 years” and that “there has never been a safety issue associated with the device.” ReGen can reapply to sell the product, but must provide convincing evidence that the product is safe and effective.

In its announcement Thursday, the FDA said removing Menaflex from patients with knee implants is probably unnecessary since the device is absorbed by the body.

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