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FDA Acknowledges Mistakes in Knee-Device Approval

Last Updated: September 25, 2009.

Agency says it will review procedure for endorsing medical devices.

By Steven Reinberg
HealthDay Reporter

THURSDAY, Sept. 24 (HealthDay News) -- The U.S. Food and Drug Administration violated procedures last year when it approved a knee repair device even though its own scientists recommended against approval, agency officials said Thursday.

The device, called Menaflex, is made by New Jersey-based ReGen Biologics and is used to help surgically repair knee damage -- specifically, damage to the meniscus. But, a report released by the agency Thursday found that some FDA scientists had recommended against approval.

"There were numerous departures from processes, procedures and practices, and there were problems with the review process for the device," Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said during an afternoon teleconference.

In addition, the FDA report noted that four New Jersey Democratic lawmakers -- Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman -- made inquiries to agency officials about the device's approval status.

"Members of the delegation apparently had conversations with the [FDA] commissioner and at least one conversation with the [former] principal deputy commissioner," the report said.

Going forward, the FDA plans to review the process by which such medical devices are approved, Sharfstein said. "It will also include a reevaluation of the clearance of this device," he said.

However, there are no plans to remove the Menaflex device from the market, officials said.

"This device has been approved by the FDA, and we have no basis to question the safety of this device so it will remain on the market," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said during the teleconference.

"What we have concluded is that the integrity of our process for reaching a decision was compromised in this case, so we are revisiting and evaluating the record and the bases for making that decision," he said.

Sharfstein said that consumers should not worry if they have a Menaflex device.

He also said the FDA is looking to refine a procedure that would mediate differences among agency personnel when approving medical devices.

On Wednesday, responding to criticism of its safety review record, the FDA asked the U.S. Institute of Medicine to examine the approval process for certain medical devices. Specifically, the institute will look at an approval process called a 510k review procedure. This allows companies to immediately introduce products similar to ones already on the market. Menaflex was approved under this process, according to the FDA.

The 510k process is supposed to speed up approval of medical devices such as wheelchairs and bandages, but it has also been used to approve devices such as heart implants and hip replacements.

More information

The U.S. Food and Drug Administration has more on medical device approval.

SOURCES: Sept. 24, 2009, teleconference with Joshua Sharfstein, M.D., principal deputy commissioner, U.S. Food and Drug Administration, and Jeffrey Shuren, M.D., acting director, Center for Devices and Radiological Health, FDA


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