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FDA admits mistake with knee device

The Food and Drug Administration Thursday took the highly unusual step of admitting that it made a mistake when it approved a device used to repair damaged knees.

The device, called Menaflex Collagen Scaffold, was approved by the FDA in December 2008 to repair and reinforce a part of the knee known as the "meniscus," which is a C-shaped disk that acts as a cushion between the ends of the bones in the joint and helps lubricate the joint.

The announcement follows a reevaluation of the scientific evidence for the device's approval that was launched after a September 2009 agency report identified problems in the agency's review of the device, including outside political pressure, the FDA said.



The Menaflex implant served to reinforce damaged or weakened tissue in the knee. (Regen Biologics)

"To correct this error, the agency will begin the process to rescind the product's marketing clearance," the agency said, adding that the FDA had asked the product's manufacturer, ReGen Biologics Inc.of Hackensack, N.J., to meet with the agency to discuss what data it would need to be convinced of the device's safety and effectiveness.

The company has the option of requesting a 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.

In a statement, ReGen Biologics Chairman and CEO Gerald E. Bisbee, Jr. said:

"ReGen received a letter today from the FDA stating that the agency is going to start proceedings to rescind the clearance of the company's Menaflex Collagen Meniscus Implant. In light of that information, the company is currently weighing its options. The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients and there has never been a safety issue associated with the device."

About 50 patients received the device in the United States, the company said.

FDA scientists had rejected ReGen's application for approval for Menaflex three times, citing concerns that patients might suffer adverse impacts or that the product would do little to help them heal from a torn meniscus. The company sought a fast-track approval that is given to products which are substantially similar to other products already on the market. But several FDA reviewers believed it was, in fact, a new product, which would have required extensive clinical trials proving safety and efficacy.

In late 2008, ReGen appealed to then-FDA Commissioner Andrew von Eschenbach, who ordered an expedited review by a panel of independent advisers and allowed ReGen input about the composition of the panel. The internal probe found that ReGen executives had unusual access to von Eschenbach and approval came after von Eschenbach met several times with members of the New Jersey congressional delegation. In December, von Eschenbach approved the company's application without any explanation for overruling the judgment of his staff.

"The FDA has now concluded that the Menaflex device is intended to be used for different purposes and is technologically dissimilar from devices already on the market," the FDA said. "These differences can affect the safety and effectiveness 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 tissue that was surgically removed. Because of these differences, the Menaflex device should not have been cleared by the agency."

Patients who received the device will probably not need to have it removed because it is resorbed and replaced with new tissue, but should talk with their doctor, the FDA said. The FDA has received two reports of adverse events in patients who received the device, officials said.

By Rob Stein  | October 14, 2010; 2:47 PM ET
Categories:  FDA, Food Safety and Recalls  
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Comments

The Menaflex controversy proved costly to FDA, which lost Dr. Robert Smith, former device reviewer, and Dr. Daniel Schultz, former director of Center for Devices and Radiological Health, who was fired by then recently installed FDA Commissioner Margaret Hamburg in August, 2009. [ Susan Heavey, FDA's Schultz resigns after meeting with commissioner, Reuters, August 11, 2009, at www.reuters.com/article/idUSN1154141520090811 ] Dr. Jeffrey E. Shuren, previously associate commissioner for policy and planning, was appointed interim CDRH director and has since become permanent durector.

In 2006 and 2007, two previous 510(k) "premarket notification" applications for the Menaflex product had been rejected. In 2008, Andrew von Eschenbach, outgoing FDA commissioner during the Walker Bush administration pressured Dr. Schultz into appointing a "special review" committee that excluded staff participating in the previous two reviews and included "sports medicine" physicians rather than orthopedic surgeons. [ Lauren Uzdienski, ReGen's 510(k) clearance under the microscope as WSJ, Orthopedic and Dental Industry News, March 5, 2009, at www.healthpointcapital.com/research/2009/03/05/regens_510k_clearance_under_the_microscope_at_the_wsj/ ]

There will probably be major legal issues of government liability for wrongdoing. The FDA has never before admitted to an error in approving a medical device. [ Gardiner Harris, FDA vows to revoke approval of device, New York Times, October 15, 2010, at www.nytimes.com/2010/10/15/health/policy/15fda.html ] After Dr. Schultz left, the CDRH began a tedious effort to review the 510(k) program. [ CDRH Preliminary Internal Evaluations, FDA Center for Devices and Radiological Health, U.S. Department of Health and Human Services, ongoing, at www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm ]

The FDA had turned to stimulating approvals of drugs and devices, disregarding its primary, statutory criteria for proof of safety (FD&C Act, 1938, following the "elixir of sulfanilamide" disaster) and effectiveness (Drug Efficacy or Kefauver-Harris Amendment, 1962, following a narrowly averted catastrophe with thalidomide). For Menaflex knee implants, former FDA Commissioner von Eschenbach stretched the standard totally out of shape. Cited predicate devices were meshes for shoulder surgery, which are not weight-bearing. [ FDA: ReGen's Menaflex data inadequate, Mass Device, March 27, 2010, at www.massdevice.com/news/fda-regens-menaflex-data-inadequate ]

Other agencies, notably the former Minerals Management Service, followed a similar path to corruption during the Walker Bush administration. Basic concerns from those incidents remain moral standards and sound judgements.

Posted by: AppDev | October 15, 2010 10:53 AM | Report abuse

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