FDA says Menaflex shouldn't have been cleared
October 14, 2010
by Brendon Nafziger, DOTmed News Associate Editor
The U.S. Food and Drug Administration said Thursday it should never have cleared a controversial collagen meniscus implant and was moving to pull marketing clearance.
The agency said it was rescinding clearance for the implant, called Menaflex Collagen Scaffold, manufactured by ReGen Biologics Inc., because it did not resemble similar devices on the market, as required by the 510(k) process it was submitted under.
The implant, designed to repair and reinforce meniscal tissue in the knee, was cleared in December 2008 by the agency. But an internal review last year uncovered problems in the clearance process, including nearly "unprecedented" outside pressure on the agency.
The September 2009 report noted heavy pressure from some members of Congress, which the director of the agency's office of legislation called "the most extreme he had seen" in his career.
"Several interviewees, including individuals with 30 years of experience with the FDA, describe the ReGen matter as among the worst experiences in their professional careers, in large part because of the chaotic sense created by persistent pressure on agency decision-makers and processes," the report said.
The FDA's review was prompted by a March 2008 Wall Street Journal article revealing how politicians lobbied to approve the device and how the product was cleared despite objections from some of the scientific reviewers who did not think it resembled other products on the market, as required by the 510(k) rules.
Controversy surrounding the device spurred investigations into the 510(k) process itself, a so-called "fast-track" process for clearing lower-risk devices. This summer, the FDA proposed reforms to the process, and last year, it commissioned a $1.3 million review of the process by the Institute of Medicine.
Pulling from market could take time
Although the FDA announced its plans to pull the device's marketing clearance, the action, known as a rescission, could "take some time," Dick Thompson, an FDA spokesman, told DOTmed News. "There has to be a panel appointed. It can be done relatively quickly, but it could take as long as a year."
For patients who have the device implanted, the agency said it's unlikely that removing the device is necessary, but they should talk to their surgeon or doctor.
Hackensack, N.J.-based ReGen responded to the FDA notice by saying it was currently "weighing its options" but defended Menaflex's safety profile.
"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," ReGen Chairman and CEO Gerald E. Bisbee, Jr. said in a statement e-mailed to DOTmed News.
The agency said it was rescinding clearance for the implant, called Menaflex Collagen Scaffold, manufactured by ReGen Biologics Inc., because it did not resemble similar devices on the market, as required by the 510(k) process it was submitted under.
The implant, designed to repair and reinforce meniscal tissue in the knee, was cleared in December 2008 by the agency. But an internal review last year uncovered problems in the clearance process, including nearly "unprecedented" outside pressure on the agency.
The September 2009 report noted heavy pressure from some members of Congress, which the director of the agency's office of legislation called "the most extreme he had seen" in his career.
"Several interviewees, including individuals with 30 years of experience with the FDA, describe the ReGen matter as among the worst experiences in their professional careers, in large part because of the chaotic sense created by persistent pressure on agency decision-makers and processes," the report said.
The FDA's review was prompted by a March 2008 Wall Street Journal article revealing how politicians lobbied to approve the device and how the product was cleared despite objections from some of the scientific reviewers who did not think it resembled other products on the market, as required by the 510(k) rules.
Controversy surrounding the device spurred investigations into the 510(k) process itself, a so-called "fast-track" process for clearing lower-risk devices. This summer, the FDA proposed reforms to the process, and last year, it commissioned a $1.3 million review of the process by the Institute of Medicine.
Pulling from market could take time
Although the FDA announced its plans to pull the device's marketing clearance, the action, known as a rescission, could "take some time," Dick Thompson, an FDA spokesman, told DOTmed News. "There has to be a panel appointed. It can be done relatively quickly, but it could take as long as a year."
For patients who have the device implanted, the agency said it's unlikely that removing the device is necessary, but they should talk to their surgeon or doctor.
Hackensack, N.J.-based ReGen responded to the FDA notice by saying it was currently "weighing its options" but defended Menaflex's safety profile.
"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," ReGen Chairman and CEO Gerald E. Bisbee, Jr. said in a statement e-mailed to DOTmed News.