Perspective

FDA reverses clearance of collagen meniscal implant

Device maker ReGen Biologics took exception to the plans by the FDA’s Center for Devices and Radiological Health (CDRH) to rescind 510(k) clearance for Menaflex.

The FDA announced October 14 it is rescinding its December 2008 510(k) clearance of the Menaflex collagen meniscal implant manufactured by ReGen Biologics Inc. (Hackensack, N.J.,) following an in-depth re-evaluation of the scientific evidence.

ReGen Biologics Chairman and CEO Gerald E. Bisbee Jr., PhD, stated in a press release issued the day of the announcement, “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.”

FDA’s re-evaluation process followed a September 2009 agency report that identified problems with the agency’s review of the device and called for a “second look” at the scientific data for the implant, according to an FDA press release. As a result, the FDA now concludes the device is intended to be used for different purposes and is technologically dissimilar from devices already on the market, what it calls predicate devices. These differences can affect the safety and effectiveness of the collagen implant, the agency noted.

In recent months approval of the Menaflex implant came under fire from Sen. Charles E. Grassley (R, Iowa) and was the focus of a special FDA orthopedic advisory committee meeting in March at which experts reviewed scientific evidence for the device, which has been used worldwide to repair and reinforce meniscal tissue in the knee.

Reactions

Bisbee said in a second ReGen press release on the topic that politics, not science drove FDA’s latest decision. “For CDRH [Center for Devices and Radiological Health] to arrive at the decision that the device has a new intended use 4 years after two senior CDRH officials informed the company that the device could be reviewed through the 510(k) program is totally unbelievable,” he stated. “Even more incredible is that they arrived at that conclusion after the second Orthopedic Advisory Panel of independent experts chosen by FDA was specifically asked about the intended use of the device and confirmed that it functioned like predicates.”

Champ L. Baker, Jr, MD, FACS
Champ L. Baker, Jr.

Those reacting to the announcement included Champ L. Baker, Jr, MD, FACS, of the Hughston Clinic, in Columbus, Ga., and Menaflex inventor and ReGen co-founder, Kevin R. Stone, MD, of the Stone Clinic, in San Francisco.

Baker, who has researched and used the implant, told Orthopedics Today, “I’m sorry the Menaflex seemed to have gotten embroiled in a political battle. I am convinced that the implant is safe and I felt it was efficacious. However now that it is no longer available, those patients will either have to accept their meniscus loss or some can be operated on with meniscus transplants.”

According to Stone, who is not directly involved with the device, said “The FDA-company sequence of events was a tragedy for everyone involved, particularly for patients. There is no other alternative for meniscus reconstruction.”

Departures noted

In addition to information that came out when FDA announced its decision to rescind approval of the Menaflex device, the agency identified in a September 2009 report and its addenda several of its departures from processes and practices that occurred over the years during CDRH’s review of the ReGen device.

As reported, those departures included:

  • FDA took at face value ReGen officials’ complaints of unfair treatment without a full investigation;
  • New Jersey politicians reportedly influenced how the FDA approached the product’s review;
  • a full scientific review of the scaffold may never have been conducted;
  • ReGen had atypical access to two FDA officials, the commissioner and principal deputy commissioner, during meetings with the FDA; and
  • prior to the November 2008 orthopedic panel meeting, the commissioner pressed for rapidly convening the panel and in a procedural irregularity reviewed the panel’s constitution.

Process to begin

To correct these errors, FDA said it will begin for the first time ever a process to rescind the product’s marketing clearance, and has asked to meet with ReGen Biologics officials before that time, to discuss the appropriate marketing pathway for the device and what data the agency would need to provide a reasonable assurance of safety and effectiveness.

Based on information in the FDA release, explantations of Menaflex devices in U.S. patients will unlikely be necessary since the device is resorbed and replaced with new tissue. However, the FDA said patients treated with the device should discuss the situation and what steps should be taken with their surgeon or another health care professional.

Rescission clarified

A rescission is an FDA action to revoke marketing clearance later determined to be erroneous. After it is implemented, the manufacturer is prohibited from further marketing the device in United States until the agency approves or clears it under a new 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, according to the FDA release.

The circumstances surrounding the Menaflex device are unique, and the FDA’s decision in this case does not impact the status of other products on the market, the agency noted.

In Baker’s opinion, reversing clearance of the Menaflex device is based not on the product’s merits, but on how it was presented. “No evidence was ever presented that it wasn’t safe,” he said.

“The company and the FDA both failed in their ability to deliver a safe technology to the marketplace,” Stone told Orthopedics Today. “The company, by following an inadequate testing and FDA strategy, and the FDA. by failing to leave the product on the market given that there has never been a safety issue. It should have, in my view, required a post-market surveillance study to determine the product’s efficacy.”

Stone has followed his original patients who received his collagen meniscus implant for more than 15 years and they are doing well, he said. He noted he used the Menaflex implant in a number of patients successfully since the FDA approved it. – by Susan M. Rapp

References:

  • Champ Baker, Jr., MD, FACS, can be reached at 6262 Veterans Parkway, Columbus, GA 31908; 706-324-6661; e-mail: cbaker@hughston.com. Baker is former advisory board member for and received travel expenses and miscellaneous support from ReGen Biologics.
  • Kevin R. Stone, MD, can be reached at 3727 Buchanan St., San Francisco, CA 94123; 415-563-3110; e-mail: kstonemd@stoneclinic.com. As the company co-founder, Stone retains some founder’s shares of ReGen Biologics stock. As the company co-founder, Stone retains some founder’s shares of ReGen Biologics stock.

Perspective

I think the FDA is making a statement that they will not be prey to external influences. Menaflex is an index case whereby the FDA is raising the bar on its 510(k) process. ReGen may appeal this, and there is no cause for the public to be alarmed as safety was never a real issue.

– John D. Kelly IV, MD
University of Pennsylvania, Department of Sports Medicine Philadelphia, Pa.

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Device maker ReGen Biologics took exception to the plans by the FDA’s Center for Devices and Radiological Health (CDRH) to rescind 510(k) clearance for Menaflex.

The FDA announced October 14 it is rescinding its December 2008 510(k) clearance of the Menaflex collagen meniscal implant manufactured by ReGen Biologics Inc. (Hackensack, N.J.,) following an in-depth re-evaluation of the scientific evidence.

ReGen Biologics Chairman and CEO Gerald E. Bisbee Jr., PhD, stated in a press release issued the day of the announcement, “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.”

FDA’s re-evaluation process followed a September 2009 agency report that identified problems with the agency’s review of the device and called for a “second look” at the scientific data for the implant, according to an FDA press release. As a result, the FDA now concludes the device is intended to be used for different purposes and is technologically dissimilar from devices already on the market, what it calls predicate devices. These differences can affect the safety and effectiveness of the collagen implant, the agency noted.

In recent months approval of the Menaflex implant came under fire from Sen. Charles E. Grassley (R, Iowa) and was the focus of a special FDA orthopedic advisory committee meeting in March at which experts reviewed scientific evidence for the device, which has been used worldwide to repair and reinforce meniscal tissue in the knee.

Reactions

Bisbee said in a second ReGen press release on the topic that politics, not science drove FDA’s latest decision. “For CDRH [Center for Devices and Radiological Health] to arrive at the decision that the device has a new intended use 4 years after two senior CDRH officials informed the company that the device could be reviewed through the 510(k) program is totally unbelievable,” he stated. “Even more incredible is that they arrived at that conclusion after the second Orthopedic Advisory Panel of independent experts chosen by FDA was specifically asked about the intended use of the device and confirmed that it functioned like predicates.”

Champ L. Baker, Jr, MD, FACS
Champ L. Baker, Jr.

Those reacting to the announcement included Champ L. Baker, Jr, MD, FACS, of the Hughston Clinic, in Columbus, Ga., and Menaflex inventor and ReGen co-founder, Kevin R. Stone, MD, of the Stone Clinic, in San Francisco.

Baker, who has researched and used the implant, told Orthopedics Today, “I’m sorry the Menaflex seemed to have gotten embroiled in a political battle. I am convinced that the implant is safe and I felt it was efficacious. However now that it is no longer available, those patients will either have to accept their meniscus loss or some can be operated on with meniscus transplants.”

According to Stone, who is not directly involved with the device, said “The FDA-company sequence of events was a tragedy for everyone involved, particularly for patients. There is no other alternative for meniscus reconstruction.”

Departures noted

In addition to information that came out when FDA announced its decision to rescind approval of the Menaflex device, the agency identified in a September 2009 report and its addenda several of its departures from processes and practices that occurred over the years during CDRH’s review of the ReGen device.

As reported, those departures included:

  • FDA took at face value ReGen officials’ complaints of unfair treatment without a full investigation;
  • New Jersey politicians reportedly influenced how the FDA approached the product’s review;
  • a full scientific review of the scaffold may never have been conducted;
  • ReGen had atypical access to two FDA officials, the commissioner and principal deputy commissioner, during meetings with the FDA; and
  • prior to the November 2008 orthopedic panel meeting, the commissioner pressed for rapidly convening the panel and in a procedural irregularity reviewed the panel’s constitution.

Process to begin

To correct these errors, FDA said it will begin for the first time ever a process to rescind the product’s marketing clearance, and has asked to meet with ReGen Biologics officials before that time, to discuss the appropriate marketing pathway for the device and what data the agency would need to provide a reasonable assurance of safety and effectiveness.

Based on information in the FDA release, explantations of Menaflex devices in U.S. patients will unlikely be necessary since the device is resorbed and replaced with new tissue. However, the FDA said patients treated with the device should discuss the situation and what steps should be taken with their surgeon or another health care professional.

Rescission clarified

A rescission is an FDA action to revoke marketing clearance later determined to be erroneous. After it is implemented, the manufacturer is prohibited from further marketing the device in United States until the agency approves or clears it under a new 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, according to the FDA release.

The circumstances surrounding the Menaflex device are unique, and the FDA’s decision in this case does not impact the status of other products on the market, the agency noted.

In Baker’s opinion, reversing clearance of the Menaflex device is based not on the product’s merits, but on how it was presented. “No evidence was ever presented that it wasn’t safe,” he said.

“The company and the FDA both failed in their ability to deliver a safe technology to the marketplace,” Stone told Orthopedics Today. “The company, by following an inadequate testing and FDA strategy, and the FDA. by failing to leave the product on the market given that there has never been a safety issue. It should have, in my view, required a post-market surveillance study to determine the product’s efficacy.”

Stone has followed his original patients who received his collagen meniscus implant for more than 15 years and they are doing well, he said. He noted he used the Menaflex implant in a number of patients successfully since the FDA approved it. – by Susan M. Rapp

References:

  • Champ Baker, Jr., MD, FACS, can be reached at 6262 Veterans Parkway, Columbus, GA 31908; 706-324-6661; e-mail: cbaker@hughston.com. Baker is former advisory board member for and received travel expenses and miscellaneous support from ReGen Biologics.
  • Kevin R. Stone, MD, can be reached at 3727 Buchanan St., San Francisco, CA 94123; 415-563-3110; e-mail: kstonemd@stoneclinic.com. As the company co-founder, Stone retains some founder’s shares of ReGen Biologics stock. As the company co-founder, Stone retains some founder’s shares of ReGen Biologics stock.

Perspective

I think the FDA is making a statement that they will not be prey to external influences. Menaflex is an index case whereby the FDA is raising the bar on its 510(k) process. ReGen may appeal this, and there is no cause for the public to be alarmed as safety was never a real issue.

– John D. Kelly IV, MD
University of Pennsylvania, Department of Sports Medicine Philadelphia, Pa.

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