An orthopedic device for the repair and reinforcement of the meniscal tissue in the knee, the Menaflex Collagen Scaffold, should not have been approved, the FDA (Food and Drug Administration) now admits, after a re-evaluation of the product. In September 2009 the FDA informs that problems with the product’s review were identified. To address this mistake, the FDA says it will start the process of rescinding* the knee device’s marketing clearance. Staff from ReGen Biologics Inc., the makers and marketers of the Menaflex Collagen Scaffold, have been asked to meet FDA officers to discuss “the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness.“

* To Rescind (v), A Rescission (n) – FDA action to revoke a marketing clearance later determined to be erroneous. (Source: FDA)

The Menaflex Collagen Scaffold was approved in December 2008, even though agency scientists and managers had objected. It appears, according to a report a year ago, that extreme pressure from Capitol Hill and company lobbyists influenced the fast-tracking decisions of the device. The FDA is now acknowledging the report.

In a communiqué, the FDA writes:

The September 2009 report recommended a scientific re-evaluation of the device because the administrative record did not supply a basis for the FDA’s December 2008 decision to clear that was adequate to dispel questions about the role of outside pressures on the review process. This re-evaluation, initiated in the fall of 2009, included a team of scientists at the agency who were not involved in previous reviews of the device. Another advisory committee meeting was also held in March 2010.

The FDA has said it now believes that the Menaflex Collagen Scaffold device is not very similar to other devices already on the market for the repair and reinforcement of the meniscal tissue in the knee – in fact, the device is not intended for that purpose, but for another one, the agency wrote. Using the device for this purpose may affect its safety and efficacy. The Menaflex knee device is designed to trigger the development of new tissue to replace surgically removed tissue, rather than just reinforcing or repairing damaged tissue, the FDA added. For this reason, the device should not have been approved for that purpose.

The FDA says it was told that the Menaflex Collagen Scaffold was very similar to other devices for the purpose for which it was eventually approved – implantation into the knee to repair and reinforce the meniscal tissue.

The agency advises patients who have had the device implanted to talk to their doctors. However, it is improbable that taking the device out is appropriate – it is reabsorbed and replaced with new tissue.

When a rescission is implemented, the manufacturer cannot market that product in the USA until the FDA has approved or cleared a new marketing application, or granted a classification petition.

The FDA also wrote:

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

Synopsys

  • The Menaflex Collagen Scaffold knee device was incorrectly fast-tracked for approval without being properly checked by the FDA’s researchers.
  • It appears outside political and commercial pressure may have influenced the FDA’s initial decision to approve the product.
  • The device, which makes the body replace tissue that has been surgically removed, was erroneously approved for another purpose, to strengthen and repair existing tissue that has been damaged.
  • Therefore the FDA is going to cancel the approval for the device.

As a result of some incidents, including this one, the FDA has proposed a more rigorous application of the 510(k) process. The 510(k) process allows for fast-tracking a device (speeding up approval) if it can be shown to be the same or very similar to other devices on the market for the same treatment. There have been several observations, comments and even complaints about the lax nature of the present system.

Source: FDA, Medical News Today (archives)

Written by Christian Nordvist