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Wednesday, May 22, 2024 | Back issues
Courthouse News Service Courthouse News Service

FDA Ducks Suit on Ban of Controversial Knee Aid

WASHINGTON (CN) - A federal judge backed the Food and Drug Administration's rejection of a controversial implant that it disavowed after a brief period of approval.

The makers of collagen scaffold have been trying to push the medical device through the FDA for more than 16 years as a treatment for meniscus injuries.

Though doctors typically treat meniscus injuries by surgically repairing the meniscus or removing damaged portions, collagen scaffold could be surgically implanted into a patient's knee to reinforce the damaged tissue.

The meniscus is the padding of tissue between the knee bones that distributes body weight, preventing damage to the underlying articular cartilage.

ReGen began clinical research of the device in 1997, and sought approval from the FDA in 2004, claiming its product was "a resorbable collagen-based surgical mesh" that "serves to reinforce and repair soft tissue. It claimed collagen scaffold was the equivalent to other surgical mesh products that have FDA approval.

The agency rejected the product, stating that the company failed to demonstrate that the device was as safe and effective as legally marketed devices.

After three years of reapplying, and letters from both New Jersey Senators in support of collagen scaffold, the FDA flipped its position and approved it.

ReGen began selling the devices in 2009, but came under scrutiny later that year after a newspaper article accused the FDA of having succumbed to political lobbying.

Both Congress and the FDA opened an investigation into the claim.

"We understand that you may be reexamining the decision to approve this device for marketing," members of the House Committee on Energy and Commerce wrote to the FDA in May 2009. "Given the questions raised by FDA scientists about the lack of data on the safety and efficacy of this device, we believe this is a prudent course of action."

The FDA admitted its mistake and rescinded its approval of collagen scaffold in March 2011.

This action sent ReGen into bankruptcy, and its successor, Ivy Sports Medicine, quickly sued Health and Human Services Department head Kathleen Sebelius under the Administrative Procedure Act.

U.S. District Judge Robert Wilkins sided with the government Wednesday, ruling that the FDA invoked its proper authority in rescinding its approval of collagen scaffolding. Wilkins found that the agency did so in a timely manner and that it properly evaluated the product based on its intended use.

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