FDA admits error in fast approval of knee implant

The Food and Drug Administration acknowledged Thursday that it made a mistake in overruling its scientists and approving a knee implant after the agency was lobbied by four members of Congress.

The FDA said in a statement that it would seek to remove the device from the market, but also would meet with the company that makes it, ReGen Biologics Inc. of Hackensack, N.J., to see if there is a process through which they could apply again for approval for the implant.

The device, called a Menaflex Collagen Scaffold, was approved by the FDA in December 2008 to repair and reinforce the meniscus, a C-shaped disc of tissue that cushions and helps lubricate bones in the knee joint.

The approval came over the objections of FDA scientific staff, who said the device offered little benefit over existing treatments.

In evaluating the device, FDA incorrectly determined that Menaflex was technologically similar to other devices already on the market, making it eligible for fast-track approval. But FDA scientists said the Menaflex device had substantial differences and should have been subjected to a full review of its effectiveness and safety.


ReGen Chief Executive Gerald Bisbee said in a statement that the company “is currently weighing its options” in light of the FDA decision.

The Menaflex device has been used in Europe for about 10 years with about 3,000 patients and “there has never been a safety issue associated with the device,” Bisbee said.

The device has been implanted in about 50 people in the United States, a company spokeswoman said.

Four New Jersey Democrats — Sens. Frank R. Lautenberg and Robert Menendez and Reps. Steven R. Rothman and Frank Pallone Jr. — lobbied FDA administrators on behalf of ReGen.

In early 2009, a group of FDA scientists complained to Sen. Charles E. Grassley (R- Iowa) that the Menaflex approval was one of several in which politics won over scientific decision-making.

In a September 2009 review of its handling of the matter, the FDA stated that several employees “describe the ReGen matter as among the worst experiences of their professional careers because of … pressure on agency decision-makers” from members of Congress, lobbyists and “from FDA leadership — in particular the FDA commissioner” Andrew von Eschenbach.

FDA’s admission of error “is very good news,” said Francesca Grifo of the Union of Concerned Scientists. “There’s an inherent tension between businesses with millions of dollars on the line and FDA scientists seeking to determine if a product is safe and effective. Every time FDA overrules its own scientists, it’s an issue.”

The FDA announcement said that it was “unlikely” that people using the Menaflex device would need to have it removed, but recommended that they check with their doctors.