10/14/10 The U.S. Food and Drug Administration, or FDA, said today that it made a mistake when it ignored the advice of its own scientific advisors and allowed the sale of a device called the Menaflex Collagen Scaffold, which is designed to repair damaged knee cartilage.
To correct the error, the agency said it would begin the process to rescind the product’s marketing clearance.
“In light of that information, the company is currently weighing its options,” said Gerald E. Bisbee, Jr., PhD, Chairman and CEO of ReGen Biologics, in a prepared statement. “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.”
Dick Thompson, a spokesman for the FDA, said it was extremely rare for a device to lose its marketing clearance. “From what I’ve seen, it’s happened fewer than 10 times,” Thompson said.
The Menaflex device is a C-shaped implant designed to act as a scaffold to support the growth of new tissue to replace damaged cartilage in the knee that’s been surgically removed.
In December 2008, despite unfavorable reviews by scientific experts, the FDA approved the device for sale in the United States under political pressure from four congressmen, as well as one of its own commissioners.
A clinical trial of the device found that it failed to work any better than routine surgery, and in reviewing the implant’s safety record, a panel of experts commissioned by the FDA noted that patients who received the Menaflex faced an “unduly lengthy recovery period” of six months and adverse events that included second surgeries.
In a press release, the FDA said it probably would not be necessary for patients to have these implants removed because they are designed to be reabsorbed by the body.
According to the FDA statement, “patients who have had the Menaflex device implanted should talk with their surgeon or other health care professional about what, if any, steps should be taken.”
Seems like somebody would investigate this.
An FDA report called pressure from four New Jersey Democrats — Sens. Robert Menendez and Frank Lautenberg and Reps. Frank Pallone Jr. and Steven Rothman, all of whom received "significant" campaign contributions from New Jersey-based ReGen, according to the New York Times — extreme, unusual and persistent and said it helped lead agency managers to overrule the agency's scientists.
http://www.massdevice.com/news/fda-regens-menaflex-our-bad
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