In 2008, under intense pressure from Democrats on Capital Hill and lobbying by the company, FDA approved a ReGen Biologics Inc. (RGBO) knee implant against the advice of its scientific staff. FDA now plans on revoking the earlier approval given to the implant, but also plans on meeting with the company to see what further data will be required to prove the safety and efficacy of the implant.
FDA now concludes that the implant, Menaflex Collagen Scaffold, is not similar to the other devices on the market at present and should not have been eligible for fast track clearance. The implant was believed to have aimed at repairing and reinforcing a knee's meniscal tissue. Now, it has come to light that the Menaflex is also intended to stimulate the growth of new tissue as compared to repairing or reinforcing it. Over 50 patients in America have already had the device implanted. The FDA has asked these patients to contact their health care provider to see if any further steps have to be taken in the light of the new revelations.
ReGen CEO Gerald Bisbee stated that the device has been in use in Europe for the last 10 years without any complaints. He said that the company is now weighing its options after the FDA’s decision to withdraw the implant from the market.
Sen. Charles Grassley (R-Iowa) had received complaints from a group of FDA scientists as early as 2009 that Menaflex was one of several such decisions in which politics played a larger role than scientific views. Francesca Grifo of the Union of Concerned Scientists feels that the admission of guilt from the FDA is good news. She says that there is always tension between the businesses which have put thousands of dollars into the product up for approval and the scientists who have to prove its safety and efficacy before approving it.
