The FDA has rescinded approval for the Menaflex Collagen Scaffold knee replacement, saying that the orthopedic implant was incorrectly fast-tracked for approval without being appropriately vetted by the agency’s researchers.
The agency is planning to issue a Menaflex knee implant recall until ReGen Biologics Inc., the manufacturer, can receive approval for its collagen scaffold through the correct approval process.
According to an FDA press release issued on Thursday, the agency was told that the Menaflex Collagen Scaffold was very similar to previous medical devices that are implanted into the knee to repair and reinforce the meniscal tissue. However, the FDA has now determined that the knee implant actually replaces tissue and stimulates new growth, and should never have gone through the agency’s controversial 510(k) approval process.
The 510(k) program allows quick approval of new medical devices if their manufacturers can show that they are functionally equivalent to devices already on the market. However critics say that the standards of the program, and the definition of “functionally equivalent” have strayed over time.
In the case of the Menaflex Collagen Scaffold knee, FDA officials say it should have never been submitted as a 510(k) candidate in the first place. The FDA announced that before a Menaflex Collagen Scaffold knee recall is sent out, agency officials will try to meet with ReGen Biologic and determine the appropriate pathway toward medical device approval and determine how ReGen can assure the that the devices are both safe and effective.
The FDA began to review the Menaflex approval process in September 2009, after the agency was questioned whether the device’s approval was the result of outside pressure. According to the FDA, the administrative record on the device’s approval did not dispel concerns over whether the agency had been unduly influenced in its decision.
As a result of this incident and other concerns, the FDA has proposed a more stringent application of the 510(k) process.
A study by the Government Accountability Office (GAO) released in June 2009 found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.