FDA Rescinds Approval of Menaflex Knee Replacement Device
The FDA has rescinded approval for the Menaflex Collagen Scaffold knee replacement, saying that the orthopedic implant was incorrectly fast-tracked for approval without being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.
3 comments
Two almost diametric problems facing the FDA:
On the one hand, due to the difficulty as well as complexity of health and medical drugs and devices — in addition to the sheer number of cases the FDA has to review per year — it is moving seemingly at snail’s pace, even on sometimes highly promising drugs and devices by small companies.
On the other, it seems like there really is a lot of pressure on the top management folks at the FDA (as well as at agencies like the SEC) to allow offical decision makers to expedite, or okay, products churned out by well connected companies. The top management of the agency, after all, are there or have moved to their position, due to favorable appointment history at the FDA or at other similar/federal agencies… favorable appointments made possible due to like-minded folks in powerful business and political circles.
It need not be immediate quid pro quo situations; but if you have strong business and/or political connection, and you also have the appropriate credentials, regardless of where your ideological stance is on most things, you can move up pretty fast, in whatever field you are, in some areas with the federal government.
Complex and diametric problems regulatory agencies like the SEC, the FDA, etc. have to deal with.
I guess the better question would be, if there has been no problem with the menaflex product in patients, why is the decision to rescind justified?
This all sounds to suspicious and is a way for the FDA to prove they will not be pushed around, if in fact that is how it really played out politically… The whole point of a product is to help people and that what it seems to be doing??
I believe I am suffering with a severe reaction to a knee replacement I had nearly 2 years ago. Most Doctors won’t even discuss it with me including the one who put it in. Who do I go to?