For anyone who has received treatment for their injuries from exercising or sports, you know the importance of getting proper medical care and you expect that whatever the doctors need to put inside you is safe. But what if a procedure done to you or device put inside you wasn’t properly approved by the medical community?
It looks like that is the case with an implant device called the Menaflex Collagen Scaffold from ReGen Biologics Inc. According to the Los Angeles Times, the device—used to repair and reinforce tissue that cushions and helps lubricate bones in the joint of the knee—had received fast-track approval in 2008 despite the objections of Food and Drug Administration scientists, who wanted more testing done on it.
How did it get approved so quickly? The FDA determined that the device was similar to those already on the market, which gave it the OK for a quick approval. It has also been used in Europe for the past decade in about 3,000 patients. FDA scientists, however, found enough differences that it warranted a full review, but were overruled.
But the approval may have been granted not based on safety or past usage, but from money. Four New Jersey Democrats—Senators Frank Lautenberg and Robert Menendez, and Representatives Steven Rothman, and Frank Pallone, Jr.—lobbied the FDA on behalf of ReGen Biologics. The company is based in Hackensack, N.J. Some of the scientists took their case to Senator Charles Grassley (R-Iowa) in 2009, which led to the FDA’s admission of error.
According to the Times, “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.”
The FDA has now acknowledged the error and will remove it from the market. It has been implanted in about 50 people in the U.S., and it was unlikely that they’d need the device removed (although they should still check with their doctors). ReGen Biologics may be able to reapply for approval.
If public safety can be compromised so easily, how much confidence should we have in our nation’s checks and balances? What do you think?
FDA admits error in fast approval of knee implant (Los Angeles Times)