Should The FDA Approve A Medical Device That Has Not Been Tested?

The short and troubled life of the DePuy ASR hip implant points to a larger more disturbing situation: a FDA implant oversight system that is malfunctioning almost as badly as the DePuy hips themselves.

The hip replacement systems in question are the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System, made by the DePuy Orthopaedics, Inc. DePuy, a subsidiary of Johnson & Johnson, recalled the implant in August 2010. About 93,000 of the devices have been implanted worldwide. Their failure rate is atrocious – about 13 percent (1 in 8) for the total replacement system, and 12 percent for the resurfacing system.

The problem arose because DePuy was not required to by the Food and Drug Administration to perform clinical trials of the ASR hips. As it stands now, manufacturers can sell implants without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients. This shortcut is allowed so that manufacturers can rapidly make minor changes to a device to improve it.

In an interview with ABC News, the highly-regarded cardiologist Dr. Steven Nissen explains.

“In my view, the regulatory system is failing. It’s failing because 98 percent of medical devices are being approved with this alternate pathway that doesn’t require inspection of facilities, doesn’t require a lot of clinical testing, it just requires that the device be similar to something else on the market.”

The problem is rooted in out-dated policy, Nissen said.

“That law, originally passed in 1976, was passed before we had all the modern implantable devices, the artificial hips and knees, and heart valves, and pacemakers and defibrillators,” he said. “And I think that the regulatory science has not kept up with the rapid pace of development of medical devices.”

So, should the FDA approve medical devices that have not been tested – even in the name of bringing improved technology to patients more quickly?

The story of the DePuy implant is a cautionary tale that gives us the answer.

The loophole that exists in the FDA policy invites abuse. There is ample evidence to indicate that DePuy knew about the problems with the ASR devices long before the recall.

• In late 2009, DePuy announced it phasing out the implants, claiming that the reason was slow sales.
• In March 2010, DePuy warned doctors that the implants might have a high failure rate.
• The director of Australia’s orthopedic database said he believed that DePuy had been less than forthright about the ASR. Data in that country, he said, showed that in 2008 the ASR was failing early at a rate higher than some competing devices.
• In the United States the first lawsuit filed against DePuy over the ASR implant was in March 2009, according to this report — nearly a year and a half before the device was recalled.

As persuasive as the claim may be that companies only want to expedite improvements on devices, sidestepping the testing process is a foolhardy practice. The FDA cannot approve devices without demanding and requiring sufficient clinical trials. Manufacturers cannot be left to monitor their own practices without oversight. The loophole must be closed. The DePuy ASR hip implant debacle is a prime example of why this must be done now.