Banning Defective Medical Devices: Report Raises Questions About Whether FDA is Doing Enough to Protect People

November 24, 2010, by Michael A. DeMayo

A new report published in BMJ, a British medical journal, is questioning the US Food and Drug Administration’s ability to keep defective and dangerous medical devices out of the market. The paper contends that inadequate manpower, an insufficient budget, lack of authority, and the agency’s co-opting by special interests, medical devices makers, and political forces are rendering the FDA unable to do its job to protect the public.

The authors of the study, Dartmouth Institute for Health Policy and Clinical Practice instructor Shannon Brownlee and medical investigative journalist Jeanne Lenzer, talk about the deficiencies in the FDA’s post-approval surveillance process. For example, since the agency approved the vagus nerve stimulator (VNS) by Cyberonics 13 years ago, there have been reports of approximately 900 deaths involving people that used the medical device. The FDA still does not know what caused these fatalities or if a VNS even was a cause of death. Some 60,000 people are currently using a VNS, which is designed for treating epilepsy and is also approved treating depression. Cyberonics is seeking to widen the approval for VNS so that it can be used for treating traumatic brain injury, stroke, and obesity.

Recently, the FDA took back its approval of the Menaflex Collagen scaffold knee replacement device. The agency admitted that it approved the medical device without properly researching it because of political pressure and the flexible requirements that exist to fast-track certain devices. Under the 510(k) program, new medical devices can be approved quickly if their makers can show that the product works in the same that other medical devices currently in the market do.

In August, DePuy Orthopaedics recalled about 93,000 artificial hips over concerns that the medical devices had a 12 – 13% failure rate. Metal particles from the implants have also been known to cause cobalt toxicity.

Our Charlotte, North Carolina defective medical device lawyers know that it can be very upsetting to discover that you or your loved one developed health issues or now have to undergo yet another medical procedure because the manufacturer of your medical device was negligent.

Is the FDA doing its job?, Washington Post, November 3, 2010

Why the FDA can’t protect the public, BMJ, November 2010

FDA Determines Knee Device Should Not Have Been Cleared for Marketing, FDA, October 14, 2010

DePuy ASR Hip Replacement Products Recalled, North Carolina Injury Lawyer Blog, September 16, 2010

Related Web Resources:
US Food and Drug Administration

VNS Therapy, Cyberonics

 
 

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