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FDA Failing to Monitor Safety of Medical Devices: Report
Date:11/3/2010

By Steven Reinberg
HealthDay Reporter

TUESDAY, Nov. 2 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) is not doing its job of properly monitoring the safety of medical devices, the authors of a new report charge.

The FDA has the authority to approve both drugs and medical devices, but the investigators believe that the division responsible for device approval and safety is lax in both its initial approval of devices and its ongoing monitoring of related problems.

"The agency often misses problematic devices," contends lead author Shannon Brownlee, an instructor at the Dartmouth Institute for Health Policy and Clinical Practice.

The report is published in the Nov. 3 online edition of the BMJ.

In their article, Brownlee and New York-based medical investigative journalist Jeanne Lenzer focus on the FDA's approval and follow-up of a device that prevents or reduces seizures in patients with epilepsy who don't respond to drug treatment.

This apparatus, called a vagus nerve stimulator (VNS) is made by Texas-based Cyberonics. The VNS, which is implanted under the skin, works by sending electrical impulses to stimulate the vagus nerve in the neck.

The FDA approved the device in 1997 and some 60,000 patients around the world are using it, according to the manufacturer. In 2005, the FDA also okayed the device as a treatment for medication-resistant depression. There are some 5,000 people who use VNS to treat depression, Cyberonics says.

Brownlee and Lenzer's concern: That during the 13 years the device has been on the market there have been 900 FDA-reported deaths of people using the device to control their epilepsy.

The question of whether any of these deaths were due to the device remains unanswered, however, even though Cyberonics did conduct the post-marketing study the FDA requested at the time of approval. However, the FDA did not require the study to rep
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