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Entries in Vague Nerve Stimulator (1)

Wednesday
Nov032010

Report Calls FDA Monitoring 'Problematic'

Photo Courtesy - Getty Images(NEW YORK) -- A new report suggests that the Food and Drug Administration (FDA) is not doing an adequate job of monitoring the safety of medical devices, according to HealthDay.

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

Brownlee joined New York-based investigative journalist Jeanne Lenzer in an article that focused on the FDA's approval and follow-up monitoring of a device that prevents or reduces seizures in patients with epilepsy.

The article claimed that the FDA did not require the manufacturer of the Vague Nerve Stimulator (VNS) to report the cause of death in patients using the device.

According to the report, over 900 deaths have been reported by the FDA in patients who had the device implanted in the 13 years it has been on the market. 

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