BMJ investigation raises concerns about the post-approval surveillance of medical devices
The report by Jeanne Lenzer, a medical investigative journalist in New York, and Shannon Brownlee from the Dartmouth Institute for Health Policy and Clinical Practice in New Hampshire, looks at the FDA's approval of a device to prevent or reduce seizures in patients with epilepsy who do not respond to drug treatment.
The device, manufactured by Cyberonics, is implanted under the skin and sends electrical impulses to stimulate the vagus nerve in the neck. It was approved by the FDA in 1997 on the condition that Cyberonics carried out a post-approval study to examine the ...






