Report Challenges FDA Oversight of Medical Devices

Report challenges FDA oversight of medical devicesA recent report in the British Medical Journal calls into question the U.S. Food and Drug Administration's (FDA) post-approval surveillance method of monitoring the safety and effectiveness of medical devices.

The report focuses on a medical device known as a vagus nerve stimulator (VNS), which was manufactured by Cyberonics to reduce seizures in epileptic patients.

During the approval process, questions were raised about a high death rate in epileptics being treated with VNS. Cyberonics denied that the medical device contributed to the deaths, and explained the deaths as being caused by "bad epilepsy," according to the report.

The FDA reportedly proceeded to approve the VNS for use, conditional on the manufacturer submitting to the FDA a post-approval report on the device's safety and links to mortality.

The BMJ report argues that in the 13 years since the device's approval, there is still no clear evidence about what impact the VNS has on patient mortality. Conclusive, large-sample studies can rarely be conducted for medical devices, so the FDA mainly relies on post-approval data, according to the report. 

The database the FDA uses, the report argues, is not comprehensive and the data within it can only send a vague signal to the FDA about the safety of a medical device.