REPORT: IMPLANTED SPINAL CORD STIMULATORS FOR PAIN RELIEF

Public Citizen – June 10, 2020 – Michael A. Carome, M.D. – IMPLANTED SPINAL CORD STIMULATORS FOR PAIN RELIEF – Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Device

Executive Summary

For years, numerous commentators and patient safety advocates, including Public Citizen, have criticized the Food and Drug Administration’s (FDA’s) dangerously lax regulatory oversight of medical devices. The goals of this report, which was prompted by concerns about the safety of implanted spinal cord stimulators for pain relief that were raised in a 2018 Associated Press investigation by Weiss and Mohr,1 were to better understand the history of the FDA’s regulatory oversight of these devices, identify the deficiencies in this oversight that endangered patients, and recommend necessary changes to address those deficiencies.

Madris Tomes, Device Events Founder & CEO, was a contributor to the report providing adverse events metrics.

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