Report: Implanted Spinal Cord Stimulators for Pain Relief – Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Devices

View report as PDF

View press release

View cover letter to the FDA as PDF

View cover letter to U.S. House of Representatives’ Energy & Commerce Committee as PDF

View cover letter to the U.S. Senate’s Committee on Health, Education, Labor & Pensions as PDF

View cover letter to the U.S. Senate’s Permanent Subcommittee on Investigations of the Committee on Homeland Security and Governmental Affairs as PDF

In a report delivered to the Commissioner of the Food and Drug Administration (FDA) and key congressional committees, Public Citizen documented the FDA’s dangerously lax regulatory oversight of high-risk implanted spinal cord stimulators for pain relief, which has resulted in unnecessary harm to patients. The FDA’s regulatory oversight of implanted spinal cord stimulators for pain relief has had serious, wide-ranging deficiencies for several decades and is emblematic of what’s wrong with the agency’s oversight of medical devices.

June 25, 2020, FDA response letter.

See Public Citizen’s other work on medical devices.