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.

In the US recently in states such as California, there have been legal innovations to aid in the legalization of medically prescribed marijuana that can be given to those suffering from excessive chronic pain. As a result companies similar to Greenbox and medically licensed dispensaries have been able to provide services to those with prescriptions that make taking this alternative medication easier.

In other countries, people have been heading down different paths when it comes to pain relief options. For example, CBD oil from has become popular as an option for those suffering from spinal, and other, injuries in the UK. Blessed CBD and other providers of these products have their work cut out in the US, however, where manual devices hold a larger market share.

Still, with the status quo as it is, it is very much worthwhile for us to investigate these devices, to see if they are able to provide the pain relief that they are touted to accomplish. If they do work, then the “lax” oversight is justified. If they do not, then there may be a push towards alternative options opening onto mass markets.

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

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