If You’re Considering a Spinal Cord Stimulator for Pain, This New Report Is a Must-Read

Spinal cord stimulators are often suggested to patients as a treatment for chronic pain. Since the device was first approved by the U.S. Food and Drug Administration in 1989, it’s been used to treat thousands of people. But a new report, called the Implant Files, sheds light on the troubling number of injuries that have been attributed to spinal cord stimulators in the last 10 years and lack of regulation of the device by the FDA.

The report, published Sunday by the International Consortium of Investigative Journalists (ICIJ) after a year-long investigation, looked at the FDA’s data on implantable medical devices from 2008 to 2017. They found that of all medical devices, spinal cord stimulators caused the third-highest number of injuries, after metal hip replacements and insulin pumps. More than 80,000 spinal cord stimulator injuries were flagged during that time period, and 500 deaths of people with the device were reported (though the report couldn’t determine if the stimulator was directly related to the death).

While some patients find spinal cord stimulators to be successful in minimizing their pain, others reported being shocked and burned by the device, experiencing additional nerve damage and needing to have the device removed, which can be a risky procedure in itself.

Spinal cord stimulators work by delivering a low-voltage electric current to the spine, blocking pain signals that go to the brain. The FDA does not reveal how many devices are implanted in the U.S. each year, but the American Association of Neurological Surgeons reports that as many as 50,000 neurostimulators are implanted worldwide each year.

The investigation noted that part of the problem is the FDA’s process for approving medical devices. The review process is quick and does not subject the device to much scrutiny. Devices are rarely pulled from the market even when there are problems.

“Regulators often don’t require large-scale human trials for devices like they do for prescription drugs. As a result, authorities have allowed faulty devices to come onto the market, where they have lingered for years even as injuries mount,” the ISIJ found.

In April, the FDA published a “Medical Device Safety Action Plan” detailing upcoming efforts to improve the safety of medical devices. It announced additional changes on Nov. 20, including a new reporting system that will provide real-time data on any problems with medical devices. This will replace the current system which relies on patients, doctors and manufacturers to report their own issues to the FDA. However, the FDA claimed the timing of the report and their plans was coincidental. On Tuesday, an FDA spokesperson said they “didn’t even know about” the investigation until October.

For those who are considering getting a medical device, the ISIJ put together a list of questions to ask your doctor and what to research, as well as a database you can use to search for any recalls, safety alerts and field safety notices issued for a device.