The investigation also found that the FDA - considered by other countries to be the gold standard in medical device oversight - puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products. The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade. Reporters analyzed millions of medical records, recall notices and other safety warnings, in addition to interviewing doctors, patients, researchers and whistleblowers. The AP reported on spinal stimulators as part of a nearly yearlong joint investigation of the global medical devices industry that included NBC News, the International Consortium of Investigative Journalists and more than 50 other media partners around the world. Most of these devices have been approved by the FDA with little clinical testing, however, and the agency's data shows that stimulators have a disproportionately higher number of injuries compared to hip implants, which are more plentiful. Medical device manufacturers insist spinal-cord stimulators are safe - some 60,000 are implanted annually - and doctors who specialize in these surgeries say they have helped reduce pain for many patients. Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports. Patients report they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows. They account for the third-highest number of medical device injury reports to the Food and Drug Administration, with more than 80,000 incidents flagged since 2008. and as a treatment for an aging population in need of pain relief.īut the stimulators - devices that use electrical currents to block pain signals before they reach the brain - are more dangerous than many patients know, an AP investigation found. Companies and doctors push them as a safe antidote to the opioid crisis in the U.S. 'But look at me.'įor years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. 'I thought I would have a wonderful life,' Taft said. Today, the 45-year-old Taft is virtually paralyzed, barely able to get to the bathroom by himself. After an operation to repair it, he said, the device shocked him so many times that he couldn't sleep and even fell down a flight of stairs.

Taft's stimulator failed soon after it was surgically implanted.

Dorsal column stimulator limitations