Most of these devices have been approved by the FDA with little clinical testing, however, and the agency's data shows that spinal-cord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far 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 of their patients. The FDA data contains more than 500 reports of people with spinal-cord stimulators who died, but details are scant, making it difficult to determine if the deaths were related to the stimulator or implant surgery. 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 that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows. Food and Drug Administration, with more than 80,000 incidents flagged since 2008. They account for the third-highest number of medical device injury reports to the U.S. and as a treatment for an aging population in need of chronic 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 Associated Press investigation found. Companies and doctors aggressively push them as a safe antidote to the deadly 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, a prisoner in his own bed, 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. It wouldn't fix the nerve damage in his mangled right arm, Taft and his wife recalled the doctor saying, but a spinal-cord stimulator would cloak his pain, making him "good as new."
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