Spinal Cord Stimulators Sometimes Cause More Harm Than Good
Medical device companies and physicians have long indicated spinal cord stimulators are the answer for millions of patients suffering from a number of pain-inducing disorders, making them one of the fastest-growing products the industry. The stimulators are complex devices which send electrical currents through wires, using a battery implanted under the skin and an external remote. They are said to be a safe antidote to the opioid crisis and a viable treatment option for an aging population experiencing chronic pain. Howeer, sometimes they cause more harm than good.
These devices account for the third-highest number of medical device injury reports to the Food and Drug Administration (FDA), with more than 80,000 incidents reported in the past decade. Stimulators can cause patients to be shocked or burned or suffer from spinal cord nerve damage. Only metal hip replacements and insulin pumps have more injuries reported in the same period of time.
The FDA data contains more than 500 reports of people with spinal cord stimulators who have died. Yet, nearly 60,000 are implanted annually. Most of have been approved by the FDA without much clinical testing. The FDA acknowledges data limitations, including mistakes, omissions, and under-reporting.
“There are over 190,000 different devices on the U.S. market. We approve or clear about a dozen new or modified devices every single business day,” Dr. Jeffrey Shuren, the FDA’s medical device director said. “The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn’t say that the system is failing. It’s remarkable that the system is working as it does.”
However, the FDA is now saying it’s taking new action to create “a more robust medical device safety net for patients through better data.” The agency added, “Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market.”
Some patients swear by their spinal stimulators. Pete Corby, who injured his back working as a movie stuntman, said a spinal cord stimulator helped him deal with his constant pain and stop using opioids. “This is the greatest thing that saved my life, literally saved my life,” said Corby, saying much of his pain was eliminated entirely.
Companies have “invested countless resources — both capital and human — in developing leading-edge compliance programs,” said Janet Trunzo, head of technology and regulatory affairs for AdvaMed, the industry’s main trade association designed to ensure products are safe and effective.
Yet, physicians continue to be bribed to illegally promote products for unapproved uses and taut the safety and effectiveness of products, and some doctors promote spinal cord stimulators without disclosing to patients they’ve received money from medical device manufacturers. And many patients say their stimulators cause debilitating symptoms and they have regretted their decision.
Jim Taft’s stimulator failed soon after it was implanted. He had a follow-up operation to repair it and afterwards, he said, the device shocked him so many times that he couldn’t sleep and even fell down a flight of stairs. Today he is nearly paralyzed, unable to perform basic everyday functions without assistance.
“This is my death sentence,” Taft said. “I’ll die here.”
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