Life-changing or too risky? Debate on spinal cord stimulators touches a nerve as experts call for ban

For years, Vietnam veteran Bill Sanday suffered constant pain in his lower back, unable to use a shovel or even bend down easily. About six months ago, the Australind man had a spinal cord stimulator surgically implanted to deliver electrical impulses to block pain. Now finally free of chronic pain, he is able to continue his travels around Australia in a caravan. But the treatment that helped him to live normally again is becoming increasingly controversial, with critics claiming spinal cord stimulators are risky and could cause more harm than good. Private Healthcare Australia called for a ban on the devices after a recent study found one in three people were having follow-up surgery because of complications. The Medical Technology Association of Australia — which represents companies selling the devices — hit back by accusing private health insurers of trying to save costs by depriving patients of an effective treatment. Mr Sanday believes a ban would be unfair for others enduring the same sort of pain that he lived with for so long. “I had tried the procedure where they burned the end of the nerves, and it worked, but only for about a month,” he said. After a successful trial before surgery, he went ahead and had the device implanted. “It’s been a 100 per cent success,” he said. “It means that I can bend down without hurting my back. “The only thing that you get is tingling up the back of your legs … after a couple of days I got used to it, and don’t even notice it.” Around 1200 privately-insured Australian patients turn to spinal cord stimulators — which cost between $15,000 and $25,000 — to target chronic pain each year. MTAA chief executive Ian Burgess argued the devices could be “life changing” for the small group of patients who relied on them, providing pain relief, better quality of life and reducing their need for opioids medication. “Attempts by private health insurers to undermine SCS are a cruel effort to deny Australians living with chronic pain access to a demonstrably safe and effective therapy, driven by a desire to protect their record profits,” he said. “Spinal cord stimulation has been in use for more than 50 years, and the overwhelming evidence, both from clinical trials and real-world outcomes, supports its effectiveness for managing chronic pain.” Mr Burgess said the MTAA had concerns about the evidentiary basis for recent publications, such as a Medical Journal of Australia article which found 35 per cent of patients had unplanned revision surgery between 2011 and 2022 because of problems with the device. But Private Healthcare Australia chief executive Rachel David said there was now a significant amount of credible research showing spinal cord stimulators could cause more harm than good, with people reporting positive outcomes experiencing a placebo effect. She said the researchers who wrote the recent MJA paper were world-leading doctors specialising in evidence-based medicine. “Who is more trustworthy here — the medical device companies making billions of dollars a year or the academics trying to make healthcare safer for Australians?” she said. “Our main concern is patient safety. People living with chronic pain are vulnerable and desperately seeking effective treatments to get on with their lives. “These people deserve to know the truth about surgical interventions that could cause them significant physical, psychological and financial pain for highly questionable gain. “Our secondary concern is that taxpayers, via Medicare and people investing in health insurance, are also paying for these procedures which can cost more than $500,000 for people with complications.” Australian personal injury law firm GMP Law is investigating a potential class action against spinal cord stimulator manufacturers, based on reports of severe complications. Victorian Ken Doutch, who had a second device implanted two years ago after the first failed to work, said he believed they “should never have been invented”. “I was getting little electric shocks most of the time,” he said. “They’re no longer in my back.” The Therapeutic Goods Administration, which regulates medical devices, received 3135 reports of adverse events relating to SCS devices between July 2012 and August this year. They range from the device not working properly, to leads moving or becoming disconnected, increased pain, numbness, infection and electric shocks. A spokesperson for the TGA said it completed a review of spinal cord stimulators in December. “The evidence reviewed by the TGA indicates that for some people, the benefits of these devices continue to outweigh the risks,” they said. “SCS devices are generally used in complex chronic pain scenarios and are often used as a last line of treatment. The use of any implantable medical device should occur after discussion between a patient and their treating healthcare professional.” Former biomedical scientist Kaleena de Voigt said calls to ban the devices altogether were “disappointing”, though she believed there should be better controls on which specialists could implant them. The Queensland mum was taking so many painkillers to cope with nerve damage, caused by a 2019 operation, that she was falling asleep on her keyboard at work and took her meals through a feeding tube. Ms de Voigt said the device had reduced her pain levels by about 85 per cent and allowed her to live normally again, including going camping, boating and riding motorbikes with her children. “I was basically either sitting in a couch or lying in bed,” she said. “I can play my musical instruments now, whereas before I couldn’t stand and hold a saxophone or sit for any long period of time in front of the piano because I was just in too much pain.” “I think that a lot of people that could have had such a better quality of life — if the doors are closed on them and they don’t have that as an option — I think that’s really sad.” Sydney-based pain specialist Marc Russo, who has worked in the field for more than 25 years, said spinal cord stimulation was used to treat nerve pain that failed to respond to any other treatment and had been shown to help four out of five patients long term. Dr Russo said a busy pain clinic might see only one or two patients a month — out of hundreds — for which the device might be suitable and it would be “an awful tragedy” if they could no longer be helped. “The products have undergone multiple reviews by the appropriate government agencies,” he said. “We should be looking at the totality of evidence to determine the appropriateness of therapy and ensuring clinical diligence.” Chronic Pain Australia chair Nicolette Ellis said as debate around spinal cord stimulators intensified, it was understandable that people living with pain felt caught between conflicting claims from groups with vested interests. She encouraged people to seek second opinions, take time to understand risks and explore non-invasive options first. “Many people have contacted us reporting serious harms from spinal cord stimulators, including worsening pain and loss of function,” she said. “Some have even compared their experience to the pelvic mesh issue and are now raising concerns with their local MPs and the TGA. At the same time, a small minority have shared positive outcomes, and both perspectives matter.”