By Liam Mannix
A $35,000 treatment at the forefront of medical technology which pumps electric pulses into the spine of patients with chronic back pain is leaving some incontinent, unable to walk or, in a few cases, dead.
An investigation by The Age and The Sydney Morning Herald reveals spinal cord stimulators, or the operations to install them, have led to 520 serious complications being reported to the Therapeutic Goods Administration, though manufacturers of the devices say the therapy is proven to be both safe and effective.
Adam Young with his spinal cord stimulator.Credit: Paul Harris
“These devices are expensive, invasive, are causing problems and are frequently being removed,” said Caitlin Jones, a University of Sydney researcher who this month published an analysis of complications linked to stimulators.
“The safety data is damning, especially given that we aren’t sure whether the treatment is effective. Using treatments where the efficacy is unclear, but where there are significant harms, is a perfect storm.”
Spinal cord stimulators are small computers wired into the nerves, spinal cord or brain, used mostly to treat back pain and chronic pain. The therapy is meant to work by using mild electric pulses to mask or interrupt pain signals before they reach the brain.
The number of Australians going in for the operation climbed from 1355 in 2008-09 to 4433 in 2016-17, and the fast-growing industry is projected to be worth $US5 billion ($A7 billion) globally in 2030.
Between July 2012 and January 2019, the Therapeutic Goods Administration received 520 reports of serious injuries linked to spinal cord stimulators. Seventy-nine per cent were severe and 13 per cent life-threatening, according to an analysis by Ms Jones. Some 83 per cent of events required surgery to correct.
The Age and Herald asked for comment from the major stimulator manufacturers. Only Boston Scientific replied, to say it stood behind the “safety, quality, and efficacy” of its devices, which were “backed by robust clinical trial data and real-world evidence”.
Nick Christelis, president of the Neuromodulation Society of Australia, says the devices come with only “minor risks”.
“Nowadays with the new technology, we can expect up to 80 per cent pain control or more,” Dr Christelis said.
Studies showing higher rates of complications were based on older devices, and anaesthesiologists were better at installing them now, he said.
“The complication rate is about one in 10 over the lifespan of the device, which could be anything from a little bit of discomfort to where the battery lies, to full-blown infection requiring removal.”
Adam Young received a stimulator to treat back pain caused by two prolapsed discs in his spine. The $40,000 device now lives in his cupboard.
“It’s just a big waste of time, and an absolute money grab,” he told The Age and Herald.
The scar on Adam Young’s backCredit: Paul Harris
“It was supposed to help me in all regards. And yet I couldn’t walk with it on. I couldn’t walk for 20 minutes. It felt like it was setting off other nerves as well. I tried to go to bed with it and I’d just toss and turn. No matter what setting I had it on. So I had to turn it off.
“Don’t do it. Exhaust every other avenue that’s possibly out there first.”
Michael Johnson, president of the Spine Society of Australia between 2018 and 2020, told The Age and Herald he was calling for the development of a spinal stimulation registry in Australia to monitor how well the devices were actually working, and how much harm they were causing.
“I think there are a moderate number of stimulators being put in inappropriately,” he said. “In the last year, I have operated on three people … and taken out a stimulator and thrown it in the bin. That’s a pretty substantial investment to just throw in the bin. And none of these people had received an opinion from a spinal surgeon.”
Lauren Iacobucci did receive good relief from her stimulator at first. But then, after a fall, she felt the electrodes come out of her spine.
“I had surgery to fix the leads, and then they became displaced again. A month after that surgery, I had another surgery to fix them again. And then the wound just wouldn’t heal. It just kept opening up and the leads would just pop through my skin.”
Mrs Iacobucci had six surgeries in total before she gave up and demanded the device be removed. “It was horrendous. I can’t describe it. It is only recently I’ve started processing what I went through.
“But don’t let my story put you off. I think it’s a rare occurrence. It could work really well for them, and be a really good option. But go into it, do your research because it’s not just a simple fix.”
‘Don’t do it. Exhaust every other avenue that’s possibly out there first.’
Adam Young
Mrs Iacobucci’s story is not uncommon, according to data obtained by The Age and Herald in response to a Freedom of Information application.
In America, spinal cord stimulators have the third-highest number of medical device injury reports made to the US Food and Drug Administration.
In Australia, device manufacturers are required to notify the TGA when serious adverse events occur and when it is suspected – but not certain - the injury was caused by the medical device or the operation to insert it. Some events may simply be random chance – a patient having a stroke during an operation, for example.
However, the true number of events may be much higher. A 2019 analysis by the TGA’s own medical device staff suggest just 0.5 per cent of all problems may end up being reported.
Among the complaints to the TGA, two patients lost use of their legs until the stimulator was removed and even then they only regained partial movement. Another lost feeling in their pelvis. Another had “arm weakness”; an MRI showed spinal damage. Another’s knees gave way; they fell, hit their head, and ended up in an induced coma.
An x-ray showing Lauren Iacobucci’s spinal cord stimulator in situ.
Some patients suffered from incontinence for long periods of time.
Others suffered tears and punctures to their spinal cord. Another suffered cerebrospinal fluid leakage. Another suffered a spinal cord tear which caused incontinence.
One patient developed infection at the surgery site, which caused multiple organ failure or sepsis, killing them. Another suffered a stroke due to spending a long time in the operating theatre, and died.
In addition, there were more-common side effects. These include overstimulation, constantly being shocked, the stimulation not working, device malfunction, headaches, infection, pain at the surgical site, or the leads detaching from the spine and moving around in the body or protruding through the skin.
Of the reported events, 296 were for device malfunctions, with movement of the electrode wires the most common problem; 83 per cent of problems required further surgery to fix. For every 10 stimulators implanted in Australia, four are removed.
Some patients chose to write directly to the TGA about their experiences.
“It shocked me painfully and uncontrollably until I struggled to reach my remote control to turn it off,” one patient wrote in a complaint to the TGA. If he had not been home with the remote, the device would have continued to cause him “torturous pain”.
The stimulator was removed by his surgeon, but the pain did not go away. A later X-ray showed the surgeon had left a lead in, which was now growing through his skin.
“The fact that the [device manufacturer] people showed no concern and made me feel like a worthless guinea pig leaves me with a feeling of hopelessness and helplessness as to my future and quality of life,” he wrote in the complaint. “Please help ASAP.”
“Since I have had it in, I have had six revisions,” another patient wrote. “Surely this can’t be right… All these procedures, the trauma and the pain. What am I to do? I don’t know who to talk to or get advice. Do I need legal advice?”
The Age and Herald supplied the database of TGA reports to Professor Christopher Maher, director of the Institute for Musculoskeletal Health and one of the world’s leading experts on back pain.
Professor Maher and a team of researchers, led by Ms Jones, published an analysis of the dataset in the Journal of Patient Safety this month.
Of the 520 events in the database, the team classified 93 per cent as serious or life-threatening. More than half were caused by the stimulator itself malfunctioning.
For every 100 stimulators inserted, 31 are later removed, the researchers noted.
Adam Young’s stimulator now lives in a cupboard.Credit: Paul Harris
How well they work – or whether they work at all – remains deeply controversial.
A 2021 Cochrane review – generally considered gold-standard evidence – concluded a stimulator probably did not provide clinically important improvements in pain compared to a placebo, although the overall evidence was of very-low-quality.
Stimulators are often implanted to help patients wean off opioids, but a study of more than half a million patients published in Anesthesiology in January found a negligible difference in opioid use over 12 months.
“People considering this procedure should be aware that while some people who receive a stimulator seem to experience substantial pain relief. We are currently very uncertain how much of that relief, if any, is provided by the specific technology and how much is the result of placebo effects,” said Dr Neil O’Connell, the Brunel University London researcher who led the Cochrane review.
A 2011 industry-funded study put the complication rate at 34 per cent. One patient in every 10 will have a lead move or fracture, typically requiring surgery to fix, the study found.
“Thirty per cent, for a reasonable human being, seems really high,” says Dr Chris Hayes, director of the Hunter Integrated Pain Service and a former dean of the Australian Faculty of Pain Medicine.
Early in his career, Dr Hayes regularly implanted spinal cord stimulators. He no longer performs the procedure.
“We decided the outcomes were not good. We were getting quite a few take-backs to theatre. Patient harm. With stimulators, it’s not that uncommon for the lead to move – then you have to take the patient back to theatre and put the lead back to where it’s meant to be.
“And these devices can be get infected. We found a reasonably high complication rate, even trying to be very careful.
“Maybe there is a place for stimulators, in very select patients. But we’re saying given the current evidence we’re not offering that treatment at this point in time.”
A spokeswoman for the TGA said that the reports of incidents associated with use of medical devices does not necessarily mean that the device was at fault and the cause of the incident.
“Spinal cord stimulators, used quite widely both in Australia and worldwide, are high-risk devices and are known to have complications associated with their use,” the spokeswoman said.
“The current information indicates that the safety and performance of these devices are acceptable. The TGA continues to monitor adverse event reports associated with these types of devices.”
After a class action in 2019, Johnson & Johnson was ordered to pay millions of dollars in compensation to Australian women affected by its defective pelvic mesh implants.
The TGA received 95 pelvic mesh failure complaints before that issue turned into a medical device regulation scandal, said Danny Vadasz, chief executive of the Health Issues Centre.
“Five hundred and twenty is a heck of a lot,” he said. “That’s enough for a class action.”
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