Teresa Burbery had barely opened her eyes, but she knew something was wrong.

It was September 2021, and she says her pain specialist was standing over her in hospital saying the same words over and over.

When she moved, her left leg felt like concrete. Then the pain kicked in.

“I just started screaming in pain,” the 40-year-old says.

“I said to them, ‘This is not my normal pain … Something is very wrong.'”

Teresa had undergone a minor procedure at a private hospital in Brisbane to ease pain in her right hip.

Previously a keen runner, she became one of the more than 3 million people in Australia living with chronic pain after a bike accident five years earlier.

After trying several treatments, she visited a new clinic.

Teresa says the pain specialist — who would go on to operate on her — recommended a spinal cord stimulator at the first consultation.

“I heard that and I thought, ‘my god, that’s life-changing. That’s me being able to go running again,'” Teresa says.

How spinal cord stimulators work

A spinal cord stimulator, or “SCS”, is a small medical device that can be recommended for patients with back pain.

They are surgically inserted near a patient’s spinal cord to send electrical impulses into it using leads, and block pain signals going to the brain.

Thousands of people in Australia have them implanted each year — and some say they work.

They are advertised as safe and effective, and social media boasts success stories from both doctors and patients.

But for the past six months, a Four Corners investigation has been examining how the devices have caused some people harm.

Teresa is just one of hundreds of patients who have experienced complications.

Her ordeal during surgery meant the device was not implanted, and what should have been a minor procedure turned into a six-week hospital stay.

She was left with paralysis in her leg and has since required the use of a wheelchair.

“Nobody tells you that paralysis means you won’t feel anything. You won’t feel any temperature … no touch, but all you’ll feel is pain,” she says.

“You’ll lose control of your proper bowel functions … bladder function, you’ll lose sexual function. Those things are all gone. Where is that in the warnings?”

Teresa was supplied with material outlining the risks of the stimulator surgery but says her specialist downplayed them.

She says she is now in more pain than before the surgery, requiring three times the amount of painkillers.

Malfunctioning devices

Others who have had the devices successfully implanted have gone on to suffer serious complications.

The Therapeutic Goods Administration (TGA), which regulates medical devices in Australia, runs a database that tracks harmful and negative patient outcomes.

It told Four Corners it has received around 2,000 reports of adverse events relating to spinal cord stimulators since 2012. They range from infections to recurring shocks, brain haemorrhage and paralysis — but the TGA notes the reports are not conclusive.

After a workplace accident left him with back pain, Gordon Myers got his first stimulator in 2013.

“The first thing that I noticed was the thing was heating up inside me when I was charging [the device]. It was giving me ‘electric’ shocks,” says the 65-year-old from Victoria.

Then it got worse.

Over the next few years, Gordon had revision surgery to fix complications with the device and had one replaced.

“I feel like a lab rat. ‘If this doesn’t work, well, we’ll try this … That didn’t work, then we’ll go a bit more invasive,” he says.

Four Corners has obtained exclusive data that shows how frequently stimulators cause patients to need further surgery.

Private Healthcare Australia CEO Rachel David looked at data from six private health insurance funds covering nearly 6,000 patients who had a stimulator over a 10-year period.

She said within three years, 41 per cent of them required some form of reintervention.

“If you compare that to another common orthopaedic procedure … which is hip replacement, over a three-year period we’d only expect 2.7 per cent to come back for further surgery,” she says.

Following Four Corners’ investigation, Private Healthcare Australia is now calling for “the immediate recall and suspension of spinal cord stimulators to protect public safety”, pending a review by the TGA.

The TGA launched a post-market review into spinal cord stimulators in 2022, but the results are yet to be published.

“Australians should be confident they are receiving safe, high-quality health care,” Dr David said in a statement.

“We’ve seen the devastating impact of harmful surgery on Australians through the recent high-profile scandals involving use of hernia mesh for pelvic organ prolapse and metal-on-metal hip implants … We need urgent action to protect Australians with back pain from a similar experience.”

Health Minister Mark Butler said he was “deeply concerned” by what was revealed by Four Corners and has asked his department to investigate. He also requested an urgent update on the TGA’s review.

“All options are on the table to ensure that medical devices are properly regulated,” he said.

Gordon had his stimulator removed in 2018, five years after getting his first.

He’s still in pain.

“It’s every day. I don’t know when that pain’s going to hit me. I get a lot of tingling down my spine, right down my feet,” he says.

“When it gets really bad, my body feels as though I’m having tremors.”

‘No better than a placebo’

The effectiveness of spinal cord stimulators has been questioned by some leading health practitioners.

Orthopaedic surgeon Professor Ian Harris co-authored a research paper on them last year and says they lack credible scientific evidence as a treatment for chronic back pain.

“They’re probably not better than a placebo procedure … [and] we don’t have good evidence on the rate of complications or just how dangerous they are.”

Medical device companies disagree.

In a statement to Four Corners, the Medical Technology Association of Australia said, “SCS has demonstrated the ability to produce clinically meaningful pain relief, improve quality of life and significantly reduce the need for medication usage in individuals suffering with chronic pain”.

“We firmly stand behind the evidence that supports the availability of SCS for Australians with chronic pain.”

Spinal cord stimulator procedures are largely done in private hospitals where they can cost more than $50,000 per procedure.

Chris Hayes, a Sydney-based pain specialist, says it is “big business” given so many people experience chronic pain.

“That then becomes a big market potentially for pharmaceutical companies and implanted device companies,” he says.

Dr Hayes stopped offering stimulators to patients years ago.

“I found that people were just not making good improvements,” he says.

Jason Parker has given up on the pain industry after having 10 stimulator-related procedures over four years.

Since an accident in July 2010 damaged his back, he was trapped in treatments that included spinal fusion, opioids and stimulators.

Between getting his first stimulator in 2019 until he got it removed last year, he suffered oozing stitches, wounds and crippling pain.

It cost his private health insurance fund more than $200,000.

“A lot of people are making an awful lot of money out of people’s misery,” the 57-year-old from the Gold Coast says.

Jason also became a double amputee after contracting an infection unrelated to the stimulator.

He says his life improved when he chose to have the stimulator taken out.

“My desire was to live with colour and joy that had all been removed by the spinal cord stimulator, the opioids, the nerve pain, the injections, the steroids, everything else.”

He is still in pain but says he’s learned to live and understand how his body deals with it.

Impacts not being reported

Four Corners also uncovered under-reporting of adverse impacts of stimulators in the TGA’s database, which Health Minister Mr Butler described as “shocking” claims.

“I’ve asked this to be investigated and I will take the strongest possible action if this is occurring,” he said.

One of the biggest device companies, Medtronic, had fewer than 10 adverse events listed over a decade.

According to data from private health funds analysed by Private Health Australia, the reporting should have been higher.

“We looked at 764 Medtronic stimulators that were implanted,” Dr David says.

“And of those, 30 per cent were revised or required some sort of premature surgical intervention to reset them within the first three years, which would be either that the device was replaced, or a lead was replaced.”

Australian sponsors of medical devices are legally required to report adverse events to the TGA. The TGA told Four Corners it has never taken any action against sponsors for failing to report an adverse event relating to spinal cord stimulators.

In a statement, Medtronic said safety is its “highest priority” and it complies with all relevant TGA requirements for adverse event reporting.

“Medtronic does not believe there has been under-reporting of adverse events related to SCS by Medtronic,” it said.

“A revision procedure does not always equate to an adverse event, nor does it indicate that the device was not working as intended.”

In a statement, the TGA said it initiated its review of the devices in 2022 in response to concerns being raised and it is working promptly to finalise it.

“The scope of our review includes complaints and adverse events reported, current risk assessment and risk management documentation from companies who supply these devices, and all clinical evidence held that demonstrates continued safety and performance of the devices,” it said.

“Any patient concerned with a medical device is encouraged to report any adverse event or near (potential) adverse event to the TGA, including where an incident involves a healthcare professional.”

Teresa says she’s had to rebuild her world after her experience.

“Every day I wake up and the first thing I see is my chair … and then I recognise the pain.”

She believes it is important to speak out about the risks of pain treatments.

“When I encounter people out in public and they straight up ask me, ‘what happened to you?’, I feel a sense of responsibility to share with them the full story,” she says.

“But I’m also absolutely terrified to tell them that a doctor did this. A doctor did this to me.”

Watch Four Corners: Pain Factory, tonight from 8.30pm on ABC TV and ABC iview.     

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