New research on the use of spinal cord stimulators to treat chronic pain has prompted calls for the use of the treatment to be reconsidered.
The paper published in the Medical Journal of Australia in July found one-in-three people are having revision surgery for complications that can end up costing hundreds of thousands of dollars.
The research looked at patterns of care, re-interventions, and costs of such treatments for private health insurers in Australia between 2011 and 2022.
Private Healthcare Australia, which represents health insurance funds, has called for the Australian government to ban the use of spinal cord stimulators for pain in light of the findings.
Spinal cord stimulators can be implanted along the spinal cord along with a pulse generator, which is usually implanted under the skin in the buttocks, and leads are implanted in the epidural space.
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While they are promoted as treatments for certain chronic pain conditions, multiple studies have cast doubt on whether spinal cord stimulation can treat chronic pain, including back pain, neck pain, nerve pain, and complex regional pain syndrome. There is also evidence they can cause harm.
Researchers examined data from five health insurers covering thousands of Australian patients.
They found about 35% had unplanned revision surgery within three years due to problems with the device.
The authors concluded: “Given the lack of supportive data for their efficacy, and a concerning harms profile, use of spinal cord stimulators for pain control should be reconsidered.”
However, advocacy body Painaustralia told Medical Forum the call to ban the therapy in such circumstances was an overreach.
A statement provided on behalf of the Painaustralia board said: “The authors presented the data in both historical and current cohorts and showed low levels of return to theatre in current therapy cohort suggesting technology/techniques have improved over time.
“Painaustralia advocates access to a broad range of therapies for pain patients so they can be used judiciously and appropriately.
“The call to ban the therapy made by the authors appears an overreach as under that policy, knee and hip replacement and pacemaker implant would need to be banned also.”
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Private Healthcare Australia chief executive Dr Rachel David said while the Therapeutic Goods Administration (TGA) last year cancelled the registration of some spinal cord stimulators and imposed conditions on others, they were still available and being used on patients.
“The regulatory action taken so far has been insufficient. Put simply, if these spinal cord stimulators were new technologies trying to get listed for Medicare funding in Australia, they would be deemed too dangerous,” she said.
“The Australian Government should ask the Medicare Services Advisory Committee to assess these devices and consider if they meet contemporary standards for listing.
“If not, the Medicare items and devices should be removed. This would protect patients from unnecessary harm and reduce wasteful expenditure for taxpayers and people with health insurance who are effectively being forced to fund this.”
Dr David said at least 90% of spinal cord stimulators were inserted in the private health sector.
“Australians should be confident they are receiving safe, high-quality, healthcare which is value for money,” she said.
The median cost to health insurers for a permanent device was nearly $56,000. Some patients’ treatment ended up costing more than $500,000, the authority said.
Dr David said there was “ample evidence” spinal cord stimulators can cause more harm than good for many people at a huge cost to them, Medicare and their health fund.
“They should be removed from the Medicare Benefits Schedule (MBS) and the Prescribed List of Medical Devices,” she added.
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