The Australian Government should ban the use of spinal cord stimulators for pain after research reveals one-in-three people are having revision surgery for complications that can end up costing hundreds of thousands of dollars.
In the Medical Journal of Australia, leading Australian doctors have called for spinal cord stimulators to no longer be used for the treatment of pain unless it is done as part of a randomised controlled trial with strict oversight and reporting of outcomes.
The researchers independently examined data from five health insurers covering thousands of Australian patients who had spinal cord stimulation procedures between 2011 and 2022. They found about 35% had unplanned revision surgery due to problems with the device. The median cost to health insurers for a permanent device was nearly $56,000. Some patients’ treatment ended up costing more than $500,000.
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 and there is evidence they can cause harm.
“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,” the researchers wrote in the journal.
Private Healthcare Australia, which represents health insurance funds and their 15 million members, backs the researchers’ calls for Australian patients to be protected from these devices.
PHA CEO 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 per cent 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. There is 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 said.
“Health funds are committed to continuing to fund evidence-based treatments which have demonstrated safety and efficacy in the treatment of chronic pain.”
Media contact: Julia Medew, 0402 011 438 or Andrea Petrie, 0412 655 264