The health insurance peak body has called for an immediate recall and TGA investigation, while Pain Australia has called for calm.
Private Healthcare Australia has called for an immediate recall and suspension of the use of spinal cord stimulators pending an investigation by the TGA.
As reported by our sister publication The Medical Republic in October, spinal cord stimulation for low back pain is risky, and the scant data on the procedure “does not support its use” in clinical settings.
Monday’s Four Corners episode quoted PHA CEO Dr Rachel David saying the PHA had submitted data from 5852 patients over a 10-year period to 2021 for academic review.
“This found 27% required surgical reintervention within one year and 41% within three years. This compares with a three-year revision rate of 2.7% for hips and 2.4 % for knee replacements,” she said.
At least 90% of installations of these devices happen in the private health sector, she said.
“These devices were introduced to the Australian market decades ago in the absence of any high-quality clinical trials or health technology assessment evaluation proving their value or effectiveness.
“The latest medical evidence has discredited this procedure, which should be immediately removed from the Medicare Benefits Schedule, and all spinal cord stimulation products removed from the Prescribed List of Medical Devices.
“Four million Australians are living with chronic back pain. They deserve accurate information about the risks and benefits of available treatment options, as there are treatments that are proven to work.
“Medical device manufacturers are required to notify the TGA when a serious adverse event is caused by a medical device. This is clearly not happening.
“A 10-year review of the TGA database for adverse events found that more than 2000 adverse events related to spinal cord stimulation had been reported during the period, but PHA data shows the real number is much higher,” said Dr David.
“In the US, spinal cord stimulators have the third-highest number of medical device injury reports made to the Food and Drug Administration. Medical technology companies in Australia who fail to report adverse events to the TGA are breaking the law and must be held accountable.”
Meanwhile the CEO of Pain Australia put in a “call for calm”.
Giulia Jones acknowledged the PHA’s demand for a recall, but said “we need to see this option remain for the relatively small cohort of consumers for whom it is an appropriate treatment”.
“We need to keep options available to consumers with chronic pain and at the same time we must improve reporting and implantation so that as a nation we have all appropriate options for consumers to choose from,” she said.
“Consumers with treatment-resistant long-term chronic pain deserve to be able to make choices about their care and have options available to them. There is already enough stigma and burden for this group of people who deserve appropriate respect and care.”
The Neuromodulation Society of Australia and New Zealand issued a statement today, saying the criticisms “were neither substantiated nor rationally based”.
“NSANZ would like to see a rational and sensible discussion of the evidence base for the role of spinal cord stimulation in refractory neuropathic pain which has the highest level of evidence of efficacy and is performed in a very small minority of suitable patients for whom other options have either been exhausted or are unsuitable,” it said.
“It is performed by highly trained medical specialists and is a therapy that intrinsically requires ongoing care and maintenance much like a pacemaker or an insulin pump requires ongoing care and maintenance.
“Without doubt, as surgery is involved, complications can and do occur and every complication is one more than is ever desired and we empathise with the patients presented and their particular lived experiences.
“In contrast to sensationalist claims, no other country’s healthcare system has any plans to deregister this therapy for either lack of efficacy or complication rates.
“Medical devices are appropriately carefully and tightly regulated by the TGA in Australia to ensure safety for all Australians.
“The provision of access to and availability of pain treatments in Australia remains woefully under-resourced and what this sector needs is sensible, rational discussion and support – rather than the approach taken by Private Healthcare Australia and the ABC in the Four Corners report.”
On the other side of the argument, the Australian Patients Association added its voice to the demands for a recall.
