Australia’s Therapeutic Goods Administration has removed 82 spinal cord stimulation (SCS) devices from its register after a series of reviews and a report from a national broadcaster claiming that the devices are neither safe nor effective, with university reports likening SCS companies to ‘big tobacco’.
SCS devices developed by the likes of international medtech giants such as Medtronic and Boston Scientific have seen a number of their previously approved devices pulled from the market following a 2022 and 2023 Cochrane review, compounded by an April report by the Australian Broadcasting Company (ABC) that found the devices were widely misused in the country with a potentially high rate of adverse effects.
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Conducted by researchers at the University of Sydney’s Institute of Musculoskeletal Health, the 2023 Cochrane review found that SCS therapy when used for lower back pain only provided a small benefit to patients that did not outweigh the risk of adverse events, which the review concludes have been poorly reported.
On 15 August 2024, the TGA ordered the removal of several SCS devices from the Australian Register of Therapeutic Goods. This does not mean that the devices have been recalled outright, but the devices can now no longer be offered to new patients, with the body imposing restrictions on the devices calling for further evidence that SCS can demonstrate compliance with its Essential Principles.
The issue so far
Outside of Australia, SCS devices have seen relatively little controversy beyond individual recalls and issues. As part of the greater market for neurostimulation devices, spinal cord stimulators have been applied in recent years across a wide range of indications and therapies.
GlobalData’s Medical Devices Database details how the global market for neuromodulation devices is estimated to be worth $6.4bn by the end of this year. Of that, SCS devices comprise approximately $2.3bn of that market, with that figure expected to rise to $3.4bn by the end of 2030.
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By GlobalDataThe Australian market for SCS devices is estimated to be worth $64.2m by the end of this year, with the market expected to see a slight fall to $61.6m by 2030.
The main indication in which the controversy has arisen is in the devices’ use in mitigating lower back pain. In 2022 and 2023, researchers at the University of Sydney’s Institute of Musculoskeletal Health, led by Dr Adrian Traeger, published two reviews in the Cochrane Library. The second of these reviews, published on 7 March 2023, examined material from 13 SCS trials comprising 699 participants. The report found that the average duration of low back pain amongst study participants varied from five to 12 years. Ten of the 13 studies had financial ties to manufacturers of spinal cord stimulation systems.
Results concluded that none of the studies had tested whether spinal cord stimulation surgery is better than placebo in patients followed up for longer than six months. At six months, the only available study found no benefit of spinal cord stimulation on back pain compared with placebo, nor were researchers able to find a study that showed the benefit of spinal cord stimulation on function compared with placebo. It also found that some studies reported serious adverse events in people receiving SCS requiring repeat surgery. The only placebo-controlled study that followed people for 12 months found that 8% of participants required repeated surgery.
Following the publication of the first Cochrane report in 2022, the TGA initiated a post-market review into all SCS devices included in the Australian Register of Therapeutic Goods which has now concluded in the devices being removed from the register.
One of the devices removed from the register includes Medtronic’s Vanta device, a recharge-free implantable neurostimulator that was granted approval by the US Food and Drug Administration (FDA) in 2021. In 2022 the device was again granted approval by the FDA for use in patients suffering chronic pain related to diabetic peripheral neuropathy (DPN). The discrepancies between the two countries in terms of these devices’ classification as effective leave room for concern among researchers.
Amid the post-market scrutiny, the Australian private health insurance industry, Private Healthcare Australia (PHA), called on the government to recall spinal cord stimulation devices from the market. As part of the request, the group brought data from 5,852 patients over ten years submitted for academic review as part of the investigation. The body says that the data shows that 27% of those patients required surgical reintervention within one year and 41% within three years, compared with a three-year revision rate of 2.7% for hips and 2.4 % for knee replacements.
A review of adverse events reported to Australia’s Therapeutic Goods Administration found that of 520 adverse events between 2012 and 2019, 79% were considered “severe” and 13% were “life-threatening”.
PHA CEO Rachel David 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 (MBS), 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.
“The fact that current federal government regulations compel health insurance funds and other health payors to pay for treatment we know to be harmful is scandalous.”
Additionally, the PHA is calling for the introduction of an Authorised Code of Conduct for the medical technology industry, which aligns with the code of conduct for pharmaceutical companies, where Medicines Australia discloses support, incentives and other benefits provided to prescribing doctors.
‘Big Tobacco’ tactics?
Away from Australia, one study conducted at a University Hospital in Norway from 2018 until 2022 compared the devices against a placebo and found that from its 50 patients, spinal cord burst stimulation resulted in no significant difference in the change from baseline in self-reported back pain-related disability.
However, the Cochrane reports themselves have been met with mixed feedback abroad where several clinical trials have concluded the devices as both safe and effective across some indications. One such report published in the journal Neuromodulation, “Spinal Cord Stimulation Improves Quality of Life for Patients with Chronic Pain—Data From the UK and Ireland National Neuromodulation Registry”, responded directly to the Cochrane report on the same day SCS devices were withdrawn from the ARTG.
Authored by researchers from the Neuromodulation Society of UK and Ireland, the report found that SCS does increase the quality of life for patients requiring surgery for pain, finding that increased quality of life sustained for six months after baseline measurements.
In its introduction, the UK report responds to claims made in the Australian Cochrane reviews arguing that they are out of step with the rest of the industry.
The report reads: “The findings of these reviews are at odds with the everyday clinical experience of implanting physicians, and their inclusion criteria, methods, presentation of results, analysis, and interpretation have been robustly criticised.
“Nevertheless, the authors draw conclusions intended for policymakers and funders, which may directly affect the availability of SCS for some patients. In this context, large “real-world” data sets showing outcomes after SCS, in a population reflective of the generality of those receiving the treatment, complementing data from clinical trials, are urgently needed.”
Across social media, the reports have been met with some hesitancy and irritation from the health industry or adjacent professionals who are set to lose out on a likely revenue stream or a means of mitigating pain in patients.
Despite some pushback, researchers at the University of Syndey have held firm to their conclusions, arguing that some spinal cord stimulation organisations have employed the same tactics as the tobacco industry to minimise their research. A viewpoint published by Adrian Traeger and colleague Lisa Bero in the Journal of the American Medical Association argued that SCS companies had sought to cast doubt over any unfavourable findings by creating industry-funded counterevidence.
Speaking with Medical Device Network following the announcement that SCS devices were set to be removed from the register, Adrian Traeger in defending his research, said: “At the time we planned the Cochrane review back in 2021 there was increasing evidence of safety issues from these procedures. There were also advancements in trial design which meant that placebo-controlled trials could be conducted. However, no review has examined the evidence on SCS for low back pain comprehensively.
“Unfortunately, the literature is littered with poorly conducted research led by people with financial conflicts. On the surface, it might seem that these devices are effective, but look closer and there are major problems with the studies in this field.
“Many are set up in a way that can only give favourable results for the industry. Combine poor quality research with a large marketing budget and regulatory policies that don’t require evidence of benefit over placebo, and you arrive at the current situation.
“Medical device companies are yet to prove SCS is superior to placebo. That should be the first step before these devices are offered to the public.”
“We outlined the evidence that some device companies use remarkably similar tactics to the tobacco industry in our paper published in JAMA Internal Medicine. We gave examples of the SCS industry flooding the scientific literature with financially conflicted research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices. This is exactly what the tobacco industry did when concerns were raised about safety.”
Despite decisions made in Australia, there have been few indications internationally that SCS devices are likely to see further withdrawal from the market. SCS is still expected to continue its rapid growth with devices pushed into more indications. With that, there will still be requirements for these companies to continue to provide evidence of the safety and effectiveness of these devices. It remains to be seen then, how those who are certain these devices don’t work will find a way to make their voices heard against an industry set on expanding its place in the market, with or without the comparatively small Australian market.
