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Japan Today
2 days ago
- Health
- Japan Today
Is spinal cord stimulation safe? Does it work? Here's what you need to know if you have back pain
By Caitlin Jones and Christopher Maher Spinal cord stimulators are electrical devices that are surgically implanted in the body to treat long-term pain. They have a battery pack and leads that deliver electrical impulses directly to the spinal cord. The devices are thought to work by providing electrical impulses that interfere with how the brain senses pain. Spinal cord stimulators are mainly used to treat chronic back pain, especially when other less invasive treatments have not worked. They also aim to reduce people's reliance on risky pain medicines. These include opioids, which research shows are ineffective and harmful for low-back pain. But research, including our own, shows spinal cord stimulators work no better than a placebo. And they can also carry risks. Do they work? In a 2023 Cochrane review, researchers reviewed data from 13 randomized controlled trials on low-back pain and found no benefits in the short and medium term. These international reviews draw together the most robust evidence to provide a detailed summary of what we know on a particular topic. Only one of the trials in the review tested efficacy in the longer term (six months). That trial found no benefits of spinal cord stimulation. An earlier Cochrane review looked at the evidence of spinal cord stimulation for chronic pain in general, including for neck pain. Reviewers looked at 15 randomised controlled trials and couldn't be certain about its benefits, largely due to the quality and reliability of the available trials. Are there side effects? Aside from disappointing results for pain relief, there are risks and side effects to consider. We co-authored an analysis of 520 adverse events reported to Australia's Therapeutic Goods Administration (TGA). We found 79% of reported events were rated as severe, with 13% life-threatening. The same research found 80% of events required surgery to correct. Our recent analysis in the Medical Journal of Australia looked at data from private health insurers. These cover 90% of spinal cord stimulation implants in Australia. Five major insurers, which covered 76% of privately insured people, contributed de-identified data. We found about one-quarter of people who had a spinal cord stimulator implanted needed corrective surgery afterwards. These surgeries occurred within a median of about 17 months. This indicates these surgeries are not routine or expected interventions, such as to replace batteries, which are meant to last five to ten years. Our previous research shows the sorts of reasons for corrective surgery. These include to replace a malfunctioning device, or the person was in more pain, had an infection, or a puncture of the delicate tissues covering the spinal cord. However, even our latest findings are likely to underestimate the risk of these devices. Sometimes the lead delivering the electrical current moves away from the spinal cord to elsewhere in the body. This requires surgery to reposition the lead, but does not necessarily require new hardware, such as a brand new lead. So this type of corrective surgery is not counted in the data from the private health insurance companies. How much does it cost? We found spinal cord stimulators cost about A$55,000 per patient, including the device, its insertion, and managing any associated additional surgeries. For people who only had a 'trial' – where the leads are implanted temporarily but the battery pack remains outside the body – this cost was about $14,000 per patient. These figures do not include any out-of-pocket costs. What do regulators say about the devices? In 2022 the TGA began a review of spinal cord stimulators on the market because of safety and performance concerns. As a result, several devices were removed from the Australian Register of Therapeutic Goods – that is, they were banned from use in Australia, but existing stock could still be used. The rest of the devices had conditions imposed, such as the manufacturers being required to collect and report safety data to the TGA at regular time points. Should I do my own online research? Yes, but be careful. Unfortunately not all online information about spinal cord stimulators is correct. Look for sites independent of those who manufacture or implant these devices. Government agencies, health departments and universities that have no financial interests in this area may be a better option. The Cochrane Library is also a reliable and independent source for trustworthy health information. What shall I ask my doctor? The Australian health department provides useful advice for consumers about medical implants. It says medical implants 'are considered higher-risk therapeutic goods, and the decision to get one should not be taken lightly'. It recommends asking your health professional these questions: do I really need this medical implant? what are the risks/benefits? is the medical implant approved? where can I get more information? what happens if I experience an adverse event? What else could I do for my back pain? There are other treatment options that are effective and have fewer risks than spinal cord stimulation. For example, education about how to manage your pain yourself, exercise, cognitive behavioral therapy (a type of psychological therapy), and non-steroidal anti-inflammatory medicines (such as ibuprofen) all have solid evidence to back them. All offer benefits that are not outweighed by their potential risks. Research has shown other types of therapy – such as sensorimotor retraining and cognitive functional therapy – are also effective. You can discuss these and other options with your health professional. Spinal cord stimulation is a good example of a treatment that got ahead of the evidence. Although the devices have been around since the 1960s, we've only had reliable trials to test whether they work in recent years. Everyone wants to find ways to help people with chronic pain, but we must ensure medical care is grounded in reliable science. Caitlin Jones is Postdoctoral Research Associate in Musculoskeletal Health, University of Sydney. Christopher Maher is Professor, Sydney School of Public Health, University of Sydney. The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts. External Link © The Conversation
Sydney Morning Herald
21-07-2025
- Health
- Sydney Morning Herald
Blanket ban urged for controversial medical device
'With the advent of National Pain Week upon us, it would be a cruel irony and frankly inhumane to remove spinal cord stimulation as an available option for a small number of patients for whom other options have not helped and their intractable pain negatively impacts their lives,' said Dr Michelle O'Brien, president of the Neuromodulation Society of Australia and New Zealand. A study published in the Medical Journal of Australia last week, based on private health insurance data, found 23 per cent of patients who receive a stimulator will need revision surgery – most within 18 months. In comparison, total knee replacement operations have a lifetime reoperation rate of about 2 per cent. Loading Private Healthcare Australia facilitated the provision of the data but did not fund the study or the researchers. The University of Sydney's Dr Caitlin Jones, who led the study, said that on the basis of the evidence her team had collected she would support a ban on new stimulation implantations outside clinical trials. Associate Professor Adrian Traeger, a University of Sydney academic who led a review of spinal cord stimulators for lower back pain, also supported a ban. 'Given the substantial risks, I'd want to see clear benefits over placebo from rigorous clinical trials before these surgeries were offered to patients,' he said. 'We expect this standard of evidence for drugs – why should it be different for surgical procedures?' Personal injury lawyers Gerard Malouf & Partners have been investigating a potential class action since late last year against stimulator makers, and have been interviewing patients, this masthead can reveal. Michael Ferraro, a researcher at medical research institute NeuRA who co-authored a review of stimulation for general chronic pain, said a ban would be useful if it pushed the industry towards conducting high-quality, placebo-controlled trials to prove the devices worked as claimed. Marcus Barlow, who received a spinal cord stimulator in 2019 and found it dramatically worsened his pain, said the devices 'absolutely' should be banned. 'I am happy to lend my support to anything that could get these vile devices banned once and for all,' he said. Ian Burgess, CEO of the Medical Technology Association of Australia, which represents device manufacturers, said there was robust clinical trial and real-world data proving stimulators' effectiveness and safety. 'We must not allow insurers to dictate clinical care, patient outcomes or to block access to therapies that can be life changing and restore dignity and function to people living with chronic pain.' In response to questions about the ban proposal, the association connected this masthead with Kaleena de Voigt, a patient who received a stimulator to deal with chronic pain from an operation. Two weeks after her operation, she was able to return to work, and she is now largely pain free. 'Within two days, my pain was down 85 per cent. Within the first three to four months, I was down 75 per cent of my opioids,' she said. Loading De Voight said she had not experienced any side effects or complications from the procedure, and that her doctors had managed to adjust the stimulation to remove persistent pain she felt in her hands, legs and feet from a separate condition. 'To deprive people of something like this that is so effective for so many, I think would be really quite sad,' she said.
The Age
21-07-2025
- Health
- The Age
Blanket ban urged for controversial medical device
'With the advent of National Pain Week upon us, it would be a cruel irony and frankly inhumane to remove spinal cord stimulation as an available option for a small number of patients for whom other options have not helped and their intractable pain negatively impacts their lives,' said Dr Michelle O'Brien, president of the Neuromodulation Society of Australia and New Zealand. A study published in the Medical Journal of Australia last week, based on private health insurance data, found 23 per cent of patients who receive a stimulator will need revision surgery – most within 18 months. In comparison, total knee replacement operations have a lifetime reoperation rate of about 2 per cent. Loading Private Healthcare Australia facilitated the provision of the data but did not fund the study or the researchers. The University of Sydney's Dr Caitlin Jones, who led the study, said that on the basis of the evidence her team had collected she would support a ban on new stimulation implantations outside clinical trials. Associate Professor Adrian Traeger, a University of Sydney academic who led a review of spinal cord stimulators for lower back pain, also supported a ban. 'Given the substantial risks, I'd want to see clear benefits over placebo from rigorous clinical trials before these surgeries were offered to patients,' he said. 'We expect this standard of evidence for drugs – why should it be different for surgical procedures?' Personal injury lawyers Gerard Malouf & Partners have been investigating a potential class action since late last year against stimulator makers, and have been interviewing patients, this masthead can reveal. Michael Ferraro, a researcher at medical research institute NeuRA who co-authored a review of stimulation for general chronic pain, said a ban would be useful if it pushed the industry towards conducting high-quality, placebo-controlled trials to prove the devices worked as claimed. Marcus Barlow, who received a spinal cord stimulator in 2019 and found it dramatically worsened his pain, said the devices 'absolutely' should be banned. 'I am happy to lend my support to anything that could get these vile devices banned once and for all,' he said. Ian Burgess, CEO of the Medical Technology Association of Australia, which represents device manufacturers, said there was robust clinical trial and real-world data proving stimulators' effectiveness and safety. 'We must not allow insurers to dictate clinical care, patient outcomes or to block access to therapies that can be life changing and restore dignity and function to people living with chronic pain.' In response to questions about the ban proposal, the association connected this masthead with Kaleena de Voigt, a patient who received a stimulator to deal with chronic pain from an operation. Two weeks after her operation, she was able to return to work, and she is now largely pain free. 'Within two days, my pain was down 85 per cent. Within the first three to four months, I was down 75 per cent of my opioids,' she said. Loading De Voight said she had not experienced any side effects or complications from the procedure, and that her doctors had managed to adjust the stimulation to remove persistent pain she felt in her hands, legs and feet from a separate condition. 'To deprive people of something like this that is so effective for so many, I think would be really quite sad,' she said.
9 News
21-07-2025
- Health
- 9 News
Doctors call for use of spinal cord stimulators to be reconsidered
Your web browser is no longer supported. To improve your experience update it here Australian doctors and health fund providers are calling for the use of spinal cord stimulators to be reconsidered after research revealed one-in-four people are having revision surgery for complications. Spinal cord stimulators have been used to treat chronic pain, including back pain, neck pain, nerve pain, and complex regional pain syndrome. The devices are made up of a small battery pack, which is implanted beneath the skin and attached to electrodes. Pulses of electricity are theoretically supposed to interfere with pain signals coming from the nerves. An image showing what a spinal cord stimulator would look like when inserted into a patient. (iStock) However, a study by leading Australian doctors, published in this week's Medical Journal of Australia , found 23 per cent of patients fitted with the device will go on to need revision surgery for complications within three years. The median cost for the permanent device is nearly $56,000, with some patients' treatment adding up to more than $500,000. "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. Lead author Dr Caitlin Jones, from the University of Sydney's Institute of Musculoskeletal Health, told The Sydney Morning Herald the risk posed by the devices was much greater than the likely benefits. "Patients should know they are taking on a substantial risk, that is exorbitantly expensive, with very little likelihood of any benefit." Private Healthcare Australia, which represents health insurance funds and their 15 million members, has backed the researchers' calls for the use of the devices to be reconsidered. 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." At least 90 per cent of spinal cord stimulators are inserted in the private health sector. "Health funds are committed to continuing to fund evidence-based treatments which have demonstrated safety and efficacy in the treatment of chronic pain," David said. The Medical Technology Association of Australia (MTAA), which represents device manufacturers has said the devices are safe and effective. Stimulators were "a demonstrably safe and effective alternative to long-term drug therapies, notably opioids", a spokesman told The Sydney Morning Herald. "[Stimulator] suppliers stand behind the safety, quality and efficacy of our SCS technologies that have demonstrated positive outcomes for patients, which are backed by robust clinical trial data and real-world evidence." health Health Services national Australia Research CONTACT US
Hindustan Times
02-07-2025
- Hindustan Times
Indian grocery store owner arrested for selling ‘Kamini' opium in Australia
The owner of an Indian grocery store and his son have been sentenced for their roles in a drug and illicit tobacco operation uncovered by Australian authorities earlier this year. The South Australian pair was found to be importing and distributing opium – disguised in part as the controversial 'Ayurvedic' preparation Kamini Vidrawan Ras – alongside large quantities of illegal tobacco. The owner of an Indian grocery store was arrested for selling opium and illegal tobacco in Australia(Australian Border Force) On June 26, they were sentenced to prison and received additional fines, according to a press release by the Australian Border Force (ABF). The investigation began in January 2024, when Australian Border Force (ABF) officers executed a search warrant at the family's Indian grocery and takeaway shop in Plympton, Adelaide. Inside, they discovered 2.2kg of opium in paste and pellet form, 29kg of illicit tobacco, and 2,080 illegal cigarettes. CCTV footage from the premises showed the son selling the products to customers. Subsequent raids at the family's Trott Park residence uncovered another 432g of opium, while a storage locker in Reynella, rented by the father, contained an additional 3.5kg of opium and 20kg of tobacco. Photos shared by ABF show rows of the 'Kamini' opium packets that were recovered from the father-son duo. What is Kamini and why is it dangerous? A key product seized in the raids was Kamini Vidrawan Ras, an opium-based preparation. According to a 2023 article published in the Medical Journal of Australia, it has been banned by Australia's Therapeutic Goods Administration (TGA) since 2016. Kamini tablets contain variable doses of opium – between 2mg and 20mg – and often include toxic heavy metals like mercury, lead, and arsenic. The article noted that Kamini poses serious health risks, including addiction, overdose, and heavy metal poisoning. The report also noted a rising trend of opioid use disorder linked to Kamini among patients of Indian background, particularly those of Punjabi origin. Sentencing and penalties The son was sentenced on 26 June 2025 to six months in prison but was released immediately on a Commonwealth Recognisance Release Order (RRO), with a $500 bond and a one-year good behaviour condition. He was also fined $6,000 and ordered to forfeit $23,450 under proceeds of crime legislation. The father received a three-month sentence, also served on immediate release under an RRO. He was fined $3,000. What ABF said on the sentencing ABF Acting Superintendent Steve Garden described the operation as an example of 'intelligence-led policing' that traced the illegal supply chain from importation to street-level sales. 'As Australia's border security agency, we use all available intelligence to end the impact of border crimes in our community, no matter the amount of illicit goods or complexity of the criminal activity," Acting Superintendent Garden said. 'Today's outcome is the result of a sustained, intelligence-led investigation that followed the illicit supply chain from importation to street-level distribution. Every seizure is a step towards safer streets and stronger communities."
