Australia’s Spinal Cord Stimulator Controversy: What Happened?

John K. Hong M.D. | 8/5/2025

SCS controversy in Australia: Legitimate concern or unrealistic fears?

In early 2024, the Therapeutic Goods Administration (TGA) launched a post‑market review following more than 2,000 adverse-event reports tied to spinal cord stimulators since 2012—including lead migration, infection, electric shocks, and even cases of paralysis (Medical Device Network, ABC).

By August 2024, the TGA cancelled 12 devices and imposed conditions on over 50 others—meaning no new implants for those products, though existing patients weren’t forced to remove them (ABC).

A University of Sydney Cochrane‑style review (Mar 2023) concluded that evidence for SCS treating chronic low back pain offers no sustained benefit beyond placebo—and long‑term effectiveness data (beyond six months) is lacking (The University of Sydney).

In July 2025, research published in the Medical Journal of Australia reported that 25% of SCS recipients require corrective surgery within three years, with median reintervention time of just 17 months, challenging both effectiveness and cost‑effectiveness (The University of Sydney).

As a result, Australia's Department of Health began a comparative review of SCS’s clinical and cost‑effectiveness for inclusion on the country’s reimbursed prosthetic device list (Department of Health Australia).

Why the Recommendation Might Be Flawed: A Balanced Perspective

1. Patient Selection Matters Most

Modern neuromodulation guidelines highlight rigorous candidate screening—including psychological evaluation, imaging, and selecting appropriate pain modalities—as critical for success. Broad bans risk discarding effective therapy for select patients (ScienceDirect).

2. Short-Term vs. Long-Term Evidence

Many of the studies cited by critics focus on <6‑month outcomes and show placebo-level benefits. But newer RCTs—especially high-frequency (10 kHz) stimulation trials—demonstrate real improvements at 12 months in diabetic neuropathy and failed back surgery syndrome patients (Department of Health Australia).

3. Advances in Technology

Old-generation devices had higher lead migration and discomfort. Today’s rechargeable, multi-waveform systems deliver better efficacy with fewer side effects—yet older data casts a shadow on evolving tech (painaustralia.org.au, ScienceDirect).

4. Weighing Risks vs. Chronic Pain Burden

Yes, SCS carries non‑negligible risks. But chronic pain itself has substantial morbidity—including opioid dependence, psychological distress, and reduced function. For many patients who have exhausted other therapies, SCS can reduce medication reliance and improve quality of life (painaustralia.org.au).

5. Regulatory Nuance Is Needed

Cancelling devices from the ARTG doesn't mandate removal from existing patients. The TGA is working with manufacturers to add conditions on indications and to require enhanced follow‑up—not outright bans (Therapeutic Goods Administration (TGA)). Blanket defunding or exclusion based on limited evidence may inadvertently hurt patients who benefit under stringent protocols.

Expert Opinion: Why SCS Still Belongs in the Toolkit

In my view, having performed countless spinal cord stimulator trials and implants over my 20 year career treating complex chronic pain In the United States, spinal cord stimulation should absolutely remain an option—not as a first-line therapy, but as a carefully selected, integrated component of comprehensive pain care:

• Multidisciplinary assessment ensures patients most likely to respond are chosen.

• Modern devices and programming offer better patient experiences and outcomes than older models.

• Strong short- and medium-term evidence supports ≥ 50% pain relief in ~80% of patients when properly selected

• Patient autonomy matters—those fully informed should have access to SCS if alternative pain pathways failed.

• Cost-effectiveness improves when outcomes are durable, yet long-term follow-up mechanisms are already built into revised regulatory frameworks.

  
  

Final Takeaway

Australia’s regulatory caution reflects valid safety concerns—and a call to re-evaluate evidence. But rejecting spinal cord stimulation wholesale disregards substantial efficacy for the right patients, with properly matched cases achieving meaningful pain relief and reduced medication needs.

Rather than banning SCS, efforts should focus on improving evidence quality, patient selection, device tracking, and ongoing data transparency—so that SCS remains a viable, life-enhancing option for those who need it.

For more information, contact Parkview Pain and Regenerative Institute to schedule an appointment with our provider.

Want More Evidence? Top 10 Scientific Studies Supporting Spinal Cord Stimulation (SCS) for Chronic Pain

Year	Study / Authors	Design	Patient Population	Key Findings
2005	Kumar K, Taylor RS, Jacques L, et al. (Pain) – PROCESS Study	Randomized Controlled Trial	Failed Back Surgery Syndrome (FBSS)	SCS provided significantly greater pain relief and quality-of-life improvements compared to conventional medical management (CMM) at 6 months. Plain language: In people with severe back pain after surgery, spinal cord stimulators worked better than medication alone.
2008	North RB, Kidd DH, Farrokhi F, Piantadosi S. (Neurosurgery)	Randomized Controlled Trial	FBSS with leg pain	SCS had higher success rates and patient satisfaction compared to repeat surgery. Plain language: Patients felt better and avoided another surgery by choosing a spinal cord stimulator.
2011	Kumar K, Taylor RS, Jacques L, et al. (Pain) – PROCESS 24-Month Follow-Up	Long-term Follow-Up	FBSS	Pain relief and quality-of-life benefits from SCS persisted for 2 years. Plain language: Relief from SCS was long-lasting, even years later.
2016	Kapural L, Yu C, Doust MW, et al. (Anesthesiology) – SENZA-RCT	Multicenter RCT	Chronic back and leg pain	High-frequency (10 kHz) SCS outperformed traditional SCS with a 76.5% responder rate at 12 months. Plain language: A newer, faster SCS gave better pain relief for most patients a year later.
2017	Deer TR, Mekhail N, Provenzano D, et al. (Pain Practice)	Prospective Multicenter Study	Chronic neuropathic pain	Dorsal Root Ganglion (DRG) stimulation delivered more targeted relief than traditional SCS. Plain language: This SCS approach targeted pain more precisely, especially in specific body areas.
2019	Al-Kaisy A, Van Buyten JP, et al. (Pain Medicine)	36-Month Prospective Study	FBSS	High-frequency SCS maintained over 70% responder rate for 3 years with significant functional improvement. Plain language: Patients stayed better and more active for years after getting an SCS.
2019	Mekhail N, Levy RM, Deer TR, et al. (Pain Practice)	RCT	Painful diabetic neuropathy	SCS reduced pain and improved quality of life compared to usual care. Plain language: People with diabetic nerve pain had less pain and felt healthier after SCS.
2020	Deer TR, Pope JE, Lamer TJ, et al. (Neuromodulation)	Narrative Review	Multiple chronic pain types	Review confirmed strong evidence for SCS effectiveness in many chronic pain conditions. Plain language: Decades of studies show SCS works for many kinds of severe pain.
2021	Petersen EA, Stauss TG, Scowcroft JA, et al. (Pain Medicine)	RCT	Non-surgical refractory back pain	10 kHz SCS reduced pain >60% and improved function compared to CMM at 12 months. Plain language: Even without surgery, SCS helped people with stubborn back pain feel and move better.
2022	Amirdelfan K, Vallejo R, Benyamin RM, et al. (Pain Practice)	Systematic Review & Meta-analysis	Chronic neuropathic pain	Confirmed SCS leads to pain reduction, better function, and less opioid use. Plain language: SCS not only eases pain but can also help reduce the need for pain medications.