Report on the Efficacy, Safety, and Sustainability of Spinal Cord Stimulators for Chronic Pain Management

Introduction: Aligning Medical Technology with Sustainable Development Goal 3

This report provides an analysis of spinal cord stimulators, surgically implanted electrical devices for treating chronic pain, with a specific focus on their alignment with the United Nations Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being). The assessment covers the efficacy, safety, cost-effectiveness, and regulatory status of these devices, evaluating their contribution to ensuring healthy lives and promoting well-being for all.

Analysis in the Context of SDG 3: Good Health and Well-being

Efficacy and Performance Against Health Targets

A core target of SDG 3 is to ensure access to safe, effective, and quality medical treatments. However, evidence regarding spinal cord stimulators raises significant concerns about their efficacy. Independent, high-quality research indicates a failure to provide tangible benefits for patients with chronic low-back pain.

• A 2023 Cochrane review of 13 randomised controlled trials found no short or medium-term benefits for low-back pain.
• The single trial in the review that assessed long-term efficacy (six months) also found no benefits from spinal cord stimulation.
• An earlier Cochrane review examining the devices for chronic pain in general concluded that certainty about their benefits could not be established due to the poor quality of available trial data.

These findings suggest that the widespread use of this technology may not contribute positively to achieving health and well-being outcomes, and may divert resources from more effective interventions.

Patient Safety and Adverse Events

Ensuring patient safety is fundamental to SDG 3. The data on spinal cord stimulators reveals a high incidence of adverse events, challenging their safety profile.

• An analysis of 520 adverse events reported to Australia’s Therapeutic Goods Administration (TGA) found 79% were rated as severe and 13% as life-threatening.
• The same analysis showed that 80% of these adverse events required corrective surgery.
• Data from major private health insurers in Australia revealed that approximately one-quarter of patients required corrective surgery within a median of 17 months post-implantation.
• Common reasons for corrective surgery include device malfunction, increased pain, infection, or puncture of tissues surrounding the spinal cord.

The high rate of complications and subsequent surgeries represents a significant burden on both patients and healthcare systems, undermining the goal of providing safe and reliable healthcare.

Economic and Regulatory Dimensions in Relation to SDGs

Cost-Effectiveness and Financial Sustainability (SDG 3 & SDG 10)

The high financial cost of spinal cord stimulators presents a challenge to the principles of universal and affordable healthcare central to SDG 3 and SDG 10 (Reduced Inequalities). The significant expenditure on a treatment with questionable efficacy and high complication rates impacts the financial sustainability of health systems.

• The average cost per patient is approximately A$55,000, which includes the device, implantation, and management of subsequent complications.
• A “trial” implantation alone costs around A$14,000 per patient.

These costs, often covered by private insurance, can create inequalities in access and place a substantial financial strain on healthcare resources that could be allocated to evidence-based treatments.

Regulatory Oversight and Institutional Accountability (SDG 16)

SDG 16 (Peace, Justice and Strong Institutions) emphasizes the need for effective and accountable institutions. In the healthcare sector, this includes robust regulatory bodies that protect public health. In 2022, the TGA initiated a review of spinal cord stimulators due to safety and performance concerns. The outcomes included:

• The removal of several devices from the Australian Register of Therapeutic Goods, effectively banning their future use in Australia.
• The imposition of conditions on remaining devices, requiring manufacturers to collect and report safety and performance data to the TGA regularly.

This regulatory action exemplifies the critical role of strong institutions in safeguarding public health and ensuring that medical technologies are held to rigorous standards.

Recommendations for Promoting Evidence-Based and Sustainable Healthcare

Informed Decision-Making for Patients

To empower patients and align with the principles of people-centered care under SDG 3, it is crucial that individuals considering medical implants are fully informed. Patients should engage with their healthcare professionals by asking critical questions:

1. Do I genuinely need this medical implant?
2. What are the potential benefits versus the risks involved?
3. Is this specific medical implant approved by national regulatory bodies?
4. Where can I access independent, unbiased information about this implant?
5. What is the process if I experience an adverse event?

Prioritizing Safe, Effective, and Accessible Alternatives

To advance SDG 3, healthcare systems should prioritize and promote treatments for chronic pain that are supported by robust evidence and have lower risks. Effective alternatives include:

• Education for patient self-management
• Exercise programs
• Cognitive Behavioural Therapy (CBT)
• Non-steroidal anti-inflammatory medicines
• Sensorimotor retraining
• Cognitive functional therapy

Focusing on these evidence-based options ensures that resources are used responsibly to deliver genuine health benefits, moving towards a more sustainable and equitable model of chronic pain management.

SDGs Addressed in the Article

1. SDG 3: Good Health and Well-being

   • The entire article is centered on health, specifically the treatment of chronic pain, which is a major global health issue. It evaluates the effectiveness, safety, and risks of a medical intervention (spinal cord stimulators) aimed at improving the well-being of patients. The article discusses the goal of reducing reliance on harmful pain medicines like opioids, which directly relates to promoting healthier lives. It also highlights alternative, safer, and more effective treatments, contributing to the overall goal of ensuring good health.

Identified SDG Targets

1. Target 3.4: By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.

   • The article addresses this target by examining treatments for chronic pain, a non-communicable condition that significantly impacts well-being. It critiques an expensive and risky treatment (spinal cord stimulators) and promotes effective alternatives like exercise and cognitive behavioral therapy. Furthermore, it mentions the goal of reducing reliance on opioids, which are “ineffective and harmful” and contribute to health risks and mortality, thus aligning with the target’s aim to reduce harm from treatments.

2. Target 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.

   • The article directly questions the safety, effectiveness, and quality of spinal cord stimulators. It cites research showing they “work no better than a placebo” and carry significant risks, including severe adverse events. The discussion of the high cost—”about A$55,000 per patient”—relates to financial risk protection and the affordability of healthcare services. The analysis challenges whether this procedure constitutes a “quality essential health-care service.”

3. Target 3.d: Strengthen the capacity of all countries… for early warning, risk reduction and management of national and global health risks.

   • This target is addressed through the article’s discussion of regulatory oversight and post-market surveillance. The analysis of 520 adverse events reported to Australia’s Therapeutic Goods Administration (TGA) is a clear example of managing health risks associated with medical devices. The TGA’s subsequent review, which led to some devices being “banned from use in Australia,” demonstrates a national capacity for risk reduction and management to protect patient safety.

Implied/Mentioned Indicators

1. Rate of adverse events associated with medical devices.

   • The article provides specific data that can be used as an indicator. It mentions an analysis of 520 adverse events reported to the TGA, finding that “79% of reported events were rated as severe, with 13% life-threatening.” This metric directly measures the safety and risk profile of the treatment.

2. Rate of corrective surgery following medical device implantation.

   • The article states, “about one-quarter of people who had a spinal cord stimulator implanted needed corrective surgery afterwards.” This quantifiable measure serves as an indicator of the device’s performance, reliability, and long-term effectiveness, reflecting the quality of the healthcare intervention.

3. Cost of healthcare interventions.

   • The article explicitly states the cost of the procedure: “spinal cord stimulators cost about A$55,000 per patient, including the device, its insertion, and managing any associated additional surgeries.” This figure is a direct indicator of the financial burden of a specific treatment, relevant to assessing financial risk protection and affordability within a health system.

4. Regulatory actions on medical devices.

   • The article notes that as a result of a TGA review, “several devices were removed from the Australian Register of Therapeutic Goods.” The number of devices reviewed, restricted, or removed from the market due to safety and performance concerns serves as an indicator of a country’s capacity for health risk management.

SDGs, Targets and Indicators

Source: theconversation.com