Spinal cord stimulators face ongoing scrutiny despite reported patient outcomes

MedTech & Diagnostics News: In response to heightened pressure to act, the Therapeutic Goods Administration (TGA) has cancelled 12 spinal cord stimulator (SCS) devices from the Australian Register of Therapeutic Goods (ARTG) and imposed conditions on the supply of another 52 medical devices.

This decision follows the ABC’s Four Corners program, “Pain Factory,” which aired in April. The program, developed in close partnership with Private Healthcare Australia, drew criticism for allegedly pushing an agenda favoured by insurers. It levied serious accusations against surgeons, anaesthetists, the TGA, and medtech industry.

In stark contrast to the evidence presented by the Four Corners program, one of the largest published studies to report long-term safety outcomes in patients using SCS for treatment of chronic pain, the RELIEF registry, collected real-world safety outcomes out to 3 years for chronic pain patients implanted with Boston Scientific SCS systems at 79 sites located internationally.

The overall yearly incidence of device explant was 3.5%, and this decreased to 1.1% for explants occurring specifically as a result of inadequate pain relief. The total percentage of device explant over the course of the registry (3 years) was 7.6% (n = 98), and this decreased to 2.5% for explants occurring specifically as a result of inadequate pain relief. The most common noted serious adverse event was implant site infection (11 total events; <1%).

The TGA cancelled devices from RQSolutions and Medtronic Australasia will not be recalled or removed from patients who have already received them. Instead, the focus is on preventing new patients from receiving these implants.

Additionally, the TGA imposed new conditions on devices from Abbott, Boston Scientific, and Nevro Medical. These conditions require sponsors to provide additional data, potentially including annual updates or limitations on the use of their devices for specific patient populations.

The Neuromodulation Society of Australia and New Zealand (NSANZ) has called for “rational and sensible” dialogue on the use of spinal cord stimulation, criticising the approach taken by Private Healthcare Australia and ABC in the Four Corners report.

Giulia Jones, CEO of Painaustralia, emphasised “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.”

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