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The TGA has been reviewing the safety and performance of spinal cord stimulator (SCS) devices.
As of 21 August 2024, 12 SCS devices have been cancelled from the Australian Register of Therapeutic Goods (ARTG). 70 SCS devices have had conditions of supply imposed.
Regulatory decisions are made on a case-by-case basis using commercial in confidence information. As a result, the TGA does not publish a stand-alone report or any interim reports.
Detailed information about the progress of the review and the outcomes for each device can be found on the spinal cord stimulator post-market review web page.
Specific information about each ARTG entry can be found by searching the ARTG public summary with the ARTG number that is found on the above webpage.
Information for consumers
Although some devices have been cancelled from the Australian Register of Therapeutic Goods (ARTG), they are not being recalled from the market and do not need to be removed if already implanted.
Consumers should consult their treating healthcare professional if they have any questions regarding the safety or performance of their SCS device.
Information for health care professionals
The Australian Commission on Safety and Quality in Health Care (ACSQHC) has published a number of documents relating to clinical practice, diagnosis, investigation and management of lower back pain. Appropriate patient selection for use of spinal cord stimulation and device suitability for individual conditions remain of utmost importance in the consideration of use of these devices.
If you have questions or concerns regarding ongoing use or maintenance of devices that have been cancelled from the ARTG, please contact the sponsor of the device directly.
