Post-market review of spinal cord stimulation devices

The TGA has completed the post-market review of SCS devices.

Note
The TGA does not publish standalone reports on the outcomes of post-market reviews. All information on the outcomes of spinal cord stimulator post-market reviews are published below.

Spinal cord stimulators

SCS are implantable devices that send low levels of electrical stimulation directly to the spinal cord with the aim of relieving pain. 

These devices are used in complex chronic pain scenarios and are generally used as a last line of treatment. 

Patients may undergo a trial stimulation period prior to placement of a long-term implantable device to ensure treatment with an SCS is suitable for their condition.

Background

We have received a range of signals related to SCS devices, including increasing reports concerning the safety and performance of these devices.

In 2022, in response to emerging signals, we initiated a post-market review into all SCS devices included in the Australian Register of Therapeutic Goods (ARTG). 

The review was to assess the safety and performance of the devices, including reviewing real-world evidence available for these devices.

As part of the review, we required all sponsors of SCS devices included in the ARTG to provide us information about their product, including:

• Number of devices supplied within Australia
• Indications and contraindications for use
• Advertising material
• Labelling information including the Instructions for Use (IFU), Patient Information Leaflets (PILs) and Patient implant Cards (PICs)
• All domestic and international incidents, adverse events, complaints, and any investigations undertaken, and corrective actions made as a result of these investigations
• Clinical data supporting the intended use of their device, and
• Evidence supporting the long-term safety of their device.

Overview

As part of ARTG inclusion sponsors and manufacturers have a range of post-market obligations. 

This includes maintaining evidence that devices continue to be safe and perform as intended throughout their lifecycle and provide this evidence to us when requested.

As part of the review, the TGA considered a range of information to ensure all regulatory decisions were evidence-based, including seeking expert advice on risks and benefits relating to these devices, including both published literature and data held by sponsors and manufacturers for their device.

Expert opinion was sought from the Advisory Committee for Medical Devices (ACMD) about patient selection, long-term safety and performance studies, patient information materials (including instructions for use), and the importance of treating the underlying cause of the pain. 

The ACMD advised: 

• Several million people are attempting rehabilitation for their chronic back pain daily and only a small percentage proceed to surgery or SCS.
• Clinicians should carefully consider patient selection for SCS devices to ensure effective rehabilitation.
• Back pain rehabilitation guidelines should be amended for clarity and should follow a valid cause-based paradigm of care and be applied in conjunction with the SCS surgery.

The adequacy of device manufacturer documentation and IFU in relation to these devices have been key considerations of the review. 

Following review of evidence provided by sponsors and manufacturers, we have taken regulatory action in relation to all SCS included in the post-market review.

Outcomes and actions

The post-market review of SCS devices is now complete. As part of the review, we have:

• Cancelled (removed) SCS devices from the ARTG; or
• Imposed Conditions of Inclusion (COI) on the SCS devices in the ARTG.

We have also taken a range of other actions, such as requiring amendments to labelling and IFUs, if deficiencies were identified. 

Additional information now includes:

• Improving information regarding the risks associated with the SCS devices including further clarification on indications and contraindications for use, and
• Providing further information about the expected lifespan and performance of the devices.

Where a SCS device has been cancelled from the ARTG, they are not being recalled from the market and do not need to be removed from patients if already implanted. The cancellation means no new patients will receive these implants.

To ensure the highest level of patient safety possible, we have imposed 'conditions' on a number of SCS that remain available in Australia. This means that for a sponsor to continue supplying a SCS device in Australia, they must meet a range of requirements.

A condition can impose further requirements as seen appropriate to support the safe ongoing use. The conditions enable us to closely monitor the devices overtime and take action promptly if any issues are identified.

The conditions imposed are different for each sponsor and may require:

• The sponsor to provide additional information, such as post-market clinical follow up studies to the TGA annually.
• Restrictions or alteration of the intended purpose of the device to specify use in particular patient populations that is supported by the evidence which allows more appropriate use of the device and patient selection.

We have worked closely with the sponsors to ensure changes are made to the intended purpose and that this information is clearly reflected in relevant labelling.

The conditions imposed on each entry can be found by searching the ARTG public summary with the ARTG number.

This webpage will be updated if any new issues are identified through the monitoring of the conditions.

For healthcare 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.

As part of the review, we have provided feedback to the sponsors and manufacturers of these devices relating to information that is provided to healthcare professionals about the safe use of these devices and more effective patient selection.

Healthcare professionals should ensure they provide sufficient information about these devices to enable informed educated consent by their patients. 

The ACSQHC has published a range of resources related to informed consent and shared decision-making.

For healthcare professionals/hospitals who want to use a device that has been cancelled from the ARTG:

• For stock already on hand (on shelves), the device can be used for the purpose it was supplied when the ARTG entry was still valid, if considered appropriate by the healthcare professional. If the device is being used for private patients and being reimbursed by private health insurers, you will need to confirm whether the private health insurer will reimburse a device no longer included in the ARTG.
• You can import or supply cancelled devices or accessories by applying under the Special Access Scheme (SAS) or Authorized Prescriber (AP) scheme if you feel your patient requires a device that is no longer included on the ARTG. To supply an unapproved device under the SAS or AP scheme there must be no suitable devices in the ARTG for the relevant condition(s) and patient(s).

If you have questions or concerns regarding ongoing maintenance of these devices, contact the sponsor of the device directly. 

This includes queries on the possible need for eventual replacement of parts for already implanted devices. 

As mentioned above, reimbursement of any potential replacement parts for a cancelled device should also be confirmed with private health insurers.

Healthcare professionals should continue to report all adverse events associated with a SCS implant to the TGA when they occur. 

Healthcare professionals should further ensure their patients are aware of how to report device concerns to the sponsor and the TGA.

For consumers

Although some devices have been cancelled from the ARTG, they are not being recalled from the market and do not need to be removed if already implanted.

Following our review, advice for all implants is as follows:

• Even if your implanted device is being cancelled from the ARTG, medical experts do not recommend removing them.
• If you have a spinal cord stimulator, you should monitor your own health, get regular clinical check-ups and follow your health care professional’s advice as per the usual process for these kinds of procedures.
• If you have any concerns, contact your healthcare professional to determine if a change in your treatment is advisable.
• If you have any concerns about the safety or performance of your device, you may also report this to the TGA.

Consumers should consult their treating healthcare professional if they have any questions regarding the safety or performance of their SCS device. 

When SCS is discussed as an option for care, ensure that you receive information on all your care options, including any education on both the risks and benefits of this treatment for you as an individual. 

You may wish to access the TGA’s “Five questions to ask your health professional before you get a medical implant.”

Reporting problems

Patient safety is a priority for the TGA. Patients should be encouraged to report all adverse events to the TGA.

Consumers and healthcare professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a healthcare professional if you are concerned about the use, outcomes, risks, possible complications, and possible alternatives.

Regulatory decisions

The review is ongoing, and we will take further regulatory action as needed.