Australian transvaginal surgical mesh regulatory actions

Approved urogynaecological mesh devices

As of 11 December 2020, we approved the following four Class III mesh devices.

See TGA actions after review into urogynaecological surgical mesh implants.

Up-classification of urogynaecological mesh

Medical devices are categorised into classes based on their level of risk. 

Classifications range from low risk (Class I) to high risk (Class III). 

Most urogynaecological mesh devices were previously classified as Class IIb (medium–high risk) devices. 

All urogynaecological mesh device applications have been classified as Class III devices since 1 December 2018. Under transitional arrangements, sponsors of urogynaecological mesh devices that were approved under the old classification had to lodge new applications with us under the new classification by December 2020 for continued inclusion in the ARTG. Where applications were not received, we removed those devices from the ARTG.

We have a risk-based approach to the regulation of medical devices. which means the regulatory requirements for medical devices correspond to the risk they pose to patients. 

Reclassifying all surgical mesh devices as Class III medical devices means they will receive the most rigorous evaluation when we receive applications to supply these devices in Australia.

Improving information for consumers

The Australian Government now requires manufacturers to provide certain specific details about their medical devices to consumers via patient information leaflets and patient implant cards.

Patient information leaflets

• Since 1 December 2018, manufacturers of new permanently implantable devices (other than those exempt devices such as sutures, tooth crowns and wires) are required to provide patient information leaflets with the device, including new urogynaecological mesh devices.
• Under transitional arrangements for urogynaecological mesh devices already on the market, patient information leaflets have been required since 1 December 2019.
• Under transitional arrangements for other permanently implantable devices (other than exempt devices) already on the market, patient information leaflets will be required from 1 December 2021. This includes surgical mesh that is not used for urogynaecological applications.

Patient implant cards

• Since 1 December 2018 manufacturers of new urogynaecological mesh devices are required to provide patient implant cards detailing the make, model and type of device.
• Under transitional arrangements for urogynaecological mesh devices already on the market, patient implant cards have been required since 1 December 2019.
• Patient implant cards have been required since 1 December 2020 for other new permanently implantable devices (other than exempt devices), including surgical mesh not used for urogynaecological applications.
• Under transitional arrangements for other permanently implantable devices (other than exempt devices) already on the market, patient implant cards will be required from 1 December 2021. This includes surgical mesh not used for urogynaecological applications.

We are working with sponsors to meet the requirements.

Together, patient information leaflets and patient implant cards assist doctors to ensure patients are aware and provide informed consent and enhances the traceability of medical devices in the health system.

Patient information leaflets help consumers understand their device, including its approved uses, intended patient population, potential adverse effects and relevant precautions for users.

Patient implant cards provide patients with the details of the medical device they have had implanted, and must include:

• the name and model of the device
• either its batch code, lot number or serial number
• its unique device identifier (if any)
• the manufacturer's name, address and website.

Since 17 January 2018, we have required sponsors to update the instructions for use (IFUs) for mid-urethral slings used to treat stress urinary incontinence, including to add information about adverse events such as severe chronic pain, groin pain and bladder perforation. 

IFUs help surgeons explain the surgery's purpose, risks, and benefits to patients.

Urogynaecological mesh and Medicare

On 1 July 2018, the Australian Government introduced changes to the Medicare Benefits Schedule (MBS) to address patient safety concerns regarding the use of urogynaecological mesh in pelvic organ prolapse surgery. 

As a result, MBS rebates are only payable for procedures that do not employ the use of urogynaecological mesh.

There are also three new interim items on the MBS for the surgical removal of urogynaecological mesh in symptomatic patients. 

More information on the changes is available on the Department of Health website.

National Clinical Quality Registries

The Department of Health published the National Clinical Quality Registry and Virtual Registry Strategy 2020-2030. 

The Australian Government developed the strategy with:

• the Australian Commission on Safety and Quality in Health Care (the Commission),
• state and territory governments and
• key stakeholders.

This work complements the Commission's Framework for Australian Clinical Quality Registries. 

A CQR is a way of monitoring the safety and quality of medical devices. Examples of existing CQRs that monitor medical devices include:

• Australian Breast Device Registry
• Australian Orthopaedic Association National Joint Replacement Registry
• Australasian Pelvic Floor Procedures Registry

Senate Community Affairs References Committee report

• Australian Government response to the Senate Community Affairs References Committee report
• Progress report: Australian Government response to the Senate Community Affairs References Committee report
• Final Report on the Australian Government Response to the Recommendations of the Senate Community Affairs References Committee Report