Australian Government actions

1998 – The TGA approved the first urogynaecological mesh devices for supply in Australia.

2006 – The first report of an adverse event related to a urogynaecological mesh device was reported to the TGA.

2008 – The TGA commenced monitoring of reported concerns about urogynaecological mesh.

2013 – Reports of adverse events began to increase significantly.

August 2016 – The TGA urged consumers and healthcare professionals to report adverse events related to urogynaecological mesh, after recognising they were likely being under-reported.

November 2017 – The TGA cancelled the approval of two types of urogynaecological mesh after determining the risks to patients outweighed the potential benefits.

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.

December 2018 – The TGA:

• cancelled the approval of all mesh devices placed transvaginally for pelvic organ prolapse and slings for stress urinary incontinence
• placed conditions on all remaining urogynaecological mesh devices used to treat pelvic organ prolapse, to stop their use in transvaginal-placement procedures
• required all mesh devices to be subject to a comprehensive review by the TGA before they can be supplied in Australia, including a requirement for detailed clinical evidence as part of the TGA’s up-classification to Class III (high risk) devices
• required manufacturers of new permanently implantable devices, including urogynaecological mesh, to provide patient information leaflets with the device.

December 2020 – The TGA:

• approved the supply of four urogynaecological mesh products (see below), which were previously approved as Class IIb medical devices, under the higher standards for Class III (high risk) devices
• extended the approval of the same four urogynaecological mesh products as Class IIb devices from 1 to 11 December as a transitional measure, until they were formally added to the ARTG as Class II devices
• cancelled the approval of all other Class IIb surgical mesh devices and removed them from the ARTG.

Approved urogynaecological mesh devices

The following four products are approved as Class III devices as of 11 December 2020, when new ARTG entries were published. Their approval as Class IIb devices remained valid during a transitional period (1–11 December 2020).

For more detailed information on approved and cancelled urogynaecological 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 re-lodge their applications with the TGA under the new classification by December 2020 for continued inclusion in the ARTG. Where applications were not received, the TGA removed those devices from the ARTG.

The TGA has 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 the TGA receives 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.

The TGA is 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 use, 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, TGA has 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. The IFUs support consultations between surgeons and patients about the purpose of the surgery and its potential benefits, risks and complications.

A list of updated IFUs is on the page, 'TGA actions after review into urogynaecological surgical mesh implants'.

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

In February 2021 the Department of Health published the National Clinical Quality Registry and Virtual Registry Strategy 2020-2030. The strategy was developed by the Australian Government in partnership with the Australian Commission on Safety and Quality in Health Care (the Commission), state and territory governments and key stakeholders.

This work complements and builds upon the Commission's Framework for Australian Clinical Quality Registries. It considers ways to provide a nationally consistent approach to the selection, funding, implementation, management and performance of CQRs to improve the safety and quality of clinical practice and patient outcomes.

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