Current status of mesh products in Australia

Introduction

On 26 October 2017, the Therapeutic Goods Administration announced the reclassification of all surgical mesh. An amendment was made to subclause 3.4(4A) of Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002, which required surgical mesh devices to be classified as Class III medical devices. This commenced on 1 December 2018. 

Surgical mesh sponsors were given three years (2018-2021) to provide evidence to the TGA to demonstrate their surgical mesh device met the regulatory requirements for a high-risk device (i.e. Class III). Prior to the regulatory amendments, surgical mesh devices were classified as Class IIb medical devices (medium-risk devices).

The timeframes for Sponsors to meet the new requirements were:

Class III requirements

There are more stringent criteria for Class III medical devices than Class IIb medical devices to demonstrate that the device meets the highest levels of safety, quality, and clinical performance.

Surgical meshes

We have prepared the following guidance: Reclassifying surgical mesh devices. This includes the range of devices classified as surgical mesh, for example:

• synthetic surgical mesh used for breast implant surgeries;
• surgical mesh used to treat male stress urinary incontinence (SUI);
• surgical support tape, non-absorbable (tissue approximation, ligaments, tendons, or other soft tissues); and
• surgical support tape, non-absorbable (reinforcement of the tendon).

Availability of devices

• Implementation of the reclassification of urogynaecological mesh devices was completed in 2020. Devices that could not demonstrate they met Class III requirements were removed from the ARTG. In Australia, they can only be supplied if approved for use under the Special Access Scheme.
• For other surgical mesh devices, we took similar steps. Sponsors who had a Class IIb ARTG entry for different mesh devices were required to do one of two things:
  1. Have an appropriate conformity assessment certificate for the Class III device or have applied for TGA conformity assessment certificate for the Class III device before 1 December 2021; or
  2. Have applied to the TGA for a Class III ARTG inclusion for the device before 1 December 2021 or within six months of the conformity assessment certificate for the Class III device being issued.

Starting 1 December 2021, we began cancelling Class IIb surgical mesh entries in the ARTG. This applies to devices that were not included in the two actions mentioned above. These cancelled devices can no longer be supplied in Australia, except under the Special Access Scheme.

Some sponsors did not proceed with reclassification.

Current status of mesh devices in Australia

All eligible mesh devices in Australia have now been reclassified to Class III. Any Class IIb mesh devices that remain on the ARTG will be removed. 

There are 4 ARTG entries approved for urogynaecological mesh, for treatment of stress urinary incontinence (SUI). 

All other surgical mesh devices included in the ARTG are not intended for urogynaecological indications.

Please see the instructions for use (IFU) for each device to identify the specific indications for use.

See the following sections for the lists of approved Class III urogynaecological and non-urogynaecological mesh devices.

Approved urogynaecological mesh devices

The following lists Class III devices for urogynaecological mesh in the ARTG.

Other mesh devices (non-urogynaecological) that were reclassified

Other mesh devices (non-urogynaecological) that were eligible for transition and have been reclassified to Class III are listed in the table below. 

Please ensure that the Class III equivalent is used. All Class IIb mesh devices will be removed from the ARTG once the Class III equivalent entries have been updated on the Prescribed List (PL).

Approved other mesh devices (non-urogynaecological)

Listed below are other surgical mesh devices (non-urogynaecological) that are classified as Class III. These include meshes containing tissues, cells, or substances of animal, microbial, or recombinant origin.