Medical practitioners' guide to up-classifying surgical mesh

This guidance informs medical practitioners and hospitals of:

• potential supply disruption of some surgical mesh devices
• options for practitioners/hospitals seeking to use devices cancelled from the ARTG.

Introduction

The Therapeutic Goods (Medical Device) Regulations 2002 were amended on 29 October 2021. 

The transitional arrangements for surgical mesh (other than urogynaecological mesh) were made more flexible.

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).

Amendments were made to the Therapeutic Goods (Medical Devices) Regulations 2002. It commenced 1 December 2018.

Classifying surgical mesh as high-risk devices was in response to serious safety concerns. Before, they were Class IIb devices (medium risk devices).

The timeframes for meeting 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 manufacture of the device meets the highest levels of safety, quality, and clinical performance.

Surgical meshes

We have prepared a guidance document. 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 up-classification. In some cases, applications to up-classify were not approved by 1 December 2021. Some surgical mesh devices may be disrupted as a result.

Options 

Here are some options for practitioners/hospitals looking to use cancelled ARTG devices.

• For stock already on hand (on shelves), the device can be used as it was supplied when the ARTG entry was still valid. If the device is being used for private patients and being reimbursed by private health insurers (via the Prostheses List), you will need to confirm if the private health insurer will reimburse a device no longer included in the ARTG.
• You can import or supply cancelled Class IIb devices by applying under the SAS (category B) or AP scheme. 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). When applying to supply a device under the SAS or AP schemes, practitioners must explain why no device in the ARTG is suitable. Having a preference for a specific device is not considered an adequate justification.
• Source an equivalent Class III surgical mesh device included in the ARTG or an equivalent Class IIb mesh device that’s still in the ARTG. See the tables below.

Approved 

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

Eligibility for transition

Other mesh devices (non-urogynaecological) eligible for the transition period are below. They have met the Class III regulatory requirements.

Some models of surgical mesh can continue to be supplied under the Class IIb entry.

A sponsor or manufacturer may choose not to continue supply of all models of products. You can get an update from your supplier on available products.

Existing

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

Contact us

Medical practitioners with enquiries can contact us via email at: DevicesClinicalAdvice@health.gov.au.