On this page: Purpose | Introduction | What is different about Class III requirements? | What are surgical meshes? | Availability of these devices to medical practitioners | Options for practitioners/hospitals seeking to use devices that have been cancelled | Approved surgical mesh devices (urogynaecological) | Approved other surgical mesh devices | Existing Class III surgical mesh devices

Purpose of this guidance

This guidance is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1 December 2021.

Supply disruption could be experienced due to some sponsors not able to demonstrate that they meet Australian regulatory requirements for safety, quality, and performance for these types of devices.

Introduction

Surgical mesh sponsors were given three years (2018-2021) to provide evidence to the TGA that demonstrated their surgical mesh device meets the regulatory requirements of a high risk device (i.e.: Class III).

This requirement was agreed through amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, commencing on 1 December 2018.

Classifying surgical mesh devices as high risk devices was in response to serious safety concerns. Previously, these devices were classified as medium risk devices (i.e.: Class IIb).

The timeframe for meeting the new requirements are:

What is different about Class III requirements?

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

What are surgical meshes?

The TGA has prepared a guidance document, including the range of devices that are 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)
• surgical support tape, non-absorbable (reinforcement of the tendon).

Availability of these devices to medical practitioners

• Implementation of the reclassification of urogynaecological mesh devices was completed in 2020. Devices that were not able to demonstrate they could meet Class III regulatory requirements were cancelled from the ARTG and no longer supplied in Australia, except for when applied for use under the Special Access Scheme.
• For other surgical mesh devices, the TGA will take similar steps to cancel ARTG entries for those devices that are not able to demonstrate they can meet Class III regulatory requirements. Sponsors who have an existing ARTG entry for other surgical mesh device will need to complete the following two actions:
  1. Have an appropriate conformity assessment certificate for the Class III device or applied for TGA conformity assessment certificate for the Class III device prior to 1 December 2021; or
  2. Have applied to the TGA for a Class III ARTG inclusion for the device prior to 1 December 2021 or within six months of the conformity assessment certificate for the Class III device being issued.

From 1 December 2021, the TGA will commence cancelling surgical mesh devices in the ARTG as Class IIb entries who have not completed one of the two actions above. The cancellation of these devices is expected to take effect from mid-January 2022, due to legislative timeframes for regulatory decisions.

It is unlikely that all the sponsors will proceed with up-classification, or the assessment and approval processes be complete by 1 December 2021 for those sponsors that are up-classifying, resulting in potential supply disruption of some surgical mesh devices.

Options for practitioners/hospitals seeking to use devices that have been cancelled

• For stock that is already on hand (i.e.: on shelves) can continue to be used as the devices were supplied to you when the ARTG entry was still valid. However, if the device is being used for private patients and reimbursed by private health insurers (via the Prostheses List), you will need to confirm if the private health insurer will reimburse a device that is no longer on the ARTG.
• You can apply under the Special Access Scheme (SAS) (category B) or Authorised Prescriber (AP) scheme to import or supply cancelled Class IIb devices. A key criteria for the supply of an unapproved device under the SAS or AP scheme is that there are no devices included in the ARTG suitable for use for the relevant condition(s) and patient(s). Practitioners applying to supply a device under the SAS or AP scheme must provide a justification to explain why none of the devices included in the ARTG are suitable; as a general rule, preferences for a specific device are not considered adequate justification.
• You can source an equivalent Class III surgical mesh device(s) that is included in the ARTG, or an equivalent Class IIb surgical mesh device that has met the transition requirements and remains included in the ARTG (see the tables below).

Medical practitioners with inquiries about these arrangements can contact the TGA at DevicesClinicalAdvice@health.gov.au.

Approved surgical mesh devices (urogynaecological)

The following table lists urogynaecological mesh devices included in the ARTG that have met the Class III regulatory requirements.

Other surgical mesh devices eligible for transition

We will update the list of other surgical mesh devices that are eligible for transition period and have met the Class III regulatory requirements. This means that 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; please check with your supplier for an update on which models will be included in the reclassification.

Existing Class III surgical mesh devices

The following table lists (non-urogynaecological) other surgical mesh devices that are already classified as Class III medical devices. These include surgical meshes that contain tissues, cells, or substances of animal, microbial, or recombinant origin.