Information for medical practitioners on up-classification of 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 may be the result of 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 to demonstrate their surgical mesh device meets the regulatory requirements for 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 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 timeframes for meeting the new requirements were:

What is different about 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.

What are surgical meshes?

The TGA has prepared a guidance document, that 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)
• 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 not able to demonstrate they met Class III regulatory requirements were cancelled from the Australian Register of Therapeutic Goods (ARTG) and can no longer be supplied in Australia, except when approved for use under the Special Access Scheme.
• For other surgical mesh devices, the TGA took similar steps to cancel ARTG entries for those devices not able to demonstrate they meet Class III regulatory requirements. Sponsors with an existing Class IIb ARTG entry for other surgical mesh devices were required to complete one of the following two actions:
  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 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 commenced cancelling Class IIb surgical mesh entries in the ARTG for devices not included in one of the two actions above. These cancelled devices can no longer be supplied in Australia, except under the Special Access Scheme.

Not all sponsors proceeded with up-classification and, in some instances, the assessment and approval processes of applications to up-classify were not completed by 1 December 2021.This has resulted in potential supply disruption of some surgical mesh devices.

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

• For stock already on hand (i.e. on shelves) the device can continue to be used as it was 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 no longer in 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 criterion 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 schemes must provide a justification to explain why no device included in the ARTG is suitable for use; noting as a general rule, preferences for a specific device are not considered adequate justification.
• You can source an equivalent Class III surgical mesh device 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

The following table lists other surgical mesh devices (non-urogynaecological) that are eligible for the transition period and have met the Class III regulatory requirements. This means 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 all models of products; please check with your supplier for an update on which models are included in the reclassification.

Existing Class III surgical mesh devices

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