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Information for medical practitioners on pending up-classification of surgical mesh devices

21 December 2020

Purpose of this guidance

This guidance is to inform medical practitioners and hospitals of potential supply issues for some surgical mesh devices due to the commencement of stricter regulatory requirements (i.e. "up-classification") on the manufacturers and sponsors of those devices. These changes do not impose any obligations on medical practitioners or hospitals; this document is for their information only.

Introduction

On 1 December 2018, amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 commenced. These amendments require surgical meshes previously classified as Class IIb medical devices to be re-classified as Class III medical devices.

The amendments respond to safety concerns relating to mesh products. They also bring the regulatory framework closer to the European Union (EU) for these devices. The Australian Government has decided to reclassify these devices ahead of the EU in order to address the serious concerns about the risks associated with the devices.

The amendments set out a transition timetable for surgical meshes already included in the Australian Register of Therapeutic Goods (ARTG) as Class IIb devices to transition into the ARTG as Class III devices:

Implementation date Type of surgical mesh
1 December 2020 Urogynaecological meshes
1 December 2021 All other surgical meshes

Sponsors of surgical meshes previously included in the ARTG as Class IIb devices must fulfil two requirements, by these dates, to transition to a Class III device:

  • have a Class III conformity assessment certificate for the device; and
  • have applied to the TGA for a Class III ARTG inclusion.

What is different about Class III requirements?

Class III medical devices must meet more stringent criteria than Class IIb medical devices to demonstrate to the TGA that the manufacture of the device meets the legislative requirements.

What are surgical meshes?

The TGA has prepared a detailed guidance document on surgical mesh, including the range of devices that constitute surgical mesh.

Availability of these devices to medical practitioners

The amendments may disrupt the supply of some mesh devices as of 1 December 2020 and 1 December 2021.

The TGA will take steps to cancel the ARTG entries of any Class IIb surgical mesh device for which the sponsor has not made an application to include the device as a Class III device by the relevant date:

  • 1 December 2020 for urogynaecological meshes
  • 1 December 2021 for all other surgical meshes.

In addition, where the TGA does receive an application by the transition date, but concludes that those devices do not meet the requirements for inclusion in the ARTG as a Class III device, the TGA will also take steps to cancel the entries for those devices.

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

Following cancellation from the ARTG of mesh devices that were previously available, practitioners and hospitals:

  • can continue to use existing stock on hand;
  • source alternative Class III devices that are included in the ARTG; or
  • apply under the Special Access Scheme (SAS) (category B) or Authorised Prescriber (AP) schemes to import or supply cancelled Class IIb devices.

Between 1 December 2020 and mid-January 2021 (when cancellation of non-transitioned ARTG entries take effect) the supply of Class IIb devices by a manufacturer or sponsor may be unlawful.

One of the key criteria for the supply of an unapproved device under SAS or Authorised Prescriber is 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 SAS or AP 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.

Approved surgical mesh (urogynaecological)

Following is a list of urogynaecological mesh devices included in the ARTG that have met the regulatory requirements. The TGA approved the supply of these devices as Class III devices from 11 December 2020. (Supply of these devices under their previous Class IIb ARTG entries was approved by the TGA from 1 December 2020, until the Class III ARTG entry was published on 11 December 2020).

Sponsor ARTG Product range
Johnson & Johnson 351635 GYNECARE TVT Device Tension Free Vaginal Tape - Product code 810041B
Johnson & Johnson 351637 GYNECARE TVT Obturator System - Product code 810081
Johnson & Johnson 351636 GYNECARE TVT EXACT Continence System - Product code TVTRL
Johnson & Johnson 351638 GYNECARE TVT ABBREVO Continence System - Product code TVTOML

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