You are here
Information for medical practitioners on pending 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 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:
Implementation date | Type of surgical mesh |
---|---|
1 December 2020 | Urogynaecological meshes |
1 December 2021 | All other surgical meshes |
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:
- Have a Class III conformity assessment certificate for the device; and
- Have applied to the TGA for a Class III ARTG inclusion for the device prior to 1 December 2021.
From 1 December 2021, the TGA will commence cancelling surgical mesh devices in the ARTG as Class IIb entries who have not completed 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 on the ARTG.
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.
Sponsor | ARTG | Product range |
---|---|---|
Boston Scientific Pty Ltd | 373424 | Advantage Blue System |
Boston Scientific Pty Ltd | 373425 | Advantage Fit Blue System |
Boston Scientific Pty Ltd | 373426 | Obtryx II System Halo |
Johnson & Johnson | 351638 | GYNECARE TVT ABBREVO Continence System - Product code TVTOML |
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 |
Approved other surgical mesh devices
We will update the list of other surgical mesh devices that are eligible for transition period and have met the Class III regulatory requirements.
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.
Sponsor | ARTG | Product range |
---|---|---|
Johnson & Johnson Medical Pty Ltd |
142608 132509 274361 117402 161186 128896 |
Abdominal hernia surgical mesh, composite-polymer |
Johnson & Johnson Medical Pty Ltd |
165926 143774 |
Mesh, polymeric, biodegradable |
LMT Surgical Pty Ltd | 148712 | Mesh, surgical |
Medtronic Australasia Pty Ltd |
214997 214694 149430 214998 258212 270737 270735 270736 252653 184443 157201 |
Abdominal hernia surgical mesh, composite-polymer |
W L Gore & Associates (Australia) Pty Ltd | 233234 | Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial |
W L Gore & Associates (Australia) Pty Ltd | 153241 | Mesh, surgical |
W L Gore & Associates (Australia) Pty Ltd |
153351 153352 175834 |
Mesh, polymeric, biodegradable |
William A Cook Australia Pty Ltd |
230911 153045 153047 153048 153051 300314 153046 153052 |
Multi-purpose surgical mesh, collagen |