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

18 February 2022

On 29 October 2021 amendments to the Therapeutic Goods (Medical Device) Regulations 2002 came into effect allowing greater flexibility to the current transitional arrangements for devices that are surgical mesh (other than urogynaecological mesh).

Under these changes, a sponsor will be able to access transitional arrangements if they have submitted an application for TGA conformity assessment certificate before 1 December 2021 and are no longer required to have previously notified the TGA.

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 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 were:

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 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 could meet Class III regulatory requirements were cancelled from the ARTG and can no longer be supplied in Australia, except for 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 that were not able to demonstrate they can meet Class III regulatory requirements. Sponsors who had an existing Class IIb ARTG entry for other surgical mesh device were required 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 commenced cancelling surgical mesh devices in the ARTG as Class IIb entries who have not completed one of the two actions above. The cancelled devices can no be longer supplied in Australia, except under the Special Access Scheme.

Not all sponsors proceeded with up-classification, or the assessment and approval processes were not completed by 1 December 2021 for those sponsors applying to up-classify, resulting in potential supply disruption of some surgical mesh devices.

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

  • For stock already on hand (i.e.: on shelves) it 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 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 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.

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 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

Other surgical mesh devices eligible for transition

The following table lists other surgical mesh devices (non- urogynaecological) that are eligible for 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 of all models of products; please check with your supplier for an update on which models are included in the reclassification.

Sponsor ARTG Product range Model name
Bard Australia Pty Ltd 122873 Mesh, surgical

3D Max Light Mesh

Bard 3D Max Mesh

Bard Mesh

Bard Mesh PerFix Plug

Bard Soft Mesh

Onflex Mesh

PerFix Light Plug

Bard Ventralex Hernia Patch

Boston Scientific 297821 Mesh, surgical (Male SUI)

AdVance XP Male Sling - 1008176

AdVance XP Male Sling System - M0067206830

AdVance XP Male Sling System - 720163-02

AdVance XP Male Sling System

Corin Australia Pty Ltd 138573 Ligament prosthesis, non-absorbable Ligament Advanced Reinforcement System (LARS) Artificial Ligament
Johnson & Johnson Medical Pty Ltd 120154 Mesh, surgical

UltraPro Mesh

UltraPro Advanced Mesh

Johnson & Johnson Medical Pty Ltd 165074 Mesh, polymeric, non-biodegradable

Prolene Mesh

Prolene Soft Polypropylene Mesh

LMT Surgical Pty Ltd 135600 Ligament prosthesis, non-absorbable LSSS Shoulder Stabilisation System
Medtronic Australasia Pty Ltd 237409 Mesh, surgical synthetic polymer (Abdominal hernia) Versatex Monofilament Mesh
Medtronic Australasia Pty Ltd 125428 Mesh, surgical (abdominal/hernia repair)

Parietene Flat Sheet Mesh

Parietene Lightweight Mesh

Parietex Hydrophillic 2D Mesh

Parietex Hydrophillic Anatomical Mesh

Parietex Hydrophillic 3D Mesh

Medical Specialties Australasia Pty Ltd 97288 Mesh, surgical

TiLOOP Bra Pocket

TiLOOP Bra MPX

TiLOOP Bra

TiLENE

TiLENE Plug Set

TiMESH

TiLENE Plug

Neosurgical Pty Ltd 169013 Surgical support tape, non-absorbable Leeds-Keio Polytape aka Poly-Tape
Neosurgical Pty Ltd 278118 Acromioclavicular joint stabilization implant Infinity-Lock Button System

Existing Class III surgical mesh devices

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

Sponsor ARTG Product range Model Name
Akva Surgical

154546

Mesh, polymeric, biodegradable

MSH – 1032, 1033, 1034, 1035, 1030, 1031

PLT - 1028, 1029, 1030, 1031, 1032, 1033, 1034, 1035
Allergan Australia Pty Ltd

206374

Silk surgical mesh SERI Surgical Scaffold
Alliance Surgical Pty Ltd 222740 Abdominal hernia surgical mesh, composite-polymer 4D Dome Semi Resorbable Mesh with Onlay patch
283655 4DMesh - Anatomical
354550 4DVENTRAL Semi-resorbable parietal reinforcement implant
Bard Australia Pty Ltd 219323 Abdominal hernia surgical mesh, composite-polymer Ventralex ST Hernia Patch
219324 Ventrio ST Hernia Patch
219332 Ventralight ST Mesh
219333 Ventralight ST Mesh with Echo PS Positioning System
365351 Ventralight ST Mesh with Echo 2 Positioning System
318473 Mesh, polymeric, biodegradable Phasix Mesh
318512 Phasix ST Mesh
376471 Abdominal hernia surgical mesh, synthetic polymer 3DMax Mesh
Baxter Healthcare Pty Ltd 219240 Multi-purpose surgical mesh, collagen Veritas Collagen Matrix
Emergo Asia Pacific Pty Ltd T/a Emergo Australia

202446

Mesh, polymeric, biodegradable TIGR® Matrix Surgical Mesh
Endotherapeutics Pty Ltd 153045 Multi-purpose surgical mesh, collagen Biodesign Anal Fistula Plug
153046 Biodesign Recto-Vaginal Fistula Plug
153047 Biodesign 4-Layer Tissue Graft
153048 Biodesign 8-Layer Tissue Graft
153051 Biodesign Hiatal Hernia Graft
153052 Biodesign Hernia Graft
230911 Biodesign Recto-Vaginal Fistula Plug Kit
317940 Biodesign Rectopexy Graft
Johnson & Johnson Medical Pty Ltd 142608 Abdominal hernia surgical mesh, composite-polymer Ultrapro Plug
132509 Ultrapro Hernia System
274361 PHYSIOMESH Open
161186 Proceed Ventral Patch Mesh
357230 Proceed Surgical Mesh
165926 Mesh, polymeric, biodegradable PDS Plate
143774 Vicryl Mesh
LMT Surgical Pty Ltd 148712 Mesh, surgical Vivosorb
Medtronic Australasia Pty Ltd

149430

Abdominal hernia surgical mesh, composite-polymer Progrip™ Self-Gripping Polypropylene Mesh
258212 Parietex Composite Ventral Patch
270737 Symbotex Composite Mesh (with pre-placed suture)
270735 Symbotex Composite Mesh
270736 Symbotex Composite Mesh (with skirts)
252653 ProGrip™ Laparoscopic Self Fixating Mesh
157201 Progrip Self-Gripping Polyester Mesh
269662 Multi-purpose surgical mesh, collagen Permacol Surgical Implant
Neosurgical Pty Ltd 380417 Surgical support tape, non-absorbable LK2 Poly-Tape
379210 Acromioclavicular joint stabilization implant Infinity-Lock Button System
Smith & Nephew Pty Ltd 340095 Multi-purpose surgical mesh, collagen ARTHRO BIOINDCTIVE IMPLANT
340096 REGENETEN™ MiniOpen Bioinductive implant
W L Gore & Associates (Australia) Pty Ltd 233234 Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial GORE DUALMESH PLUS Biomaterial
153241 Mesh, surgical Preclude Pericardial Membrane
153351 Mesh, polymeric, biodegradable Seamguard Bioabsorbable Staple Line Reinforcement
153352 Seamguard Bioabsorbable Staple Line Reinforcement - CBSG
175834 Gore BIO-A Tissue Reinforcement
William A Cook Australia Pty Ltd 300314 Multi-purpose surgical mesh, collagen Biodesign Otologic repair Graft