Introduction
On 26 October 2017, the Therapeutic Goods Administration announced the reclassification of all surgical mesh. An amendment was made to subclause 3.4(4A) of Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002, which required surgical mesh devices to be classified as Class III medical devices. This commenced on 1 December 2018.
Surgical mesh sponsors were given three years (2018-2021) to provide evidence to the TGA to demonstrate their surgical mesh device met the regulatory requirements for a high-risk device (i.e. Class III). Prior to the regulatory amendments, surgical mesh devices were classified as Class IIb medical devices (medium-risk devices).
The timeframes for Sponsors to meet the new requirements were:
| Implementation date | Type of surgical mesh |
|---|---|
| 1 December 2020 | Urogynaecological meshes |
| 1 December 2021 | All other surgical meshes |
Class III requirements
There are more stringent criteria for Class III medical devices than Class IIb medical devices to demonstrate that the device meets the highest levels of safety, quality, and clinical performance.
Surgical meshes
We have prepared the following guidance: Reclassifying surgical mesh devices. This 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); and
- surgical support tape, non-absorbable (reinforcement of the tendon).
Availability of devices
- Implementation of the reclassification of urogynaecological mesh devices was completed in 2020. Devices that could not demonstrate they met Class III requirements were removed from the ARTG. In Australia, they can only be supplied if approved for use under the Special Access Scheme.
- For other surgical mesh devices, we took similar steps. Sponsors who had a Class IIb ARTG entry for different mesh devices were required to do one of two things:
- Have an appropriate conformity assessment certificate for the Class III device or have applied for TGA conformity assessment certificate for the Class III device before 1 December 2021; or
- Have applied to the TGA for a Class III ARTG inclusion for the device before 1 December 2021 or within six months of the conformity assessment certificate for the Class III device being issued.
Starting 1 December 2021, we began cancelling Class IIb surgical mesh entries in the ARTG. This applies to devices that were not included in the two actions mentioned above. These cancelled devices can no longer be supplied in Australia, except under the Special Access Scheme.
Some sponsors did not proceed with reclassification.
Current status of mesh devices in Australia
All eligible mesh devices in Australia have now been reclassified to Class III. Any Class IIb mesh devices that remain on the ARTG will be removed.
There are 4 ARTG entries approved for urogynaecological mesh, for treatment of stress urinary incontinence (SUI).
All other surgical mesh devices included in the ARTG are not intended for urogynaecological indications.
Please see the instructions for use (IFU) for each device to identify the specific indications for use.
See the following sections for the lists of approved Class III urogynaecological and non-urogynaecological mesh devices.
Approved urogynaecological mesh devices
The following lists Class III devices for urogynaecological mesh in the ARTG.
| Sponsor | ARTG | Product range |
|---|---|---|
Endotherapeutics Pty Ltd (previous sponsor - Johnson & Johnson) | 351635 | GYNECARE TVT™ Device Tension Free Vaginal Tape - Product code 810041B |
| 351637 | GYNECARE TVT™ Obturator System - Product code 810081 | |
| 351636 | GYNECARE TVT™ EXACT™ Continence System - Product code TVTRL | |
| 351638 | GYNECARE TVT™ ABBREVO™ Continence System - Product code TVTOML |
Other mesh devices (non-urogynaecological) that were reclassified
Other mesh devices (non-urogynaecological) that were eligible for transition and have been reclassified to Class III are listed in the table below.
Please ensure that the Class III equivalent is used. All Class IIb mesh devices will be removed from the ARTG once the Class III equivalent entries have been updated on the Prescribed List (PL).
| Sponsor | Class IIb ARTG | Product range | Model name | Class III equivalent ARTG |
|---|---|---|---|---|
| Bard Australia Pty Ltd | 122873 | Mesh, surgical | Bard Soft Mesh | 410979 |
Device Technologies Australia Pty Ltd (previous sponsor - Corin Australia Pty Ltd) | 138573 | Ligament prosthesis, non-absorbable | The ARTG entries for the equivalent Class III device have been split into separate entities for each model. The Class III ARTG entries are listed in the rows below. | |
| LARS - Anterior Cruciate (DB) | 460516 | |||
| LARS - Posterior Cruciate | 460517 | |||
| LARS - Knee Lateral Ligaments (Straight) | 460518 | |||
| LARS - Knee Lateral Ligaments (Y) | 460519 | |||
| LARS - Patellar Tendon | 460520 | |||
| LARS - Achilles Tendon | 460546 | |||
| LARS - Ankle Ligaments | 460547 | |||
| LARS - Soft Tissues - Tendons and Ligaments | 460548 | |||
| LARS - Soft Tissues - Muscles, Tendons and Ligaments | 460549 | |||
| LARS - Soft Tissues - Muscles and Tendons | 460550 | |||
| LMT Surgical Pty Ltd | 135600 | Ligament prosthesis, non-absorbable | LSSS Shoulder Stabilisation System | 433851 Note: The Class IIb ARTG entry 135600 has been cancelled by the Sponsor. All models are now supplied under the Class III ARTG entry 433851. |
| Medtronic Australasia Pty Ltd | 125428 | Mesh, surgical (abdominal/hernia repair) | The ARTG entries for the equivalent Class III device have been split into separate entities for each model. The Class III ARTG entries are listed in the rows below. Note: The Class IIb ARTG entry 125428 has been cancelled by the Sponsor. All models are now supplied under the Class III ARTG entries below. | |
| Parietene Flat Sheet Mesh | 421377 | |||
| Parietene Lightweight Mesh | 421381 | |||
| Medical Specialties Australasia Pty Ltd | 97288 | Mesh, surgical | The ARTG entries for the equivalent Class III device have been split into separate entities for each model. The Class III ARTG entries are listed in the rows below. | |
| TiLOOP Bra Pocket | 503628 | |||
| TiLOOP Bra | 503627 | |||
| TiLENE | 521537 | |||
Approved other mesh devices (non-urogynaecological)
Listed below are other surgical mesh devices (non-urogynaecological) that are classified as Class III. These include meshes containing tissues, cells, or substances of animal, microbial, or recombinant origin.
| Sponsor | ARTG | Product range | Model Name |
|---|---|---|---|
Asia Actual Australia (previous sponsor - Alliance Surgical Pty Ltd) | 222740 | Abdominal hernia surgical mesh, composite-polymer | 4D Dome Semi Resorbable Mesh with Onlay patch |
| 283655 | 4DMesh - Pre-shaped | ||
| 354550 | 4DVENTRAL Semi-resorbable parietal reinforcement implant | ||
| 516305 | Abdominal hernia surgical mesh, composite-polymer | INTRAMESH T1 | |
| 516306 | BIOMESH CA.B.S’.Air Composite | ||
| 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 | |
| 394752 | Bard Mesh PerFix Plug | ||
| 398775 | OnFlex™ Mesh | ||
| 398770 | 3DMax™ Light Mesh | ||
| 400716 | Ventralex™ Hernia Patch | ||
| 400494 | PerFix™ Light Plug | ||
| 404318 | Bard Mesh | ||
| 490385 | 3DMax™ MID Anatomical Mesh | ||
| Boston Scientific Pty Ltd | 388082 | Male stress urinary incontinence surgical mesh | AdVance XP Male Sling System |
| Device Technologies Australia Pty Ltd | 460515 | Ligament prosthesis, non-absorbable | LARS - Anterior Cruciate |
| 460516 | LARS - Anterior Cruciate (DB) | ||
| 460517 | LARS - Posterior Cruciate | ||
| 460518 | LARS - Knee Lateral Ligaments (Straight) | ||
| 460519 | LARS - Knee Lateral Ligaments (Y) | ||
| 460520 | LARS - Patellar Tendon | ||
| 460546 | LARS - Achilles Tendon | ||
| 460547 | LARS - Ankle Ligaments | ||
| 460548 | LARS - Soft Tissues - Tendons and Ligaments | ||
| 460549 | LARS - Soft Tissues - Muscles, Tendons and Ligaments | ||
| 460550 | LARS - Soft Tissues - Muscles and Tendons | ||
| Edwards Lifesciences Pty Ltd | 154067 | Patch, myocardial | Edwards Bovine Pericaridal Patch Model 4700 |
| Emergo Asia Pacific Pty Ltd T/a Emergo Australia | 310096 | Cardiovascular patch, animal-derived | XenoSure Biologic Patch |
Endotherapeutics Pty Ltd (Previous sponsor - William A Cook Australia Pty Ltd) | 153045 | Multi-purpose surgical mesh, collagen | Biodesign Anal Fistula Plug (C-AFP-0.6X9.5) |
| 153047 | Biodesign 4-Layer Tissue Graft | ||
| 153051 | Biodesign Hiatal Hernia Graft | ||
| 153052 | Biodesign Hernia Graft | ||
| 300314 | Multi-purpose surgical mesh, collagen | Biodesign Otologic repair Graft | |
| Johnson & Johnson Medical Pty Ltd | 357230 | Abdominal hernia surgical mesh, composite-polymer | PROCEED™ Surgical Mesh |
| 390525 | ULTRAPRO™ Mesh | ||
| 390526 | ULTRAPRO ADVANCED™ Mesh | ||
| 389989 | Abdominal hernia surgical mesh, synthetic polymer | PROLENE™ Soft Polypropylene Mesh | |
| 389990 | PROLENE™ Mesh | ||
| 165926 | Mesh, polymeric, biodegradable | PDS Plate | |
| 143774 | Vicryl Mesh | ||
| 448305 | ECHELON ENDOPATH™ Staple Line Reinforcement | ||
| 132509 | Mesh, polymeric, composite | J&J Intl ULTRAPRO Hernia System | |
| 142608 | ULTRAPRO Plug | ||
| 161186 | PROCEED Ventral Patch | ||
Life Healthcare Pty Ltd (previous sponsor - LMT Surgical Pty Ltd) | 148712 | Mesh, surgical | Vivosorb |
| 433851 | Ligament prosthesis, non-absorbable | Lockdown Acromio-clavicular (AC) Device | |
| Medical Specialties Australasia Pty Ltd | 503627 | Abdominal hernia surgical mesh, synthetic polymer | TiLOOP Bra |
| 503628 | TiLOOP Bra Pocket | ||
| 521537 | Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable | TiLENE | |
| Medtronic Australasia Pty Ltd | 149430 | Mesh, surgical | Parietene Progrip |
| 258212 | Parietene Progrip | ||
| 270737 | Abdominal hernia surgical mesh, composite-polymer | Symbotex Composite Mesh with pre-placed suture | |
| 270735 | Symbotex Composite Mesh | ||
| 270736 | Skirted Symbotex Composite Mesh | ||
| 252653 | ProGrip™ Laparoscopic Self Fixating Mesh | ||
| 269662 | Multi-purpose surgical mesh, collagen | Permacol Surgical Implant | |
| 399213 | Abdominal hernia surgical mesh, synthetic polymer | Parietex™ Hydrophilic Anatomical Mesh | |
| 399214 | Parietex™ Hydrophilic 3D Mesh | ||
| 399630 | Parietex™ Hydrophilic 2D Mesh | ||
| 449258 | Parietene Macroporous Mesh | ||
| 421377 | Parietene Flat Sheet Mesh | ||
| 421381 | Parietene Lightweight Mesh | ||
| Naton Medical Aus Pty Ltd (previous sponsor - Akva Surgical) | 154546 | Mesh, polymeric, biodegradable | Inion CPS, OTPS Biodegradable Mesh Plates |
| Neosurgical Pty Ltd | 380417 | Surgical support tape, non-absorbable | LK-2 Polyester Fabric (Poly-Tape) |
| 379210 | Acromioclavicular joint stabilization implant | Infinity-Lock Button System | |
| Smith & Nephew Pty Ltd | 384118 | Multi-purpose surgical mesh, collagen | REGENETEN Bioinductive Implant with Arthroscopic Delivery System |
| Surgical Supplies Australia Pty Ltd | 202446 | Mesh, polymeric, biodegradable | TIGR® Matrix Surgical Mesh |
| W L Gore & Associates (Australia) Pty Ltd | 153241 | Pericardium prosthesis | Preclude Pericardial Membrane |
| 153351 | Mesh, polymeric, biodegradable | Seamguard Bioabsorbable Staple Line Reinforcement- EBSG | |
| 175834 | Gore BIO-A Tissue Reinforcement | ||
| 401130 | Abdominal hernia surgical mesh, composite-polymer | GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL | |
| 454187 | GORE® SYNECOR Preperitoneal Biomaterial |
Page history
Updated to include a 'current status of mesh devices in Australia' section.
Made structural changes to data tables.
Updated to include a 'current status of mesh devices in Australia' section.
Made structural changes to data tables.