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Information for medical practitioners on up-classification of surgical mesh devices
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.
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 one of the following two actions:
- 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
- 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 that had not been included in 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 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.
|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 Mesh PerFix Plug
Bard Soft 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 Advanced Mesh
|Johnson & Johnson Medical Pty Ltd||165074||Mesh, polymeric, non-biodegradable||
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
TiLENE Plug Set
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|
|Mesh, polymeric, biodegradable||
MSH – 1032, 1033, 1034, 1035, 1030, 1031PLT - 1028, 1029, 1030, 1031, 1032, 1033, 1034, 1035
|Allergan Australia Pty Ltd||
|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|
|Boston Scientific Pty Ltd||388078||Male stress urinary incontinence surgical mesh||AdVance XP Male Sling System 720163-02|
|Boston Scientific Pty Ltd||388082||Male stress urinary incontinence surgical mesh||AdVance XP Male Sling System|
|Emergo Asia Pacific Pty Ltd T/a Emergo Australia||
|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|
|161186||Proceed Ventral Patch Mesh|
|357230||Proceed Surgical Mesh|
|165926||Mesh, polymeric, biodegradable||PDS Plate|
|LMT Surgical Pty Ltd||148712||Mesh, surgical||Vivosorb|
|Medtronic Australasia Pty Ltd||
|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|
|384118||REGENETEN™ 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|