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TGA actions after review into urogynaecological surgical mesh implants

Update - Stress Urinary Incontinence (SUI) mid-urethral slings

17 January 2018

This advice supplements previous advice from the 22 December 2017 statement.

Mid-urethral slings are urogynaecological surgical mesh implants, which are used to treat Stress Urinary Incontinence (SUI) in women. Urogynaecological surgical mesh products have been involved in patients experiencing a number of complications, with information being previously published on the TGA website (see links under 'Related information').

Consumers and health professionals are advised that as a result of the TGA's 2017 post-market review of urogynaecological mesh implants, the TGA required sponsors to include information about certain adverse events such as severe chronic pain, groin pain and bladder perforation in the device Instructions for Use (IFUs). To date the following device IFUs has been updated.

Boston Scientific devices:

  1. Advantage Single Handle Kit (UPN M0068502000);
  2. Advantage Fit – single (UPN M0068502110);
  3. Advantage Fit - 5 pack (UPN M0068502111);
  4. Lynx Suprapubic Mid-Urethral Sling Sys. (UPN M0068503000);
  5. Lynx Suprapubic Sling Syst 5-Pack (UPN M0068503001);
  6. Obtryx Curved Single System Device (UPN M0068504000);
  7. Obtryx Halo Single System Device (UPN M0068505000);
  8. Obtryx Halo System 5-Pack (UPN M0068505001);
  9. Obtryx II, Halo, Single unit (UPN M0068505110); and
  10. Obtryx II, Halo, 5 pack (UPN M0068505111).

Coloplast devices:

  1. Aris (UR3010);
  2. Aris kit with Aris mesh (UR3105); and
  3. Supris kit with Aris mesh (519562)

TGA undertakes regulatory actions after review into urogynaecological surgical mesh implants

22 December 2017

The TGA decided on 28 November 2017 to remove transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG).

This follows a review by the TGA of the latest published international studies and an examination of the clinical evidence for each product included in the ARTG and supplied in Australia. Based on this new information, and since the publication by the TGA of the Results of review into urogynaecological surgical mesh implants, the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.

As a result, the TGA has taken a series of regulatory actions in relation to transvaginal mesh products and single incision mini-slings (see Table 1 below). Information about any further actions can be found in the Tables.

The TGA also considers that there is a lack of adequate scientific evidence before the TGA for it to be satisfied that the risks to patients associated with the use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence are outweighed by their benefits. These products will be removed from the ARTG. It should be noted that mini-slings are different devices to mid-urethral slings, which are not being removed from the ARTG.

The TGA has issued a range of cancellation notices and notices to impose conditions under the Therapeutic Goods Act 1989 to a number of sponsors in relation to their mesh and sling products. The Therapeutic Goods Act 1989 provides that cancellation from the ARTG and the new conditions will take effect 20 working days after the notices are issued, being 4 January 2018. The products will remain on the ARTG until that date and may continue to be lawfully supplied until then. The Therapeutic Goods Act 1989 gives a sponsor a right of review in relation to the decision to issue a cancellation notice and a notice to impose conditions. Sponsors have 90 days within which to seek review of the TGA's decisions in relation to their mesh products.

Since the review commenced in 2013, 45 devices have been removed from urogynaecological use by the TGA – 43 cancelled from the ARTG and a further two have been limited to non-urogynaecological procedures (see Table 2 of Devices Cancelled below). Additional devices have been removed from the ARTG by sponsors of the device, due to commercial reasons.

Devices which will remain included on the ARTG and available for legal supply in Australia for urogynaecological repair procedures, effective 4 January 2018, are listed in Table 3.

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ARTG Sponsor Manufacturer Brand/Product Name Regulatory and other Action
150342 Boston Scientific Pty Ltd Boston Scientific Corporation PRF Kit (Pinnacle) Range All models discontinued; condition of inclusion imposed to remove the devices from the ARTG entry
150342 Boston Scientific Pty Ltd Boston Scientific Corporation PRF Kit (Uphold) Device discontinued; condition of inclusion imposed to remove the device from the ARTG entry
150342 Boston Scientific Pty Ltd Boston Scientific Pty Ltd Uphold Range

Uphold LITE w/Capio SLIM model cancelled from the ARTG

A recall was issued on 15 December 2017, RC-2017-RN-01508-1, to remove the device from hospital shelves.

Uphold LITE Vaginal Support System model discontinued; condition of inclusion imposed to remove the model from the ARTG entry

150342 Boston Scientific Pty Ltd Boston Scientific Pty Ltd Upsylon Y-Mesh Kit Conditions of inclusion imposed: not to be implanted transvaginally. The Instruction for Use, labelling and promotional documentation must be amended to include this information
104326 Boston Scientific Pty Ltd Boston Scientific Corporation Solyx

Device has been cancelled from the ARTG

A recall was issued on 15 December 2017, RC-2017-RN-01508-1, to remove the device from hospital shelves.

190172 Coloplast Pty Ltd Coloplast AS Restorelle DirectFix Range Device has been cancelled from the ARTG
190172 Coloplast Pty Ltd Coloplast AS Restorelle Range

Conditions of inclusion imposed: not to be implanted transvaginally. Instruction for Use, labelling and promotional documentation must be amended to include this information

A recall was issued on 21 December 2017, RC-2017-RN-01542-1, to remove the device from hospital shelves.

190173 Coloplast Pty Ltd Coloplast AS Altis

Device cancelled from the ARTG

A recall was issued on 21 December 2017, RC-2017-RN-01542-1, to remove the device from hospital shelves.

ARTG Sponsor Manufacturer Device/Product name
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH TVA Sling
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH TOA Sling
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH CR-Mesh
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH CR-Mesh (Total)
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH CR-Mesh Consensus
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH CR-Mesh Set
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH CR-Mesh Set (Total)
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH CR-Repair Kit
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH CR-Repair Kit (Total)
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH Upper Vagina Repair Kit
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH E-Mesh
158894 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH Multi Purpose Sling
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious DPS
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious DPL
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious AS
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious AL
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious V
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious PL
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious PS
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious DAL
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH InGYNious DAS
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH EndoGYNious
200723 Endotherapeutics Pty Ltd Ami Agency For Medical Innovations GmbH BSC Mesh
118082 Endotherapeutics Pty Ltd Promedon SA Ophira Minisling
118082 Endotherapeutics Pty Ltd Promedon SA Safyre T
118082 Endotherapeutics Pty Ltd Promedon SA Safyre T Plus
174659 Endotherapeutics Pty Ltd Promedon SA Safyre VS
180392 Gytech Pty Ltd Desarrollo E Investigation Medica Aragonesa SL Contasure Remeex female
180394 Gytech Pty Ltd Desarrollo E Investigation Medica Aragonesa SL Contasure Needleless
180395 Gytech Pty Ltd Desarrollo E Investigation Medica Aragonesa SL Contasure Prolapse
189722 Gytech Pty Ltd Desarrollo E Investigation Medica Aragonesa SL KIM
132657 TFS Manufacturing Pty Ltd TFS Manufacturing Pty Ltd Tissue Fixation System – TFS
97288 Medical Specialties pfm medical titanium GmbH TiLOOP Tape
97288 Medical Specialties pfm medical titanium GmbH TiLOOP Two
97288 Medical Specialties pfm medical titanium GmbH TiLOOP Total 4
97288 Medical Specialties pfm medical titanium GmbH TiLOOP Total 6
97288 Medical Specialties pfm medical titanium GmbH TiLOOP Fix
97288 Medical Specialties pfm medical titanium GmbH TiLOOP Mesh
97288 Medical Specialties pfm medical titanium GmbH TiLOOP Patch
97288 Medical Specialties pfm medical titanium GmbH TiLOOP Clip
174671 Pharm 3 Pty Ltd FEG Textiltechnik Forschungs und Entwicklungsgesellschaft mbH DynaMesh SIS Range
174671 Pharm 3 Pty Ltd FEG Textiltechnik Forschungs und Entwicklungsgesellschaft mbH DynaMesh PR Range
219240 Baxter Healthcare Pty Ltd Synovis Surgical Innovations (A Div of Synovis Life Technologies Inc) * Veritas Collagen Matrix - Multi-purpose surgical mesh, collagen
153047 William A Cook Australia Pty Ltd Cook Biotech Incorporated * Biodesign 4 Layer Tissue Graft
157074 Coloplast Pty Ltd Abiss Novasilk
ARTG Sponsor Manufacturer Brand/Product Name Regulatory and other Action
174878 Boston Scientific Pty Ltd TEI Biosciences Inc Xenform Tissue Repair Matrix Condition of inclusion imposed: Instructions for Use and labelling include 'This device is not intended for any pelvic organ prolapse repair via a transvaginal approach', effective, 4 January 2018
150342 Boston Scientific Pty Ltd Boston Scientific Corporation Upsylon Y-Mesh Kit Conditions of inclusion imposed: not to be implanted transvaginally. The Instruction for Use, labelling and promotional documentation must be amended to include this information, effective 4 January 2018
104326 Boston Scientific Pty Ltd Boston Scientific Corporation Advantage Range Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 17 January 2018
104326 Boston Scientific Pty Ltd Boston Scientific Corporation Lynx Range Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 17 January 2018
104326 Boston Scientific Pty Ltd Boston Scientific Corporation Obtryx Range Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 17 January 2018
190172 Coloplast Pty Ltd Coloplast AS Restorelle Range Conditions of inclusion imposed: not to be implanted transvaginally. Instruction for Use, labelling and promotional documentation must be amended to include this information, effective 4 January 2018
157074 Coloplast Pty Ltd Abiss Aris mesh Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
160738 Coloplast Pty Ltd Coloplast AS Aris kit with Aris mesh Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
160738 Coloplast Pty Ltd Coloplast AS Supris kit with Aris mesh Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland Gynecare TVT W/Abdominal Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland Gynecare TVT Device Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland Gynecare TVT Obturator Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland TVT Exact Retropubic system Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland TVT ABBREVO Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018

There is a special access arrangement available under the Therapeutic Goods Act 1989 for practitioners to access unapproved Therapeutic Goods that meet certain criteria.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices, including all incidents requiring revision. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.