TGA actions after review into urogynaecological surgical mesh implants

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

Background

In August 2017, supply of the Pinnacle LITE Pelvic Floor Repair Kit was discontinued from the Australian market.

In December 2017, the indications for use of the Xenform Soft Tissue Repair Matrix were amended to remove the indication for transvaginal placement of pelvic organ prolapse (POP). This device has other indications for use in the repair of soft tissue defects and thus remains on ARTG for these other uses.

Current action

A recall was issued by Boston Scientific Corporation Pty Ltd on 2 May 2019, RC-2019-RN-00681-1 to remove any remaining unimplanted product from the Australian market for:

  • Pinnacle LITE Pelvic Floor Repair Kit, Posterior
  • Xenform Soft Tissue Repair Matrix, with the indication for transvaginal placement of POP.

Table 3 in the December 2017 statement has been updated to include this action for Xenform. The ARTG for Pinnacle LITE Pelvic Floor Repair Kit, Posterior was cancelled by the sponsor and as such does not appear in the tables below.


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

17 May 2019

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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ARTGSponsorManufacturerBrand/Product NameRegulatory and other Action
150342Boston Scientific Pty LtdBoston Scientific CorporationPRF Kit (Pinnacle) RangeAll models discontinued; condition of inclusion imposed to remove the devices from the ARTG entry
150342Boston Scientific Pty LtdBoston Scientific CorporationPRF Kit (Uphold)Device discontinued; condition of inclusion imposed to remove the device from the ARTG entry
150342Boston Scientific Pty LtdBoston Scientific Pty LtdUphold 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

150342Boston Scientific Pty LtdBoston Scientific Pty LtdUpsylon Y-Mesh KitConditions of inclusion imposed: not to be implanted transvaginally. The Instruction for Use, labelling and promotional documentation must be amended to include this information
104326Boston Scientific Pty LtdBoston Scientific CorporationSolyx

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.

190172Coloplast Pty LtdColoplast ASRestorelle DirectFix Range

Device has been cancelled from the ARTG

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

190172Coloplast Pty LtdColoplast ASRestorelle 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.

190173Coloplast Pty LtdColoplast ASAltis

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.

ARTGSponsorManufacturerDevice/Product name
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHTVA Sling
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHTOA Sling
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHCR-Mesh
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHCR-Mesh (Total)
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHCR-Mesh Consensus
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHCR-Mesh Set
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHCR-Mesh Set (Total)
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHCR-Repair Kit
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHCR-Repair Kit (Total)
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHUpper Vagina Repair Kit
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHE-Mesh
158894Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHMulti Purpose Sling
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious DPS
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious DPL
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious AS
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious AL
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious V
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious PL
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious PS
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious DAL
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHInGYNious DAS
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHEndoGYNious
200723Endotherapeutics Pty LtdAmi Agency For Medical Innovations GmbHBSC Mesh
118082Endotherapeutics Pty LtdPromedon SAOphira Minisling
118082Endotherapeutics Pty LtdPromedon SASafyre T
118082Endotherapeutics Pty LtdPromedon SASafyre T Plus
174659Endotherapeutics Pty LtdPromedon SASafyre VS
180392Gytech Pty LtdDesarrollo E Investigation Medica Aragonesa SLContasure Remeex female
180394Gytech Pty LtdDesarrollo E Investigation Medica Aragonesa SLContasure Needleless
180395Gytech Pty LtdDesarrollo E Investigation Medica Aragonesa SLContasure Prolapse
189722Gytech Pty LtdDesarrollo E Investigation Medica Aragonesa SLKIM
132657TFS Manufacturing Pty LtdTFS Manufacturing Pty LtdTissue Fixation System – TFS
97288Medical Specialtiespfm medical titanium GmbHTiLOOP Tape
97288Medical Specialtiespfm medical titanium GmbHTiLOOP Two
97288Medical Specialtiespfm medical titanium GmbHTiLOOP Total 4
97288Medical Specialtiespfm medical titanium GmbHTiLOOP Total 6
97288Medical Specialtiespfm medical titanium GmbHTiLOOP Fix
97288Medical Specialtiespfm medical titanium GmbHTiLOOP Mesh
97288Medical Specialtiespfm medical titanium GmbHTiLOOP Patch
97288Medical Specialtiespfm medical titanium GmbHTiLOOP Clip
174671Pharm 3 Pty LtdFEG Textiltechnik Forschungs und Entwicklungsgesellschaft mbHDynaMesh SIS Range
174671Pharm 3 Pty LtdFEG Textiltechnik Forschungs und Entwicklungsgesellschaft mbHDynaMesh PR Range
219240Baxter Healthcare Pty LtdSynovis Surgical Innovations (A Div of Synovis Life Technologies Inc)* Veritas Collagen Matrix – Multi-purpose surgical mesh, collagen
153047William A Cook Australia Pty LtdCook Biotech Incorporated* Biodesign 4 Layer Tissue Graft
157074Coloplast Pty LtdAbissNovasilk
ARTGSponsorManufacturerBrand/Product NameRegulatory and other Action
174878Boston Scientific Pty LtdTEI Biosciences IncXenform Tissue Repair Matrix

Condition of inclusion imposed: Instructions for Use and labelling include ‘This device is not intended for any pelvic organ prolapse (POP) repair via a transvaginal approach’, effective, 4 January 2018.

A recall was issued on 2 May 2019, RC-2019-RN-00681-1, to remove all remaining unimplanted stock of the device from the Australian marketthat may still be labelled with indications for transvaginal placement of POP.

150342Boston Scientific Pty LtdBoston Scientific CorporationUpsylon Y-Mesh KitConditions 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
104326Boston Scientific Pty LtdBoston Scientific CorporationAdvantage RangeCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 17 January 2018
104326Boston Scientific Pty LtdBoston Scientific CorporationLynx RangeCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 17 January 2018
104326Boston Scientific Pty LtdBoston Scientific CorporationObtryx RangeCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 17 January 2018
190172Coloplast Pty LtdColoplast ASRestorelle RangeConditions 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
157074Coloplast Pty LtdAbissAris meshCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
160738Coloplast Pty LtdColoplast ASAris kit with Aris meshCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
160738Coloplast Pty LtdColoplast ASSupris kit with Aris meshCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandGynecare TVT W/AbdominalCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandGynecare TVT DeviceCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandGynecare TVT ObturatorCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandTVT Exact Retropubic systemCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 17 January 2018
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandTVT ABBREVOCondition 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

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