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.

Table 1. Regulatory action effective 4 January 2018

Table 2. Devices CANCELLED or REMOVED from urogynaecological use since 2013

Table 3. Devices included on the ARTG effective 4 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.

• Special Access Scheme
• Authorised Prescriber
• Clinical trials

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.