TGA undertakes regulatory actions after review into urogynaecological surgical mesh implants

The TGA has today decided 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 today taken a series of regulatory actions in relation to transvaginal mesh products and single incision mini-slings (see Table 1 below).

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 today 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.

Show more information about Table 1. Regulatory action effective 4 January 2018

Show more information about Table 2. Devices CANCELLED or REMOVED from urogynaecological use since 2013

Show more information about 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