The TGA decided on 28 November 2017 to remove transvaginal mesh products, for which the sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG). The TGA also considers that there is a lack of adequate scientific evidence for it to be satisfied that the risks to patients associated with the use of mesh 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. Devices which will remain included on the ARTG and available for legal supply in Australia can be found on the TGA website.
There is a special access arrangement available under the Therapeutic Goods Act 1989 for practitioners to access unapproved therapeutic goods that meet certain criteria. For further information, see the pathways below:
A new regulatory framework for surgical mesh devices and provision of information to consumers for all implantable medical devices was approved by the Minister for Health, The Hon Greg Hunt. The changes are intended to maintain the alignment of the Australian regulatory framework with similar initiatives recently announced in Europe. The timing proposed for implementation reflects Australian public health imperatives.
Under the proposals, from 1 December 2018, all new surgical mesh devices, including urogynaecological mesh devices, seeking approval from the TGA will need to meet the higher evidentiary requirements of a Class III medical device.
A transition period will apply for surgical mesh devices currently on the market. In light of concerns expressed by many women who have undergone surgery with an urogynaecological mesh device, a two years transition period applies for this up-classification measure from the commencement of the regulations. This means that existing urogynaecological devices will need to lodge a re-classification application no later than December 2020.
A three year transition period to December 2021 is proposed to apply for other surgical mesh devices.
|Up-classification||Device info leaflet||Patient implant card|
|New devices||1 Dec 2018||1 Dec 2018||1 Dec 2018|
|Existing devices||1 Dec 2020||1 Dec 2019||1 Dec 2019|
|New devices||1 Dec 2018||1 Dec 2018||1 Dec 2020|
|Existing devices||1 Dec 2021||1 Dec 2021||1 Dec 2021|
|Implantable devices (other than those exempted)|
|New devices||NA||1 Dec 2018||1 Dec 2020|
|Existing devices||NA||1 Dec 2021||1 Dec 2021|
From 1 December 2018 manufacturers of all new permanently implantable devices (other than those exempted) will need to have a patient information leaflet in the TGA approved format. This summary document about the device is intended to be similar to the consumer medicines information leaflet given to the patient. A graduated transition period is proposed to apply reflecting public health imperatives: from December 2019 for urogynaecological mesh devices and December 2021 for all other permanently implantable devices.
Patient cards for implantable medical devices will also be required for all new urogynaecological mesh devices from 1 December 2018.The TGA will work with the consumer, industry, professional clinical organisations, states and territories to co-design the format of the patient information materials so as to deliver effective and efficient information to the consumers over the lifecycle of the device.
The enhanced patient information materials will contribute to better informed consumers and assist consumers and doctors in the informed consent process as well as greater traceability of the use of the device through the health system.