Resources for consumers, clinicians and health service organisations - transvaginal mesh and sacrocolpopexy
The Commission produced a range of resources and guidance documents to improve health care for women considering the treatment options for pelvic organ prolapse (POP), stress urinary incontinence (SUI), and complications of transvaginal mesh.
These documents were informed by detailed consideration of the peer-reviewed evidence and consultation with consumers, clinicians, relevant colleges and surgical specialty societies, state and territory health departments, the Australian Government Department of Health and the Reference Group that was convened to support this work.
These resources have taken into account recent changes to the registration of a number of transvaginal mesh devices on the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA). While registration of transvaginal mesh products for treatment of POP has been cancelled, there is still potential for clinicians to use these devices with the necessary approvals. For this reason, the Commission has continued to produce guidance documents for POP.
Consumer resources on treatment options
These resources have been developed following extensive consultation with women affected by complications of transvaginal mesh.
The resources explain the symptoms of POP, SUI and complications of transvaginal mesh, the range of treatment options – doing nothing, non-surgical and surgical treatments – and their risks and benefits. Information is included about changes made by the TGA to remove transvaginal mesh products from the ARTG, where the sole use is the treatment of POP via transvaginal implantation, and to remove single incision mini-slings for treatment of SUI. The resources also include advice that use of these mesh products in Australia now requires special approval.
Each resource also includes information on complications which may result from insertion of transvaginal mesh, and where to find more detail about the complications. A list of questions which women might consider asking their doctor, prior to these procedures is also included.
Implantable devices: Patient Information Leaflets and Patient Implant Cards
The Therapeutic Goods Administration has produced resources for clinicians and consumers to complement the requirement that from 1 December 2021 all implantable and Active Implantable Medical Devices are required to have patient information materials available in the form of both Patient Information Leaflets and Patient Implant Cards, unless specifically excluded from these requirements.
The care pathways describe clinical considerations to be made when clinicians are assessing women who have POP, SUI and transvaginal mesh complications. The pathways provide clinicians with an evidence-based approach to first line management, specialised surgical and non-surgical care and the types of medical specialists who may be involved in providing care.
The care pathways provide an opportunity for alignment with the pathways used by a number of Primary Health Networks to guide the discussions between women and their general practitioners.
There are also surgical pathways for POP and SUI. These use a traffic light approach (red, yellow, green) to identify options for surgical treatments, based on the strength of evidence and potential patient outcomes for each type of procedure:
To support the use of the pathways an interactive care pathway, with anatomical illustrations of procedures, is available via the links below. Once the pathways open you can click on the preferred pathways for pop-up windows which describe grade of recommendations and images, as is relevant.
Guidance for hospital credentialing of senior medical practitioners to implant and remove transvaginal mesh
Credentialing is the process used by public and private hospitals to ensure that only suitably experienced, trained and qualified medical practitioners provide particular types of services. Credentialing is essential to ensure the safety of patient care.
Guidance has been finalised for hospital credentialing and training of senior medical practitioners who perform transvaginal mesh surgeries and mesh removal including:
The Guidance describes the experience and qualifications that senior medical practitioners need to be credentialed to implant and remove mesh for treatment of POP and SUI. It also includes recommendations on device specific training, the requirements for maintaining skills, monitoring and reporting on patient outcomes, the types of specialty supports services hospitals should have if they offer implantation and removal of transvaginal mesh and the requirement for post-operative follow-up.
The states and territories will consider the use of the Guidance in their local credentialing processes. The private health sector also undertakes credentialing processes, and the Commission will be working with the private health sector to promote the use of these Guidance documents for credentialing across private hospitals.
Credentialing guidance for abdominal sacrocolpopexy to treat POP
Credentialing guidance has been prepared by the Urological Society of Australia and New Zealand and the Urogynaecological Society of Australasia and the Australasian Gynaecological Endoscopy and Surgery Society Society for the performance of abdominal sacrocolpopexy to treat POP.
Service Model Framework
The Commission has completed a service model framework to support state and territories and the private sector in their planning of services for the use and removal of transvaginal mesh devices and management of mesh-related complications. Clinical care pathways, models of care, and workforce considerations also inform the development of services. The framework was developed with input from the reference group and informed by each of the states and territories. The model of care and the approach to planning these services need to be informed by consumer experience to date to enhance services for transvaginal mesh implantation, treatment for complications, and/or removal of mesh. This resource also provides information provided by the states and territories on local services.