The Commission has developed resources for consumers, clinicians and health services on the use of transvaginal mesh products for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) and mesh removal.
Following a request from state and territory health department representatives, the Commission developed resources for consumers, clinicians and health services on the use of transvaginal mesh products for the treatment of POP, SUI and mesh removal to support improved outcomes for women considering the use of transvaginal mesh.
The Commission considered the peer-reviewed evidence; consulted with clinicians; and held consumer forums with women around Australia to ensure that the available evidence and a breadth of views were considered in the development of resources. A number of issues were raised by women who attended the forums conducted by the Commission, which informed the development of the Commission’s submission to the Senate Inquiry and its resources.
The Commission convened a Reference Group consisting of consumers, clinical experts nominated by specialist colleges and surgical specialty societies, state and territory health department representatives and the Therapeutic Goods Administration (TGA) to advise on the development of the resources. The Transvaginal Mesh Reference Group was chaired by Dr Robert Herkes, Chief Medical Officer at the Commission; the work of the Reference Group is now complete.
The resources included::
- Consumer information resources
- Care pathways for POP, SUI and complications of transvaginal mesh
- Guidance for hospital credentialing of senior medical practitioners to implant and remove mesh for treatment of POP and SUI
- Service model framework for transvaginal mesh complications and removal
During the development of the resources, the Commission identified a number of issues impacting on the safety and quality of procedures involving transvaginal mesh including:
- The lack of definitive data on the number of procedures involving transvaginal mesh performed in Australia, patient outcomes following implantation, and the number of women having mesh removed. In conjunction with the TGA the Commission will consider options for improved data collection and advice concerning post-market surveillance to ensure that high quality data is available to support clinical decisions in the future
- Concerns raised by women regarding informed consent prior to surgery, and their views that there was a lack of responsiveness to issues of pain and suffering following the implantation of the transvaginal mesh
- The need for more accessible information to be provided to women and clinicians concerning the potential complications of transvaginal mesh procedures and the recognition of these complications by general practitioners and specialists
- The complexity and time impost, for both patients and clinicians, of the reporting process to the TGA for adverse events. As a result it appears that there is under-reporting of these events through the TGA process, when women have advised that they have spoken with their general practitioners and specialists about symptoms.
A number of factors impacting on the recording of these events have been noted, including the variable timeframes for onset of symptoms, from immediately post-surgery to a number of years post-procedure. When women reported symptoms to their general practitioner or specialist these were often not directly linked with mesh.
Information about mesh and adverse event reporting is available on the TGA website.
Consumer information resources
The consumer information resources to assist women considering treatment options in regard to Pelvic Organ Prolapse, Stress Urinary Incontinence, and transvaginal mesh complications, and provide support for discussions with their health care professionals include:
The Commission is very grateful to the many women who contributed to the development of the resources through a number of meetings held across the country. The women brought to this process a range of experiences and important advice to inform the resources, and the personal information that they were willing to share was extremely valuable and appreciated.
These resources have been distributed to professional colleges and societies, all states and territories and other relevant stakeholder groups.
The Commission made two submissions and also appeared at the Senate Inquiry on two occasions. More information is available here.