Safety and Quality > Our Work > Transvaginal Mesh

Following a request from state and territory health department representatives, the Commission is developing guidance 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).

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 summary of issues raised by women who attended the forums was published by the Commission.

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). The Transvaginal Mesh Reference Group is chaired by Dr Robert Herkes, Chief Medical Officer at the Commission. The Reference Group met on 4 occasions in 2017; the last meeting was held on 1 December 2017.

Members of the Reference Group have supported the Commission in its development of the guidance in relation to:

  • Patient information resources
  • Treatment pathways for pelvic organ prolapse and stress urinary incontinence
  • Training and credentialing of clinicians who implant and remove mesh for treatment of POP and SUI
  • Service models for mesh complications and mesh removal
  • Information for general practitioners

The Commission has identified a number of issues impacting on the safety and quality of these procedures, 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. 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 has been 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.