About the review
A urogynaecological mesh is a net-like device that can be placed in, or attached to, the pelvis. MUS are a type of urogynaecological mesh used for the treatment of stress urinary incontinence.
The Therapeutic Goods Administration reviewed urogynaecological mesh devices due to safety concerns. Multiple devices were removed from both the Australian Register of Therapeutic Goods and the Prescribed List.
MUS remain approved for use in Australia.
There had never been a Health Technology Assessment on MUS.
The review process
We engaged an external consultant to assess and report on the comparative clinical effectiveness and cost-effectiveness of MUS for the treatment of stress urinary incontinence.
The post-listing review considered:
- the external consultant report
- submissions from sponsors and stakeholders
- clinical evidence
- guidelines
- health technology assessments
- utilisation data
- expert urogynaecological advice.
Result of the review
The external consultant's report recommended retaining MUS devices on the PL at the same benefit amount and in the same group. The Medical Devices and Human Tissue Advisory Committee (MDHTAC) supported this recommendation.
The outcome of the post-listing review is that the PL listings for these devices are unchanged.
Read the external consultant's report.
Read our report.
Confidential information, such as committee-in-confidence or commercial-in-confidence material is redacted in both reports.