Urogynaecological surgical mesh is a netlike device. It is placed in and attached to the pelvis.
They are also known as transvaginal or pelvic mesh, 'sling', 'tape', 'ribbon' and 'hammock'.
The mesh is mostly used to treat two conditions:
- pelvic organ prolapse
- stress urinary incontinence.
Some women have benefited from urogynaecological mesh implants. However, these devices have also caused serious complications for other women.
As of 2017, two types of urogynaecological mesh were no longer approved by us:
- urogynaecological mesh inserted through the vagina to treat pelvic organ prolapse
- single incision mini slings used to treat stress urinary incontinence.
In Australia, these mesh devices are not available.
We continue to monitor the safety of all urogynaecological mesh implants. Please report any adverse events associated with these devices.
Reason they are no longer supplied
We have determined that certain types of mesh devices pose more risks than benefits.
This determination followed reviews of international studies published in 2016 and 2017. Additionally, it looked at clinical evidence for each mesh device included in the ARTG.
These devices cannot be supplied in Australia unless they are part of the special pathways for accessing unapproved products.
It can take many years to fully understand the risks and benefits of a medicine or medical device. We are a regulatory agency and aims to balance timely access to medical treatments and patient safety.
In 1998, we approved the first urogynaecological mesh in Australia. We first received a report of an adverse event in 2006.
There were very few reports of adverse events until 2013, when the number began to increase. Patients have experienced problems like long-lasting pain and mesh erosion in the vagina. The use of transvaginal mesh has caused serious problems for many women.
Some other types of urogynaecological mesh remain approved for supply in Australia because their use continues to be supported by evidence. These include:
- mid-urethral slings for the treatment of stress urinary incontinence
- urogynaecological mesh devices inserted through the abdomen.