Review into urogynaecological surgical mesh implants
Behind the news
This TGA behind-the-news article was published on 28 May 2014. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.
The TGA has completed a review into urogynaecological surgical mesh implants as a class of products. Details of the review were published on 20 August 2014.
Urogynaecological surgical mesh implants are used in some surgical procedures to treat the symptoms of pelvic organ prolapse and stress urinary incontinence.
TGA reviews and monitoring
The TGA has been monitoring urogynaecological meshes since 2008 and in 2010 undertook a detailed clinical review of these devices. This review found that the reported rate of complications was low. When complications did occur the review found that this was closely linked to the skill and training of the surgeon and the patient's circumstances. This outcome was endorsed by the Advisory Committee on the Safety of Medical Devices (then known as the Medical Device Incident Review Committee), an independent group of experts that advises the TGA on medical device post-market issues.
The TGA subsequently undertook a further review of these meshes and established the Urogynaecological Devices Working Group (UDWG) to advise on this work. The working group met in August and October 2013 and there will be further meetings in 2014 during the course of the review.
The ongoing TGA review will advise on whether the adverse events associated with urogynaecological devices have occurred due to the design and/or the materials used; or whether other factors, such as devices being supplied and/or used inappropriately, patient characteristics or training experience, are contributing to these adverse events.
Twenty-five adverse events reports have been included on the Database of Adverse Events Notifications (DAEN) which publishes reports submitted from July 2012. The majority of reports are from the sponsors and manufacturers of these devices. There have been many thousands of these mesh devices implanted in Australian patients.
The TGA also has consulted the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Urogynaecological Society of Australia (UGSA) as part of our monitoring program. These bodies advise that surgeons should have special training on performing these procedures; on patient selection; and the need to ensure patients understand the possibility of complications associated with this type of procedure.
How these meshes are approved by the TGA
These meshes are medical devices which the TGA regulates in accordance with an internationally harmonised model. Under this model medical devices are regulated according to the level of risk. Most of these surgical meshes are Class IIb.
Class IIb devices cannot be sold in Australia unless approved by the TGA following an assessment by the TGA. Our assessment is often based on an initial assessment by a European body that is approved and monitored by European regulators.
Information for consumers
If you have an implanted urogynaecological surgical mesh and it causes pain, or if you have concerns about any implanted device, contact your surgeon.
Consumers and health professionals are encouraged to report problems with medical devices, including all incidents of revision. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.