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Results of review into urogynaecological surgical mesh implants
Behind the news
This TGA behind-the-news article was published on 20 August 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 of urogynaecological surgical mesh implants and found that, while there may be a benefit in certain patients there is little evidence to support the overall effectiveness of these surgical meshes as a class of products.
The findings from the review have highlighted the importance of:
- appropriate patient selection
- surgeon experience
- the need for fully informed patient consent.
The TGA has been monitoring surgical meshes since 2008 and has continued to publish information for the public and health professionals, the latest being an announcement of a formal review into urogynaecological surgical mesh implants, published on 28 May 2014.
As a result that review, which has raised a number of concerns, the TGA will nowreassess the clinical evidence for each individual mesh implant to determine if they comply with the Essential Principles (see ARGMD Part 1) which set out the requirements for safety and performance necessary for inclusion on the Australian Register of Therapeutic Goods (ARTG).
Where individual meshes are found not to be compliant, regulatory action, such as cancellation or suspension of particular devices from the ARTG, will be pursued. Cancellations and suspensions of medical devices from the ARTG are published on the TGA's website.
TGA review outcomes
The TGA's latest review included analysis of the available published literature, the information supplied with each device and associated training materials provided by sponsors and manufacturers. The Urogynaecological Devices Working Group (established under the Advisory Committee on the Safety of Medical Devices) met in August and October 2013 and provided expert advice to the TGA on this review.
As part of the review, the TGA undertook a literature search of published materials since 2009. The overall quality of the literature was found to be poor. As a consequence, there was an absence of evidence to support the overall effectiveness of these surgical meshes as a class of products. However, the literature did identify the known adverse outcomes associated with their use.
Specifically, the review found that the use of urogynaecological surgical mesh devices for the surgical treatment of stress urinary incontinence and abdominal pelvic organ prolapse repair is adequately supported by the evidence.
However, due to the poor quality of the studies undertaken, the evidence to support the use of these meshes for transvaginal pelvic organ prolapse repair, particularly, posterior repair, is not well established.
The TGA review also found that, while adverse events involving these devices are most likely under-reported, the reported complication rate remains low considering many thousands of these mesh devices have been implanted in Australian patients. From July 2012 to 3 April 2014, the TGA received 32 adverse events reports involving urogynaecological surgical meshes. The most frequently reported adverse events were pain and erosion.
The TGA review identified inadequate training/experience for implanting surgeons as a factor in increasing the risk of complications. Certain patients, including those who smoked or were obese, were found to be at higher risk of adverse events and repeated procedures.
The TGA review of each urogynaecological surgical mesh product has begun and findings will be published on the TGA website for the information of consumers and health professionals.
Information for consumers
Information on surgery for pelvic organ prolapse is available on the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) website. This information includes the need to ensure you discuss this procedure in detail with your surgeon.
If you have an implanted urogynaecological mesh and it causes any symptoms, including pain, or if you have concerns about any implanted device, contact your surgeon.
Information for all health professionals
If a patient experiences pain or any other symptom that they suspect is being caused by an implanted urogynaecological mesh, or they have any questions or concerns regarding this issue, refer them to their surgeon.
Information for urogynaecological surgeons
The RANZCOG and the Urogynaecological Society of Australasia (UGSA) have published guidelines on the use of polypropylene vaginal mesh implants for vaginal prolapse.
The guidelines cover the need for:
- informed patient consent
- surgical training
- appropriate patient selection
- reporting adverse events to the TGA
They also include information on patient groups in whom caution should be exercised when considering the use of transvaginal mesh implants.
The expert advice received by the TGA is consistent with the guidance provided by RANZCOG and UGSA that the decision to use mesh should be made on a case-by-case basis and should include a detailed discussion of the risks and benefits of the use of mesh in prolapse repair with each individual patient.
Consumers and health professionals are encouraged to report problems with medical devices, including all incidents requiring 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.
- Urogynaecological surgical mesh implants are used in some surgical procedures to treat the symptoms of pelvic organ prolapse and stress urinary incontinence