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Concerns with urogynaecological surgical mesh implants

16 October 2012

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

In 2010 the TGA conducted a review of urogynaecological meshes. The TGA continues to monitor the rate of complications with surgical mesh, along with other international regulatory bodies.

In 2010, the TGA found that compared to the number of women who had received a mesh insertion, the number of complications was low. In addition, the complication rate did not appear to differ between products, but factors such as the skill and training of the surgeon, selection of the patient and procedure were important. This outcome was endorsed by the Medical Device Incident Review Committee, an independent group of experts that advised TGA on medical device post-market issues.

The TGA review took into account the 2010 Cochrane Review of the surgical management of pelvic organ prolapse in women which examined some forty randomised controlled trials, evaluating 3773 women.

Since 2010 the TGA has continually monitored these products through its adverse event reporting system and information available from other regulators. TGA has also worked with organisations such as the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, (RANZCOG) and the UroGynaecological Society of Australasia (UGSA).

These organisations have issued statements emphasising the need for surgeons to participate in training programs in the relevant surgical techniques and to discuss all clinical options with their patients. A 2011 RANZCOG media statement can be found on the RANZCOG website.

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 either an initial assessment by a European body that is approved and monitored by European regulators or by the TGA. In all cases, there needs to be clinical evidence for the benefit of using the device for its intended purpose.

At the time a new medical device is approved for use in clinical care it is not possible to know all the possible complications that may develop with its use. This is because some of these complications are very rare and may only become apparent when the medical device is being used to treat large numbers of patients. To identify all complications occurring at this rate would involve clinical trials involving tens of thousands of patients. Such large-scale trials would prevent life-saving technologies being made available within the Australian health system in a timely manner.

Information for patients

If your device causes pain or you have concerns about any implanted device, including meshes for pelvic organ prolapse, please contact your surgeon.

Reporting an adverse event

The TGA relies on adverse events being reported to the TGA. Consumers and health professionals are encouraged to report problems with surgical meshes to the TGA, including all incidents of revision. Please use the TGA Incident Reporting and Investigation Scheme (IRIS).

You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

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