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Surgical mesh failure rates unacceptably high, expert says

Better evaluation needed of use in operations involving pelvic region organs, review says

The use of surgical mesh to treat pelvic organ prolapse and urinary incontinence has been banned or restricted in many countries. Photograph: iStock

Failure rates in some treatments using “surgical mesh” products are unacceptably high and as a result many women have been condemned “to a lifetime of pain and discomfort”, according a Trinity College Dublin materials expert .

In recent years, a large number of patients – mainly women – have been implanted with pieces of mesh to correct urinary incontinence and prolapse of organs such as the vagina, which occurs frequently after childbirth.

Surgical mesh is a fabric-like material which has been used successfully for more than 50 years for repair of hernias. However, in recent years medical companies developed new products using this same mesh, for operations involving organs in the pelvic region.

A review by TCD professor of materials engineering David Taylor concludes more should have been done to evaluate the use of mesh in such circumstances.

“More experiments should have been conducted to properly assess how surgical mesh would behave in some of the bodily environments in which it has recently been used, such as the vagina and urinary system,” he said.

“Many of these women have been condemned to a lifetime of pain and discomfort because the mesh has caused damage to surrounding organs and tissues, and it cannot be removed,” he said.

Banned

As a result, the use of these products has been banned or restricted in many countries including the United States, UK, Australia and New Zealand.

In Ireland “we have been slow to realise the extent of the problem”, he said.

In July this year Minister for Health Simon Harris announced “a pause had been placed on the use of these products pending a full investigation into their use and the risks involved”.

The review article by Prof Taylor considers the findings of a wide variety of scientific and medical sources, from material test reports to clinical case studies. It has been published the Journal of the Mechanical Behaviour of Biomedical Materials.

“The use of surgical mesh to treat pelvic organ prolapse and urinary incontinence seems to provide another example in which new products have been developed that expand the use of existing materials without conducting the necessary experiments to properly understand the material, and how it will react in its new application,” Prof Taylor said.

“Very severe consequences can result from mesh erosion, when the mesh material damages the surrounding tissues. The prolapse products caused mesh erosion in over 10 per cent of cases, rising to almost 30 per cent in some studies, which I concluded was unacceptably high,” he said.

“In the case of urinary incontinence products, erosion occurs less often, around 2 per cent to 3 percent, so my opinion is that patients should be given more information to allow them to make an informed decision about the risks involved, “ he added.

Technique

Chemical degradation of the material due to bacterial infection, and poor surgical technique are two potential reasons for the failures, Prof Taylor said, “but further work is needed – especially the examination of failed mesh products – to properly determine the underlying causes of this problem.”

In a statement, the Department of Health said the HSE had paused the use of mesh products. It said the chief medical officer has been asked to complete a paper on the clinical and professional issues involved to ensure the use of mesh implants was in line with international best practice.

“A programme of work has commenced in the HSE to advance priority recommendations relating to mesh products including patient information and consent, surgical professional training, collection of appropriate data concerning use of mesh implants and the development of aftercare services for women suffering from complications,” a spokeswoman for the department said.

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