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Vaginal mesh: the evidence

10 April 2019. Published by Peter Rudd-Clarke, Legal Director

NICE report provides guidance

Last week, NICE (the National Institute for Health and Care Excellence) published new guidelines on the use of vaginal mesh. The guidelines have been published at a time when litigation concerning mesh products has been well documented and the period of “high vigilance restriction” announced by the Government in 2018 remains in place, pending the results of a review by Baroness Cumberlege.

Against this backdrop, the following points set out by NICE regarding the evidence of the risks and benefits associated with mesh products may be particularly relevant for parties defending claims, whether manufacturers, hospitals or their insurers:

 

  • There is evidence of benefits associated with mesh procedures, but limited evidence on the long-term adverse effects  

  • The true prevalence of long-term complications is unknown  

  • Discussion with patients should refer to the uncertainty surrounding the long-term adverse effects for all procedures, including those involving mesh materials  

  • There is limited evidence regarding the benefits of partial or complete removal of mesh products, compared with choosing not to remove such products  

  • Equally, there is limited evidence of the long-term effectiveness and complications for some alternatives to surgical procedures 

  • NICE supports the use of a national registry to provide more reliable evidence than is available currently on the use of mesh procedures in England and Wales, and their long-term effects 

 It is well known that large numbers of women in the UK are reported to have experienced serious side effects as a result of surgery involving mesh products. There have been many reports of the impact these complications have had on the lives of the patients involved. Patients and their families, as well as hospitals and manufacturers, will study the Cumberlege report in detail when it is published later this year. In the meantime, the NICE guidelines published last week do not add anything of significance to what was already known, but they do at least offer a starting point for the debate about the evidence regarding mesh products and the extent to which the benefits outweigh the associated risks.

 

A link to the NICE guidelines can be found here, including the appendices to the report that detail the research carried out into the available evidence: https://www.nice.org.uk/guidance/ng123