NICE takes action following outcome of First Do No Harm report on vaginal mesh

Posted: 08/10/2020

In July, the Independent Medicines and Medical Devices Safety Review published its report into how the healthcare system in England had responded to claims that surgical mesh used for pelvic organ prolapse and stress urinary incontinence was harmful. It found that had guidance from the National Institute for Health and Care Excellence (NICE) been followed more closely, then much of the harm suffered by patients may have been avoided. The review, led by Baroness Cumberledge, highlighted that “more should have been done to ensure that healthcare professionals were aware of and following guidelines”.

In response to this, the NICE board has agreed more work will be carried out with regulators and professional organisations to reinforce the use of NICE guidelines. On 17 September 2020, the NICE board, led by chairman Sharmila Nebhrajani, agreed to the following steps:

• to consider how to facilitate the production of a single and collaboratively produced patient decision aid;
• to work with NHSX and other system partners to co-create databases and registries which could be used to inform guideline development; and
• to review the guidelines on the management of urinary incontinence and pelvic organ prolapse.

Elise Bevan, a solicitor in the clinical negligence team at Penningtons Manches Cooper, said: “It is of paramount importance that there is collaboration to ensure a more integrated approach to patient safety, so it is welcome news that NICE has reacted to the review in the way that it has. We have brought many claims on the basis that there was a failure to follow the guidelines and, as a result, women had mesh surgery that was not indicated and, in a significant number of cases, that they did not give consent for. A more rigorous approach to using and complying with the guidelines will hopefully prevent similar situations from occurring in the future.”

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