Intended for healthcare professionals

Re: Surgical mesh and patient safety

The life changing complications experienced by some women following vaginal mesh procedures should prompt us all to reflect on the lessons to be learnt for improving how the health system monitors and responds to potential harms from medicines and medical devices.

Improving outcomes for people using the NHS is a priority for NICE and this is underpinned by the guidance we produce.

NICE first made recommendations about how mesh should be used for the treatment of prolapse in 2005. This stated that clinicians should inform the clinical governance leads in their Trusts, ensure that patients understood the uncertainty about the procedure’s safety and efficacy and were fully informed of the alternative treatment options. Clinical outcomes of all patients having the procedure should be audited and the outcomes reviewed.

This advice is re-iterated in subsequent mesh related interventional procedures (IP) guidance and reinforced by our new draft clinical guideline on managing stress urinary incontinence and pelvic organ prolapse.

Responsibility for implementation of our guidance does not rest with NICE, but requires a system wide approach. The arrangements were previously outlined in the Health Service Circular (HSC) 2003/011.

In their editorial, Carl Heneghan and Fiona Godlee refer to NICE having been ‘ineffectual’. However if those in the system responsible for the implementation of our guidance had acted as intended and the restrictions given in our guidance on mesh followed from the time when they were published, much of the current circumstances around mesh would have been avoided.

The system could provide better supervision of the application of NICE interventional procedure guidance. This could include oversight by the regulator to ensure that providers of health care have governance structures in place to review, authorise and monitor the introduction of new interventional procedures in line with the recommendations from NICE.

Trust appraisal systems could also be used to ensure clinicians take due account of our clinical guidance, and importantly comply with requirements for consent, data collection and audit, and report complications. Where NICE has recommended that data are submitted to National Registers, this should be supported; the data must be properly analysed and published to allow the evidence base for the technology to develop in order to inform future reviews of the guidance by NICE.

These principles apply to any interventional procedure, not just those related to the use of mesh. Without improvements it is possible that the issues that have arisen with mesh will be repeated elsewhere.
Using data to continually ensure the procedures carried out on patients are safe will mean that any pattern of complications or harms are identified quickly. Then coherent and coordinated action can be taken where necessary to reduce risks to patients in future.

Using data to continually ensure the procedures carried out on patients are safe will mean that any pattern of complications or harms are identified quickly. Then coherent and coordinated action can be taken where necessary to reduce risks to patients in future.

Professor Gillian Leng, NICE deputy chief executive and director of health and social care

Professor Kevin Harris, programme director and clinical advisor of NICE's interventional procedures programme

Competing interests: No competing interests

23 October 2018
Professor Gillian Leng
NICE deputy chief executive and director of health and social care
Professor Kevin Harris, programme director and clinical advisor of NICE's interventional procedures programme
NICE, Spring Gardens, London, SW1A 2BU