Date lodged: 24 July 2018
To ask the Scottish Government what (a) its and (b) the Chief Medical Officer for Scotland's position is on the (i) safety and (ii) efficacy of using mesh in procedures to treat conditions other that pelvic organ prolapse or stress urinary incontinence.
Answered by: Jeane Freeman 13 August 2018
The use of mesh in procedures to treat conditions other that pelvic organ prolapse or stress urinary incontinence is accepted, not only in Scotland, but throughout the United Kingdom and beyond. This is supported by a substantial body of evidence and reports of true adverse responses to mesh are rare.
With particular reference to the use of mesh in hernia repair, NICE views this as being established clinical practice (performed for decades) whose safety and efficacy is well understood. NICE is not aware of any published evidence or professional advice which has called into question the procedures’ efficacy and safety. Current guidance remains on the NICE ‘static’ list. However, if NICE is notified of a significant change to the evidence base at any stage in the future, this could trigger a formal review proposal.
This notwithstanding, Scottish Government officials are mindful of public anxiety and are in regular liaison with the MHRA (responsible for the regulation of medical devices in the United Kingdom), to appraise and respond to new information as it emerges. In addition, the Chief Medical Officer has written to Health Board Medical Directors to highlight the emerging, broader anxiety about the use of mesh in other sites. Medical Directors have been asked to ensure clinical colleagues discuss the use of mesh as part of acquiring informed consent, in line with guidance on consent and the principles of Realistic Medicine . Furthermore, the Chief Medical Officer has emphasised that all options should be considered, including non-operative management and non-mesh surgery. In addition, Medical Directors and thus their colleagues, have been reminded of their obligations with regard to medical devices and adverse event reporting.