Chamber and committees

Adverse incidents involving any medical device must be reported as per General Medical Practice guidance.

The Independent Review has awaited the publication of several key studies that it wished to consider as part of its deliberations. These were published at the very end of last year, and the Review aims to issue its final report this spring.

The Independent Review has met three times since the publication of the interim report: March 2016, January 2017 and March 2017.

A member of the MHRA has served on the Independent Review, and therefore endorsed the interim report. The report was featured on the MHRA website in October 2015.

https://www.gov.uk/government/publications/use-safety-and-efficacy-of-transvaginal-mesh-implants-in-the-treatment-of-stress-urinary-incontinence-and-pelvic-organ-prolapse-in-women.

Neither Scottish Government Ministers nor officials have met with, or contacted, manufacturers in relation to mesh devices.

The number of transobturator mesh tape and prolapse mesh procedures carried out by the NHS between June 2014 to Sep 2016 are set out in the following tables. The numbers of procedures carried out by each Health Board are not broken down by month due to the small numbers of patients involved.

Note: where a figure is not given, this is to protect patient confidentiality due to the small numbers involved.

Source: NHS National Services Scotland.

Until the Independent Review’s recommendations are published it is not possible to comment on them. In general terms, clinical research in Scotland is governed by the Scottish Executive Health Department Research Governance Framework for Health and Community Care, published in 2006. The RGF sets exacting and well established standards around the ethics, science, patient care, information, health and safety, finance and quality research culture for clinical research studies. It also details the responsibilities and accountabilities of key people and organisations involved in research studies to ensure robust governance arrangements are in place to assure these standards are maintained. The full document is available from the Scottish Government website.

http://www.gov.scot/Topics/Research/by-topic/health-community-care/chief-scientist-office/6864/6933.

Informed consent and shared decision making are expected prior to any procedure being carried out. The Chief Medical Officer goes into this in more detail in her Realistic Medicine report.

http://www.gov.scot/Resource/0051/00514513.pdf.

Options for the treatment of both stress urinary incontinence and pelvic organ prolapse are discussed in the Independent Review’s interim report.

http://www.gov.scot/Publications/2015/10/8485/4.

I understand that attempts have been made to make the Review’s final report as accessible as possible. However, as with any report of this kind, it will contain necessarily detailed, in-depth analysis of medical evidence that is, by its very nature, complex. An Expert Group is tasked with taking forward the recommendations of the Review. In response to previous recommendations it produced a patient-centred information and consent leaflet, and it will be expected to continue to take a patient-friendly approach in relation to the Review’s final recommendations.