Chamber and committees

The information requested is not held centrally. The independent review of transvaginal mesh implants will appraise the current research evidence on synthetic mesh implants. The review will report early next year and will publish all clinical trials and studies appraised.

The independent review has invited a consultant in public health from NHS Information Services Division to support the group when considering coding of procedures.

The UK working group, chaired by Professor Keith Willett, on surgery using vaginal mesh is considering how data collection can be improved. This will include coding of mesh procedures.

The Deputy Chief Medical Officer is representing the Scottish Government on this group.

Additionally, NHS National Services Scotland is reviewing the national adverse incident reporting system in light of the under-reporting of pelvic floor mesh incidents. This has already resulted in the introduction of a new code specifically for recording and monitoring mesh-related adverse incidents.

The Scottish Government has put patient safety first and taken action to investigate concerns regarding transvaginal mesh implants. It has not discussed the financial implications of litigation in respect of mesh implants with NHS boards.

Yes, the Scottish Government intends to publish all minutes and relevant documents relating to the independent review, where appropriate.

All documents, once published, can be viewed at the following web address from mid November 2014:

http://www.scotland.gov.uk/About/Review/Transvaginal-Mesh-Implants

The Deputy Chief Medical Officer is currently developing a pathway for women experiencing complications and has met with a healthcare planner. Any resource implications will be considered as part of this process.

The Scottish Government received one representation regarding a conflict of interest.

The European Commission has confirmed that all experts participating in the Scientific Risk Assessment Advisory Structure need to declare commitment, confidentiality, and interests in the subject matter before participating in the work. Declarations of interests are updated orally at each meeting. The declarations will be published once the work on the particular subject matter has been concluded. Likewise, the composition of a working group is published only once an opinion has been approved by the scientific committee.

The letter from the Deputy Chief Medical Officer to medical directors, dated 16 July 2014, reaffirms the guidance issued to medical directors by the Acting Chief Medical Officer on 20 June 2014, which stated:

“If women are being considered for entry into clinical trials then use of mesh can be approved for women being entered into the arm(s) of the trial using this option. The Cabinet Secretary endorses this position”.

The clinical trials in question have appropriate ethical approval from the National Institute of Health Research for the procedures being used, including the necessary fully informed consent processes. They are funded from the public sector and are not funded by any manufacturer or supplier.

The information requested is not held centrally.

The Scottish Government wrote to the Chair of the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks in May and June 2014 regarding the regulation of mesh implants.

The correspondence outlined the concerns raised by women who have experienced serious complications as a result of mesh implants.

The decision to request that boards consider suspending the routine use of synthetic mesh implants for these procedures does not prevent individual women and their clinicians agreeing on the need for a particular service – this is still available.

The letter reaffirmed my statement that for the improvement of our future evidence and where women fully consent, if they are being considered for entry into clinical trials then use of mesh for the conditions affected (pelvic organ prolapse) can be approved for those entered into the arm(s) of the trial using this option.