Chamber and committees

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.

As at 22 October 2014, the Scottish Government has been made aware of the following potential or pending litigations against NHSScotland.

314 claims and summonses, of which 139 summonses have been served and 12 of which have been lodged.

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 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 information requested is not held centrally.

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.

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 Scottish Government has not had specific discussions regarding the independent review with the Medicines and Healthcare Products Regulatory Agency (MHRA). I met with Sir Gordon Duff, Chairman of the MHRA, in June 2014 and following this meeting formally invited a representative of the MHRA to participate in the independent review, sharing the draft terms of reference.

The Scottish Government has corresponded with the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks to acknowledge that the commission is seeking further research and expert opinion on ‘The safety of surgical meshes used in urogynaecologial surgery’ and that we look forward to receiving the results in January 2015.

The Deputy Chief Medical Officer has also corresponded to seek reassurance of the declared interests of members of the working group and that any declared interests of members will not influence the work of the group or of its recommendations when the opinion is published. The European Commission have provided this reassurance.

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.

Pathway documents have been developed by the expert group and the Deputy Chief Medical Officer is now working with healthcare planners to implement the necessary changes to deliver this new service.

Currently NHS Greater Glasgow and Clyde, NHS Ayrshire and Arran, NHS Lothian and NHS Grampian have accredited subspecialist surgeons and are developing multi-disciplinary teams that are able to provide clinical support to women experiencing complications. The Glasgow team has consistently demonstrated adequate expertise accompanied with relevant workload and success rates in dealing with advanced mesh complications requiring highly specialised surgical techniques.

Depending on individual conditions, some patients will require treatment in the local hospital, some will need referral to the regional centre and some will require referral to the national centre. The pathway document details the referral criteria specific to each patient presentation and guides patients and their surgeons to the best place to provide further treatment tailored to their individual condition.

The Deputy Chief Medical Officer has written to all NHS boards requesting information on current practice in the surgical treatment of stress urinary incontinence and pelvic organ prolapse, including confirmation of the number of subspecialist urogynaecologists.

NHS boards are in the process of collating this information, which will be published once available.

The most common procedure used to treat women experiencing complications is partial removal of mesh device (or excision of mesh erosion). This procedure is performed by a number of surgeons around the country and, in most situations, no further treatment is required. However, if further partial removal is required and/or if complete removal is being considered, the pathway document developed by the expert group indicates forward referral to the national centre where expertise will be concentrated to provide such highly-specialised service to patients. This service will also deal with patients who have developed complications such as fistula tracts or bladder or bowel involvement.