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.

The terms of reference and membership of the independent review group will be published on the ‘Independent Review of Transvaginal Mesh Implants’ website, which will be available from mid November 2014. The website address is as follows:

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

Membership of the group is reviewed periodically and additional members invited to attend when necessary. This is to ensure the appropriate level of expertise and range of opinion is represented. The composition of the group has been developed to represent all interested parties, including:

One chairperson (retired public health consultant)

Two patients who have experienced complications

Two patients who have experienced a positive outcome

Four clinicians with a special interest in urogynaecology practicing in Scotland

One public health consultant

One researcher

Three professional bodies

Three Scottish Government officials (two clinicians and one policy officer)

One medicines and healthcare products regulatory agency official

Members attending periodically:

One physiotherapist

Two clinicians (unique device identifier project lead)

One Scottish Government public health consultant

Members to be confirmed:

One pain management consultant

One general practitioner

One clinician with a special interest in urogynaecology

One Information Services Division consultant in public health

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.

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 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 has not discussed the potential financial implications with mesh manufactures or NHS boards.

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 information requested is not held centrally.

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.

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.