Chamber and committees

The reporting of adverse events is voluntary, although clinicians are encouraged to report incidents which is also a requirement set out in Good Medical Practice, guidance for Doctors from the General Medical Council. We will work with the Scottish Association of Medical Directors to identify barriers to reporting amongst Scottish clinicians so that we can find ways of increasing notification.

Adverse incidents concerning medical devices in Scotland should be reported to the Incident Reporting and Investigation Centre at Health Facilities Scotland (HFS), which is part of NHS National Services Scotland, as well as the Medicines and Healthcare products Regulatory Agency (MHRA). HFS liaises closely with the MHRA, notifying it of each adverse incident reported in Scotland and the results of any investigation.

In September 2013, Healthcare Improvement Scotland published its document Learning from adverse events through reporting and review: a national framework for NHSScotland. The work on adverse events, commissioned by the Scottish Government, provides a framework to support NHS boards to standardise the processes of managing adverse events across NHSScotland. The framework aims to help ensure that there is a common approach to the identification, reporting and review of adverse events and the dissemination of best practice across the NHS in Scotland. It has been produced following consultation and engagement with NHS boards, clinicians, patients and a number of national organisations.

The treatment options for the removal of transvaginal mesh implants should be viewed on an individual basis. The duty of care for offering the appropriate treatment lies with individual NHS boards, offered through their clinicians in consultation with patients.

The Patient Rights (Scotland) Act 2011 aims to improve patients experience of using health services and to support people to become more involved in their health and health care. The Act, which reinforces the Scottish Public Services Ombudsman’s recommendations, made provision for:

Health care Principles (included in http://www.sehd.scot.nhs.uk/mels/CEL2012_07.pdf) that must be upheld by everyone involved in the delivery of NHS services in Scotland and this includes communication and patient participation;

The Charter of Patient Rights and Responsibilities explains the patient’s rights in relation to communication and participation. The supporting patient information leaflet on communication and participation is available at: http://www.scotland.gov.uk/Resource/0040/00407729.pdf;

Information for staff on the Act developed by NHS Education Scotland is available at http://www.knowledge.scot.nhs.uk/making-a-difference/making-a-difference/patient-rights-scotland-act-2011.aspx.

NHS boards provide information services, including directing patients to the leaflets of professional organisations such as The British Society of Urogynaecology and The British Association Urological Surgeons to provide the required information to make an informed consent.

The Scottish Government has received a number of letters raising issues relating to transvaginal mesh implant surgery. Where concerns on potential adverse events have been raised, those raising the concerns have been asked to report these to the Medicines and Healthcare products Regulatory Agency and NHS National Services Scotland’s Incident Reporting and Investigation Centre who have responsibility for incidents relating to medical devices.

No specific instruction was given to NHS boards on the use of transvaginal mesh implants. NHS boards have a duty of care towards their patients which includes providing appropriate information to allow informed consents to be made.

This information requested is not held centrally. Information on the number of patients that have had to undergo multiple operations following a procedure to remove transvaginal mesh implants is not available as there are no specific clinical codes used to identify the removal of transvaginal implants.

However, available data shows that between 2007-08 and 2012-13, 15 of the 101 patients who had a procedure involving the removal of unspecified prosthesis from organ or the removal of other unspecified repair material from organ, were involved in a subsequent procedure during the year following treatment which could be related to the original removal procedure.

The Deputy Chief Medical Officer met with Mark Lloyd Davies, Senior Director, Johnson and Johnson, and a colleague from the Association of British Healthcare Industry on 16 July 2013 to hear views on research and medical device regulations. There was no discussion on the suspension of the use of transvaginal mesh implants. A research paper was provided on biocompatibility for information.

The information requested is not held centrally.

The consideration of clinical procedures including the use of ultrasound as a treatment in the removal of transvaginal mesh implants will be considered by the transvaginal mesh working group. This working group has been set-up to look in detail at issues surrounding transvaginal mesh implants. The next meeting of the working group will take place 13 December 2013.

The Deputy Chief Medical Officer and colleagues have participated in discussion with the Medical and Healthcare products Regulatory Agency and other professional bodies on the reporting and use of the implant database. The professional bodies have agreed in principle to work together on reporting complications and outcomes. There have been no discussions on suspending the use of transvaginal mesh implants.