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Cabinet Secretary for Health and Social Care submission of 2 July 2021

PE1865/BB - Suspend all surgical mesh and fixation devices

I refer to the above petition, currently under consideration by the Public Petitions Committee. The Scottish Government takes all issues relating to the use of mesh very seriously. As a consequence and mindful of public concerns, the then Chief Medical Officer wrote to all Health Board Medical Directors in February 2018 about the use of mesh in sites other than the vagina. I think the key points of guidance offered then to Health Boards do align closely with the current concerns raised by the petitioners:

• Sharing information with patients and allowing them to consider the options available for treatment are fundamental. This must include consideration of non-surgical management and interventions that do not involve the use of mesh. Colleagues should be reminded of this as well as the importance of ensuring that patients understand and consent to the use of mesh as part of any procedure.
• Patients who report complications or side-effects following mesh surgery must be carefully listened to. Their concerns should, at all times, be taken seriously and acted upon appropriately.
• The management of patients with mesh related complications must follow agreed pathways which should involve a multidisciplinary team of clinicians with appropriate skills and experience.

I have included the full text of the CMO letter, an as annex, for your information.

With regard to the use of mesh in gynaecology, this was addressed in the Chief Medical Officer’s letter of September 2018. The use of transvaginal mesh for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse was halted, and a high vigilance scrutiny protocol was introduced for some other procedures including those raised by the petitioners. These measures are still in place across NHS Scotland. You can view the letter online here.

Consent

The petitioners assert that mesh should only to be used with the fully informed consent of the patient. I wholeheartedly agree with this. It is essential that patients understand the nature of their surgery and give their permission for the use of implanted materials such as mesh. They must have knowledge of the risks involved and these risks must be balanced against the potential benefits. Meaningful discussion arising from the consideration of risks and benefits is crucial in shared decision making. This is a key principle of Realistic Medicine as well as the recently updated General Medical Council guidance on consent, in which Scottish Government officials were closely involved. This guidance is available here.

Further, Scottish Government officials have also been in liaison with the British Hernia Society and EIDO healthcare (who produce patient information to support shared decision-making), to encourage the development of improved information resources and consistent practices.

Evidence and further research

With reference to the petitioners call for a review of relevant surgical procedures and connected matters, the Scottish Government has commissioned research in to the use of mesh in a commonly performed hernia repair. This resulted in the publication of the Scottish Health Technologies Group (SHTG) report on the use of mesh in primary inguinal hernia repair in adult males, published in early 2020. This is available online here. The report concluded that, compared to non-mesh procedures, using mesh resulted in lower rates of recurrence, fewer serious adverse events and similar or lower risk of chronic pain. The advice for NHS Scotland was therefore that surgical mesh should be used for elective repair of inguinal hernia in adult males, following a process of shared decision making and informed consent. In the light of this, the Scottish Government does not consider that there is evidence at present that might justify a ‘pause’ in the use of relevant devices.

The Scottish Government has now asked SHTG to examine hernia repair in men and women, and to analyse the outcome of mesh surgery in different hernia types as well as tacking devices. Patient engagement is included and the responses gathered will be considered alongside analysis of the published evidence in developing recommendations.

The report is due for publication in late summer, and this will be accompanied by a clinical consensus statement as well as a plain language summary. On receipt, the Scottish Government will write again to Medical Directors and relevant professional bodies to draw the report to their attention and also to note public interest in this matter. The Scottish Government will encourage Health Boards to consider development of local clinical groups and broader clinical networks for the management of complex cases. Consideration will also be given to the development of skills in non-mesh procedures where these are required. I would be very happy to keep the Committee and/or petitioners updated as this progresses.

Outcome Data

NHS England / NHS Digital are developing a Pelvic Floor Database and Registry to monitor and improve both quality of care and patient safety. The intended focus is gynaecological procedures and NHS Scotland is currently working with NHS Digital on this UK-wide initiative.

Although it is not anticipated that hernia mesh will be included here, it is planned that through the Scottish Government’s Unique Device Identifier Programme, information on use of all implants will be captured and entered into electronic patient records, and it is envisaged that analysis of outcomes will be possible through links with routinely collected data. This work will also facilitate accurate recording and reporting of adverse events and to enable patients to be traced in the event of a product recall or a safety concern.

The issues raised by the petitioners are important and I hope this letter explains how they are being addressed by the Scottish Government. I trust this response with commentary on ongoing activity is helpful but I will be happy to provide any further information, if necessary.

HUMZA YOUSAF

ANNEX – CHIEF MEDICAL OFFICER’S LETTER

Chief Medical Officer Directorate

Chief Medical Officer and Deputy Chief Medical Officer

Medical Directors

Primary Care Leads

NHS Scotland Health Boards

19 February 2018

Key points:

• Debate about the use of prosthetic mesh continues and concerns about broader aspects of medical practice have been raised in the Scottish and UK Parliaments, in the media and in the wider community. These include-

Consent, Management of adverse events, Conflicts of interest

Actions:

• Distribute this letter to relevant individuals. Some of the themes are generic and are therefore germane to all clinical colleagues. Those responsible for governance, procurement and finance should also be made aware of these concerns.

Dear colleague

I am writing to you to make you aware of ongoing issues associated with the use of mesh implants. These have attracted media coverage, they have been raised in Parliament and they have also been the subject of enquiries from MPs, MSPs and the general public.

Although most attention has focused on vaginal mesh, concern has also been raised about the use of mesh at other sites and in particular in repair of abdominal wall herniae. In recent months, use of mesh for the latter has been the subject of a number of letters received by Ministers from Parliamentarians and patients. These have highlighted consistent themes, some of which are generic. I believe they are important and I feel I should draw them to your attention.

Consent

Patients have the right to make choices about their own lives and doctors have both an ethical and legal responsibility to involve their patients as much as possible in making decisions about their own health and care. Furthermore, sharing information with patients and allowing them to consider the options available for treatment are fundamental. This must include consideration of non- surgical management and interventions that do not involve use of mesh. Colleagues should be reminded of this as well as the importance of ensuring that patients understand and consent to the use of mesh as part of any procedure. This must be recorded in the patient record.

Adverse events

It is important to stress that patients who report complications or side-effects following mesh surgery must be carefully listened to. Their concerns should, at all times, be taken seriously and acted on appropriately. An e-learning aid created by NHS England (and modified for use here in Scotland) will shortly be circulated to Primary Care Leads. It is intended that this will be disseminated widely to relevant clinicians in Primary Care and is designed to assist recognition of complications in those with vaginal mesh implants.

The management of patients with mesh-related complications must follow agreed pathways which should involve a multi-disciplinary team of clinicians with appropriate skills and experience. In a situation where a patient requests a second opinion, clinicians should take care to ensure that they provide necessary support, advice and assistance. It will be helpful to consider the progress you have made with clinical pathways at board, regional and national level. I will ask Ian Wallace to include this on the agenda for a forthcoming SAMD meeting, ideally to coincide with discussion about the work of the Oversight Group with the Chair and colleagues from HIS also present.

Adverse event reporting

Adverse event reporting and analysis for clinical care in general remain a key aspect of the Patient Safety Programme and local learning methodologies. Reporting adverse events is therefore mandatory, in line with The General Medical Council’s Good Medical Practice which states that, to help keep patients safe, clinicians must:

“report adverse incidents involving medical devices that put or have the potential to put the safety of a patient, or another person, at risk.”

Further, in paragraph 47 of the Prescribing guidance, the GMC states that the MHRA must be informed. This can be achieved either directly by the Yellow Card scheme (MHRA) or reporting to Health Facilities Scotland’s Incident Reporting and Investigating Centre (IRIC: IRIC website).

Conflicts of interest

The suggestion that clinical practice might be influenced by financial or other gain is not new however, it has recently been the subject of concerns aired in the Scottish Parliament and we should all be aware of the possibility of increased scrutiny that could follow. I think colleagues need to be made aware how their activities might be misconstrued and they should be encouraged to declare interests where appropriate. Declarations should be held by Health Boards and made available for public examination.

I would be grateful if you would ensure that this letter is distributed to appropriate clinicians and other relevant individuals within your Health Board area.

Yours faithfully

Chief Medical Officer