Seòmar agus comataidhean

Minister for Public Health, Women's Health and Sport submission of 9 December 2021

PE1865/WWW - Suspend all surgical mesh and fixation devices

At the session on 6 October, on the issue of hernia repair, I explained that in 2019, the Scottish Government commissioned a review by the Scottish Health Technologies Group (SHTG) of the use of mesh in primary inguinal hernia repair in men. SHTG published their report in early 2020 and this concluded that, compared to non-mesh procedures, using mesh resulted in lower rates of recurrence, lower rates of serious adverse events and similar or lower risk of chronic pain. The advice for NHS Scotland was that surgical mesh should be used in elective repair of inguinal hernia in adult males. 

After giving consideration to that report, the Scottish Government then asked SHTG to examine hernia repair more broadly, to include women, and to review the outcome of mesh versus non-mesh surgery in a variety of groin or abdominal wall hernias. SHTG have published their report today and you can see this online at: Elective surgery using mesh to repair primary or incisional hernias in adults (shtg.scot).

A key conclusion from the report is that current evidence does support the continued availability of surgical mesh for elective repair of primary ventral hernias, incisional hernias, and primary inguinal hernias in adults in Scotland. This notwithstanding, SHTG also recommends that consideration should be given to patient preference and that patients should have access to alternative hernia treatment options such as non-mesh (suture and natural tissue) repair. Once again, the importance of shared decision making and informed consent has been emphasised. 

The Chief Medical Officer (CMO) has written to Board Chief Executives and Medical Directors to draw their attention to the report’s findings. The CMO has also asked Health Boards to consider the availability of non-mesh surgery within their Health Board, and how any skills-gaps, where they exist, can be addressed. This will provide a clearer overview of provision of non-mesh surgery in Scotland, including the use of contemporary techniques, like Shouldice Natural Tissue repair. The CMO has also asked Health Boards to consider the development of local clinical groups and broader clinical networks for the management of complex cases. 

The CMO will discuss this report at a forthcoming Scottish Association of Medical Directors (SAMD) meeting, and we will continue to work with Health Boards, Specialist Associations and relevant Royal Colleges on the issues raised.

Informed Consent 

You have asked what work is being undertaken to progress issues around informed consent. I know that this is one of the key areas of concern raised by the petitioners, and I agree with the petitioners that, with the exception of clinical emergencies, mesh should only be used with the fully informed consent of the patient. The Committee will know that this is a key principle of Realistic Medicine and again, this was emphasised by the SHTG. Consequently, the CMO has asked Medical Directors to remind clinicians of their obligations, and has emphasised the importance of recording both the content and outcome of such discussions. The Scottish Government will also bring the SHTG report to the attention of NHS Scotland Realistic Medicine Clinical Leads.

More generally, and in response to the recommendations from the Citizens’ Jury on shared decision making, the Scottish Government funded NHS 24 to launch a public awareness campaign “It’s Ok to Ask” to support patients and health and care professionals to have positive conversations about care and treatment. The key message of the campaign is that it’s okay to ask questions of health and care professionals. NHS Scotland have suggested four key questions for patients to ask, which can be remembered by the acronym BRAN:

• What are the Benefits of my treatment?
• What are the Risks of my treatment?
• Are there any Alternative treatments I can try?
• What if I do Nothing?

We know that when patients have a better understanding of their treatment and care options, they are empowered to make informed decisions about their care. 

Further information about the campaign, including a range of resources for both patients and professionals, is available on NHS Inform. “It’s OK to Ask” posters and leaflets are being promoted in primary, secondary and community healthcare settings across Scotland. The BRAN questions are also displayed in Near Me virtual waiting rooms, while people wait to consult their healthcare professionals. 

We have also worked closely with the General Medical Council (GMC) on their updated guidance on Decision making and consent. The updated guidance focuses on person centred care and aligns with the Realistic Medicine agenda here in Scotland. It promotes shared decision making and informed consent as the key to ensuring people receive the treatment and care that they want and need.

Medicines and Healthcare Regulatory Agency (MHRA)

During my Committee appearance on 6 October, you raised the issue of materials used during the manufacture of surgical mesh products. As was touched upon during the session, the Scottish Government contacted the MHRA, in 2018, in light of concerns that had been expressed about the quality of certain raw materials, specifically the unprocessed resins, used in the manufacturing process. The MHRA, in response, confirmed that it was aware of media attention in respect of this issue. However, the Agency also stated that it had not found any new evidence which would prompt regulatory action and, as such, and in its view, the products in question remained acceptably safe when used as intended, as part of an appropriate treatment pathway.

Separately, and around the same time, concerns were also expressed about the alleged use of counterfeit materials during the manufacture of mesh. Again, the Scottish Government contacted the MHRA about this. The Agency confirmed that, subsequent to the claims being made, it had contacted manufacturers, as well as the Dutch Healthcare Inspectorate and the US Food and Drugs Administration (FDA). The Agency also reviewed adverse incidents in relation to mesh. In conclusion, it found that there was no evidence to justify the claims. The MHRA also noted that the FDA, having itself investigated this issue, concluded that there were no safety or effectiveness concerns that warranted further action. The MHRA noted that, in coming to this conclusion, and in order to thoroughly address the allegations, the FDA, although usually concerned with determining the safety and effectiveness of finished products only, had exceptionally reviewed the raw materials used in the manufacturing process, as well as the finished product. 

As Committee members will be aware, responsibility for the MHRA and the regulatory process ultimately lies with the UK Government. Nonetheless, the Scottish Government was pleased to see publication, last year, of the Independent Medicines and Medical Devices Safety Review’s final report. The Scottish Government is fully supportive of the findings of that Review, including the recommendations made in respect of the regulation of medical devices and the MHRA. The Scottish Government’s response to the Review’s findings, including those that relate to the MHRA, can be viewed here.

As was explained during the Committee session on 6 October, EU exit has resulted in the introduction, in the UK Parliament, of a Medicines and Medical Devices Bill. The Bill gives UK Ministers power to make regulations about the way in which the MHRA will undertake its functions. The MHRA has thus commenced work to revise its corporate plan and ways of working and the Scottish Government will, of course, continue to work with and encourage the Agency during this period of development and reform.