Transvaginal Mesh

Part of the debate – in the Scottish Parliament on 26th June 2019.

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Photo of Jeane Freeman Jeane Freeman Scottish National Party

I am pleased to update members on the progress of our work in relation to transvaginal mesh. In doing so, I thank all those who are involved in the Scottish mesh survivors group for their tireless campaigning, and members across the chamber who have supported them.

In September 2018, I announced my decision to halt the use of transvaginal mesh in cases of pelvic organ prolapse and stress urinary incontinence. I set out that I required high vigilance from boards to ensure that my decision was implemented, and that such a halt would be lifted only if a restricted-use protocol could be developed to my satisfaction.

Our chief medical officer, Dr Catherine Calderwood, duly instructed health boards on the restriction to practice and, in compliance with my statement, established a group of board accountable officers to consider aspects of service and care that are available to women who suffer from stress urinary incontinence and pelvic organ prolapse. The group has met once, and the minutes were published on the Scottish Government website. To be as clear as possible, I see no prospect of the halt that I instigated being lifted, and I have not asked for any planning to lift the halt.

I wrote to the chief executive of the Medicines and Healthcare products Regulatory Agency on 31 October 2018, and the CMO was in contact with the director of medical devices in November and December, which was followed by a phone call later in December. In those exchanges, we raised our concerns about the approvals process, and I hope that we have been not only listened to but understood. The MHRA has set out that it takes those views extremely seriously, and it has invited NHS Scotland to join all cross-cutting initiatives, including the work on the unique device identifier and the improved communication with patients on the potential outcomes from the use of all types of medical devices. The MHRA says that it stands ready to support us and our healthcare system to ensure the safety of all patients who need treatment. I am sure that members across the chamber will join me in ensuring that we hold the MHRA to that commitment.

In March this year, following a members’ business debate, the CMO and I met a group of women from the mesh survivors group. I am grateful to them for their time and for their courage and willingness to share their experiences with me. Following that meeting, I set in train the work that I had promised the women that I would.

A mesh complications short-life group was set up to consider the physical and psychological needs of the women who experience complications; to consider what additional steps are needed to offer choice to women who are clinically suitable for and want mesh removal; and to review and identify areas of best practice, wherever it happens, and determine how such practice can be provided in Scotland.

In addition—again, in line with the commitment that I gave—I ensured that the voices of women would be heard in the short-life group’s deliberations through the membership of Dr Wael Agur, whom members of the mesh survivors group wanted to represent them, and the Health and Social Care Alliance Scotland. As members will be aware, I set out details in four Government-inspired questions, on 8 March, 6 June and 13 June, and through an update that was provided on 19 June.

A key part of the mesh complications working group’s actions is to ensure that the care and treatment that is provided for women who have been affected is as good, if not better, than that offered in any other centre here in the United Kingdom or elsewhere around the world. That requires benchmarking processes and outcomes with other centres, as well as sharing experience and techniques with clinicians.

In that context, Dr Veronikis’s offer to come to Scotland to work is very welcome, and I recognise that a number of patients are eager for him to come here. As a result, and in consultation with the service here in Scotland, I have asked that we look to bring Dr Veronikis to Scotland as soon as possible. The intention will be for him to work with the clinical service in a complementary fashion to provide treatment, expert advice and training. I want there to be a valued partnership that benefits patients now and over the long term.

In saying all that, it is important that we are all clear that such an arrangement is subject to agreement and regulatory approval. As regulation in the area is reserved, I have written to the United Kingdom Government’s health secretary and to the General Medical Council to highlight the case and to ask that, on their part, steps are taken as expeditiously as possible.

I am pleased that the GMC has responded quickly and positively with an assurance that it will do all that it can to ensure that the important regulatory process is completed quickly and smoothly. With appropriate agreement and sponsorship by the service, I hope that Dr Veronikis can visit by the autumn. I await a response from the UK Government.

The mesh complications working group has been working to establish a national complex case review unit in NHS Scotland. The work to finalise the details and the important connections between the unit and the relevant health board is being taken forward through our service design processes, with the intention that the unit be established by mid-2020.

The working group has also taken forward a number of other measures, which are designed to ensure that patients have choice, and all the information that they need to exercise that choice. That includes the establishment of clear care pathways—through primary care as well as in acute services—that are consistent throughout Scotland.

I repeat my thanks to the Scottish mesh survivors group. The group’s initial work and campaigning was intended to ensure that in the future no other women would suffer the pain and life-changing effects of mesh use that they had suffered and still suffer. The halt that I instructed last September was a direct response.

The women then, rightly, sought the attention and care that they themselves are due. From all the correspondence that I have received, from the representations that members have made to me and, most important, from the women themselves, I understood clearly the areas where the care and attention—and choice—that is being offered could be improved. The update that I have provided today directly responds to that.

Our health service is there to provide safe, effective and person-centred care. In this area, and for the women who suffer complications from mesh, my intention is that what I have set out today should take us ever closer to providing that focused, safe and person-centred care.

I commend this update to the Parliament and I am happy to take questions.