I am pleased and privileged to open the debate on behalf of the Public Petitions Committee and to play a small part in the opportunity to bring this critical issue to further public attention. Petition PE1517, on polypropylene mesh medical devices, was lodged in April 2014, receiving more than 1,700 signatures of support and attracting 212 comments. The committee will consider a draft report on the petition in due course and it will reflect on this debate in its deliberations. What is said today will help to shape that important report.
Before I move on to the key themes and concerns raised by the petition, I would like to place on record my thanks, on behalf of the committee, to the petitioners, Elaine Holmes and Olive Mcllroy, and all the other women and their husbands, partners, friends and families who have provided their testimony on the impact that mesh has had on their lives. That testimony was often given at huge personal cost. Although, through their courage, we have been given a window into what they have suffered, we do not live with the daily impact of mesh on every aspect of our lives. The testimony is set out in the 80-plus written submissions that we have received on the petition to date. It would be remiss of me not to acknowledge the members who do not sit on the committee but who have joined us in our consideration of the petition. I expect that Jackson Carlaw, Neil Findlay, Alex Neil and John Scott will contribute to the debate, just as they have contributed to the committee’s deliberations.
The session 4 committee’s consideration of the petition started in June 2014 with evidence from the petitioners. It is an indication of the impact of the evidence that just two weeks later, Alex Neil, then the Cabinet Secretary for Health and Wellbeing, gave evidence to the committee. It was in the course of that evidence session that the intention to establish an independent review and the request for a moratorium on the use of mesh devices were announced. It is worth reflecting on that moratorium, as it transpired that mesh operations continued while that was in place.
We heard during our most recent evidence session from Dr Wael Agur that the cabinet secretary’s request was disseminated to health boards by the chief medical officer. The request asked the boards to consider suspending the use of mesh in procedures for pelvic organ prolapse or stress urinary incontinence. However, it became clear that boards retained autonomy over their operations and, as such, were under not under a binding obligation to act upon the request or to confirm whether it was intended that mesh procedures would continue in their area. Although I cannot speak for the members of the session 4 committee, that would not have been their understanding of what a moratorium should entail. That should be reflected on in any future circumstances in which a moratorium may be requested. I would welcome a commitment from the cabinet secretary to ensure that that is done.
With that said, members will understand that I wish to focus most of my opening remarks on the process and outcomes of the independent review. The review group comprised urologists, researchers, public health professionals, patient representatives and representatives of professional bodies, the regulatory body for medical devices and the office of the chief medical officer. Secretariat support to the chair was provided by the Scottish Government. The independent review’s published remit was:
“to evaluate both the efficacy and the extent and causes of adverse incidents and complication rates associated with SUI and for POP”.
Its formal title was the Scottish independent review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women.
At our most recent meeting, the petitioners informed the committee that they had to fight to get the word “safety” put in the heading of the review. That certainly gave me pause for thought, as I am sure it did for other committee members.
The independent review group got to work and reached a milestone when it published an interim report in October 2015. Its interim report was tentatively welcomed, in so far as it represented signs of progress and enabled interested parties—not least the Government and mesh survivors—to reflect on the interim conclusions.
It should be noted, however, that the petitioners produced a minority report and that the Scottish mesh survivors group considered that the recommendations should be actioned immediately and that outcomes should be monitored before any further mesh procedures took place.
The interim report produced eight conclusions. They related to the need for robust clinical governance; the need for multidisciplinary team working, with appropriate levels of audit activity to ensure the recording and reporting of adverse events; and the need to ensure that women have the opportunity to discuss with their clinician all the options that are available to them, and the pros and cons of each, so that they can give fully informed consent. There was a “serious concern” that some women who had reported adverse events were not believed. There were concerns about the efficacy of short-term studies of the safety and effectiveness of mesh procedures, given that many adverse effects do not become evident until five, 10 or more years after a mesh procedure.
There were also concerns about the lack of reliable or robust information systems to record the number of procedures that are carried out and, by extension, difficulties in accurately measuring adverse events. There were other concerns around the use of transobturator mesh procedures, rather than retropubic mesh tape procedures, for what was referred to as “routine surgery” for stress urinary incontinence; those concerns were based on information that was produced in chapter 6 of the interim report and accompanied by a number of tables. Similar concerns were expressed in the report about the use of mesh in surgery for pelvic organ prolapse.
It was explained that the October 2015 report was interim because the independent review was awaiting the outcomes and findings from two key pieces of work. The first of those was the final opinion of the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks on the safety of surgical meshes used in urogynaecological surgery, which was published in December 2015. Its recommendations included that
“Implantation of any mesh for the treatment of POP via the vaginal route should only be considered in complex cases, in particular, after failed primary repair surgery”,
and that
“The amount of mesh should be limited for all procedures where possible.”
The second piece of work was the “Prolapse Surgery: Pragmatic Evaluation and Randomised Controlled Trials” study, which is referred to as the PROSPECT study. One of the primary outcomes to be assessed in that three-year study was the quality of life for women who had reported prolapse symptoms. Its final report was published in The Lancet in December 2016. It concluded that
“augmentation of a vaginal repair with mesh or graft material did not improve women’s outcomes in terms of effectiveness, quality of life, adverse effects or any other outcome in the short term”.
In addition, it found that more than 1 in 10 women—approximately 12 per cent—experienced a complication associated with mesh. The study concluded that follow-up was “vital” to identify whether there were any potential longer-term benefits for women and, conversely, to identify any potential serious adverse effects of mesh procedures for pelvic organ prolapse.
With those two pieces of work completed, the independent review’s final report was published in March this year. It would be a significant understatement to say that the final report was not as well received as the interim report. There were resignations from the independent review group shortly before publication of the final report, amid reported concerns that it was not fully independent, was misleading and was a backwards step from the interim report. Indeed, the petitioners were reported by the BBC as feeling “betrayed” and concerned that the report was “a whitewash”. Concerns were expressed by the petitioners and members of this Parliament that information had been either omitted altogether or moved to a different part of the report.
Significant concerns related in particular to the removal from the final report of the tables on shared decisions in chapter 6. Those concerns have already been raised in this chamber, both at topical questions and during the cabinet secretary’s statement to the Parliament on 30 March.
In May, the committee took evidence from the chair of the independent review and then from the cabinet secretary and the chief medical officer. It was unfortunate that the evidence that we heard seemed to produce more questions than answers. We were unable to establish a clear understanding of how decisions were taken in the independent review. We could not establish whether decisions were taken by sub-groups, the full group or at the discretion of the chair. The committee thought that that lack of clarity could have been avoided through the provision of readily accessible minutes or notes of correspondence.
There was also confusion about the timeline of communications between the petitioners, the cabinet secretary and the chair of the independent review, which extended to decisions that were made following receipt of the petitioners’ communications asking for the removal of all their contributions from the report, which did not happen.
The review’s final report recommends the mandatory reporting of mesh adverse events. That is welcome, although it appears from the evidence that we heard that that conclusion was reached quite late in the day. A number of other recommendations are also welcome, in so far as they address systems and practices that should be in place as a matter of clinical governance.
I want to focus on two recommendations. First, the recommendation in conclusion 7 of the final report, which relates to stress urinary incontinence, is:
“women must be offered all appropriate treatments (mesh and nonmesh) as well as the information to make informed choices.”
I cannot stress how important it is that when women are considering their options they have the opportunity to discuss them with their clinician and have their views listened to. Discussions must be based on the most up-to-date information available.
Conclusion 8, on the surgical treatment of pelvic organ prolapse, is that a mesh procedure does not provide “any additional benefit” over natural tissue repair. However, that conclusion seems somewhat qualified by the next sentence, which is:
“Transvaginal mesh procedures must not be offered routinely.”
I emphasise the word “routinely”.
In evidence to the committee, the cabinet secretary advised that the Scottish Government would establish an oversight group to take forward the recommendations. She added:
“the key safeguards that are to be put in place ... must be implemented before any procedures using mesh are reintroduced routinely”.—[Official Report, Public Petitions Committee, 18 May 2017; c 24.]
When I sought clarification from the cabinet secretary on whether the moratorium would remain in place until the recommendations have been implemented, she replied that the suspension would not be lifted until medical directors have assured the chief medical officer that all the recommendations in the final report have been implemented.
It could be argued that much of what the petition called for has been delivered. For example, a moratorium was put in place, an independent review was initiated, reporting of adverse events will be mandatory, and progress is being made towards fully informed consent. However, the outcome of the independent review is such that it would be absolutely inappropriate for the petition to be closed at this point.
That is reflected in the fact that the cabinet secretary has commissioned Professor Alison Britton to conduct a review of the independent review. Along with the deputy convener of the committee, I have had the opportunity to meet Professor Britton, to explore her remit and flag up to her some of the concerns and issues that have come to light in recent months as part of our consideration of the petition.
The cabinet secretary has offered her reassurance that the recommendations of the independent review’s final report stand, pending the conclusion of Professor Britton’s review of the review. However, the overriding concern that has come across during our consideration is people’s lack of confidence in the independent review process and therefore in its outcomes. Given people’s already fragile confidence in the independent review’s governance and findings, if Professor Britton’s review finds that the process was significantly flawed, how can the cabinet secretary, this Parliament and, most important, the public be assured that the independent review’s outcomes are robust and credible? I hope that today’s debate provides an opportunity for that question and others to be answered.
We might, sadly, have to confront the harsh truth that the damage that was done to the petitioners and others cannot be repaired, but we must do what we can to ensure that their experience is not repeated. Believing all those women and responding to their well-founded understanding of what must change would be a good start. [Applause.]
I move,
That the Parliament notes public petition PE1517 on polypropylene mesh medical devices.