Thank you, convener. I welcome this further opportunity to speak to the committee and members of Parliament on this important topic, following my statement in the chamber at the end of March.
The independent review came about as a result of the efforts of many women who were affected and who strove to make their voices heard. Two of the women—Elaine Holmes and Olive McIlroy—who lodged the petition with the committee, later directly took part in the independent review.
Before I outline the Scottish Government’s response to the review’s recommendations, I inform the committee—I have written to the convener about this—that I have commissioned Alison Britton, who is a professor of healthcare and medical law, as an independent expert to examine and to report on the process of the independent review. Professor Britton, who works at Glasgow Caledonian University, is a specialist in public healthcare, clinical negligence, mental health law and professional ethics. She will produce a report on how the independent review process was undertaken and, importantly, what lessons can be learned for the future.
I turn to the report. On its publication, the chief medical officer wrote to the chief executives and medical directors of all health boards about the review’s conclusions. In particular, she highlighted the conclusions on the circumstances in which mesh procedures should and should not be offered in cases of pelvic organ prolapse and in cases of stress urinary incontinence. She also made clear the importance of health boards ensuring that detailed and patient-friendly information is available to all women. That information must be provided so that women can make careful and fully informed decisions on the best treatment in their case. In addition, the CMO has instructed all health boards to limit the number of surgeons who carry out mesh procedures and to ensure the mandatory reporting of adverse events.
The Scottish Government will establish an oversight group, which will be expected to work with health boards in progressing the review’s conclusions. That will include working on guidance for nationally agreed pathways, publishing patient-centred versions of sections of the independent review’s report, and producing leaflets on pelvic organ prolapse and post-operative information. I expect patients to be involved in the oversight group’s work. I also confirm that Scottish Government officials continue to work with colleagues across the UK to explore a mesh registry pilot. The development of e-learning packages is also being considered for use in general practice.
I want it to be absolutely clear that the key safeguards that are to be put in place as a result of the review must be implemented before any procedures using mesh are reintroduced routinely to healthcare services in Scotland. The chief medical officer has met the medical directors of the health boards to gain assurance that those measures will be in place.
As the people who are here today know, during the independent review’s concluding stages, three members felt that they had no choice but to resign from it. That was, of course, deeply disappointing, and it caused me a great deal of concern. I met Olive McIlroy and Elaine Holmes after their resignation because I was very keen to hear directly about their concerns, which I put to the chair of the independent review when I met her.
I turn to the petition that was presented to the committee in 2014. It is worth briefly considering the demands that are contained in it and the progress that has been made towards meeting those demands. First of all, the petition called for the suspension of the use of polypropylene transvaginal mesh procedures. The Scottish Government requested that health boards suspend use of mesh until the independent review published its final report. As I have said, routine service provision will recommence only once the medical directors and chief executives are assured that the recommendations have been implemented.
Secondly, the petition called for a public inquiry and/or comprehensive independent research to be initiated to evaluate the safety of mesh devices using all the evidence available, including evidence from around the world. The independent review was initiated to fulfil that request and has published its final report.
Thirdly, a call was made for the introduction of mandatory reporting of all adverse incidents by health professionals. The final report makes it clear that that is mandatory.
Fourthly, the petition requested that a Scottish transvaginal mesh implant register be set up, with a view to linking it with national and international registers. Scottish Government officials are exploring that with colleagues in NHS England.
Fifthly, it was requested that fully informed consent be introduced, with uniformity throughout Scotland’s health boards. Health boards will be required to make every woman fully aware of all the options that are available in her individual case.
Sixthly, the petition asked that the MHRA be written to, to ask it to reclassify mesh devices. The reclassification of surgical mesh has been under consideration by the European Commission and was adopted by the European Parliament on 5 April this year.
Despite the concerns that have been raised, which I fully understand, I believe that progress has been made on the issues that were raised in the original petition. I am happy to take questions.