Thank you very much, convener; I also thank you for the opportunity to discuss this issue this morning. I thank the ladies behind me in the gallery, too, for bringing the matter to the attention of the committee and Parliament.
The first thing to say is that we should all be very concerned to hear how the implants have affected the lives of some women in Scotland and elsewhere. I have met women who have been adversely affected, including Mrs Holmes and Mrs McIlroy, and was deeply troubled to hear how they have suffered. They have my full sympathy and support, and we will certainly do everything that we can to improve the situation. No one should have to experience the level of suffering that those women have experienced.
I will set out the actions that the Scottish Government is taking to address the issues that have been raised.
I asked the deputy chief medical officer, Dr Elliot, to investigate and to recommend actions to address the matter. We estimate that each year in Scotland about 1,500 women who suffer from stress urinary incontinence and 350 who suffer from pelvic organ prolapse have synthetic mesh implant surgery. Those conditions result in reduced quality of life and I understand that traditional surgery techniques have a high failure rate of between 20 and 30 per cent for primary pelvic organ prolapse surgery. Based on the 2012 York report, which was a study commissioned by the Medicines and Healthcare Products Regulatory Agency—MHRA—it is estimated that about 1 to 3 per cent of women experience complications following stress urinary incontinence surgery. According to the MHRA, the percentage of women who experience complications following POP surgery is slightly higher; it is estimated to be between 2 and 6 per cent. That contrasts with the failure rate of between 20 and 30 per cent for traditional surgery for POP, which I mentioned.
That means that a majority of women—based on that estimate, the figure is about 1,450 annually—would appear to benefit from the surgery without complications. Of course, that is not to diminish the seriousness of the situation for the women who do suffer complications. However, I add that the percentage of complications is probably substantially underestimated because of underreporting and non-reporting of adverse events. I therefore regard the figures as not being entirely reliably accurate.
I asked Dr Elliot to chair a working group that includes clinicians and patient representatives to consider the issues in more detail. That group has now met twice. I thank Mrs Holmes and Mrs McIlroy for their on-going contribution to it. The group has made progress; it has produced a new patient information and consent booklet for SUI, copies of which I have with me for the committee. The booklet clearly demonstrates the risks that are associated with the procedure and the alternatives that are available before women make a decision on whether they wish to proceed. The information in it will be the absolute minimum information that is provided to patients by national health service boards.
Two patient guidance booklets that set out the pathway for the management of POP and for women who present with complications are being developed. Dr Elliot will work with NHS colleagues to develop that service as a matter of urgency.
I can confirm that, in the past year, the chief medical officer has written three times to all general practitioners, through medical directors, to alert them to the possibility that women may suffer complications following insertion of the mesh implants, and that all adverse events must be reported to the MHRA, which is the regulatory authority.
I will explain the regulatory framework. As members have already heard, mesh implants are classified as medical devices and are governed through the European Union medical device directives. The MHRA is the competent authority for the whole United Kingdom and has responsibility for removal of any device from the market for the whole UK. Obviously, evidence is required for it to take such a step.
Individual medical devices follow procedures that are set out in the EU directives by manufacturers in order that they can gain a CE mark, which is conformity marking that is awarded by notified bodies. The MHRA oversees the work of those organisations in the UK and performs regular audits. The rules for classifying medical devices are applicable across all EU member states.
I have spoken to the MHRA’s chief executive and medical director about mesh implants and agreed that a dossier that details the experiences of women in Scotland should be given to them to help them to reach a decision on use of the implants. In the discussion with the MHRA, I was reassured that it is taking the issue very seriously. The Scottish Government will continue to assist that agency to provide answers on a way forward. I have another discussion arranged with the chairman later this month.
I have also written to the European Commission, which is currently working towards formulating a scientific opinion on the safety of the devices. That work will be available in January 2015.
We are aware of the US Food and Drug Administration’s proposal to reclassify mesh for POP from a moderate-risk device to a high-risk device. Currently, of course, Europe has the device classification IIb, which is moderate to high risk.
The Scottish Government will participate in the UK working group, whose remit includes consideration of how data on complications and reporting of adverse events can be improved. The group will meet for the first time next week.
Having said that, I am convinced that more needs to be done by us in Scotland. Therefore, in addition to what I have already outlined, I am announcing today that an independent review will be set up urgently to report on all the issues that have been raised, including complication rates and underreporting of adverse events. That review will report in 2015 and will take account of the European Commission’s study on the devices which, as I said, is due to be published in January 2015. I hope to announce the specific remit and the chair of the review before the summer recess.
In addition, I have asked the acting chief medical officer this week to write to all health boards to request them to suspend immediately the POP and transvaginal tape procedures until further evidence becomes available from the two reports next year—the EU report and the report of the independent review that I have set up. I believe that that is the right thing to do and that we should base any future decisions on the evidence as presented by those two reports.