Good morning and thank you, convener. I thank the committee for providing me with an opportunity to respond to the interim report of the independent review of transvaginal mesh implants.
We all appreciate how harrowing this has been for the women concerned and their families. I have met women who have experienced complications and have read numerous letters and emails expressing their pain and distress. It is deeply concerning to hear the extent of their suffering, and they have my full sympathy.
The report came about as a result of the affected women bringing the issue to the forefront. It is clear that this is an emotive subject on which views differ, and the report has provided evidence and informed opinion to help us to understand why there are so many apparently conflicting facts and opinions about transvaginal mesh procedures. Regardless of someone’s opinion on the issue, the report will help to improve services to benefit all women who are suffering from such conditions. I will say more later on the legacy of those who brought the issue forward.
As the committee knows, I received the interim report from the independent review only recently, and I thank the review group’s members for their hard work in producing it. I understand that the committee has just heard evidence from the review’s chair; I will set out the Scottish Government’s initial response to the conclusions and recommendations, which, although not yet developed in detail, certainly set out the way forward.
The work supports the call from the women in the Scottish mesh survivors group for improvements in care. The review was asked to determine the safety and relative efficacy of mesh implants for stress urinary incontinence and pelvic organ prolapse. The two conditions are entirely different, and the review has—rightly—considered them separately.
The review has recommended that improvements should be made in the management of individual patients and the Scottish Government agrees. I confirm that the expert group will continue its work with NHS planners on developing pathways of care for stress urinary incontinence and pelvic organ prolapse. That will mean developing pathways of care that, first, are consistent with national guidance and delivered by a multidisciplinary team that includes primary care and other relevant community services and, secondly, ensure that surgery is considered only after conservative measures fail. If surgery is needed, all types of surgery will be considered.
We concur with the view that clinicians should provide evidence of involvement in multidisciplinary team working, including an audit of their activity and a record of their reports of adverse events. The expert group will be asked to develop that protocol with a view to medical directors as responsible officers incorporating that into clinicians’ appraisal process.
I completely agree that informed consent is a fundamental principle that underlies all healthcare and I commend the expert group’s earlier work on developing the patient information and consent leaflet for SUI. That valuable work will be developed and the leaflet revised to include additional information, including details of the specific implant that is to be used. That means that if a woman experiences a complication she will have the information that is required to report an adverse event to the Medicines and Healthcare Products Regulatory Agency. The concept of that leaflet will also be extended to POP procedures.
The development of care pathways for the conditions will take account of the time that a patient needs to discuss and reflect on the information that has been provided before making a decision. One of the key areas that the report highlights is the gap in evidence relating to long-term outcome data, and the report has recommended that that be addressed through research. I have therefore asked the expert group to encourage research in that area in discussion with the chief scientist office and other research funders.
My predecessor, Alex Neil, asked for an independent review because of growing public concern about the number of women who were experiencing complications and about the underreporting of adverse events. The NHS’s Information Services Division has undertaken a thorough analysis of existing hospital discharge records that highlights the complex decisions with which clinicians are presented when they treat women who have such conditions, and the report distils that complex information in a way that will help women and clinicians to make informed decisions when they agree a treatment plan.
ISD’s work has highlighted areas for improvement, and work on those areas has already commenced. That includes work on a UK basis to ensure that procedures have codes and that those codes are implemented to allow the procedures to be reliably identified in routine data as quickly as possible.
My officials have met ISD to consider how to develop existing information systems, in conjunction with other work on the unique device identifier, to support active monitoring of the procedures. The expert group will lead on that workstream and will liaise with UK-wide bodies to investigate the feasibility of developing and maintaining a registry.
I am happy to endorse the view that the expert group should review the training and information that are available to clinical teams and look at ways of incorporating patient views in multidisciplinary team working. I am pleased to say that a helpline was launched in August, which has been a welcome addition. Officials are continuing to work with those involved, and posters to advertise the helpline are being planned.
I am content to endorse the recommendations on the routine surgical approach when mesh surgery has been agreed, subject to the outcome of the final report. I understand that interpretation of the available evidence and informed opinion support the routine use of the retropubic approach for stress urinary incontinence, with any variation considered as part of the multidisciplinary team assessment. Interpretation of the available evidence for the use of mesh in pelvic organ prolapse repair has also led to the review concluding that the procedure should be available only in exceptional circumstances, with any variation considered as part of the multidisciplinary team assessment.
The independent review awaits the final publication of key research reports before it can publish its final report. Although I am content for the expert group to develop the foundations of the services as outlined in my preceding statement, I have requested that the services not be introduced until I have received the final report and until I am satisfied that the improvements have taken account of all the evidence. We can then work to introduce improved services uniformly across all health boards in Scotland.
I thank Dr Wilkie and the members of the review group for their work. It is clear that both the evidence review carried out by the Scottish public health network and the analysis of health data by the NHS’s Information Services Division have been thorough and have brought clarity to what are complex issues.
I understand how incredibly difficult this has been for those who have been involved in the review process. For some, it has highlighted issues that are extremely painful to consider because of their personal experience. I reiterate my gratitude to them and hope that they can see the difference that each of them has made. Because they have been prepared to speak publicly on very sensitive issues and to work through the difficulties that they have encountered, women who need such services in the future will benefit. That improvement in the services for women who experience these distressing conditions is the legacy of those who have been involved.
I understand that the independent review expects to publish its final report early in 2016. Subsequently, the Scottish Government will publish a full response and ensure that the committee is informed of it. Thank you for hearing my initial response to this important work.