I am grateful for the opportunity to make a short statement today on transvaginal mesh in NHS Scotland. I was appointed Cabinet Secretary for Health and Sport less than 80 days ago. Since then, this issue is among those to which I have given my highest attention.
I expect that most members of this Parliament have received letters from or met women who have suffered significant and life-changing complications following vaginal mesh surgery. I think that we would all want to acknowledge the bravery of the women who have come forward to tell their story—doing so would be by no means easy for them, given their pain, the impact on their lives and the very sensitive nature of the problem.
As members will be aware, regulatory power over medical devices is reserved to the Medicines and Healthcare products Regulatory Agency and the United Kingdom Government. However, within the limits of the powers that are available in Scotland, progress in restricting the use of mesh and improving surgical consent procedures has been made under the guidance of my predecessors Alex Neil and Shona Robison.
In 2014, in response to concerns about safety, the then acting chief medical officer requested that health boards suspend the use of vaginal mesh. That led to a substantial reduction in mesh implant surgeries. An independent review of the use of vaginal mesh was established, and a final report was published last year.
As a result of the recommendations made by the review, which are similar to those that have been made in other reviews across the UK and further afield, a number of actions are being taken. The development of clinical pathways is being progressed by individual health boards and through work at regional level. Management of patients throughout the care pathway has been considered, including care for women who experience complications from treatment.
It has been stressed that the care for each and every patient must be considered by a multidisciplinary team, and that that must occur in all cases. In addition, the need to restrict the number of surgeons who undertake procedures has been highlighted to medical directors, and application of existing National Institute for Health and Care Excellence guidance on a minimum number of procedures to ensure sufficient experience has been advised.
Healthcare Improvement Scotland has established an oversight group, which is reviewing evidence and trends in procedures and reported adverse events. The group’s work will influence the nature of clinical pathways and provide high-level external review.
The chief medical officer, Dr Catherine Calderwood, has been clear that all patients must be provided with information to help them to make informed decisions about their treatment. Scottish Government officials are working in partnership with colleagues from the Department of Health and Social Care in England and the devolved nations to establish a mesh registry, which will collect information on all procedures.
The CMO has continued to keep the issue under review. She and I have listened to the voices of the women who have been affected, and we have discussed what steps would be necessary that would satisfy me that every action has been taken to ensure that the national health service treatment options that are available are as safe as possible, irrespective of the views of the MHRA.
As a result, I have today asked the chief medical officer to instruct health boards immediately to halt the use of transvaginal mesh altogether in cases of both pelvic organ prolapse and stress urinary incontinence, pending the implementation of a new restricted use protocol that will ensure that procedures are carried out only in the most exceptional circumstances and subject to a robust process of approval and fully informed consent. Such a halt in use will not affect other uses of mesh—for example, transabdominal and in hernia repair—but we will continue to keep those areas under review.
The instruction to halt is, I believe, a proportionate measure while a rigorous, high-vigilance restricted use protocol for any future practice is developed and put in place. The lifting of the halt in use can be considered only once there is confidence that there is sufficient evidence that the protocol will be triggered in only the most limited of circumstances, informed by any new evidence and the forthcoming NICE guidance on the management of pelvic organ prolapse and stress urinary incontinence that is expected in the spring of next year.
There is one exception to this effective ban. A very small number of women are presently waiting for a mesh procedure under the treatment time guarantee. Such operations will be allowed to go ahead, provided that that is the women’s express wish and that their clear, informed consent is demonstrated.
The chief medical officer will write to health boards today to set out the high-vigilance restricted use protocol to be implemented, many elements of which are already occurring as a result of the recommendations of the independent review. The purpose of the protocol is effectively to ensure that transvaginal mesh is not used in Scotland’s NHS save in the most exceptional circumstances, when there is absolutely no clinical alternative and it is the fully informed and consented wish of the woman concerned.
Subject to the evidence, should the halt be lifted, transvaginal mesh would be available in the NHS in Scotland only under the restricted use protocol, which would require the health board’s medical director—who would become the accountable officer—to consider and agree each case individually, taking account of the clinical evidence, and would be subject to evidenced, informed and voluntary consent being obtained from the woman. The medical director will therefore be responsible for signing off the use of transvaginal mesh on an individual named patient basis, and no such mesh will be able to be used or procured by a surgeon except under those circumstances.
Even in those circumstances, and with those requirements, NHS procedures will then be permitted only in a very small number of designated centres of expertise, and only where the woman concerned has made the choice, with full information, to have such a procedure by using transvaginal mesh. Health board medical directors will be responsible for ensuring that the appropriate high-vigilance process is followed in each individual woman’s case. Clinicians will be asked to document and retain confirmation of the information provided to patients, the agreement and consent of the patient, and the discussions of the multidisciplinary team assigned to the case. They will ensure that every patient is given documentation that details their procedure, the product used and the name of the surgeon. They will document all procedures in a local or national registry, report all complications to Health Facilities Scotland’s incident reporting and investigation centre, and give patients information on how to report any complications. The chief medical officer will also make it clear that this high-vigilance procedure must apply to all treatments for pelvic organ prolapse and stress urinary incontinence—not only when the treatment option is mesh.
Finally, the chief medical officer has announced a prospective audit of all procedures carried out in Scotland in future, which will run until such time as a UK-wide registry, which I touched on earlier, is developed.
In addition to the measures that are being taken directly by the CMO, the further NICE guidance that I have already mentioned is expected to be available for consultation in October and November of this year. We will, of course, consider any additional recommendations that are given in the guidance when it is published and take those into account when treating women in Scotland, regardless of the treatment chosen.
As the power over the approval of medical devices is a reserved one, the instruction to halt that we are instigating cannot extend beyond the bounds of NHS Scotland.
The measures that I have set out are intended to underline the clear message and my determination that our care is as safe as possible and that patients are listened to, are heard and, when confronted with decisions on their care, have the full facts available so that they can make informed decisions.
I thank the women who have campaigned tirelessly on the issue. I hope that all we have done, including the additional measures that I have announced today, gives them confidence that we have heard what they have said, taken their concerns seriously and, within the limits of our powers, acted.