Transvaginal mesh implants independent review: final report

Appendix A - Patient member views on the process of the IR and mesh implants

The paper included here outlines the experiences, and the views on the process, of the member of the Review who considered herself a patient with a positive experience.

i. Personal views of member of the IR with positive experiences

Background

In 2013 the Independent Review ( IR) was set up at the request of the former Cabinet Secretary for Health and Wellbeing to assess the evidence relating to surgery using synthetic mesh implants for the treatment of stress urinary incontinence ( SUI) and pelvic organ prolapse ( POP) in Scotland. This followed a range of investigation prompted by a petition presented by some of the women who have been damaged by mesh procedures, now known as the Scottish Mesh Survivors' Group ( SMS). I was invited to join the IR as a patient who had a successful outcome from mesh surgery for Pelvic Organ Prolapse ( POP). At the beginning of 2016 I was also invited to join the Expert Group (formerly the Scottish Government's Short Life Working Group) which is addressing the various issues raised by the Survivors' Group petition. I would therefore like to offer my views from the patient perspective and also identify what to me are some of the important issues.

To date, the issue of the severe damage experienced by some women has been given maximum publicity through media coverage, the Survivors' Group campaign and the action of the Scottish Government in requesting the suspension of SUI operations pending investigation. The extremely negative and aggressive media coverage has vilified clinicians involved in this work, and the NHS in general. So far as I am aware there has been no publicity about the success of mesh operations for the many thousands of women who have been helped over the last 10+ years since these were introduced. The female public has, therefore, been subjected to a gross imbalance of information all of which has a completely negative bias. This lack of balance needs to be addressed and a proper perspective attained.

I understand that for more than the past ten years mesh procedures have proved to be beneficial for thousands of women, myself included. My concern is that a minor percentage of women who have been severely damaged by mesh surgery, dreadful though that must be, cannot be allowed to dictate the fate of the majority of women who could potentially benefit from it in the future, nor deny them the opportunity to choose their own pathway. I feel strongly that women should continue to have the choice of which surgical procedure to have, provided they are given all necessary information beforehand, together with guidance from appropriate health professionals to help them arrive at the right decision for them.

The on-going gathering of evidence and future analysis on use of mesh will continue to influence the decision making process for health professionals and prospective patients, and relevant information will be updated to reflect that. However, the immediate future of mesh surgery cannot be decided at an emotional and personal level, but on the basis of the evidence presented by this independent investigation, which has to be recognised by all parties.

Comment

The on-going work of the Expert Group over the past four years has been to address the various issues of concern raised by the SMS Petition to Government, in order to identify what actions need to be taken and how these can best be implemented. This will result in the introduction of new systems and the tightening up of existing systems, procedures and governance which will benefit all women suffering from the extremely unpleasant and humiliating conditions of stress urinary incontinence and will be extended to pelvic organ prolapse. In this regard the input of the Scottish Mesh Survivors' group has been invaluable.

During my membership of the Expert Group I have been impressed by its commitment to the task. It is my understanding that actions as agreed are being implemented by the respective departments within the NHS, and will continue to be so, and that progress will continue to be monitored by the Expert Group. Some of these changes will inevitably take longer to implement than others due to their inherent complexity and universality. In addition, all of this work has to be phased-in with the on-going and ever-escalating needs of patients that still have to be met on a daily basis.

A few of the areas I consider are especially important, from the patient point of view, are touched on below.

Requested Suspension of Mesh Procedures

The actions of the Survivors' Group have resulted in the Scottish Government's interim suspension request of mesh procedures since June 2013. The former have stated that they do not wish other women to suffer what they have suffered, which is very understandable in their position. It is an unalterable fact, however, that all surgery carries risks irrespective of how straightforward the procedure: nothing can be guaranteed. Simplistically, there is also a great diversity of patient characteristics, medical devices, pertinent surgical approaches, as well as the unexpected factors that can adversely affect the outcome of a procedure. We mustn't, however, lose sight of the fact that historically there are many thousands of women who appear not to have suffered major trauma and have had successful outcomes over the last 10+ years.

The reality of the present suspension request therefore, is that there are now many hundreds of women in Scotland who are having to live with distressing, unpleasant and humiliating symptoms, because they are being denied the opportunity to decide whether or not to have mesh surgery. They must be given a choice.

Adverse Effects

Under Reporting

There is some evidence of a degree of under reporting of adverse events to the appropriate medical body ( MHRA) in the past, which may or may not have identified many other cases of severe damage sustained by mesh surgery. This has cast some doubt on the statistical evidence available. It seems to me, however, very unlikely that a large percentage of women have been prepared to suffer severe damage following an operation for SUI over a 10+ year period without seeking help and suitable investigations subsequently being carried out. Conversely, nor are they going to publicise to the media, hospitals or even perhaps their surgeons, that they are delighted with their surgery: that just doesn't happen, mainly because they have experienced exactly what they expected to, i.e. a successful outcome.

Reporting and Recording in Data Base /Registry

The Expert Group are currently preparing a system which will establish a clear procedure enabling surgeons to ensure that all adverse events are recorded and reported as they become known. Work is also being undertaken in conjunction, with other professional bodies, to develop a universal information system in which stored data will be accessible to the medical community. A project of this magnitude will inevitably take some time to fully implement.

Serious Adverse Events / Adverse Events

A personal concern of mine is the way in which the terms Serious Adverse Events ( SAEs) and Adverse Events ( AEs) are sometimes used. My understanding is that SAEs can cause the type of damage that the SMS members have obviously suffered, and AEs are less serious adverse events that often resolve spontaneously, can be successfully treated, or are expected to occur in any surgical procedure. The distinction between the two is obviously medically defined, but I am aware that the term AE at times seems to be used almost as a generic term encompassing the more serious SAE type events. This could cause confusion mainly for the patient community in wrongly applying the term SAE to what is in effect a less serious AE, which could conceivably distort the 'weighting' applied to events until they can be appropriately medically classified.

National Governance

To date no other country in the world has banned the use of mesh procedures for SUI or POP. As a patient I think it is vitally important that the choice of having mesh surgery does not become a geographical issue in any part of the UK. The SMS petition and subsequent Scottish Government Action has allowed the Independent Review to identify areas in which important changes in practice and governance can and should be made. The NHS in Scotland is now running with this particular ball: work will continue, changes will be made, and women will be able to make informed choices about their treatment. On the basis of this commitment and my understanding of the changes already being implemented, I would advocate on behalf of women in the future, that the requested suspension should be lifted now. The needs of women are not going to change and the volume of need is only going to increase. Hundreds of women are awaiting treatment: they must be given the choice of deciding their own pathway.

Patient Information Leaflet ( PIL)

A revised PIL is available which has been approved for use in the UK. This contains all the information a woman will need in order to make an informed choice about her treatment. This will be updated every two years, and should be made available to patients at their clinic appointment.

Multi-Disciplinary Team Working and Shared Decision Making

In future the decision on which treatment is considered appropriate for each patient will be made by a Multi-Disciplinary Team ( MDT). The MDT will consist of health professionals with the appropriate skills needed to arrive at the best decision for each patient, including the patient's consultant surgeon, and within which the patient's own wishes will also be considered. This practice of shared decision making and clinical interaction together with the written information given in the PIL will give the patient much more confidence in what is proposed for her.

Manufacturers' Responsibility

The responsibility of manufacturers is being reviewed regarding the introduction and provision of new devices such as mesh tapes and the kits needed to insert them, as required in treatment of SUI and POP This will address quality of product, fitness for use and training and will ensure suitability of product before being introduced into routine surgery.

Negative Repercussions of the Mesh Controversy

While this controversy has undoubtedly had many positive outcomes for which I as a patient am very grateful, in my opinion other issues may arise that could leave women disadvantaged.

• A general 'climate of caution' may prevail in which some surgeons may become unwilling to undertake mesh procedures so as to avoid possible serious adverse outcomes, with the consequent repercussions and possible litigation.
• Manufacturers may decide to stop manufacturing the devices necessary for SUI and POP mesh surgery.
• The longer the suspension of mesh surgery is in place the longer waiting lists will become. Some surgeons may no longer be able to undertake the traditional procedures due to the focus on the newer less invasive procedures over the past 10+ years: and skills in mesh procedures may also be affected, requiring retraining of surgeons.

The reputations of surgeons and the NHS have been severely undermined in the female community, by the very negative and aggressive media publicity. The public depend on the skills of clinicians and none of us know when we might need their help. Young women who have already had procedures carried out will probably need more work done as they grow older. Patient confidence must be restored in the work of surgeons and delivery of good medical care for women, the majority of whom are prone to damage arising from what only women can do, that is - have babies. In turn, surgeons must ensure that they are properly trained and fully competent to carry out mesh procedures.

In Conclusion

The scope of the Independent Review is comprehensive and I have confidence as a participant and as a patient, that the way forward will be clearly identified. I am also confident that the work already being implemented, as addressed in the notes above, will result in better and more patient-centred care for women suffering SUI and that the NHS are committed to delivering this. I would therefore advocate that no further time delays should be put in the way of the many hundreds of women presently awaiting surgery, as alluded to in the Patient Stories in chapter 3 of this document. They must be allowed to choose their own path as soon as possible.

The conclusions below are offered from my perspective as a patient.

1. All parties must recognise the findings of the Independent Review and future action should be based upon that evidence until further evidence becomes available in the future.

2. The suggested suspension of mesh procedures in Scotland should be lifted now while the actions agreed by the Expert Group continue to be implemented and monitored.

3. While the Independent Review is the Scottish Government's initiative, the future of mesh surgery and the impact on all women should not be a unilateral decision by the latter but based on a consensus of all countries within the U.K.

4. The success and volume of mesh surgery historically must be recognised and acknowledged, unless evidence proves otherwise.

5. The need for SUI and POP procedures is increasing year by year. Governments must consider the future status and consequent effect on women, if mesh surgery is proscribed.

6. The incidence of women reporting adverse events many years after mesh surgery should be considered in perspective, if they have had, say, 10 years of trouble free life which they may not otherwise have had. The opportunity to achieve this, and perhaps an even longer term successful outcome would, in my opinion, be worth considering.

7. The PIL should only be given to patients during their clinic appointment with the consultant to ensure that only the most up to date version is used.

8. The major contribution of the SMS to the improvement of systems and procedures in areas pertaining to mesh operations should be widely acknowledged.

Isobel Montgomery
February 2017