Transvaginal Mesh Case Record Review

Moderator’s Introduction and Overview

Polypropylene pelvic mesh implants are medical devices used in a number of operations to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Historically, synthetic materials were employed in surgery for stress incontinence in the second half of the last century but largely abandoned because of problems with erosion and infection. More recently, the use of polypropylene mesh in the form of a tension free vaginal tape/sling for the treatment of stress incontinence of urine in women was popularised in the 1990s. Extensive publications demonstrated that it was as effective as all other procedures previously described.

The success of the stress incontinence surgery led to the development of procedures for the treatment of pelvic organ prolapse with polypropylene mesh augmentation of the repair. This involved much larger pieces of mesh and has been associated with significantly more reports of mesh related complications.

Following the first approval by the American Food and Drug Administration in 1996 there were a ‘cascade’^[1] of devices similarly approved based on the fact that they were of ‘substantial equivalence’.^[2] Although the majority of these operations have delivered good outcomes,^[3] details began to emerge that a number of women were experiencing post-surgical adverse events including pain (especially vaginal and groin pain), specific pain during intercourse (dyspareunia), worsening of urge incontinence and mesh exposure.^{[4] [5]} These experiences have been the subject of intense scrutiny and debate not only in Scotland,^[6] but across the world.^[7] In April 2014, medical mesh devices were the subject of a petition to the Scottish Parliament’s Public Petitions Committee.^[8] The Petition was lodged to draw attention to a number of women who had experienced serious complications following procedures to treat pelvic organ prolapse and stress urinary incontinence. The Petition received over 1700 signatures and 212 comments.^[9] In June 2014, Alex Neil – then the Cabinet Secretary for Health and Wellbeing – informed the Committee that he intended to commission an Independent Review. The Review would not only explore the evidence that the petitioners had provided, but also consider complication rates and under-reporting of adverse events as well as reviewing the overall evidence base for mesh devices.

On 27 March 2017, the Scottish Government published the Mesh Review’s Final Report.^[10] It received widespread criticism over a range of concerns including the evaluation and inclusion of certain evidence, the nature and quality of the independence of the review process, and the inclusion of the two petitioners’ input despite their resignation and request for their contribution to be removed.

In May 2017, I was commissioned by Shona Robison, then the Cabinet Secretary for Health and Sport, to investigate the process by which the review came to its conclusions. The findings of our Investigative Review were published in October 2018.^[11] The report highlighted a number of failings and made recommendations on how independent reviews should be conducted in future. Despite being well received,^[12] to date, none of the 46 recommendations made have been implemented by the Scottish Government.

In November 2019, the First Minister met a number of women who had experienced complications after having had surgery for mesh implants. In addition, some of these women expressed concerns about their clinical care, how it was documented in their case records and how it was reported to them. Following those meetings, the First Minster confirmed that these women would be given an opportunity to raise their concerns and offered them a review of their case records.^[13]

On the 12th February 2021, the then Cabinet Secretary for Health and Sport, Jeane Freeman, introduced the Transvaginal Mesh Case Record Review.^[14]

This Report presents the findings of the Review. Our Terms of Reference required us to undertake an assessment of our Review processes including their value and their impact on any similar, future work. This work would be regarded as a ‘pilot’ which would include recommendations for requesting, scoping and conducting a future case review for a larger number of women.

Our Report comprises nine chapters and is divided into two parts. Part l takes a reflective and chronological approach, starting with the rationale for the commissioning of the Case Record Review, and then goes on to describe the advance planning, process and methods that were adopted.

The nature of the Review required us to engage with a number of parties and our report considers their role and their contribution. Central to our work was the review of participants’ case records and this Report reflects on how we initially engaged with the participants and describes the process of requesting, retrieving and collating their case records. The final part of that process was to evaluate their medical records and to provide an individual report to each participant, detailing the Panel’s findings. In every case, the Panel was unanimous in its findings and feedback for every set of records that we reviewed. The final chapter of Part l explores alternative approaches and considers how other countries have reached out to women who have raised concerns following transvaginal mesh surgery. Unsurprisingly there is a common theme to these concerns and it is interesting to see how other countries have responded to these challenges and whether their approach may have value in shaping some of the future thinking in Scotland.

It is never an easy task to start any project, particularly when you are starting with an almost blank sheet. We had to design a process which would facilitate a new, innovative approach concerning the review of medical case records. We were given the names of 47 women who would be invited to participate in the review, all of whom had met with the First Minister or Cabinet Secretary for Health in November 2019. Out of the 47 selected, 19 women chose to meet with us, with 18 requesting a review of their records. All 18 remained engaged with the process – some for nearly two years – until the conclusion of their case record review and the receipt of their report.

The different rates of complications between stress incontinence surgery and prolapse surgery employing polypropylene mesh is often not highlighted in the debate about use of polypropylene mesh in gynaecological reconstructive surgery. All 18 participants in this Review underwent surgery using polypropylene mesh specifically for stress incontinence. Of the 18 women, 15 had a transvaginal tape- obturator (TVT-O) and 3 had a transvaginal tape(TVT) device. All had given birth to at least one child. Some of these women had additional surgeries at the time, for separate urogynaecological issues, such as prolapse. It is not known whether this was a chance occurrence or if this represents a trend in surgical complications associated with mesh surgery in gynaecology in Scotland.

The volume and extent of what we would request in terms of records for our Review was left for the Panel to decide. We were very aware from the outset, that the breadth and depth of any request would have an impact not only on us as a Panel in terms of our time but also upon those tasked within the relevant Scottish Health Boards with retrieving the case records on our behalf. Our initial requests to the Health Boards were made only a month or so after Scotland was emerging from its second Covid-19 lockdown in 2021. Whilst the timing was not ideal, the Accountable Officers, whom the Scottish Government had agreed would be the named contact for each Health Board to assist us, seemed largely unaware of the existence of the Review and their role within it. A lot of time was spent, up to several months in some cases, in trying to identify the name of the person from the Health Boards who would work with us. In several instances, this was not resolved without the intervention of the Scottish Government. This delay impacted upon the Panel’s work and was frustrating especially given the pilot involved only a total of 18 sets of case records.

In terms of the volume and extent of our requests, whatever we decided was unlikely to satisfy all parties who would have a different understanding of what would be sufficient to meet the aims of our Terms of Reference and Remit. We are grateful to the Boards who provided us with what we requested. The Panel recognise that, in the majority of cases, our requests were extensive.

This can be explained by the fact that we were initially advised that all 47 women on the list that we were given had undergone either full or partial mesh revision surgery. This was not the case, and applied initially to only two of the 18 participants with a further four receiving mesh revision surgery over the next two years.^[15] This meant that the majority of those who participated in the Case Record Review had not undergone any revision surgery, and their concerns focused instead upon a broader range of matters regarding their treatment and experiences of their healthcare. This required the Panel to revise its thinking not only in terms of what needed to be requested from the Health Boards but significantly extended the focus and duration of our work. Ultimately, we agreed that because of the diversity of issues that the participants raised, we would need to understand the chronology of what had led them to where they were currently, in terms of their outcomes. We would need to be prepared to request records that started with their initial consultation, moving on to any conservative treatments, consent processes, surgery (including any revision surgery) and other relevant treatments up to the time when we first met with the participant.

The practical consequence of this meant that we requested more than 40,000 pages of records. From our initial meeting with each participant, the subsequent request of case records to the completion of each report, it is estimated that some 45-50 hours was spent on each participant’s case. We wrote 18 bespoke participant reports. It was a significant and resource intensive undertaking. We recognise that this was especially so when the participant numbers were not large.

We believe it was time well spent. Collaborating with the participants for nearly two years, brought valuable insights and understanding as a Panel and participants told us that they appreciated not being rushed and being able to define their journey in their own way and in their own time. Although we undertook a brief qualitative feedback process at the end of the Review, we believe that further work is required to ascertain a more in-depth picture of the participants’ views on their experience of the Review and its outcomes. Importantly, since this was a pilot, we were constantly reflecting upon, learning from, and adapting the review process as we went along, and we came to recognise that our initial approach would not be sustainable for a larger number of women who may wish to have their case records reviewed. We have suggested ways in which this process may be streamlined to accommodate a larger number of participants in the concluding chapter of Part I.

The second part of our Report considers some recurring themes that arose during our conversations with the participants. We encouraged all the women who were part of the Review to describe their lived experience. Many alluded to feeling that aspects of their lives had diminished or been lost altogether, whether this was engagement with family, intimacy with a partner, loss of job, financial independence, or the side-effects of medication. Often spoken about were feelings of anxiety and the practical consequences of the enforced isolation of lockdown during Covid-19 including the impact this has had on receiving treatment. Whilst much of this aspect may have been unavoidable, it continues to leave some women in a vacuum of uncertainty regarding next steps in the management of their care.

The importance of clear and informative dialogue between the women and their healthcare practitioners is considered in the light of the legal and clinical evolution of information disclosure and consent and good clinical case record keeping. By current legal and professional standards, this means not only recording a choice of treatment or option, but also documenting how that decision was reached. Informed decision making is central to the vitality and trust within a health professional’s relationship with their patients; consent is not a ‘one off’ or a tick-box process, it is an integral and perpetual part of good clinical practice.

A significant theme in Part ll of this Report concludes that if clear and commonly understood language had been used to explain to women potential treatments and outcomes (even if these were uncertain prior to surgery), this may have alleviated many of the issues that subsequently arose over the course of their clinical journey.

Every patient is entitled to expect and receive accurate information both before any treatment is chosen and to be advised on the effectiveness and consequences of any intervention. Most of the cases that we reviewed did not meet these standards.

We recognise that a generic consent form was used in most of the cases, certainly for the initial mesh surgery, and that this was in keeping with consent practices at that time. In some of the more recent cases that we reviewed, there was documented evidence of what appeared to be informed discussion, but the participant had no recollection that this had occurred. This highlights the need to create opportunities and time for patients to reflect, revisit and ask questions regarding potential treatments and alternatives. Discussion should be accompanied by accurate and comprehensive documentation to include information leaflets and procedure specific consent forms.

If a patient makes a request to be accompanied to a consultation or record a consultation, reflecting current professional guidelines, such requests should be encouraged and supported. The law and professional guidelines have changed progressively over the last 20 years, and significantly so post the case of Montgomery,^[16] which brought to the fore the legal requirement to explain the specific risks and benefits of treatment options tailored to each individual patient. This is a foundation on which all good medical practice should be based and is not confined to this particular discipline of healthcare.

The final observations of Part II look to the future and consider the role of the complex mesh surgical services in Scotland.^[17] It is vital to first understand the impact of the legacy of treatment that many of the women carry with them. Some of these legacies are not new and have been well documented elsewhere, but their significance means that they bear repeating and re-evaluating so that they may be kept to the forefront of decision making around the treatment and care of those who have experienced harm following a transvaginal mesh implant.

When mapping the process set out in Part I against the emergent themes set out in Part ll of this Report, we asked ourselves whether a Case Record Review is the correct mechanism to address such themes. The answer is yes, partly, but not completely. Whilst a Review of this nature was requested by a number of women, was it really the most effective way to provide answers to all the questions that the women had raised?

We recognise that women had concerns about the accuracy and content of their case records and that this required to be explored. If they were to move forward with their lives, some women needed to have it acknowledged that they were not imagining the circumstances in which they find themselves. The review of case records highlighted, in many instances, a lack of clarity regarding the necessity of surgery, the outcome of conservative treatments, if any had been undertaken, or an explanation of the risk and benefits of potentially undergoing mesh surgery. Of note, in a number of the cases, we observed a lack of clarity in the case records documenting the nature and potential outcome of mesh revision surgery.^[18] Some notes were misleading, but other cases, did not bear any reflection to the surgery that had occurred, nor its outcomes. These matters may have not come to light, without the commissioning of the Review.

Two points have stayed with me. First, by its very nature, the Panel could only review what was documented in the case notes; we could make no comments on conversations that had occurred verbally because there was no means or evidence on which to do so. Second, the Review focussed entirely on retrospective events. This gave rise to a number of questions including what could be gleaned from this Review to effect women’s present and future care? The Panel agreed that it was impossible to extrapolate from a review of case records how these women felt. Matters of respect, dignity, and being listened to, cannot be evidenced solely by a case record review, nor can they be enhanced as a natural consequence of one. Having to exclude the lived experiences of the women from the practicalities of what could be evidenced in the case records, has made the Panel realise that the mechanics of a case record review cannot address the more nuanced parts of a lived experience, and the Remit of the Review did not include speaking to any of the clinicians involved in a participant’s care. Something more inclusive is required and this Report makes some proposals on how to address this.

Is there a better way to manage care and meet the needs of these women’s care in the future? Mesh revision surgery may not be the only solution; it may not even be the best solution. However, where it is clinically indicated and it is the woman’s choice, it will have a role for a finite number of women.

In terms of the chronology of care, we have reached a crossroads where future management of care should include the involvement of multidisciplinary healthcare teams. We recognise that this is already happening through the combination of the Complex Mesh Surgical Services in Scotland who are integrated with healthcare teams at a local level. Where the responsibility of care lies, along with the referral processes have to be clear and we do not believe that this is yet the case.

The definition of healthcare in these contexts are broad. Recognising that their circumstances may require participants to require care and support for the rest of their lives, women are seeking support on matters which will enhance their quality of life; management of pain, diet and exercise, financial advice, companionship and they want to be part of shaping what these provisions may look like in Scotland. It is imperative that they are.

As a Panel, we completed what we were asked to do, and drawing on our experience from conducting this pilot Review, we suggest ways that a workable process for all parties could be made available to a larger group of patients. Importantly, we believe that a case record review should form an important but only a part of this process.