Transvaginal mesh implants independent review: interim report

Chapter 3: Women's experiences

3.1 "Telling the Story"

In Scotland, the story of those women whose experiences of mesh implant surgery was poor was first told in newspaper reports. These stories were characterised by the histories of painful and debilitating complications; often experienced several years after the original SUI or POP; of being told by clinicians that their experiences were rare; not being believed when they sought help; of further surgery; of loss of quality of life; and even that it was no longer worth living. This review was put in place in the light of such personal experience by women for whom mesh surgery had not been a success.

However, these stories at not the only ones that came to be told. Other stories of good outcomes and everyday lives restored also came to light. Experiences of women for whom mesh surgery had been successful. It can be acknowledged that there are fewer of these, but that is perhaps not surprising when it is considered that for many women, successful surgery is not something that they feel the need to discuss, especially when it is about a delicate subject, or they simply want to move on.

Without detailed, qualitative research evidence, it is hard to fully understand these differing experiences from women who have had similar mesh surgery. Such research does not - as yet- exist and to undertake such research is beyond the scope of this review. However, some insight at least is possible into aspects of the experiences; though it does need to be understood that interpreting such data must be done with some care.

3.2 Evidence availability

As the UK MHRA safety review noted, what evidence exists from the personal experiences of women who have had SUI and POP surgery using mesh tends to be that which highlights the realities of long-term, life changing adverse outcomes [UK1]. Data on those women for whom their outcomes were successful, or where the surgery did not give a lasting cure are less easy to identify. In other words, what evidence does exist is presenting only one side of the overall picture.

We have been able to identify three sources of data relating to the personal experiences and reported outcomes amongst some of the Scottish women who have received mesh implants. These data are drawn from three sources: (1) from personal, written statements by women in regard of their mesh surgery, sent to the Cabinet Secretary for Health, Wellbeing and Sport; the collected experiences of those women who are associated with the Scottish Mesh Survivors Group (SMSG); and the experiences of women within the ongoing PROSPECT (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials) trial of POP surgery. Of these, only the third source of data have been collected as part of a formal research process and this means that drawing firm "scientific" conclusions from this evidence is difficult. For example, the evidence is such that we cannot be sure that we have not heard the same story more than once, captured in each of the three types of data. This is unavoidable. By not over-interpreting the evidence, such bias as could arise from this 'double-counting' should be limited.

In exploring this evidence we are not seeking to establish a rigorous set of scientific findings. Rather, we are seeking to throw some light on these patient experiences and draw out what insights it can offer.

3.3 Methods

The quality of the data available is such that a formal set of qualitative and quantitative statistical analyses would be unhelpful. Each source of data have its own limitations which have a bearing on how it can be interpreted.

Patient stories - all written responses to the Cabinet Secretary were reviewed and a sample of these, representing the balance of experiences were turned into anonymised patients stories. Whilst women were asked to provide such written responses, the specific content of them was very much left up to the women themselves. As a consequence it is not possible, for example, to know when the surgery occurred or the type of mesh used in all cases. All the women whose stories are included have given consent for this.

Analysis of SMSG data - All women who are in contact with the SMSG were asked to complete a questionnaire concerning their experiences. All completed questionnaires were made available to the Independent Review and the data they contained was transcribed to allow a descriptive analysis to be completed. For questions which provided either "yes/no" or categorical data a simple extraction scheme was used. For more qualitative data, a coding frame was developed by the data analyst and agreed by the author.

PROSPECT trial qualitative data - Personal experience data from women undergoing the PROSPECT trial has been collected at one year and two years post surgery. These data have only recently become available and only a very preliminary analysis is included in the review. This has simply calculated the number of positive versus negative comments at the two post-surgery time intervals.

3.4 Results

3.4.1 Patient stories

In total nine patent stories were developed from the written submissions to the Cabinet-secretary. Five of these describe adverse outcomes and four positive ones. These are contained in Table 3.1 at the end of this chapter.

These stories speak for themselves. However, it is clear that women have experienced both very positive outcomes as well as very negative ones. They also show a remarkable intensity associated with their experience. Irrespective of the outcome, women do feel passionately about the impact that mesh procedures have on their quality of life.

3.4.2 Analysis of Scottish Mesh Survivors Group data

The SMSG questionnaire was circulated to approximately 80 women, though no precise record was made of this. This provides an approximate response rate of 77.5% (95% CI: 67% - 85%) completed questionnaires. No demographic data were collected, which focussed on details of the mesh procedure and the women's subsequent experiences.

The dates of the mesh procedures ranged from 1999 to 2014, with two thirds (66%) taking place between 2008 and 2012. Some 10% of women had multiple mesh implants (n=5, two procedures, n=1, three procedures),

The questionnaire asked what was the reason for which the mesh was used. Data in answer to this question was provided by 61 (98%) of the responders. These data are shown in Figure 3.1 below.

Figure 3.1 Reasons women reported for undergoing mesh procedures

(Data labels = n of reason, % of responders)

As Figure 3.1 highlights, the largest proportion of procedures were for SUI alone (54%), followed by SUI and POP procedures (21%). Single POP procedures accounted for 1 in 5 procedures (20%). Of the 62 responders, over half of them do not know what mesh product was fitted (58%) and just under one third aware that they had received the Ethicon™ product. This is shown in Figure 3.2.

Figure 3.2 Types of mesh product used in the procedure

(Data labels = n of reason, % of responders)

Before survey the women commented on the information they had received and about informed consent. Only 10 of responders answered the question about the information they were given, pre-operation about mesh (35% of the responders). Most (n=7) said that it was inadequate and three women said they were given no information. Almost all of the women (n=61/62, 98%) said their consent to mesh surgery was not informed. One woman said she had been denied access to her patient records by the NHS Board responsible.

The questionnaire asked the women to describe how the mesh had affected them. From this it has been possible to identify the symptoms they experienced post mesh surgery. These self-reported health states, are shown in Table 3.2 below.

Table 3.2 Self-reported health state / symptoms experienced after mesh surgery

	Number of women reporting ever experiencing	Percentage of all women surveyed (n=62)
Pain	55	89%
Impaired Mobility	31	50%
Incontinence/Frequent Urination	24	39%
Relationship/Marriage Difficulties	21	34%
Sexual Difficulty	21	34%
Loneliness/ Social Withdrawal or Exclusion	19	31%
Depression	17	27%
Recurring infection	16	26%
Lethargy	15	24%

Overall, some 74% (n=46/62) of the women reported that their symptoms were still current. Only a small proportion of these reported that their symptoms had improved / resolved over time (7%). Symptom severity was reported to have been unchanged by 72% and over a fifth reported their symptoms were getting worse (22%).

The questionnaire also asked the women about their experiences of healthcare. This question provided an opportunity for a wide range of issues to be raised. These may be summarised as:

• 65% of women described their surgeon's aftercare. Of these 70% (n=28/40) indicated that their surgeon was not open to the idea that mesh was the cause of their symptoms;
• 77% of women reported that they had repeatedly told a clinician about their symptoms or asked for a referral, of these, 40% (n=19/48) indicated that their case had not been followed up;
• 82% of women reported on their current status, of these 33% (n=17/51) were not receiving ongoing care; and of the 66% who were ongoing care, some 38% (n=13 /34) were critical of the treatment they were currently receiving; and
• 32% of respondents made a comment indicating they had lost faith in medical professionals or the healthcare system.

More widely smaller numbers of women mentioned issues such as: concerns over the processes of medical device manufacture and regulation; and the lack of financial support available from the public sector.

These women consider that there is no capacity in Scotland for full removal of mesh as no surgeons are trained. They also acknowledge that, for some of them, partial removal can leave some mesh and enhance erosion into organs.

3.4.3 PROSPECT Data

As part of the PROSPECT trail, women were asked at one and two years about their personal experiences. These data were collected using a questionnaire developed specifically for inclusion in the research. Only the additional comments have been made available to the Independent Review for preliminary analysis. No demographic detail was provided and it should be noted that this study includes experiences of women from other parts of the UK.

Table 3.3 Positive and negative patient comments at one and two years within the PROSPECT trial.

	One year follow up	Two year follow up
Positive comment	16	54
Negative comment	18	53

As can be seen, whilst there is an increase in the number of comments between follow up at year one and year two, the number of positive and negative comments are roughly equal. A simple Chi² test shows these differences are not significant (p = 0.844, ns).

Clearly, a more detailed analysis of these comments, notably seeking to understand the content of them more fully, will be undertaken by the PROSPECT trial team in due course.

3.5 Interpretation

The data we have regarding the experiences of women who have undergone mesh surgery is limited and needs to be handled in a manner which does not over analyse it. We also have to be careful in interpreting the data and in framing any conclusions from it.

Ideally, it would have been helpful to be able to undertake formal research into the experiences of these women, those with both positive and adverse outcomes. This did not prove to be appropriate in the context of the Independent Review and may have been difficult to undertake. What data we have, whilst is has been considered in a scientific manner, is not without its potential sources of bias and this has been taken into account in the analyses underlying this chapter.

Long-term, adverse outcomes in mesh surgery for SUI and POP are real and can profoundly affect the everyday lives of some women. For many of the women who have been so affected, they report that they were not able to give informed consent, were unaware of the type of mesh device implanted, and have lost confidence in medial follow up, even though some are still experiencing unpleasant and debilitating symptoms that reduce their capacity for everyday life.

However, for other women, there are positive outcomes which have occurred. These have been experienced as strongly as have adverse outcomes. Where the data have captured something of the positive stories from women as well as those of adverse outcomes, they seem to be broadly equal in number.

Finally, it can be noted that the largest proportion of women who have had mesh surgery have not shared their personal experiences. Theirs are the silent voices, the absent evidence is the most difficult to interpret. For some, this silence is evidence for successful treatment and reflects that fact that these women have had positive outcomes. For others, it is a sign that - at best - the surgery has not worked, but these women have chosen not to seek further intervention as this was their "last, best hope". Finally, there are some for whom this is evidence that there are women in Scotland who are still "suffering in silence". In the absence of specific research to hear these stories, this must remain an absence of evidence for which no single interpretation is possible.

Table 3.1 Patient stories

Adverse experiences
I watched and listened intently to [the Scottish Parliament's] Question Time this morning and heard you say that those of us who have approached our GP regarding the implant should tell what reaction we got. I would like to let you know what my experience has been. In June 2003 I received [a TVT] implant. By 2008 I was having some problems and must say that they were investigated, but was told that they did not know the cause. These problems have got worse but I never associated them with the implant until I read Marion Scott's article in Sunday Mail in April 2013. When I visited the GP to discuss her reaction was "You are just scaremongering like the mothers' who questioned the MMR Vaccine and did I not realize all the trouble we caused the Medical Profession". Reluctantly she referred me to the consultant who had performed my operation and I met with him on 8th August 2013. Only remark I took away from that appointment was "We don't know everything". On 23rd January 2014 I wrote the consultant to ask to be referred to X at Southern General in Glasgow. His reply said that he had forwarded my letter to my GP. At 3.10pm this afternoon I checked with Appointments Dept at Southern General and no request has been received. I have no way of ever finding out what, if any, damage the implant has done. If a record of how patients are treated is going to be set up I would like my experience to be added.
I am writing to inform you that I have read about your concerns surrounding the TVT mesh implant! I have had two attempts at this surgery and have been left with on-going complications. I am now in the process of being re-referred to my gynaecologist! This has led to 4 separate surgical procedures with no avail and now I have been left with severe problems. I had requested after the first tape erosion to have the procedure done the old fashioned way with skin graft but was refused point blank. I am pleased there is finally someone listening to us ladies on this matter. Let me know if I can do anything to help you with this matter or if I can do anything about it for myself. I'm only too happy to help.
I am a 51 year old female who until recently enjoyed a long career as a senior theatre nurse. That all changed, however, when in November 2013 I began to suffer pain in my groins and legs which was diagnosed as being mesh related. I had mesh inserted in 2010 and again in 2011. The reason for this email is to make you aware of the problems I am having at the moment with the DWP. I was assessed by ATOS on 25th November 2014 as I was receiving ESA and they sent report to DWP who then decided that I was fit to work. I was then taken off ESA and put on JSA. Having never signed on in my life I have found this extremely traumatic and upsetting. I appealed the decision and have now got to the stage where my case should go in front of a tribunal. However, another decision maker at the DWP has reassessed my claim and again taken the evidence of the ATOS assessment, basically disregarding all the evidence I produced (and there was a ton of that!!) and has recommended that the tribunal not go ahead. I feel as if I'm fighting a losing battle with this. According to the letter I was sent I "believe that I am unfit for work". This is not my decision to make. I would love to still be working but because of this material inside me I have been declared unfit to work by medical professionals, my GP consultant gynaecologist and an NHS Occupational Health consultant. THIS IS NOT MY FAULT !! It also states that the report "does not indicate if the Health Care Professional is familiar with X's diagnosed condition" and that she " gave an opinion that her assessment does not indicate significant functional restriction". As it is, I am in constant pain for which I now take regular analgesia and I cannot stand or sit for any length of time without having to change position regularly. My home life has completely changed. I do not sleep well which means my husband doesn't sleep well before doing a full day's work. My two sons see me in constant pain. I have no income and my pay off from the NHS is now finished so I have no idea how I am going to pay my mortgage and household bills from next month. This is just a very small insight into my life with this material inside me. This email was just really to let you know how hurt and disgusted this now makes me, being treated like a scrounger and all through no fault of my own.
I am one of many women left in pain daily through mesh implant and would like to know what help is being put in place for so many injured women. I have recently lost my home after 17 years paying mortgage had to quit my job after 25 years' service fight to receive benefits after being told to visit a food bank to feed my family. I have been told I'm not entitled to PIP. I have never had benefits in my life and am struggling on a daily basis due to this. I have had to double up dose of antidepressants due to having my life taken away from me I'm only 49 and feel my life is over due to this please put some help in place for those of us crippled through no fault of our own.
I am writing to you as I recover from my 5th surgery to repair the problems left in my body by Mesh. I am now 46 years old and the last 6 years of my life have been hell since being implanted with this device after the birth of my daughter. I won't go in to all the medical intricacies of my situation, as I frankly am an emotional wreck at present, as I try to recover from a removal that was unsuccessful. I am a working mum and always have been. I am a Faculty Head in Education, a job that I love and enjoy. However, once again I have been forced to take time off from my job for another surgery that I had to wait one year for - from referral to surgery. This isn't good enough. I am losing valuable years of my child's life, and my own. If I am unable to return to work I risk losing the home that I have worked so hard to make. This has to be dealt with now, to allow women who have been injured and left in a disgusting state a better quality of life. I am urging you to ensure that the 'right thing' is done.
Positive experiences
Below is an email I sent supporting the continuing use of tape in urinary incontinence. He has encouraged me to copy you so that you are aware of the many lives that have been dramatically improved by this surgery. "With so much adverse publicity I just want to say how much my life was changed following insertion of a TVT. I'm running twice a week (not that far!) and could never have undertaken this before. I have never felt fitter which is a real bonus in mid 50s! There is no way I would have contemplated a colposuspension. "I am sure for everyone who feels their life has been adversely affected; there are hundreds whose lives have been transformed for the better".
I have been advised by my Gynaecologist that fitting women with tapes to support their bladder has been suspended due to a tiny amount of problems. I would like to share my experience. I was advised there was a small chance of the procedure not being a success. Before I had these tapes inserted, I was housebound. I was wetting myself up to 20 times a day. I couldn't bend over, kneel down, carry a bag, lean over anything.. it was so humiliating. Lifting or hugging my grandkids was impossible too. My life has been given back to me.. I AM 49 YEARS OLD and am far too young to have lost my dignity and freedom. I am now going to the gym, lifting weights let alone being able to carry shopping. It is the MOST AMAZING procedure. 7 I would ask you, for the sake of the many women looking in desperation for a cure to this awful problem, Please, please lift this suspension. I have been advised that 4 young women have been refused this simple procedure and that only from ONE surgeon. Any surgery has its risks. but we are warned beforehand. Any woman considering having this done is at her wits end and desperate for help. You cannot deny them the chance of freedom from all the problems connected with having no bladder control.
I accompanied my friend to yet another appointment relating to incontinence issues, as a support. She is a young 66 years old, fit and active, takes care of herself well. She is absolutely shattered with her health situation. She has endured her incontinence for over 9 years. Was diagnosed with triple prolapse and operated on previously. Although prolapse now repaired, her incontinence continues. She was waiting for TVT surgery, but obviously this option is no longer available for time being. How long is this going to go on? What alternatives are being put in place? I can hardly believe that with the existing - and growing - number of women who are victims of this situation, there is so little help available. Her current option is to try (again) various medications. There may be some relief for her if she was able to use a newish product, some kind of tampon like insert ('vaginal rockets'- sound more exciting than they are!!) but these are not available on prescription, and are very expensive to buy privately. First of all - Why?? If there is no surgery available currently, then why on earth are these products not being given on prescription? Second - why the terrible expense? although previously expensive enough, it seems that the producers, with an eye on the (lack of) surgery options, have latched on to the opportunity to make a few bucks, and are charging ridiculous prices for items that are desperately needed. Thirdly - What is happening with TVS? I appreciate that some women have suffered as a result of these operations, but what is the % in comparison to the rest of the successful procedures? This situation is only going to grow and grow. You can just bet that the people making the decisions about both the surgery options, and the help available, are either men who obviously don't suffer from this, or women who don't suffer this condition at its 'full strength'. Well woe betide them!!! When they start to encounter this, I really hope it is as bad as my friend's situation. And I hope they think back and wish they had done more, fought harder! It absolutely scunners me, that this - a situation brought on mainly because of childbirth, is being side-lined. Think of the expense if all women decide they are not going to 'push' and go for C-sections? And the number of hospital beds that will impact?? And yes - this IS written on behalf of my chum - but I am also thinking of the future and the possibility of similar situation for myself. PLEASE get this back in focus and off the subs bench!
I refer to the letter recently sent to X (of which I received a copy) in response to the concerns I raised re Transvaginal Implant procedures. On 13 January I received an email from Y, referring to my email about these procedures "particularly how these have been reported lately." In my original letter to X two thirds of that letter concerned the present coverage of the issue by the press. I was very disappointed to see that it gave no mention whatever to the issue of press coverage, far less to the nature of that coverage. In the articles that I read I could find no vestige of any form of balanced reporting. It's clear that there are patients who experienced very serious problems indeed. However, no mention was made of any successes. One year ago I underwent one of these procedures because of a long standing and intractable problem. Despite the very best efforts of health professionals and myself my condition failed to respond to conservative treatments. In no way was surgery the first course of action. I was provided with very comprehensive written and verbal information which was very straightforward and easy to understand. I was encouraged to discuss this with family and friends. My family practitioner was able to discuss the proposed surgery in detail and to study closely all the written information. lt was originally planned that I was to be a participant in the trial. My operation was carried out Z in a private hospital but because this hospital did not permit its premises to be used for research purposes I was no longer eligible to be part of that trial.
Media is the means by which information flows and the information that flows from certain press coverage makes no mention of any success. Certain aspects of the press continue to vilify in the most extreme terms the doctors who carry out these operations. I could imagine that these doctors may find themselves in a state of limbo, unable to respond to the allegations while their reputations and professionalism are savaged. Confidence is a fragile commodity and in the wider medical world patient confidence in their surgeons and physicians is currently to an extent being undermined.