Pelvic Mesh – Do No Harm

Reflections on the Cumberlege Committee Report from a Clinical Negligence Perspective by Henry Charles and Vanessa Cashman

“The system does not know, so neither do we, just how many women have been treated for stress urinary incontinence and the repair of pelvic organ prolapse using polypropylene mesh. The system does not know, so neither do we, how many women have been cured of their incontinence, or been successfully treated for their prolapse – only then to experience a long list of life-changing conditions that include loss of sex life, chronic pain, infection, difficulty voiding, recurrent urinary incontinence, permanent nerve damage or damage to surrounding organs, haemorrhage, autoimmune disease and psychiatric injury.” ^[1]

The system does not know, all too many women do know.  

Clinical negligence claims in respect of pelvic floor related mesh do suggest some common problems:

(a)      The consent process

(b)       Surgical technique

(c)        The culture surrounding ‘popular’ procedures.

This should be seen in the context of health issues that are highly personal, where eliciting concerns, questions, and expectation may be difficult.  That may be particularly  with stress urinary incontinence where there may not only be embarrassment but a lack of knowledge as to what is normal and commonplace and how it may be dealt with. 

We’ll look at these issues in turn, from a clinical negligence perspective. Colleagues have undertaken a web event in relation to the product liability angle. 

The Consent Process

Montgomery v Lanarkshire Health Board [2015] UKSC 11 held that obtaining consent must be framed around what information an individual patient requires. In fact that reflected the development of Royal College guidance.

Where there has been a pelvic prolapse^[2] the treatments in the armoury have been pelvic floor exercises, hormone treatments, vaginal pessaries and surgery. For patients this has been a difficult route to navigate.

NHS England published a patient guide in 2017: https://www.england.nhs.uk/wp-content/uploads/2017/11/pelvic-organ-prolapse-mesh-leaflet-v12.pdf

The guide makes a respectable attempt at explaining the range of treatments for a complex subject, which includes, of course, mesh repair. At the end it suggests questions the patient might ask the surgeon, and asks the patient to write them down having read the guide. Here they are:

Example questions: 

• Do I need prolapse surgery? 
• Which of my symptoms is the surgery aimed at improving? 
• Do I need a vaginal mesh/graft implant? 
• Is my own individual risk different from those mentioned in the leaflet? 
• Are your success and complications rates comparable to national figures? 
• What sexual problems may be encountered with use of mesh and traditional surgery and/or other procedures?
• What happens if surgery does not work? 
• What would happen if I had a complication? 
• If I had a complication related to the mesh, can the mesh be removed safely and completely
• Is there anything I can do myself to help make my surgery more successful? 
• ………………………………………………………………………………………………………………..
• ………………………………………………………………………………………………………………..
• ………………………………………………………………………………………………………………..

There is also a section giving examples for discussion with the surgeon:

1. My expectations from surgery 

What do you expect the operation to do for you?
What activity do you expect to be able to do again after surgery? 

Example expectations for discussion with your surgeon: 

• Treat the bulge. 
• Feel more comfortable. 
• Be able to exercise or do sport regularly. 
• Be more socially confident. 
• Enjoy sexual life in general. 
• Reduce my bladder problems 
• Reduce my bowel problems 
• ………………………………………………………………………………..
• ………………………………………………………………………………..
• ……………………………………………………………………………….

And then a checklist.

Please read the following points and write your initials in the boxes next to each statement. 

I confirm that I have read and understood all the information in the booklet to the best of my ability including: 

The details of the procedure proposed and the desired outcome 

All available alternatives of this procedure and their advantages and disadvantages

All information on possible risks including my own
All my questions were answered.

Similarly,  information is available with regard to Stress Urinary Incontinence. Here is a link to former NICE guidance^[3]: https://www.nice.org.uk/guidance/ng123/resources/surgery-for-stress-urinary-incontinence-patient-decision-aid-pdf-6725286110

This guidance might be seen as more patient-centric in terms of explaining risk with pictograms. It also has a perhaps more comprehensive way of eliciting patient concerns:

How do you feel about the options?
Issue	How important is this to me?

	Very important	Important	Not that important	Not at all important
How troublesome my symptoms are now
How effective the options might be at improving my symptoms
The length of me I would have to spend in hospital and recovering
My plans for pregnancy in the future
The possibility of complications from mesh surgery
The possibility of damage to other organs
The possibility of pelvic organ prolapse
The possibility of problems emptying my bladder properly or other problems urinating
The possibility of pain or other problems having sex
The possibility of pain in the pelvis

Other things I want to talk about:

My current choice is (please circle your choice) Colposuspension • Rectus fascial sling • Retropubic mesh sling • No surgery Bulking agent* Not sure This is because: I realise I can change my mind. Bulking agent • Not sure

The problem is that written questions reflect the patient’s concern, but don’t intentionally reflect their actual symptoms and how they rate their symptoms against the risks. Nor, for example, do they provide the clinician with information as to patient vulnerabilities or assist them in an understanding of what is within a ‘normal’ range of experience.

Here we come to a core problem reflected in the Cumberlege Review and indeed in the SUI guidance which at one point noted:

“The evidence is very limited and it isn’t possible to say for sure whether one type of operation is better at treating stress urinary incontinence overall than either of the others.” 

So common sense, as the Cumberlege Review points out, might suggest not implanting something permanent, something designed to be literally enmeshed in surrounding tissue. However it is that permanence which may make it sound attractive to both clinician and patient. From our case experience, we know that this is exactly what was at the forefront of some clinicians’ minds when considering the appropriate treatment for the patient.  

What does concern us though, on the basis of experience, is that on occasion there has been: 

(a) inadequate conservative treatment, inadequately explained or offered, inadequately recorded. We have seen cases in which literally no options other than mesh were offered for SUI as a first line treatment. 

(b) inadequate analysis for example in SUI of why there has been an increase in SUI. In one case the suspicion was that the increase in a patient’s worsening of SUI a persistent heavy cold, with sneezing was ignored.  

(c)  We also fear that on occasion clinicians may have been cavalier, or exasperated and moved to a surgical option with no adequate consideration as to the alternative treatments. We understand from our experts that many surgeons became entrenched in their preferred treatment and, on the NHS, it is essentially a “lucky dip” as to which surgeon (and therefore treatment option) the patient will get. 

(d) A consequent absence of an adequate and informed consent process, it being almost taken for granted by the clinician and patient that there is one treatment option, the risks of which simply must be borne. The details of those risks therefore are treated as being beside the point. 

For the lawyers this means that more than ever we need, in respect of consent-based claims for claimants^[4], to be looking at (a) medical records in respect of the index treatment (b) comparing those medical records with the patient’s general records (c) listening particularly carefully to the client and comparing (a) and (b) with (c). That task if clearly going to be difficult or impossible when defending a claim, although as ever the defendant has the advantage of the contemporaneous medical records being likely to trump individual recollection. That in turn makes a detailed claimant witness statement critical. We also consider that in this particular area, a detailed study of the literature which was relevant at the time is crucial. This was (and is) an ever-changing vista in respect of the risks, benefits and recommended treatment options. The lawyer and expert must have a good grasp of how the knowledge and study of mesh had been evolving and what the index clinician should have known and explained at the material time. 

For example, in two cases involving TVT procedures at the same Trust, we have seen consent forms from 2012 and 2015. They are identically worded save that after the risk described as “permanent mesh”, the 2012 consent form says in brackets “this is not known to be a risk factor at present”. By startling contrast, the consent form for 2015 simply says “this is known to be a risk factor at present”. The mere removal of “not” without further alteration in the consent form to reflect the evidential developments in the field during the intervening period is extraordinary, in our view. 

A further practice point to note is that many Trusts constructed their own information leaflets about mesh procedures. As part of investigating the case on consent, it is essential to establish (a) whether any copies remain in existence and (b) the contents of any such leaflets. 

Surgical Error

We would suggest that wider healthcare economics have been in play.

The Cumberlege Review points inter alia to the lack of available surgeons trained and experienced in non-mesh procedures, the relative speed (and concomitant relative simplicity) of mesh repairs, all of which has the potential to reduce cost.

It would be interesting to look at the early years data for mesh in comparison with the position when it became more commonplace. Arguably when mesh was introduced in some volume it was at a time when surgeons had more hours ‘on the clock’ and where considerable caution would be applied.  That reflects 2003 NICE guidance. The Cumberlege Review touches on this, also noting the initial approach that there should be a maximum number of procedures per day by surgeons, with pauses built in.  

Now, as noted by the Cumberlege Review, surgeons are de-skilled in non-mesh techniques, and although 2019 NICE Guidance was envisaging a reduction in mesh based procedures carrying that into effect may be difficult, particularly in a post-Covid-19 world. That issue of lack of training/experience in alternative techniques leading to a particular technique being ‘pushed’ by a clinician will be familiar to lawyers doing clinical negligence work.

A challenge in cases of sub-standard surgery, for example in respect of placement, can be the variables involved.  Of course that is not unique to  mesh surgery and a report stating that the outcome is not good and the level of care suspicious but difficult to classify as substandard will probably ring bells of recognition.

A particular difficulty we have encountered with mesh claims is the extrusion of the mesh into the vagina back through its initial entry point. Whilst such extrusion could well indicate substandard surgical technique it is equally legitimate to state that the entry point will always be an area of weakness and such extrusion may be a non-negligent consequence. It may be nearly impossible for an expert to state which of the two options is the most likely in any one isolated instance. This reiterates the importance of investigating consent in these cases.  

The Culture of a Popular Procedure

There is no need to repeat the Cumberlege Review comments on the role of drugs companies and device providers in training and product promotion. There is every need to dwell on the problem of a new procedure appearing to provide a panacea, appearing to offer benefits of speed and cost creating a self-perpetuating bandwagon which has trampled too many women.

Summary

The rush to mesh engages serious issues as to consent and as to surgical evaluation, practice and follow-up. The bandwagon of mesh for pelvic use may have paused and gone into reverse, but it well illustrates the difficult interface between plugging away with conservative treatment and going to surgery where the complexities of alternatives are baffling, and where the patient is liable to be worried, embarrassed, lacking information as to what is ‘normal’ and the reality of the risks. We wonder if Zoom type consultations in a COVID-19 world may worsen those issues. 

We would also suggest  – and we acknowledge that this is with the benefit of hindsight – that the pelvic mesh problem is another example of a proper approach to informed consent being valuable not only to the patients but the medical profession, as a mirror reflecting common sense. In the case of pelvic mesh perhaps above all (a) is it a good idea to put something permanent in (b) how do we remove it (c) why don’t we have wider statistics?

A statutory or voluntary scheme has been floated as an idea, whether that is now practicable is another matter. Short of a statutory scheme some cases may be soluble via product liability law. For many patients the ‘standard’ issues of consent and surgery will apply.

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^[1] Paragraph 1.16 of the Review

^[2] Pelvic organs dropping out of position, for example the bladder pushing into the wall of the vagina

^[3] But note: (i) mesh for treatment of SUI is paused, (ii) by NICE Guidance IPG599 mesh cannot be used transvaginally for pelvic organ prolapse unless part of a research trial and (iii) other abdominal pelvic organ prolapse mesh procedures including rectopexies for rectal prolapse can only be done under high vigilance regimes

^[4] Obviously though, and hopefully rarely, there will be barn door breach of duty immediately apparent