Background
This is a clinical negligence claim centring on a mesh TransObturator Tape (TOT) surgical procedure in 2013. The Claimant had severe mixed urinary incontinence that had already required two Botox bladder injections.
After surgery, the claimant suffered pain and worsening of her incontinence. She required surgical division of the mesh TOT device, which was not successful.
The claimant’s case was that: she was not offered Urethral Bulking Agent (UBA) injections. Had she been offered such injections, she would have avoided the mesh TOT surgery with its complications.
Expert Evidence
Both the claimant’s and defendant’s expert had agreed on the technical matters, greatly assisted the judge in addressing the factual ones.
The procedure was performed only two months following the publication of NICE Guideline in 2013. The surgeon was “quite content that this guideline should be used as the yardstick for his management”, rather than the earlier version of 2006. The judge had noted that the draft 2013 guideline had been widely circulated some months before the publication date.
MultiDisciplinary Team (MDT) had established the TOT surgery was appropriate, in line with NICE Guideline.
Despite lower success rate, the Urethral Bulking Agent (UBA) injections were agreed as reasonable surgical alternative to the mesh TOT procedure, that should have been offered. The surgeon confirmed it was his standard practice to offer UBA injections to women considering SUI surgery
Judgement
The 2021 judgement dismissed the claim on both breach and causation. The surgeon’s account on counselling was preferred and the judge questioned the accuracy of the claimant’s evidence.
The judge called into question the overall accuracy of the claimant’s evidence on the following grounds of discrepancies:
- Stating no patient information leaflet had been provided – when the contemporaneous records documented the provision of a leaflet.
- Stating unawareness that two types of incontinence were present- when the records documented the intention to control of the overactive bladder component first, before addressing the stress urinary incontinence condition.
- Confirming she had put her trust in the surgeon at the time, but subsequently stating she would have gone against the surgeon’s recommendation of the mesh TOT procedure.
- When asked about the reasons of preferring the alternative to mesh surgery, she referred to the complications she had developed after the mesh surgery. She, therefore, “allowed her current predicament to colour her recollection of the past”.
In Perspective
Comparative Invasiveness:
The urethral bulking agent (UBA) injections were presented to court as only marginally less invasive than the TransObturator Tape (TOT) procedure, with only 10 minutes difference in procedure timing.
In all consciousness, the UBA injections must be substantially, not marginally, less invasive than the TOT procedure. The TOT involved significant tissue dissection, risked organ damage, implanted a permanent mesh device, carried substantial uncertainty about safety (with qualification in NICE Guidelines) and was associated with risk of late complications can be life-changing with a requirement of extensive removal surgery.
UBA injections are associated with none of these adverse events.
The expert evidence provided to the court in this respect may not have detailed that distinction of risks and invasiveness, in quantity and quality, between UBA injections and the mesh TOT.
As to efficacy, it is already known that women prioritise safety over cure when it comes to choosing surgery for stress urinary incontinence. That is why UBA injections are preferred to the mesh option, despite lower chance of success.
Comparative Safety – Pre-existing Overactive Bladder Condition:
The claimant had a severe overactive bladder (OAB) condition that had already required Botox injections and was likely to further worsen with a mesh TOT surgery, but not with UBA injections. Therefore, the UBA injection would have been much safer in this context. However, this part of the claim was “certainly not at the forefront of the oral evidence”.
Interestingly, the OAB symptoms are not so well tolerated and lead to greater impairment of quality of life in women, as shown by several studies including Robinson 2003 and Kelleher 1997. Therefore, a reasonable woman would have attached significance to the risk of worsening of the pre-existing OAB symptoms following TOT surgery and may have preferred a UBA injection instead.
The Way Forward
Contemporaneous documentation is the best reflection of what had happened. The judge preferred the surgeon’s account and also found that the claimant would, in any event, have followed the surgeon's recommendation and received the mesh surgery, regardless of her coloured retrospective views.
Clear documentation of offering the alternatives, including a discussion of the risks and benefits of each is good investment of time and resources for busy clinicians. Relevant video resources and Patient Decision Aids (PtDA) are available for this purpose.
Failure to document a discussion of the alternative options does not equate a failure to offer such alternatives. While this sounds reassuring to us to resolve a legal claim, we can do better to prevent it arising in the first place.
Let’s drop the unique and sophisticated intuition in the method of communicating treatments that leads patients to choose what we want them to choose. Such approach is not only unnecessarily prescriptive, but is also long outdated, bog standard paternalism.
Balanced counselling, genuine offering of alternatives and meaningful value-based discussion of benefits and risks will empower our patients, improve our results and future-proof our surgical practice against litigation.
In Lockley v University Hospitals of Derby & Burton D22YX716 – Nottingham CC – 7/12/21