Pre-operation consent and information on risks and side effects
15. Mrs A says the Trust did not fully consent or inform her of the risks and side effects involved in the autologous sling operation before the procedure, specifically, that she may not be able to pass urine naturally or have to use a catheter. Mrs A says if she had known, she would never have had the surgery in the first place.
16. She says she spoke with the surgeon on the morning of the operation who went through the risks and stated, ‘less than five percent of having to empty the bladder fully and may need to self-catheterise to empty fully’.
17. She says she was told in 10 years of the surgeon performing the operation, only one other patient struggled to pass urine and was taken back to theatre to loosen the sling (material taken from your own body to hold organs in their correct positions) which was successful. Mrs A decided to go ahead with the surgery given this advice and information.
18. Mrs A says the Trust suggests the surgeon discussed the risks in detail before the surgery, but she disagrees stating the conversation was five minutes in a room with just herself and the surgeon who told her exactly what was on the consent form.
19. She says the surgeon did briefly describe voiding dysfunction (difficulties in fully emptying the bladder, bladder function, and urination) on the day of surgery as a possibility, in terms of not emptying the bladder fully and the possibility of self-catharising every few days if needed. She says there was no mention of possibly not weeing naturally again or having to have a permanent tube through her stomach to wee through and constant infections, pain, bladder spasms, bleeding, and leaks.
20. In its response letter to Mrs A’s complaint the Trust apologised for the negative experience she had. The Trust say the surgeon did advise Mrs A of the risks of the surgery on the day of operation, including the risk of voiding dysfunction. The Trust also said the surgeon made it clear to Mrs A the outcome of surgery could not be guaranteed at the time.
21. The Trust said the surgeon has acknowledged he informed Mrs A prior to her surgery taking place he had one previous patient who had been completely unable to void following surgery, therefore advising Mrs A this was a possibility.
22. To establish whether there were any indications of failings in the care and treatment the Trust provided to Mrs A, and whether the care provided was to the expected standards and in line with relevant guidance and standards, we reviewed Mrs A’s medical records and sought specialist advice from a urology consultant.
23. Mrs A initially had an appointment with the surgeon on 8 November 2022. He informed her she could have an operation to try and solve her continence issues, and said he would provide her with a leaflet so she could choose which operation she wanted to proceed with.
24. Mrs A says she was provided with a BAUS leaflet (2018 version) which documents alternative treatments for stress urinary incontinence. The leaflet documents difficulty passing urine as a complication of autologous slings with a risk of five to 10 percent. Mrs A says after researching the operation, including the risks and advantages, she decided to go ahead with autologous sling operation.
25. Mrs A says the 2018 leaflet she was provided with was out-of-date, and she has since seen (after her operations) an updated BAUS 2020 leaflet which was the most updated version at the time of her operation which mentions difficulties with voiding disfunction and catheterisation as risks.
26. A clinic note dated 8 November 2022 states ‘we discussed her options for further management using the BAUS patient information leaflet on stress incontinence surgery. I am going to send Mrs A a copy of the leaflet in the post and have advised her to contact me when she has decided how she would like to proceed. In the interim we will discuss her case in our Multi-disciplinary Team Meeting.’ The medical notes do not say which BAUS form was provided to Mrs A and the Trust has since confirmed to us it cannot confirm what leaflet was provided to Mrs A.
27. Mrs A chose to proceed with the autologous sling operation which was scheduled for a year later.
28. The GMC consent guidance says doctors should discuss with patients the benefits and harms of all procedures it proposes to carry out. This includes the probability of a benefit or harm occurring based on the patients’ individual clinical circumstances and likelihood of success for each option.
29. The GMC consent guidance also says doctors should include information such as recognised harms patients would want to know about, effects on an individual’s circumstance on a harm occurring or being a significant harm, and how likely it is for a risk or harm to occur.
30. We have not seen sight of a documented conversation or clinical note in the medical records on the day of her surgery which states a discussion was specifically held about the possible risk of use of a permanent catheter before her operation. Mrs A has told us a conversation did take place, albeit brief, about the risks and side effects including voiding dysfunction and the Trust has confirmed the same despite this not being documented on the morning of the operation.
31. We have viewed the consent form dated 9 November 2023, signed by Mrs A, which includes pain, infection, bleeding, bladder injury, persisting incontinence, and voiding dysfunction as the common risks and side effects.
32. On the consent form under ‘statement of health professional’ the surgeon has signed and dated the form confirming the procedure was explained to the patient including the intended benefits of the procedure, the common side effects and the significant, unavoidable, or frequent occurring risks or complications.
33. It is clear the surgeon discussed and informed Mrs A of the risks and side effects of the surgery, including voiding dysfunction. Whilst it is not documented in the medical records on the day of surgery the possibility of needing a catheter was specifically discussed pre-operation, in Mrs A’s initial complaint form she says she spoke to the surgeon on the morning of the operation stating ‘he went through the risks less than 5% of having to empty bladder and may need to self-catheterise to empty fully.’
34. The Trust apologised and expressed regret the surgery resulted in an inability to empty her bladder. It said the symptoms she experienced were all unfortunately recognised complications of the operation which were discussed and on the consent form.
35. It is difficult to know exactly what form Mrs A was given pre-operation and when, without a written record confirming this. Mrs A says the Trust did provide the 2018 form to her, and the Trust say it cannot confirm which form was posted to her (BAUS 2018 or 2020). On the balance of probabilities, we believe Mrs A did receive the 2018 leaflet and we do not doubt what she says.
36. In the medical records, a clinical note from 12 November 2023 after Mrs A’s surgery states Mrs A was advised pre-operatively during the consent process of the following:
• patient to go home with catheter today and return for trial without catheter in three to four weeks • if trial without catheter is not completely successful, options include Intermittent Self-Catheterisation (ISC) or surgery to divide the sling. A note states Mrs A understands this may result in recurrent stress urinary incontinence (SUI).
37. This suggests a conversation did take place about voiding dysfunction and use of a catheter before her operation.
38. We have seen evidence suggesting Mrs A was initially provided with information about the different options for treating her incontinence a year before the surgery took place. We have also seen evidence that the Trust appropriately provided Mrs A with information on all the risks, side effects, and benefits of the operation, including the percentage of these happening, on the day of the surgery. This is in line with GMC guidance.
39. Whilst we appreciate Mrs A says she was not provided with information about the risk of using a catheter, our adviser said this is linked to the risk of voiding dysfunction. If voiding dysfunction occurs after surgery, catheterisation is a method of treating this.
40. We cannot conclude whether Mrs A would have had the surgery or not if she had been provided with the 2020 BAUS leaflet that specified catheterisation as a risk. The risk of permanent catheterisation is low (which is between two percent and five percent in the current updated information leaflet), and we cannot say Mrs A would not have chosen this option if she had been told this information before her surgery.
41. Mrs A has also told us she researched the operation options beforehand, including the advantages and disadvantages of the autologous sling operation, and decided this was the right option for her. The consent form Mrs A signed does specifically state the common side effects including voiding dysfunction which was discussed with the surgeon pre operation.
42. We understand how distressing it has been for Mrs A and the pain and complications she experienced from this. We appreciate the impact that this has had on her life.
43. We consider the information provided by the Trust about the risks and side effects was in line with the GMC guidance. Mrs A has confirmed she researched the operation before she agreed to the surgery, confirmed a conversation did take place before surgery (albeit brief) about voiding dysfunction and the possibility of self-catheterisation, and she signed the consent form.
44. On this basis, we can see the Trust informed Mrs A of the risks and side effects of the surgery and we have seen no indications of failings.
On ward care and treatment relating to a concern about her over filled bladder
45. Mrs A complains about the care and treatment she received on the ward after her initial surgery on 9 November 2023. She says her bladder was ‘grossly over filled’ and she was left in the toilet in agony and not able to pass urine.
46. She says the ward staff did not monitor what fluid intake she had which resulted in her suffering from agonising pain and having 2000mls drained from her ‘bursting bladder.’ She says this was not addressed and was unacceptable.
47. We are sorry to hear about the pain Mrs A suffered from and the impact the experience has had on her and her family. We appreciate Mrs A has been through a very upsetting and distressing time.
48. The 2020 BAUS information leaflet says most people stay in hospital overnight after the autologous sling operation. When awaking, a patient may have a catheter in their bladder and when a patient first passes urine, it may be uncomfortable, and the urine flow may be slower than usual. Nurses will measure the amount of urine a patient passes and then check a scan of the bladder afterwards to make sure a patient is emptying well. If the bladder does not empty well, the bladder catheter may be replaced for a few days, or the patient is taught how to perform intermittent self-catheterisation.
49. After the operation, Mrs A says she had been drinking lots of fluids and had tried to pass urine and it felt like her bladder was going to ‘burst.’ She pulled the emergency cord for the nurse to come due to the pain she was in.
50. In its complaint response dated 20 November 2024, the Trust acknowledges Mrs A’s concerns about whether her bladder had overfilled. The Trust confirm the reason she was unable to void was due to obstruction at the level of the sling and not an overdistension injury (condition where the bladder becomes excessively stretched due to the accumulation of urine).
51. To establish whether the Trust monitored Mrs A’s fluid correctly and in line with guidance and standards, we assessed Mrs A’s medical records and sought advice from our adviser.
52. Mrs A’s medical records show on 9 November 2023, staff inserted a urethral catheter after she was diagnosed with voiding dysfunction which occurred following surgery. Until Mrs A could empty her bladder naturally, she required the catheter. Our adviser said this is standard procedure when complications happen with this surgery such as continued or new problems urinating.
53. The medical records show an ultrasound scan was performed and re-catheterisation due to problems with bladder emptying. Mrs A was kept in hospital overnight to recover with morphine to help with pain. The following day her catheter was removed.
54. In a medical note dated 11 November 2023, it explains Mrs A may need to go home with a catheter. A clinical note the same day states ‘All cares given with patients consent.’ In a Nursing Specialist Assessment (NSA) note, a ‘Yes’ tick box has been ticked for whether Mrs A required assistance with catheter or stomach.
55. Mrs A’s fluid balance charts show her fluid balance was appropriately checked. On 12 November 2023, when Mrs A was discharged, the clinical notes state Mrs A was ‘tolerating diet and fluids well.’
56. A clinical note from 12 November 2023 when Mrs A was discharged, states Mrs A was advised of the following possibilities pre-operatively during the consent process, says:
• patient to go home with catheter today and return for trial without catheter in three to four weeks • if trial without catheter is not completely successful, options include Intermittent Self-Catheterisation (ISC) or surgery to divide the sling. A note states Mrs A understands this may result in recurrent stress urinary incontinence (SUI).
57. The clinical note states Mrs A’s preference was to avoid ISC even if this meant a continued small volume of incontinence and states she felt reassured.
58. The NMC code says accurate and clear records must be kept at the time or as soon as possible after an event. Records should identify any risks or problems that have arisen and if so, steps must be taken to deal with them. The NMC code says staff should accurately identify, observe and assess signs of normal or worsening physical and mental health in the person receiving care.
59. We have seen evidence which shows Mrs A’s fluid balance was appropriately recorded immediately post operatively and prior to her discharge. It is documented Mrs A had a failed trial without catheter, and she had an ultrasound scan and re-catheterisation at this time to help with emptying her bladder and to relive pain.
60. We explored whether it is a usual outcome from this surgery to result in an inability to empty the bladder naturally. Our adviser says retention of urine requiring catheterisation is a recognised complication of this procedure and in this case has been managed well despite complications occurring.
61. The medical records show Mrs A’s fluid balance was appropriately recorded throughout her time at the Trust and was monitored correctly in line with the NMC code. This does not take away our appreciation and understanding of the pain Mrs A was experiencing at the time.
62. Unfortunately, Mrs A experienced some of the side effects that can occur after the surgery. After considering all evidence, information, advice and guidelines, we consider staff properly monitored Mrs A’s fluid intake.
63. Therefore, we have not identified any indications of failings here. We appreciate Mrs A has concerns about the care she received on the ward, but we would like to reassure her we have seen no evidence the care and treatment provided to her fell below expected standards and guidelines.
Concerns about the time between each surgery and the impact this had
64. Mrs A complains she had to wait for six weeks for further surgery after her initial operation, where a sling was created underneath the urethra (water pipe from the bladder to the outside) using a strip of her own tissue (fascia) taken from the wall of the abdomen. The further surgery was scheduled to release the sling and had not helped improve her voiding.
65. Mrs A believes the wait between being discharged after initial surgery and the further surgery to release the sling was too long a wait and believes this caused her further problems with voiding.
66. In the medical records, a clinical note from 12 November 2023 states Mrs A was discharged home with a catheter and she would return after three to four weeks to start a trial without catheter. There was no plan at discharge for further surgery at that point.
67. Our adviser said this is standard practice as there can be a lot of swelling post operatively which may reduce the likelihood of a successful trial without catheter. Our adviser said a six week wait for the second operation would be in keeping with standard practice, as you would need to allow time for the swelling to reduce, and time to see if the issues improved, before deciding whether further surgery was required.
68. After Mrs A’s initial surgery, discharge, and trial with catheter, the Trust decided to carry out a further operation to resolve complications that occurred with voiding dysfunction.
69. The second procedure on 14 December 2023 was intended to improve Mrs A’s voiding and maintain her continence by releasing the sling and placing a stomach catheter to allow her urethra to heal.
70. The GMC guidance say a patient should be adequately assessed taking into account symptoms, the patients’ needs and to carry out a physical examination where necessary. It also says doctors should promptly provide or arrange suitable treatment where necessary.
71. We consider the Trust acted in line with the GMC guidance and provided prompt treatment to Mrs A when this was found to be necessary. We can reassure Mrs A the plan after her initial surgery was to assess her after three to four weeks and then start a trial without a catheter. At the time of discharge, there was no plan for further surgery. Unfortunately, due to complications, a further operation was scheduled, and the Trust promptly arranged this. We therefore could not identify a failing for this point.
72. We offer our sympathies for the experience Mrs A has been through and can only imagine how upset, uncomfortable, stressed, and anxious she has been throughout this journey.
73. We wish Mrs A good health for the future, and we hope this decision brings her some reassurance the Trust did provide the correct care and treatment to her and therefore there are no indications of failings found. We thank Mrs A for taking the time to bring her complaint to our attention.