Abnormal uterus 23. Miss H says the hydrothermal ablation she had in 2012 failed as she started to bleed again in 2014. She says she began to suffer with considerable pain which she did not have before the procedure.
24. Miss H says she had an MRI scan at a different NHS hospital and had the results on 22 February 2021. The results showed she had a septate uterus (when the uterus is divided into two parts by a membrane called the septum) and significant damage to her uterus. She says a septate uterus is a contraindication when assessing whether a hydrothermal ablation is appropriate for a patient.
25. Miss H says she believes that due to having an abnormal uterus, she should never have had the procedure done in the first place.
26. The Trust said in the final response letter that there is no evidence of any uterine abnormality before the ablation took place. It said its consultant obstetrician and gynaecologist reviewed the ultrasound scan reports and images, as well as the hysteroscopy pictures from 2011 and 2012. They said there is no evidence Miss H had a septate or bicornate uterus (malformed uterus) at that time, and that she had a normal uterus in size and shape.
27. The Trust explained the appearances on the MRI scan now are due to the adhesions that form within the womb secondary to scarring from the hydrothermal ablation. It said this can make the uterus appear to have a septum due to scar tissue.
28. The Trust further said the ultrasound scan arranged on 9 May 2016 suggested there were two endometrial cavities, which seemed to indicate a bicornate uterus and therefore an MRI scan was not deemed to be necessary.
29. The Trust added that due to Miss H’s raised BMI and history of thrombosis, she would have been at high risk for a hysterectomy and therefore an endometrial ablation was an appropriate option for her.
30. We have reviewed Miss H’s medical records and have found there is no evidence she had a septate/malformed uterus before the procedure in 2012.
31. The medical records show Miss H had numerous interventions including an ultrasound scan, hysteroscopy, and laparoscopy prior to the procedure. During these examinations, clinicians did not find any evidence of or diagnose any uterine anomaly.
32. Our adviser also reviewed Miss H’s medical records and said whilst this anomaly was reported in 2015 onwards, the hysteroscopy was reported as having clear views and without mention of any uterine anomaly. Our adviser said it is more likely to have become more prominent after the procedure took place rather than it being the result of any significant abnormality which was missed.
33. Our adviser also said it was appropriate to decline hysterectomy and offer ablation to Miss H as she was high-risk surgically and anaesthetically.
34. NICE guidelines for ‘Heavy menstrual bleeding: assessment and management’ says hysterectomy should usually only be considered as a last option and endometrial ablation should be considered preferable to hysterectomy.
35. We have found no evidence of Miss H having a uterine anomaly prior to having the procedure in 2012. The Trust offered her the ablation in line with the relevant guidance, we hope this provides reassurance to Miss H.
Consent 36. Miss H says she was not informed of the long-term complications of the ablation procedure when she was giving consent.
37. The Trust said it has reviewed the consent form for the ablation, and the risks were documented but not the risk of cervical stenosis (scar tissue forming over the cervical opening) and scarring.
38. The Trust explained, in 2012, the long-term effects of endometrial ablation were known, but not the exact details such as likelihood as this was a relatively new procedure. It said long term follow up was not widely known or recognised, which is most likely why the above-mentioned risks were not documented in the consent form she signed.
39. The Trust added that Miss H had an unfortunate complication of hydrothermal ablation which is now recognised and has offered a sincere apology for the delay in diagnosis and treatment of it.
40. On the consent form, the Trust listed infection, bleeding, perforation but not failure rate, intrauterine adhesions (scar tissue between the inner walls of the uterus), irregular vaginal bleeding or chronic pain. Our adviser assured us these risks/side effects were common knowledge in 2012 and before, and the technology was assessed by NICE as early as 2004.
41. NICE guidelines for ‘Fluid-filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding’ says:
‘2.11 Possible perioperative adverse effects with the first-generation EA techniques include electrosurgical burns, uterine perforation, haemorrhage, infection, and fluid overload (which may cause congestive cardiac failure, hypertension, haemolysis, coma and death).’
42. Our adviser says clinicians should counsel patients appropriately before offering treatments which can have profound life-changing impact.
43. NICE guidance for ‘Heavy menstrual bleeding: assessment and management’ says:
‘1.5.5 If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, consider referral to specialist care for:
• investigations to diagnose the cause of HMB, if needed (see section 1.3) taking into account any investigations the woman has already had and
• alternative treatment choices, including:
• pharmacological options not already tried (see recommendations 1.5.2 and 1.5.3)
• surgical options:
• second-generation endometrial ablation
• hysterectomy.’
44. Our adviser said it is unlikely Miss H would have been offered any other treatment, had she been counselled appropriately. As per the guidelines above, the only two surgery options were endometrial ablation and a hysterectomy which the Trust had decided was too high risk at the time.
45. We find that the Trust should have informed Miss H of all the known risks of the procedure before she gave consent as this information was available at the time.
46. There is a chance Miss H would still have agreed to the endometrial ablation even if she had received appropriate counselling, and the risks were fully explained to her. If Miss H was counselled properly, she still would have been told the benefits outweighed the risks of the procedure. We also recognise Miss H was experiencing chronic heavy bleeding which was impacting her quality of life so was keen to have a solution, and this was the only option available.
47. However, we recognise Miss H now feels that she made her decision based on incomplete/inappropriate counselling and given what she experienced thereafter, we understand she feels dissatisfied in how her care was provided at the time.
48. Whilst we have found that the consent was not in line with guidance, we cannot link this failing to the claimed injustice as we cannot say with any certainty whether Miss H would have gone ahead with the procedure. This is taking into account the symptoms she was experiencing, the limited treatment options and the benefits outweighing the risks.
Alternative treatment 49. Miss H says the endometrial ablation failed in 2014 and she began to experience bleeding again with considerable pain which she did not have before the procedure.
50. Miss H says the consultants who were involved and responsible for her care, left her to suffer with incredible pain for seven years without rectifying the damage.
51. The procedure is performed to destroy the inner lining of the uterus with the aim to stop heavy or abnormal vaginal bleeding.
52. The Trust said in the final response that Miss H experienced scarring following the procedure, which is a recognised complication of this surgery. Our adviser has confirmed this is correct and as we have set out above, the Trust should have advised Miss H this was a possible complication of the procedure she agreed to.
53. The Trust also explained Miss H had been suffering continuously from pelvic pain and it appreciates how distressing this will have been for her. It also said Miss H has had several ultrasound scans that showed evidence of intrauterine adhesions (scarring).
54. The records show Miss H contacted the Trust in 2014 as she began experiencing pain and bleeding. Due to this, it was determined that the procedure had failed.
55. The records show Miss H had a scan in September 2015 which identified the scar tissue and trapped blood.
56. Miss H was seen by a gynaecologist in January 2016 who diagnosed her with scar tissue and planned to complete a hysteroscopy. In May 2016, the Trust attempted a hysteroscopy but could not access her cervix so she was referred back for further management with a recommendation of hysterectomy.
57. The records show Miss H wanted to have a hysterectomy but the Trust said the risk of completing the surgery was increased because of her weight.
58. Our adviser said they are supportive of the decision made in January 2016 for Miss H to have the hysteroscopy but when this failed, she was referred back and nothing further was done. They said this should have been followed up but it was not.
59. The Royal College of Obstetricians and Gynaecologists guidance for ‘Providing quality care for women’ says:
‘Following discharge from hospital, whether or not the woman was admitted, there should be a clear plan shared with all relevant healthcare professionals and the woman herself. This should make clear the next stage of care, where and when it will be provided and who is responsible for ongoing care.’
60. The records show the Trust recommended Miss H should have a hysterectomy in 2016 but clinicians were still discussing this in 2018 to 2020.
61. The records show Miss H’s BMI was 50 in 2016. Miss H says her BMI was not 50 in 2016, but accepts it was high. Our adviser said ideally someone’s BMI would be below 30 to reduce complication rate and a BMI of 40 and above is a higher risk, but there are no set guidelines on safe BMI for hysterectomy.
62. Our adviser said if the Trust did not have the skills to complete the surgery, it should have referred Miss H to another hospital.
63. Our adviser said the Trust could have worked with Miss H and her GP to reduce her BMI by providing weight management therapies and reviewing her progress. They could have spent 6-12 months doing that so by 2017 they could have reached a point where they could either treat her or refer her to another Trust for surgery. Our adviser said if that was the case, she likely would have had the procedure by 2018 – as normally within two years would be reasonable given the additional consideration for raised BMI.
64. Our adviser said the Trust could have also considered giving her injections to stop her periods and make her menopausal. Our adviser said you cannot give this treatment for more than six months, but the Trust did not explore or offer her other options.
65. The records show in 2021, Miss H had a raised BMI and was awaiting a hysterectomy at Princess Royal (another Trust). The Trust was aware she was on the waiting list at another hospital. She was referred to the Princess Royal in November 2020.
66. Our adviser said from 2016 to 2020, the Trust had sufficient time to try treatments to resolve her issues and the failure to do so is not acceptable. Our adviser said the Trust should have offered the hysterectomy or referred her elsewhere if it could not complete the surgery.
67. The following GMC guidelines apply:
‘15 You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must:
• adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary • refer a patient to another practitioner when this serves the patient’s needs.’
68. For seven years, between 2015 and 2022, Miss H was in severe pain resulting in her being taken to A&E via ambulance on many occasions and having to repeatedly visit the gynaecology department.
69. Miss H told us that she and her family have suffered as she has not been able to do normal everyday things due to the pain. She says tasks such as driving, shopping, housework and socialising had become impossible.
70. She says she stopped going on family holidays due to her chronic pain as the pain escalated in the last three years before her surgery.
71. Miss H has also told us she was unable to work from the beginning of 2021 due to having to take opiate medication for the intense pain in her pelvis. She says she was practically house bound from then up until having the hysterectomy.
72. She says it has also had a large emotional impact on her, it made her very anxious and distressed, feeling worthless and she has developed a phobia of hospitals and not being able to trust medical professionals.
73. Miss H has told us, since she had her hysterectomy in 2022, her chronic pelvic pain has gone.
74. We find that the Trust should have looked into and arranged for Miss H to have weight management therapies with the GP in 2016 to lower the risk of surgery. We recognise this could have taken place over 6-12 months.
75. We believe that whether Miss H lost weight during this period or not, we would expect the Trust to have offered the hysterectomy surgery or if the Trust was not specialised to complete the surgery, to have referred Miss H to another hospital.
76. We find it is likely Miss H would have had the surgery by 2018, allowing up to two years for this to be arranged due to the higher risk, either by the Trust or if it was unable to, she would have been referred to another hospital.
77. Miss H had her hysterectomy in 2022, therefore, there was a four-year period where she was in unnecessary pain and discomfort.
78. We believe the severe pain Miss H experienced due to the delay in surgery caused her to have a reduced quality of life for four years. We accept the pain was so severe that it stopped Miss H from being able to spend quality time with her children, go on holiday with her family or socialise. She has described how the pain she experienced had a significant impact on her life and we think this could have been avoided if the surgery was done sooner.
79. We also find the pain restricted her from being able to do basic everyday tasks such as driving, shopping or housework which took away her independence. This also caused Miss H a lot of emotional distress and upset as she was isolated due to being unable to leave her home.
80. Miss H took 14 months off work due to taking opiate medication for the pain she was experiencing as her job included working 1:1 in the community.
81. We find the unnecessary pain had a significant impact on her life for a prolonged time.