The Trust’s communication to Miss E regarding the size of her fibroids and the risks of fibroids to pregnancy
18. A fibroid is a non-cancerous (benign) growth of the womb (uterus). Fibroids are common and usually cause no symptoms. However, they can sometimes cause heavy periods, tummy (abdominal) swelling and urinary problems. Miss E says she was referred to a gynaecologist in September 2022, as she was trying for a baby, and she was asked to have a pelvic exam. Miss E said she had an ultrasound exam on 22 September 2022, and she was informed her GP would tell her the results of the ultrasound. Miss E says she was booked in for a follow-up appointment on 30 March 2023 to discuss her results. Miss E says she did not hear back from the Trust or her GP, and she was told by her GP the Trust would only contact her if further action needed to be taken. Miss E said she did not hear anything back from the Trust regarding her results, and so she thought her results were ok. Miss E says the Trust also failed to inform her of the risks that fibroids posed to her pregnancy when the Trust was aware she was trying to become pregnant. She says this relates to ultrasounds examinations and consultations she had with the Trust in 2020, 2021 and 2022.
19. Miss E says she became sick in December 2022 where she noticed that her periods became very heavy and her stomach got tight and uncomfortable, to the point it was swollen. She spoke to her GP and did a pregnancy test and subsequently found out she was pregnant. Miss E says she then had a pelvic ultrasound exam at the Trust, and it informed her she was pregnant, but it was difficult to see her baby due to the size of her fibroids. Miss E says the Trust informed her she had five fibroids, with the biggest being 9cm, and in September 2022 her biggest fibroid was 7cm.
20. Miss E says the Trust should have informed her of the size of her fibroids at the time of the examination in September 2022, or as soon after as possible. Miss E says whilst she was aware she had fibroids, as she had been told this some years earlier, the Trust had never informed her of the size of her fibroids, and she considers it should have done this, particularly as it was aware she was trying to become pregnant. Miss E says she would have had the option to seek treatment to reduce her fibroids at an earlier stage of she was aware if the size of her fibroids at the time of the examination.
21. In its response to Miss E, the Trust said it was sorry that the results of Miss E’s pelvic scan were not communicated to her, however, it would not have been routine practice to inform her of the results sooner than the next consultation date, unless the results showed a change to the treatment plan was needed. The Trust said that in these circumstances, it is normal practice to go through the results at the next appointment. The Trust said the results of the scan showed the largest was a subserosal (outer wall of the uterus) fibroid measuring 75 x 55 x 68mm.
22. To robustly and thoroughly investigate this, we have carefully reviewed Miss E’s clinical records, reviewed the Trust’s response, and we have reviewed the GMC guidance on good practice, and guidance provided by the British Fibroid Trust. We have also received clinical advice on this from our clinical adviser.
23. Miss E’s clinical records show she had an ultrasound scan on her pelvis on 11 December 2020. The ultrasound report showed that Miss E had five fibroids, with the biggest measuring 5cm. The Trust sent a clinic letter dated 8 July 2021 to Miss E’s GP (copying Miss E into this) stating that Miss E had been under investigation for subfertility.
24. The Trust stated Miss E’s scan showed a fibroid uterus, but there was no evidence of submucous fibroids.
25. Fibroids are benign (non-cancerous) tumours. They grow on or in the muscle layer of the uterus (womb). Submucosal fibroids grow under the lining of the womb. It is clear the Trust was aware of Miss E trying to become pregnant as she was being treated for subfertility, and it outlined she had been trying to get pregnant for over a year in its letter to her GP dated 20 October 2020. However, there is no evidence that the Trust explained any of the potential complications to Miss E that can arise when being pregnant with the presence of multiple fibroids.
26. Miss E had a further scan on 26 September 2022. The scan showed there was some growth of the fibroids, with the largest measuring 75mm. Miss E became pregnant at the very end of 2022, and she sadly suffered a miscarriage (having had bleeding episodes through the early part of pregnancy) in March 2023.
27. The GMC’s Good Medical Practice (2014) states ‘You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must b) Promptly arrange suitable advice, investigations or treatment when necessary.
28. As we have outlined above, there is no evidence that the Trust informed Miss E of the size of her fibroids, or that it informed her of any of the associated risks of having fibroids in relation to pregnancy, despite it knowing she was actively trying to become pregnant.
29. Our clinical adviser stated that given the initial scan findings, it would have been reasonable for the Trust to have given some explanation to Miss E (in the consultation of July 2021) of the several general issues which may be associated with multiple fibroids in pregnancy, mainly: • pain in pregnancy due to fibroid degeneration • possible increase in miscarriage if the fibroids are submucosal • increased risk of bleeding in pregnancy and abruption • preterm labour • obstetric interventions such as caesarean section • postpartum haemorrhage.
30. Based on the clinical advice we have received and the guidance we have referred to, we consider the most appropriate opportunity for the Trust to discuss the possible effects of fibroids on pregnancy was in July 2021, after Miss E had her first scan. This should have been done and it was not.
31. The Trust had a further opportunity to discuss the findings of the second scan with Miss E after her scan in September 2022, as the fibroids had grown. We have not seen any evidence to show the Trust discussed the findings of the scan with Miss E prior to her becoming pregnant. We have seen no evidence that of the Trust discussing the associated risks of having fibroids whilst trying to become pregnant. Miss E became pregnant towards the end of 2022, and she did not find out about the size of her fibroids until her pregnancy scan in early February 2023.
32. Based on the evidence we have seen, we have not found that the Trust discussed the risks of having fibroids whilst pregnant with Miss E, nor did it inform her of the size of her fibroids following on from the scans she had in 2020 and 2022. We have found the Trust failed to adequately communicate to Miss E the size of Miss E’s fibroids, and the risks of having fibroids whilst trying to become pregnant or being pregnant. We will discuss the impact of this later in our report.
Lack of further tests or treatment plan following the fibroid scans
33. Miss E says the Trust did not act on the results of the scan, by either arranging further tests or creating a management plan to remove the fibroids.
34. In its response, the Trust stated a subserosal fibroid is one that is growing outside of the uterus, and there is no evidence that subserosal fibroids lead to fertility issues, and there was likely to be any recommended surgical intervention for fertility treatment at that time (when Miss E had her second ultrasound scan of pelvis). The Trust said the ultrasound scan of 2022 did not show a significant growth of the fibroids from Miss E’s scan in 2020. It said there was only a change of 2cm in the size of her largest fibroid, and this was not concerning.
35. To determine if the Trust should have arranged for any further tests or arranged a treatment plan for Miss E when it received the results of her ultrasound scan in September 2022, we have reviewed her clinical records, and we have referred to guidance provided by the British Fibroid Trust. We have also received clinical advice from our adviser on this.
36. The ultrasound report of December 2020 showed Miss E had five fibroids, with the largest measuring 56mm. Miss E’s ultrasound scan of September 2022 showed some growth of her fibroids, with the largest measuring 75mm. Miss E’s fibroids were subserosal, this means they grow on the outer wall of the uterus and usually cause no symptoms until they grow large enough to cause interference to adjacent organs. The guidance produced by the British Fibroid Trust states that subserosal fibroids do not cause fertility problems. It outlines that there is evidence to support the notion that subserosal fibroids have no detrimental effect on fertility outcome. Therefore, in most cases of non-tubal obstructing subserosal fibroids (fibroids outside of the womb), fibroid removal is not mandatory in women who are wanting to become pregnant. NHS guidance on the treatment of fibroids states treatment may not be necessary if you have fibroids but you do not have any symptoms, or if you only have minor symptoms that are not significantly affecting your everyday activities.
37. Further to this, the NICE clinical knowledge summary on the management of fibroids outlines that if a woman has fibroids that are asymptomatic (which Miss E’s were at the time of her ultrasound scan in September 2022) then no treatment or follow-up is needed routinely. This guidance was revised by NICE in April 2023. NICE explained this was a minor update whereby the link to the contraception assessment topic was updated. There were no further updates at that time, and the previous update was in July 2022 which pre-dates when the events happened, and so this guidance is relevant to refer to.
38. Our clinical adviser outlined that it would have been appropriate for the Trust to have already discussed the issues with fibroids and pregnancy with Miss E in 2021 and to have acknowledged that these risks were probably now slightly increased with the fibroid growth. However, our adviser stated there were no further tests that were required, and at the time of Miss E’s scan in 2022, she was not pregnant, and so it may have been reasonable to adopt a wait-and-see approach to see how any pregnancy would proceed.
39. Whilst the Trust should have discussed the associated risks of fibroids and pregnancy with Miss E, particularly as the fibroids had increased in size, as we have outlined earlier in the report, we have not identified that the Trust should have arranged for any further tests or any further treatment for Miss E following on from her scan in September 2022. We have not identified a failing with the Trust not providing any further scans or treatment specifically after the ultrasound scan in September 2022. It is important to acknowledge that this does not detract from Miss E’s experience nor the impact this has had on her.
The Trust’s communication to Miss E regarding her heavy vaginal bleeding
40. Miss E says she became sick in December 2022, where she noticed that her periods became very heavy, and her stomach got tight and uncomfortable, to the point it was swollen. Miss E says she then discovered that she was pregnant. She says she visited the Trust on three occasions for early pregnancy scans. These were on 8, 10 and 21 February 2023.
41. Miss E says she suffered with a lot of abdominal pain during the pregnancy, and she struggled to walk. She also said that she was bleeding heavily every day during her pregnancy, but the Trust wrongly informed her that daily heavy bleeding when she was pregnant was normal and nothing to worry about. Miss E says during her pregnancy her fibroids grew in size which resulted in her having severe symptoms such as back, leg, and stomach pain, pelvic pressure and stomach discomfort.
42. In its response, the Trust stated that that bleeding in early pregnancy is not uncommon. Nevertheless, it does indicate a risk of miscarriage, and the Trust apologises that Miss E was told that bleeding in early pregnancy is normal.
43. The Trust has acknowledged that it was not appropriate to advise Miss E that bleeding during early pregnancy was normal when she was attending for her scans in February 2023. To address this, we have reviewed the evidence that Miss E has provided, we have reviewed the NICE clinical knowledge summary on miscarriage, and we have also received clinical advice on this.
44. The Trust was aware that Miss E was pregnant in February 2023 when she was suffering her heavy vaginal bleeding. Miss E was within the first 12 weeks of her pregnancy at this point. The NICE clinical knowledge summary on miscarriage states that miscarriage should be suspected if a woman who is pregnant presents with vaginal bleeding, with or without pain, in the first 24 weeks of pregnancy. This shows that it was inappropriate for the Trust to have advised Miss E that vaginal bleeding was normal during pregnancy. This guidance was revised by NICE in October 2023. NICE explained that no major changes to the clinical recommendations were made during this revision. The previous changes were made in December 2022, which are before the events complained about. This means the guidance is applicable to be referred to for the purposes of making findings on this section of the report.
45. We also received clinical advice on this from our adviser. Our adviser outlined that bleeding in pregnancy is never normal, and it was not appropriate for Miss E to have been told this.
46. Based on the evidence we have received; we have found this to be a failing in the Trust’s communication to Miss E. We will discuss the impact of this in the impact section of the report.
The Trust’s telephone consultation with Miss E regarding her miscarriage
47. Miss E says the Trust arranged a telephone consultation with her to discuss her miscarriage. Miss E says this was inappropriate and insensitive, and she says the consultation should have been face-to-face. Miss E also says the consultant made an insensitive comment on the call by saying to her that earlier treatment for her fibroids would not have changed the overall outcome. This must have been very upsetting for Miss E to hear.
48. In its response, the Trust said it was sorry that Miss E found the consultation to be distressing, specifically when the consultant said that if Miss E had surgical intervention sooner to manage her fibroids, it would not have changed the outcome of her having a miscarriage. The Trust said the management or removal of submucosal fibroids may help fertility (these are fibroids that develop very close to or inside the uterine cavity). The Trust said that in September 2022, Miss E’s fibroids were identified as subserosal (on the outside of the uterus). The Trust said there is not enough evidence from clinical studies to determine that removal of fibroids located outside the cavity may improve fertility or impact on miscarriage outcomes. The Trust apologised for upsetting Miss E, and it outlined it would not have been the consultant’s intention to cause her any distress.
49. The Trust said the consultant has reflected on the consultation and accepts that Miss E’s appointment to discuss her miscarriage should have been face to face.
50. The Royal College of Surgeon’s guidance on communicating effectively outlines that doctors should communicate clearly and compassionately with patients, giving them the information they want or need in an appropriate language. The Trust has explained why the consultant made the comment about the Miss E’s miscarriage. The British Fibroid Trust guidance outlines there is moderate level evidence to support the notion that subserosal fibroids have no detrimental effect on fertility outcome. These are the type of fibroids that Miss E had.
51. The Trust has outlined that on reflection, it would have been more appropriate to have had the consultation face-to-face, and it has apologised to Miss E for any distress she was caused during the consultation. We understand that the consultation would have been very upsetting for Miss E, and the comments made during the consultation would have caused added upset to Miss E at what was already a difficult time. The NHS Complaints Standards say organisations should set out what happened and whether mistakes were made, and they should fairly reflect on the experiences of everyone involved. Based on this guidance, we have found that the Trust has responded appropriately to Miss E’s concerns regarding the consultation, as it has reflected on what she has said, and it has explained the consultation should have been face to face. It has also explained the consultant’s comments, and it has apologised for any distress that was caused.
52. Our clinical adviser stated that at the time, many Trusts had established remote consultation as a common method of conducting follow up in the wake of the COVID-19 pandemic. Our clinical adviser added that whilst there is some evidence of an association of fibroids (in certain parts of the uterus) with early pregnancy loss, there is no clear evidence at present that suggests that fibroid treatment reduces this risk of miscarriage.
53. Whilst we do consider the communication could have been delivered in a more compassionate way (the information regarding the miscarriage) we have not identified a failing with the decision to hold the consultation over the telephone, or with the information the Trust provided to Miss E during the consultation.
The time taken for the Trust to arrange a follow up appointment for Miss E following on from her miscarriage
54. Miss E says that after her miscarriage, she remained in hospital for five days. She says that whilst she was in hospital, the Trust informed her it would follow up on her fibroids as they had grown so large. Miss E says she received a letter in the post stating that her next appointment with the gynaecological outpatient department was on 15 August 2023.
55. Miss E says this was shocking to her, as she was seen by the doctors, nurses and specialists and they could see how big her fibroids had developed and the pain she was in. Miss E says despite the Trust having her results, she had to wait five months for an appointment. Miss E says her appointment was cancelled on 9 August 2023 and it was rescheduled for 9 April 2024. Miss E says she found this shocking, as this means she would have had to wait 13 months to be seen following her miscarriage.
56. In its response to Miss E, the Trust stated that following on from her miscarriage, the Trust did not offer any follow-up care for five months. The Trust apologised that there was a considerable length of time before she was going to be seen further to discuss her fibroids. It said there is a long waiting list for women to receive a gynaecology outpatient appointment and unfortunately this contributed to the waiting time she experienced. The Trust said the appointment would have been the first appointment available.
57. The Trust said that as these appointments are booked well in advance, it may be necessary to reschedule appointments to facilitate consultant leave, and this is what happened in Miss E’s case, and this is what led to her appointment being rescheduled to April 2024. The Trust said it understands this would have been a very long wait for her, and patients will understandably get frustrated and upset a such delays. The Trust said the senior management team are working towards developing a better system of rescheduling appointments, where required, to avoid patients being rebooked so far in advance. The Trust said the aim is that rescheduled appointments will be no longer than 6-8 weeks after the original appointment.
58. We have found that the Trust acknowledged that the wait Miss E was subjected to was not acceptable. Our Principles of Good Administration says public bodies should provide effective services with appropriately trained and competent staff. Public bodies should do what they say they are going to do. If they make a commitment to do something, they should keep to it, or explain why they cannot.
59. Based on the evidence we have seen; we have found the Trust’s management of arranging the follow up appointment to be a failing. Miss E was given an appointment five months post her miscarriage, and 11 months post her ultrasound scan to discuss her fibroids. This was then cancelled with less than a weeks’ notice and rescheduled for eight months later. We have not seen evidence of the Trust providing an effective service, or keeping what it said it was going to do with regards to Miss E’s scheduled appointment. We don’t consider this is in line with our principles of good administration. The Trust itself has acknowledged this was not acceptable by saying it is trying to improve its system for rescheduling appointments. We will discuss the impact of this in the impact section of the report.
Our findings in relation to impact
60. Miss E says because the Trust did not inform her of the size and seriousness of her fibroids, and because it did not treat her fibroids, she became pregnant, and the fibroids contributed to her ultimately suffering a miscarriage. Miss E says the fibroids caused her a lot of pain when she was pregnant, and she struggled to walk.
61. Miss E says she has been upset and distressed at the lack of communication from the Trust with regards the size of her fibroids, and the risks these posed to her when she was pregnant.
62. We have identified three failings with the standard of care Miss E received from the Trust. The most significant of these failings is the Trust not informing Miss E of the size of her fibroids or discussing the associated risks of fibroids and pregnancy. The first reasonable opportunity for the Trust to discuss this with Miss E was when she had the consultation with the Trust in July 2021. There was a further opportunity following on from Miss E’s second scan, as there was a gap of three months from Miss E’s scan to her discovering she was pregnant.
63. Based on the evidence we have reviewed; we cannot say the failings we have identified led to Miss E suffering a miscarriage. This is because it cannot be said that the lack of explanation about the fibroids, and lack of discussion about possible management of the fibroids impacted on Miss E sadly suffering a miscarriage.
64. Miss E says if she would have known the full extent of her fibroids in 2022, she would not have got pregnant and she would have instead sought treatment for the fibroids. We understand Miss E sought private treatment for the fibroids after her miscarriage in 2023. Miss E says she had no choice but to seek private medical care, as she was bedridden, and the pain became unbearable. When she went to the consultant, she was informed that she had no option but to have abdominal surgery, due to the size of the fibroids.
65. We cannot speculate or say on the balance of probabilities what would have happened had the Trust informed Miss E of the situation and associated risks of her fibroids and pregnancy in 2021 and 2022. However, we can say that not informing Miss E made a difference to the choices Miss E may have made, as it is possible that Miss E may have opted to have her fibroids removed sooner, had she been aware of the extent of them.
66. We cannot say on the balance of probabilities she would have stopped trying to become pregnant, but there was a loss of opportunity for Miss E to make an informed choice. This is because Miss E was aware she had fibroids, but she was not aware of the extent of them, how big they were, or the associated risks around having fibroids and being pregnant.
67. We recognise this will be a source of upset and distress to Miss E, as she will never know what the outcomes would have been for her if she had been told of the severity of the fibroids at an earlier time (specifically before she was pregnant).
68. We have found the Trust’s lack of communication regarding her fibroids would have led to worry and concern for Miss E when she did discover the true extent of the fibroids, as by this time she was already pregnant. This news would also have highly exacerbated Miss E’s emotional upset and distress at what was already a very upsetting time when she was going through a miscarriage. It would have been concerning and unsettling for her to learn about the size of her fibroids in 2023, as whilst she knew of their presence, there’s no evidence to say she was aware of the size of them, or risks involved regarding pregnancy.
69. We have also found that Miss E was wrongly told that bleeding was normal during pregnancy, and that the Trust failed to appropriately arrange a follow-up appointment for her in timely manner for her to discuss her fibroids. Miss E was caused added distress and upset at what was already a difficult time by learning of the extent of her fibroids. This was compounded by the Trust misinforming her regarding her vaginal bleeding, and this led to a very poor experience for Miss E. This would no doubt have impacted upon Miss E’s trust in the services the Trust was able to provide.