Communication
16. Mrs U says on 21 September a consultant breast surgeon gave her bad news about the outcome of her surgery insensitively. She says she was told by telephone, the tumour was bigger than previously reported and she would require further surgery as sufficient surgical margins had not been achieved. She says she was told this in a dismissive and uncaring manner and was not given the opportunity to ask questions.
17. The Trust advised it is routine practice to call patients with operative results, unless they specifically ask to have these face to face. It said a face to face appointment was arranged as soon as it became clear Mrs U was not happy with information being shared by telephone.
18. The Trust apologised to Mrs U for the upset and distress caused and the consultant said they were very sorry they had come across as dismissive and uncaring as this was never their intention.
19. The Trust considered Mrs U’s comments about providing face to face appointments. It said there were challenges in balancing best practice with the constraints of meeting service delivery times. It said adding more face to face appointments would reduce the ability of the team to meet the demands on the service and waiting times for treatment and surgery would increase. The Trust felt this was a less acceptable risk to take.
20. The records show the consultant called Mrs U on 21 September to advise she would need further surgery. The notes state Mrs U was unhappy and so she was offered a face to face appointment to discuss the matter. The face to face appointment took place on 26 September.
21. The General Medical Council’s Good Medical Practice states, ‘you must communicate sensitively and considerately, particularly when you are sharing potentially distressing issues about the patient’s prognosis and care’.
22. There is no national requirement for Trusts to routinely provide face to face appointments to share information. We have seen no indication of failings and will take no further action on this part of Mrs U’s complaint.
23. In the Trust’s final response, the consultant breast surgeon personally apologised for coming across as uncaring. This is in line with our complaints standards, which say ‘staff should give meaningful and sincere apologies’. We consider this apology remedies Mrs U’s concern about the surgeon’s manner. This is because we consider this issue to be level one on our severity of injustice scale. Level one will usually see injustices such as annoyance or frustration where we would generally consider an apology to be an appropriate remedy.
24. In no way do we wish to minimise the impact this matter had on Mrs U. We recognise Mrs U’s distress and understand receiving this news would have been very upsetting and frightening.
Change of diagnosis
25. Mrs U says on 29 September 2023 her breast surgeon called her into an urgent consultation to be told her diagnosis had changed from ductal breast cancer to lobular breast cancer. Mrs U says it was only because she had questioned the breast surgeon on 26 September, this change in diagnosis was realised.
26. We reviewed this issue with help from our oncologist adviser, using Mrs U’s medical records to understand if the Trust correctly followed relevant guidelines to diagnose breast cancer.
27. Our oncologist adviser told us there are many different sub-types of breast cancer. The most common is ductal, also known as no specific type. Lobular breast cancer is the second most common sub-type. These are differentiated by visual appearance and immunohistochemistry.
28. Immunohistochemistry testing looks at whether the cancer has ER (oestrogen) or PR (progesterone) receptors and so is fed by these two hormones, and whether it expresses an excess of Her2 (human epidermal growth factor receptor 2) which stimulates its growth.
29. The biopsy is a small sample of the cancer and is used to decide if surgery, or upfront chemotherapy, will be offered as a first treatment. Because this is a small sample, when the entirety of the cancer is removed by surgery, the whole sample is re-evaluated, and this can lead to a change in sub-type.
30. Section 1 of the NICE guidance for diagnosis of breast cancer states:
31. 1.1.1 for people having investigations for early and locally advanced invasive breast cancer perform pretreatment ultrasound evaluation of the axilla (armpit) and if abnormal lymph nodes are identified perform ultrasound-guided needle sampling.
32. 1.1.2 do not routinely use MRI of the breast as part of the preoperative assessment of people with biopsy-proven invasive breast cancer or ductal carcinoma in situ (DCIS).
33. 1.1.3 offer MRI of the breast as part of preoperative assessment to people with invasive breast cancer:
• if the extent of disease is not clear from clinical examination, mammography and ultrasound assessment for treatment planning • if accurate mammographic assessment is difficult because of breast density • to assess the tumour size if breast-conserving surgery is being considered for invasive lobular cancer
34. Section 1.3.2 of the NICE guidance states ‘consider further surgery (re-excision or mastectomy, as appropriate) after breast-conserving surgery for invasive cancer with or without DCIS if tumour cells are present within 1mm of, but not at, the radial margins.
35. Section 1.6.1 says assess the oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) status of all invasive breast cancers simultaneously at the time of the initial histopathological diagnosis.
36. Section 1.6.5 says ensure the ER, PR and HER2 statuses are available and recorded at the preoperative and postoperative multidisciplinary team meetings when systemic treatment is discussed.
37. On 14 August 2023 the Trust carried out a core biopsy and reported grade 2 invasive ductal carcinoma in the right breast. The Trust tested and recorded the ER and PR statuses on 14 August and the HER2 status was recorded on 22 August. This is in accordance with the above guidance.
38. The breast team held MDT meetings on 17 and 24 August in which the plan for Mrs U’s treatment was discussed. The breast team scheduled a wide local excision also known as a lumpectomy for 6 September. These actions are in line with the above guidance.
39. A lumpectomy involves the removal of the tumour along with a margin of healthy tissue to ensure no cancer cells are left behind. Re-excision surgery is sometimes necessary if the pathologist finds the cancer is close to or involving the margins of the breast tissue that was removed. Re-excision surgery is to remove some further tissue to try and achieve clear margins.
40. On 6 September 2023 the Trust carried out a guided ultrasound evaluation of the armpit and a lumpectomy. A pathologist reported on the lumpectomy on 20 September. The report stated the cancer was predominantly of lobular appearance but with some duct formation. Calcification associated with invasive carcinoma was reported.
41. Our oncologist adviser noted there was no calcification seen in the core biopsy, but there was in the lumpectomy, which would suggest the core biopsy was not representative of the whole cancer. They told us this would be in line with the change in cancer type from ductal to lobular.
42. Our oncologist adviser explained, the core biopsy is a small sample of the cancer and is used to decide if surgery, or chemotherapy, will be offered as a first treatment. Because this is a small sample, when the entirety of the cancer is removed by lumpectomy, the whole sample is re-evaluated, and this can lead to a change in sub-type. A biopsy may be from an area of the cancer that looks ductal rather than lobular. However, when the whole cancer is removed and can be examined under the microscope then it may be seen that it is in fact lobular. This is something that can and does happen during the investigative process and is not uncommon.
43. On 21 September, the breast team discussed Mrs U’s case in an MDT meeting and decided she needed re-excision surgery as the margins were not clear. This is in line with the above guidance.
44. A letter was sent to Mrs U’s GP that day, stating a consultant breast surgeon had called Mrs U to explain the findings of the lumpectomy and the need for re-excision surgery. The letter states the cancer is lobular.
45. On 26 September Mrs U had a face to face meeting with a breast surgeon and discussed the need for re-excision surgery. This is the appointment at which Mrs U says her many questions prompted the breast surgeon to realise the cancer was lobular.
46. On 28 September the breast team discussed Mrs U’s case in an MDT meeting. The breast team agreed Mrs U would need an MRI scan to review breast density and ensure the full information was available prior to the re-excision surgery.
47. On 3 October the Trust spoke to Mrs U to explain it was felt an MRI was needed prior to re-excision surgery and so the re-excision surgery planned for 4 October, was cancelled and re-arranged after the MRI scan had taken place.
48. We saw no indication the change in diagnosis was only realised because of Mrs U’s questioning on 26 September. Lobular cancer was reported on 20 September and discussed in the breast multidisciplinary team meeting on 21 September, therefore diagnosis of lobular cancer was made prior to Mrs U’s outpatient appointment of 26 September.
49. We have seen the change in diagnosis from ductal to lobular cancer, from the biopsy to reporting of the lumpectomy sample, was not due to any failure in the investigative process. We saw the Trust followed NICE guidance for the reporting of the biopsy and lumpectomy.
50. We appreciate how distressing it was for Mrs U to receive news she had breast cancer and how her anxiety around the diagnosis was exacerbated when learning the diagnosis had changed. We hope this report will provide some reassurance to Mrs U she was assessed and diagnosed in accordance with the relevant guidance.
Treatment plan and consent form
51. Mrs U says on 27 November 2023 an oncologist told her she would require partial breast radiotherapy. She says on 7 December another member of the clinical team contacted her by telephone to inform her she should receive full breast radiotherapy instead.
52. She says the clinician told her she would have to reconfirm the consent form she had previously signed, which the clinician had already altered and initialled. Mrs U says she did not think it was appropriate to alter the consent form prior to discussing the new treatment plan with her.
53. We reviewed this issue with the help of our oncologist adviser and Mrs U’s medical records.
54. The records show the requirement for whole breast radiotherapy rather than partial breast radiotherapy was picked up by radiology during the checking process. This was realised and corrected before any treatment was commenced. This is the purpose of the checks undertaken.
55. We recognise the change of treatment plan added to Mrs U’s distress and anxiety. We are reassured to know she did not receive any incorrect treatment and there was no lasting physical impact as a result of this matter.
56. NHS advice for consent to treatment says a person must give permission before they receive any type of medical treatment, test or examination. This must be done on the basis of an explanation by a clinician. There is no policy which states the patient needs to be present when the consent form is filled in or amended.
57. A consultant radiographer gave an explanation to Mrs U over the telephone, and she was invited to countersign the amended consent form in person following this call. We consider the Trust acted in accordance with NHS guidance for gaining consent to treatment by informing Mrs U by telephone about the change to her treatment plan.
MRI surveillance
58. Mrs U says she is extremely concerned about plans for future monitoring using mammograms rather than MRI scans. She says the Trust has acknowledged the presence of occult tumours and she has dense breast tissue meaning she fits the criteria for MRI surveillance. She told us she is at lifelong risk of the cancer returning and the only way to relieve her stress would be to offer MRI surveillance.
59. We reviewed this issue with help from our oncologist adviser, using Mrs U’s medical records.
60. NICE Guidance for follow up says ‘offer annual mammography for 5 years to all people who have had or are being treated for breast cancer. For women, continue annual mammography past 5 years until they enter the NHS Breast Screening Programme in England. Do not routinely use ultrasound or MRI for post-treatment surveillance in people who have had treatment for invasive breast cancer.’
61. Our oncologist adviser told us no screening tool is 100% sensitive and specific. After treatment for breast cancer, the annual mammograms for 5 years are offered to pick up any early recurrence in the breast that has had cancer, and, because there is a slightly higher risk of developing a new breast cancer, to check the opposite breast. Mammograms pick up calcification, or a mass that is big enough to distort tissue.
62. Mrs U had a breast cancer that was visible on mammogram, from MRI we know this was solitary not multifocal, and in one breast only. There is nothing in the medical records to suggest Mrs U had an occult breast cancer. An occult breast cancer is one that is not visible on imaging. Mrs U’s breast cancer was visible on all modes of screening.
63. Guidance from The Royal College of Radiologists states ‘patients who are diagnosed with early breast cancer and are already of breast screening age should be offered yearly mammograms for 5 years. MRI is not currently recommended for routine surveillance but can be useful for problem solving. Surveillance ultrasound may be used when the primary tumour was occult (not visible) on mammogram’.
64. Although one of the criteria for using MRI in assessing a cancer diagnosed on mammogram is in women with dense breasts, this was not the reason Mrs U was offered a post-operative MRI scan. The reason was that lobular cancers are more likely than ductal cancers to be multifocal or bilateral. The purpose was to assess that at the time of diagnosis.
65. We asked our oncologist adviser if there was anything in the records to show Mrs U had dense breasts. They told us the MRI states both breasts are fatty and glandular, with minimal glandular enhancement. It does not state the breasts are dense. The tumour was seen on the mammogram, so the breast tissue was not dense enough to prevent that. We can therefore see nothing in the notes to suggest Mrs U having a need for surveillance MRI scans due to exceptionally dense breast tissue.
66. We consider the Trust’s decision to not offer MRI surveillance is in accordance with the above guidance.
Complaint handling
67. Mrs U told us she had to request the complaints policy three times before the Trust sent it to her. She says when she received the policy, it was incomplete. Mrs U said the Trust just sent an overview, and it was only after she insisted, it then sent the full policy. Mrs U says it was wholly unacceptable and added to her feelings of frustration. She says the Trust should have supported her and not added to her stress.
68. On 27 March 2024, Mrs U emailed the Trust to say she was not happy with the Trust’s complaint response and enquired what her next steps were. She wrote, ‘please can you provide me with details of the next stage of your complaints procedure and what I need to do in order for my complaint to proceed to it.’
69. The Trust responded to say Mrs U could send her further concerns in and the clinical team would consider them. The Trust asked Mrs U if she would like a meeting to discuss her concerns or a written response.
70. Mrs U responded and said she did not believe review by the clinical team would help as she thought they would just defend their position. Mrs U said she believed there should be a step in the complaints procedure which would provide an independent review.
71. Mrs U asked to be provided with full details of the complaints procedure. The Trust responded telling Mrs U about the next steps in the complaints procedure.
72. On 28 March, Mrs U responded saying she wanted a written copy of the full complaints policy and procedures, saying she had already asked twice in her previous emails. The Trust responded with a copy of the concerns and complaints policy.
73. Mrs U responded to say the document was not very accessible and she could not see where it refers to disputed complaint responses and additional concerns. On 2 April, the Trust responded to Mrs U advising section 12 covers local resolution and offered a face to face meeting or written response to her further concerns.
74. Mrs U responded to say the policy was confusing. Mrs U said in the absence of any information in the policy, could she be provided with a clear expectation of how long she would have to wait for a further response.
75. On 4 April, the Trust responded to say a further response could take 40 working days however this could depend on the specific points raised. The Trust said once the service group had sight of the concerns they would be able to advise on a timeframe.
76. On 5 April, Mrs U sent her further concerns to the Trust. On 7 April, the Trust responded to Mrs U to advise the service group had reviewed her further concerns and had nothing more to add. The Trust confirmed local resolution was complete.
77. Mrs U told us she asked the Trust to send the complaints policy on three occasions. She says the Trust only sent an overview and it was only when she insisted on seeing a policy did the Trust send it.
78. We saw on 27 March, Mrs U was in an email conversation with the Trust asking about the next steps in the complaints procedure as she did not agree with the final response sent on 13 March. The Trust responded to Mrs U with an overview of the next steps.
79. Mrs U did not specifically ask to see the complaints policy until 28 March. After requesting to see the policy, the Trust sent the complaints policy straight away by return email. Mrs U responded to the Trust saying the policy was confusing and did not refer to disputed complaint responses. On 2 April the Trust responded to Mrs U to advise section 12 covered local resolution.
80. We consider the Trust responded appropriately to Mrs U’s request for further information about the complaints procedure, acting in accordance with the Ombudsman’s Principles for Good Administration which says organisations should deal with people helpfully, promptly and sensitively.
81. We recognise from the conversation we had with Mrs U this has been a very difficult time for her. We have not identified anything went wrong in the care and treatment provided by the Trust and therefore we are taking no further action on this complaint. We hope our decision provides some reassurance to Mrs U about the care and treatment she received.