Something went wrong with the biopsy and the aftercare
The biopsy
26. Mrs L says the Trust did not tell her straight after the procedure something had gone wrong with the biopsy and she had suffered a complication. She says the Trust was aware something had gone wrong but only gave her a small care leaflet with the advice not to remove the dressing for 48 hours.
27. The Trust acknowledged Mrs L developed a haematoma after the biopsy procedure. It stated in its second complaint response that this was a complication from the biopsy. It did not indicate in its complaint responses that anything went wrong in the biopsy.
28. The Trust’s records do not state anything went wrong during the procedure. There is also no document of a haematoma immediately after the biopsy, or that the Trust was aware of a haematoma or any complications straight after the biopsy.
29. Our consultant radiologist adviser explained, from their experience, there is always a small risk of excessive bleeding and developing a haematoma after a biopsy. A haematoma can happen after any sharp or blunt injury, including surgery and biopsies. They said it is much more likely than not the haematoma Mrs L developed was a recognised complication of the biopsy procedure rather than that something went wrong during the procedure.
30. We have considered Mrs L’s account as to why she thinks the Trust knew about the haematoma but did not tell her. She says she heard the clinician saying to their assistant ‘put good pressure on that’ after the biopsy, when they were putting the dressing on her breast. She is concerned this comment means they had cut into a vessel and caused bleeding.
31. Our senior lead clinician explained that after an invasive procedure, a clinician would advise to put pressure on the area. This is to try and prevent a haematoma or minimise the size of any haematoma, like what happens after a clinician does a blood test. But given what happened later, and that she did not see the area before the clinician applied the dressing, we can understand why Mrs L is concerned about what the clinician’s comment meant.
32. Mrs L’s haematoma was a result of the biopsy procedure. But we could only ask the Trust to take some action to put things right if we thought that happened because it got something wrong. When we weigh up the evidence, the strength of that evidence indicates the Trust did not do something wrong during the procedure, but that Mrs L developed a recognised complication from the procedure. The biopsy carried a risk of haematoma due to the invasive nature of the procedure, which caused a blunt injury. We do not think the clinician’s comment to put pressure on the biopsy area shows us the Trust knew she had a haematoma – it is more likely than not to have been to try to prevent one.
33. We have therefore not found any failings in how the Trust carried out the biopsy or that it did not tell her she had a haematoma at the time.
The aftercare
34. Mrs L says the Trust should have done an aspiration on 3 July 2020 but it did not and advised her to use Arnicare (a cream used in the symptomatic treatment of bruises). She says the Trust constantly dismissed her as the original lump it investigated was benign. She says it gave her no other advice than to wait for her haematoma to resolve and it still has not resolved.
35. We took advice from our consultant surgeon adviser. Our adviser confirmed they reviewed the following guidelines, which outline good practice, before advising on this complaint: • Association of Breast Surgery: Guidance platform, Breast Screening, March 2021 (a guidance platform of guidelines which were in place at the time of the events) • The Royal College of Radiologists: Quality Assurance Guidelines for Breast Cancer Screening Radiology, second edition, March 2011 • National Library of Medicine: Ultrasound-guided procedures to treat sport-related muscle injuries, January 2016 (includes detail around consent, aspiration procedures and haematomas) • The Royal College of Surgeons: Good Surgical Practice, September 2014 • Guidance on screening and symptomatic breast imaging, fourth edition, November 2019 • General Medical Council (GMC), Good Medical Practice, updated April 2019.
36. Our consultant surgeon adviser confirmed there are no specific guidelines for managing a haematoma from Public Health England, the National Institute for Health and Care Excellence, the Association of Breast Surgery and the Royal College of Radiology.
37. Guidance from the National Library of Medicine states: ‘the procedure (aspiration of a haematoma) cannot be performed until most of the haematoma has sufficiently liquefied; so, the ideal time is between one and two weeks after injury’.
38. Our consultant surgeon adviser explained that the blood clots in a two-day old haematoma would be solid/semisolid and not easy to aspirate. Because of this, on the balance of probabilities, an earlier aspiration, on 3 July 2020, would have been unsuccessful. Our consultant surgeon adviser explained after one to two weeks, the blood clots will liquefy, and it may be possible at that stage to aspirate the haematoma. They advised attempting aspiration two days after a biopsy will carry a higher risk of causing further trauma (even more haematoma).
39. The consultant surgeon adviser explained there is also no specific national guidance about how to manage haematomas if an aspiration is unsuccessful. In some cases, a small asymptomatic haematoma is best left alone. A large haematoma which is causing pain due to the pressure and/or causing pressure symptoms - for example skin necrosis or pressure on major nerves/blood vessels - may need drainage. They advised there is no clear cut off point and a clinician will make an individual decision for each patient. This is in line with the GMC’s ‘Good Medical Practice’ (paragraph 3): ‘You must use your judgement in applying the principles to the various situations you will face as a doctor’.
40. The Trust advised Mrs L to use a cream treatment (Arnicare) on 3 July 2020. It attempted its first aspiration on 10 July 2020, nine days after the biopsy. We can appreciate that Mrs L was extremely concerned about what had happened to her breast and wanted the Trust to take more prompt action. We appreciate why she would be concerned that it gave her a cream as a treatment, when she says the changes to her breast and the haematoma looked so alarming. When we weigh up the evidence, we can see the Trust acted in line with the relevant standards when it gave her a cream treatment and tried aspiration at a later date, when the haematoma was less solidified.
41. The Trust’s complaint response stated it was important for Mrs L to wait for the required six to eight weeks’ timeframe to enable the haematoma to resolve itself, before it saw her again in clinic. It said she could make an appointment with the clinic, if not resolved.
42. We have considered whether the Trust should have done anything further when Mrs L’s haematoma had not resolved. We can see there is no specific guidance which states the Trust should have done anything more. We understand from our consultant surgeon adviser that this is a decision based on clinical judgement and there are two schools of thought: to leave the haematoma alone to resolve itself or to aspirate the haematoma. Our consultant surgeon adviser said not all aspirations will be fully successful, and most haematomas should resolve over time.
43. It seems Mrs L has unfortunately experienced an unusual outcome – a haematoma which has not resolved itself. We can see in the records that the Trust considered the risks and benefits of further aspiration and waiting for the haematoma to resolve on a number of occasions. It discussed these options with Mrs L. She declined further aspiration on 15 September 2020. There is no clear cut pathway for a patient in Mrs L’s situation, and we can see the Trust acted appropriately when it attempted both of the accepted possibilities.
44. We understand that Mrs L has been left with a haematoma which has not resolved, and sadly this is not common. It is clear from her account how badly this has affected her. Again, we can only ask the Trust to take action if we this was because it did something wrong. When we weigh up the evidence, we cannot see the Trust has done anything wrong that stopped Mrs L’s haematoma resolving. We have not found any failings in how the Trust managed her haematoma.
Consenting process for the biopsy
45. Mrs L told us she consented to have the aspiration procedure on 1 July 2020 and straight after the procedure the nurse told her ‘now we are going to do a core biopsy’. She said it all happened very quickly and she did not know what the biopsy involved or what the possible complications could be. She says the Trust did not consent her verbally or in writing for the biopsy procedure, including an explanation of risks and complications.
46. Mrs L says the Trust should have asked her about any medication she was on which would have affected skin healing as she was on isotretinoin (a treatment for severe acne and some other skin conditions). She says when she went for private breast surgery her surgeon asked her to delay taking isotretinoin until four months after the surgery as it causes bruising and healing issues. She questions why the Trust did not ask her if she was on this medication before the biopsy if it can contribute to bruising and healing issues.
47. The Trust said in its complaint response whenever it carries out a biopsy it is departmental protocol to give a verbal explanation of the procedure, along with the warning that bruising, bleeding and infection could happen after the procedure. It said it is not standard practice to ask for written consent when in the middle of a procedure as it considers it is undignified for the patient to complete paperwork in a state of undress.
48. The Trust said its consultant radiographer was adamant she explained to Mrs L that the purpose of the biopsy was necessary to make sure the area was nothing more worrying, such as breast cancer. It also said it had no reason to doubt Mrs L’s account of events.
49. The Trust said that if a patient is on isotretinoin, this carries a slightly higher risk of associated bruising. It said the Trust does not routinely ask patients if they are on this medication prior to a biopsy, in accordance with the British Society of Breast Radiology best practice guidelines.
50. We looked to see if there was any supporting evidence in the records. There are no notes in the records to state the Trust consented Mrs L either verbally or in writing.
51. The Trust said it gave Mrs L a leaflet called ‘what happens at a breast clinic’. The Trust does not explain if it gave Mrs L this leaflet before or after the biopsy. Mrs L says she received it after the biopsy.
52. The GMC’s ‘Decision making and consent’ (paragraph 6) states: ‘Obtaining a patient’s consent needn’t always be a formal, time-consuming process. While some interventions require a patient’s signature on a form, for most healthcare decisions you can rely on a patient’s verbal consent, as long as you are satisfied they’ve had the opportunity to consider any relevant information and decided to go ahead’.
53. The GMC’s ‘Consent: patients and doctors making decisions together’ (paragraph 50) states: ‘if it is not possible to get written consent […] you must still give the patient the information they want or need to make a decision. You must record the fact they have given consent, in their medical records’.
54. Guidance from the Royal College of Radiologists also states the Trust should explain any procedure clearly to the patient, including its potential risks and benefits before undertaking the procedure. This need not be a formal or written process.
55. Our consultant radiologist adviser explained there is no guidance which states that a clinician must ask if a patient is on isotretinoin before performing a biopsy. The British Society of Breast Radiology guidelines state that radiologists should ask a patient if they are taking any anticoagulation or anti platelet medication (blood thinning tablets) before a biopsy. The guidance states that biopsies can still be performed on these patients with caution after the patient is warned of increased risk of bleeding, bruising and haematoma formation.
56. We have seen from the British Society of Breast Radiology guidance that it was not imperative for the Trust to ask Mrs L if she was on isotretinoin before the biopsy and that this would not form part of the standard consenting process. We have not found a failing on this point.
57. Looking at the consent process as a whole, when we weigh up all the evidence we have, the strength of the evidence suggests that Mrs L did not get the information she needed, and the Trust did not follow the GMC’s and British Society of Radiology’s guidelines. Mrs L gives a compelling account of how quickly the biopsy took place and how she did not know exactly what was happening at the time. She was also shocked to see the changes to her breast and the haematoma after she removed the dressing from her breast. This indicates she was not warned this could happen before the procedure.
58. The Trust also did not document the consent, in line with the guidelines. We have considered the radiologist’s account that she was sure she told Mrs L verbally the purpose of the procedure. We also considered this was an account in hindsight and there is no supporting evidence in the records. We acknowledge the radiologist’s account, but we have seen no evidence in the records or from the radiologists’ account that the Trust warned Mrs L of the risks of the biopsy before the procedure. We have therefore found failings in the consenting process before the biopsy as the Trust did not give Mrs L the information she needed to make an informed decision about whether to go ahead with the biopsy.
59. We have considered the impact this failing had on Mrs L.
60. Mrs L says she lost the opportunity to make an informed decision about having the biopsy, which was important for her as she had just had breast reduction surgery. She says if the Trust had explained the risk of haematoma to her, she would have delayed having the biopsy due to her breast size and the fact she had just had breast reduction surgery. She says she would not have had the biopsy at the Trust and would have waited to see her private surgeon, who did her original breast surgery. She says after the biopsy she got a letter from her private surgeon asking her to book in an appointment and she saw him three weeks after the biopsy. She says she would have waited to see her private surgeon to get his views. She says she was not concerned she had cancer at the time as she had recently had a mammogram.
61. She says she was shocked the biopsy led to a large lump and a distorted breast and nipple as the Trust did not prepare her for this. She says she went to the Trust to investigate a lump but it created a second and damaged the breast reduction work she had paid a lot of money for. She says her breast eventually returned back to normal, but the haematoma remained.
62. She says this haematoma has affected her sex life, personal life and her body image. It also causes her pain. She feels if the Trust had not dismissed her after the procedure, then she would not be left with a permanent lump as it could have done something about it.
63. Mrs L gives compelling reasons as to why she would have given it considered thought if the Trust had told her there was a risk of a haematoma from the biopsy. She was conscious of her recent surgery and that she was only receiving NHS care because the impact of COVID meant she could not see the private surgeon. We have to weigh that up against what Mrs L knew at the time, and not with hindsight.
64. At the time of the biopsy, the private hospital had told Mrs L that she could not have an appointment with the private surgeon due to COVID. So there was no prospect in the near future that she would be able to get her breast lump checked out privately. The appointment at the Trust was for the purpose of ruling out breast cancer. We appreciate Mrs L says she was not concerned about cancer. Her attendance at the Trust shows that she was keen to rule out any small concerns she may have had. We acknowledge that just two weeks later Mrs L got a letter from the private hospital offering her an appointment. We have to look at what Mrs L’s options were at the time of the biopsy. Mrs L had a concerning breast lump. She had the choice of an indefinite wait for an appointment at the private hospital, or agreeing to a second test to rule out a cancer diagnosis after the first she had just had.
65. We also have to weigh up what the Trust would and would not have told her. It would have explained the biopsy was to check if the lump was cancerous. It would not have told her she might develop a haematoma that would not resolve, as this is very uncommon. So she would not have known she could end up in the situation she unfortunately is now. She would have known the procedure was needed to rule out cancer and only that it carried a risk of her developing a haematoma that would likely resolve if it happened.
66. We would have to see clear evidence that being told about the risk of haematoma that would likely resolve would have persuaded her to wait longer for, or even decline an investigation to rule out cancer. It is worth noting the risk of haematoma is linked to the procedure, not who did it or where she had it. If she had waited to see her private consultant and they had done the investigation, she would have faced the same risk, just later.
67. Because of the seriousness of the purpose of the aspiration and biopsy, we cannot rule out that had the Trust warned her of the risk of haematoma, she may have still gone ahead with the biopsy to make sure the lump was not cancerous. When we weigh up the evidence, we cannot say on the balance of probabilities that Mrs L would have declined the biopsy at the time if the Trust had consented her as it should have done.
68. However, we do think the failings we found had an impact on Mrs L. Because she was not warned of the risks and complications, she suffered a lot of distress and shock when she saw the complications two days after the biopsy. She was not prepared for what she saw, which was extremely concerning for her. We can see it led her to question whether the Trust had done something wrong and not told her. Not knowing about the possibility before it happened has made a very difficult experience worse for her.
What the Trust has done to put things right
69. The Trust has not acknowledged the failings we found in its complaint response.
70. It states that Mrs L’s complaint has prompted learning but it does not outline what it has learned from the complaint. It states that it would discuss Mrs L’s concern about the consenting process at its departmental image quality meeting on 30 September 2020. It did not update Mrs L about this, and we do not know if it took any further action.
71. We can see it focused on the issue of the lack of written consent, rather than whether the consenting process as a whole was adequate in this complaint.
72. The Trust outlined in its response it will review procedural leaflets and assess whether they are clear about known complications. It did not update Mrs L about this, and we do not know what the outcome of the review was.