Insertion of a magseed and consent
16. Mrs O says had she known a trainee was to perform the procedure, she would not have consented to it. She says surgeons were unable to find the tumour or remove it during surgery due to the incorrect insertion of the magseed.
17. A senior trainee in radiology performed the procedure to insert the magseed under supervision of a consultant radiologist. The records note the procedure was uneventful with satisfactory placement of the magseed in terms of its location.
18. We reviewed Mrs O’s mammogram taken on 16 February to see if the location of the magseed can be seen. Our radiology adviser said the mammogram shows the magseed was placed correctly within the tumour by the trainee radiologist.
19. Unfortunately, at some point after insertion, the magseed migrated away from where the doctor had placed it to the back of the breast.
20. The magseed study from 2022 on the efficacy and accuracy of using magseeds report it is uncommon, but not impossible, for a magseed to migrate from where it is placed.
21. Although is it an uncommon occurrence for a magseed to migrate, in Mrs O’s case this appears to be what happened. We have seen no evidence to suggest the Trust placed the magseed incorrectly. We know this led to her to experience some complications with further breast surgery to help locate the tumour and we recognise the distress this caused her.
22. GMC guidelines on consent say;
‘a patient should have all of the information of the procedure, all of the options and be able to weigh them up in sound mind to come to their own decision.
Consent should be appropriately recorded in the medical notes with record of what was discussed and by whom.
Written consent is not necessarily required and is not always “better” than verbal consent – the key points are of the transfer of clear information about the procedure and understanding of the patient’.
23. Consent for the procedure was gained verbally as documented by the Trust and in line with Mrs O’s account of the events. Our surgeon adviser says verbal consent is common practice in radiology for simple interventional procedures like this.
24. The only documentation relating to the procedure from the Trust is a report written after a procedure. The notes document the names of the staff who performed the procedure but do not specify whether consent had been taken, in what manner and what had been discussed.
25. Recording verbal consent details on a Radiology Information System report is usual practice. There is no retrospective way to prove consent was even gained at the time of procedure and by whom.
26. Nor is it possible to know what was discussed at the time of verbal consent. We therefore cannot say if the trainee doctor properly introduced themselves including their role and seniority. If a patient is not aware a procedure is to be carried out by a trainee and is not given an option to refuse this and they do not understand their options, this is not valid consent and is outside of guidance from the GMC.
27. In its response to Mrs O’s complaint, the Trust said it is common for junior doctors to undertake procedures, either independently or under supervision, depending on the case and the doctor’s level of experience. It says the junior doctor carried out the procedure under the supervision of the radiology consultant lead.
28. The Trust apologised to Mrs O if the doctor’s level was not made clear and acknowledged it should have been. It says it discussed Mrs O’s concerns with the junior doctor, and they will reflect on any actions they can improve going forwards including the importance of ensuring clarity of job roles when introducing themselves to patients. The Trust has apologised to Mrs O for this not being specifically discussed before the procedure.
29. We consider most of the distress Mrs O has experienced is due to the complication arising from the magseed placement. As we have already explained, we saw no indications anything was wrong with that. We consider the Trust’s apology and actions going forwards are enough to prevent a recurrence of any communication errors and remedy the additional distress they caused Mrs O.
Antibiotics
30. Mrs O says the Trust gave her the wrong antibiotics when she developed an infection after surgery.
31. The consent form Mrs O signed included the possibility of infection, seroma, scarring, missed cancer and further surgery, all of which unfortunately happened in this case.
32. Guidance from NICE on the choice of antibacterial therapy says:
‘First choice antibacterials
• Oral or Intravenous first line: • Flucloxacillin • Alternative in penicillin allergy or flucloxacillin unsuitable: clarithromycin, oral erythromycin (in pregnancy), or oral doxycycline’.
33. The Trust gave Mrs O a prescription for clarithromycin as the initial treatment for the infected seroma. Flucloxacillin is normally used as a first choice.
34. However, Mrs O is allergic to penicillin-class antibiotics and flucloxacillin is a penicillinclass antibiotic. Clarithromycin is a reasonable alternative as noted in guidance from NICE. The use of antibiotics was in line with guidance from NICE.
35. Mrs O experienced a number of rare and unfortunate complications following surgery. We have seen no indication the Trust managed her treatment inappropriately.
36. We recognise the frustration Mrs O experienced in the clinical care and treatment she received following a diagnosis of breast cancer. We acknowledge the distress this caused her and her family. We are grateful to Mrs O for bringing her concerns to our attention.