Miss N did not provide informed consent for a different consultant to perform her surgery
17. Miss N says she did not provide informed consent for a different consultant to perform her surgery in November 2023. She gave consent for Consultant A to perform the surgery but following the surgery she found out two consultants in Consultant A’s team did it.
18. The Trust said when Miss N consented for the procedure, she was consenting to have the procedure under Consultant A’s team but not necessarily performed by Consultant A. The consent form record states ‘I [Miss N] understand that you cannot give me a guarantee that a particular person will perform the procedure’. The Trust has also apologised if it did not make it clear to Miss N who was present for the surgery.
19. We understand how frustrating and upsetting this situation was for Miss N, especially given the importance of accurate communication around surgery.
20. As only Miss N and the consultant were present at the time, and there is no independent record of the conversation around consent, we do not have sufficient evidence to help us determine exactly what was said. As we do not consider we can reach a robust conclusion on what happened, we cannot reach a view on whether the Trust got things wrong. For this reason, we have decided not to consider this matter further.
The urology consultant deployed the SNM despite records stating it was not in the right place or giving the right response
21. Miss N says the consultant deployed the SNM implantation during her surgery even though records show it was not in the right place or giving the right response. She says the surgery was described to her as difficult and not going to plan by a nurse following her surgery.
22. In its response, the Trust says the procedure did go to plan as it delivered a trial of sacral neuromodulation. It explains that when both the foot and the muscles around the anus contract it means the lead is in a good position.
23. We asked our adviser what should have happened. Our adviser explained the procedure was to remove the old implantable device and electrode from the right side and insert a new test electrode on the left. As it was a test, the consultant needed to ensure the best positioning and response before implantation of a new permanent device.
24. Our adviser explained the records describe the placement of the test electrode whilst continually reviewing response to stimulation as its position was adjusted intraoperatively. Initially staff found no response and then found better responses, so they decided to leave the electrode in that position. Our adviser says this decision was made in accordance with the Manufacturer’s Guidance.
25. We can see from the record the device was moved around in order to find a good response. Once the consultant was happy with the response, they made the decision to leave the electrode in that position. This shows the surgery was carried out in line with the Manufacturer’s Guidance explained above, and there were reasons to support the consultant placing the device where they did.
26. As we feel the consultant carried out the surgery in line with the above guidance, we have seen no evidence something went wrong. For this reason, we have decided not to consider this matter further.
27. We appreciate Miss N’s view of the surgery is very different to our findings. We are sorry for any further distress this may cause Miss N.
The consultant left three incision sites on Miss N’s left side from the procedure
28. Miss N explains following the surgery in November 2023 she was left with three incision sites on her left side. She says the Trust has never addressed this when she complained. We are sorry to hear Miss N felt the surgery left her with more incision sites than were necessary.
29. Miss N’s complaint to the Trust in December 2023 states she wished to know why she had more incision sites than her medical records stated. In an email to the Trust in January 2024 she asks specifically why there were three incision sites on her left side.
30. The Trust has responded to this explaining the surgical team used the standard number of incisions required for the SNM procedure. This included both removal of the old SNM device on the right side and the new trial on the left side.
31. We asked our adviser what the records show. Our adviser said the records show three incisions are documented. The first was to remove the old SNM device, the second to remove the old electrode and the third to place the new electrode on the opposite side. Our adviser confirms all three incisions would have been needed to fit the new SNM in line with the Manufacturer’s Guidance.
32. There is a difference between Miss N stating there are three incision sites on her left side and the Trust and records stating there were three incision sites in total on both the left and right side. We carefully weighed up these accounts to reach a view on the balance of probabilities on what happened. As the medical records were written at the time of these events and are detailed, we consider them a very strong source of evidence. This is in line with Good Medical Practice, which states records should be clear, accurate and contemporaneous. The Trust’s response is also in line with this guidance.
33. With this in mind, on the balance of probabilities, we consider it more likely there were three incision sites in total. We did consider if Miss N would have photographic evidence of the incision sites to send us however, she has had further surgery in this region to remove the test SNM. We would therefore not be able to definitively say which incision marks related to the surgery from November 2023.
34. This means, having weighed the available evidence, we conclude staff made three incisions during Miss N’s surgery. As this is in line with what our adviser would expect to see, and the Manufacturer’s Guidance, we saw no evidence of a failing on this issue.
35. We recognise this may be a difficult and disappointing decision for Miss N to reconcile. We hope we have clearly explained how we reached our decision, and it gives Miss N assurance we only did so after carefully considering the evidence.
Trust staff inappropriately discussed the complaint with Miss N ahead of her second surgery
36. Miss N says Trust staff discussed her complaint with her on the morning of her surgery in January 2024. She says she felt as though she had been ‘bombarded’ and it made her extremely anxious and intimidated. Miss N says she received an email on 11 January 2024 asking that following her discussion with the consultant was she happy to close her complaint. Miss N says this proves the intent of that discussion was premeditated to encourage her to drop her complaint.
37. The Trust’s email from 11 January 2024 asks Miss N if she was happy with the complaint responses from the consultant or if she would like the answers written down in a formal response.
38. We understand Miss N’s description of this event made her feel anxious and we do not wish to take this away. We appreciate speaking about her complaint on the day of her surgery was distressing.
39. As we were not present at the time, and we see no further available evidence beyond what we described in paragraph 36 and 37, it is not possible for us to reach a view on how the conversation took place. We are not able to comment on the details of the conversation or the tone. We cannot say it was done to intimidate Miss N nor could we say it was done in a supportive way.
40. As we cannot reconcile these conflicting factors, we cannot reach a view on what happened in respect to how staff spoke to Miss N and whether staff got things wrong. We will therefore not be taking this part of the complaint further.
The Trust failed to address points within Miss N’s complaint and do so in a timely manner
41. Miss N complained to the Trust on 11 December 2023. She says the Trust took too long to respond to her complaint and did not address all of the points she raised. Miss N feels this was another attempt to make her withdraw her complaint.
42. The NHS Complaint Standards state an effective complaint system makes sure people get a fair and open answer to their questions based on the facts. It also states a good response letter should set out the issues, explain how the organisation has looked into the complaint, present the evidence it considered and explain the outcome.
43. Miss N’s complaint to the Trust raises seven questions she wanted it to respond to. Its response on 18 April 2024 set out each of these points separately with a response below. In its responses, the Trust referred to information it gathered from sources like Miss N’s care records, the staff involved in her care and the information she gave in her complaint. From this we are satisfied the Trust’s response is in line with the above guidance and addressed the points she made.
44. We are sorry the Trust’s answers do not meet Miss N’s desired outcomes and appreciate she may find our findings disappointing.
45. The Trust attempted to discuss Miss N’s complaint with her in January 2024 in person. Miss N was not satisfied with the outcome and raised further points in an email on 19 January. On 18 April 2024, the Trust responded to Miss N’s complaint. It states it responds to the complaint made on 11 December 2023 and also the additional points raised on 19 January 2024.
46. In email correspondences between the Trust and Miss N, the Trust apologises for its delay in providing a response. It explains the delay is due to staff involved in the complaint taking annual leave.
47. We appreciate Miss N chased the Trust on numerous occasions in April to find out when she would receive its response to her complaint. The Complaint Regulations say the relevant period for responding to a complaint is six months. The regulations also state organisations should notify the complainant and provide reasons why there are delays.
48. We understand Miss N’s frustration it took five months to receive the Trust’s response and appreciate the time taken could have caused further distress. The Trust responded within six months to Miss N and where there were delays, it apologised and provided reasons. We have therefore not found indications the Trust has done anything wrong and will not be taking this part of the complaint further.
49. We understand our decision is unlikely to align with Miss N’s view, and it is likely to be disappointing for her. We do hope this statement explains our decision and the careful work we have done to look into her complaint.