The vasectomy procedure and complications
16. We first looked at Mr R’s complaint about the procedure itself. Our adviser referred us to FSRH Standards for Vasectomy in Sexual and Reproductive Health Services and the patient information document published by BAUS. This sets out the risks of complications of vasectomy procedures. The BAUS information document says the risk of someone developing bleeding after a vasectomy happens in between one in ten and one in 50 patients.
17. Mr R attended the Trust for a discussion prior to his procedure on 24 January. He also signed a consent form. This included information about the risks of haematoma occurring and explained that other procedures may be necessary, including a further procedure on the scrotum if he developed bleeding or infection. Mr R had the procedure on 16 February.
18. We understand Mr R found the procedure painful, and how distressing this was. Our adviser explained the medical records do not suggest anything went wrong. Part of his concern stems from his worry about the amount of anaesthetic the doctor needed to use and how many injections were used. He said he was given four to five anaesthetic injections because of the pain he was in.
19. Our adviser said that guidelines do not specify a particular local anaesthetic agent to use or say what dosage to use. The package leaflet for mepivacaine (the anaesthetic used) says the amount is dependent on the weight of the patient. It provides a formula for drug administration. It says the amount of anaesthetic someone should receive is dependent on their weight. The maximum dose for an adult over 70kg is 10ml of three percent solution. It does not say what minimum dose should be used.
20. The medical records show the Trust used 6ml of mepivacaine during Mr R’s procedure. There is nothing mentioned about how may specific injections it gave him. During the complaints process, the Trust said the surgeon gives an injection to each side of the scrotum. Our adviser said a second injection is often required, but up to five is unusual.
21. We understand it must have been worrying for Mr R when the surgeon used more than one anaesthetic injection. We cannot say exactly how many injections he had. This means we cannot go onto reach a view of maladministration about this. We can, however, comment on the amount of anaesthetic he received. The medical records say Mr R weighed 98.4kg. The dosage of mepivacaine the Trust used during Mr R’s vasectomy was within the leaflet guidance.
22. Mr R attended the Trust for a post procedure appointment on 21 February. The medical records say he was in discomfort, and he had swelling of the scrotum. The nurse thought this was a haematoma.
23. Mr R was diagnosed with a post vasectomy scrotal haematoma and had a second procedure on 21 February. The medical records say there was no evidence of testicular injury.
24. Our adviser helped us to understand the swelling and pain Mr R experienced, was caused by post-operative bleeding from the procedure site. The Trust explained to Mr R that clotting is a natural response by the body to stem further blood flow.
25. We understand it was distressing and worrying for Mr R when he suffered bleeding and pain post procedure. It must have been upsetting when he found out he needed a second procedure. Unfortunately, there is a known risk of developing haematoma after the procedure, as set out in Mr R’s consent form. It is unfortunate this occurred, there is no indication this was because of anything going wrong during his vasectomy procedure.
The doctor’s telephone calls
26. We understand Mr R became worried and suspicious when the doctor who carried out his first procedure called him after he experienced the complications. Our adviser referred us to Good medical practice. This expects a duty of candour from doctors when complications occur after procedures. This is to ensure openness and transparency.
27. RCS guidelines also say doctors should ‘take full responsibility for patient management, leading the surgical team to provide best care. Responsibility should encompass preoperative optimisation and postoperative recovery’.
28. The Trust’s response explained the nurse practitioner who advised Mr R to attend hospital, had notified the doctor who carried out the procedure. It said the doctor then called him as they wanted to ensure appropriate after care was being provided to Mr R. The Trust apologised for any degree of suspicion this caused.
29. The Trust told us there is an expectation that clinical staff follow up with patients. As part of their induction, it tells medical staff, to follow up patients by telephone whenever vasectomy complications arise.
30. The doctor telephoned Mr R on 26 February to discuss the post vasectomy complication. Mr R said the pain and swelling was much better and there was no need for further calls.
31. We understand the telephone call raised suspicion to Mr R and we appreciate this made him feel something had gone wrong with the procedure. It is our view it was appropriate and in line with GMC and RCS guidance for the doctor to contact Mr R. There is no indication the doctor was wrong in taking this action.
Complaints process
32. The NHS Complaints Standards sets out a summary of expectations. This includes welcoming complaints in a positive way and giving fair and accountable responses. The Trust’s own complaints policy says it should investigate and respond to complaint within 35 days. Mr R felt the process was lengthy and impersonal and complains the Trust ignored and undermined parts of his complaint by lessening his experience.
33. Mr R emailed the Trust with his concerns on 26 February. The Trust arranged a telephone call with Mr R to discuss and understand his complaint on 1 March. It acknowledged his concerns in a letter dated 5 April, apologising for the delay in doing so. It explained it would send a written response by 10 May.
34. The Trust sent its complaint response letter on 3 May. Mr R raised further questions on 9 May, which the Trust acknowledged on 22 May. It explained it would consider this and respond by 3 July. It sent a second complaint response letter dated 10 June. The Trust signposted Mr R to the Ombudsman.
35. We can see there was a short delay in the Trust acknowledging Mr R’s complaint. We are pleased to see it apologised to him for this, and do not consider it needs to do anything else. The Trust then responded in line with its own complaints policy and sent its response letters before the deadline. We have not seen any other delays in the complaints process which suggest it was lengthily. It complied with its own internal complaints policy and the NHS Complaints Standards.
36. During our consideration of Mr R’s complaint, we have read the complaint file including the Trust’s emails and letters. The Trust noted all of Mr R’s concerns and although it did not find anything went wrong, it answered all his questions and acknowledged the impact caused. It noted how distressing the events had been for him. There is no evidence it ignored or undermined any of his concerns. We understand going through a complaints process can be stressful and adds to the distressing events that have occurred. It then complied with its own internal complaints policy and the NHS Complaints Standards and showed compassion towards Mr R.
37. We understand the stress and worry these concerns have caused Mr R. It must have been very painful for him and worrying having to attend for a second procedure. We are mindful of how important his complaint is to him and the difficult experience he has had. We hope our decision on what happened can bring some closure to his complaint about the Trust.