Procedure was rushed
21. Mrs I says her experience left her feeling that the procedure was rushed. She explains that on the day of the appointment the gynaecologist was running late. She says she started to undress in preparation for the procedure in one room, before the gynaecologist asked her to return to the waiting room. After a short wait, the procedure was then undertaken in another room.
22. Mrs I thinks the rushed nature of the procedure may have contributed to the lack of information she received and the pain she experienced.
23. The hospital has also told us that the gynaecologist did initially think they may be unable to perform the procedure on that day due to clinic demands and the lack of an available treatment room. It has also told us that Mrs I expressed a preference to have the procedure on that day.
24. The hospital says the gynaecologist then established that a treatment room was available at 10am, and they were also free at that time. As such the treatment took place on the day. The gynaecologist says they followed their routine clinical practice when treating Mrs I.
25. We reviewed the records relevant to this part of the complaint. We saw that the ‘sign-in’ section of the safety checklist was completed at 10.20am. The treatment record and final safety checks were completed at 10.50am.
26. The records show that the procedure, safety checks, and pre and post procedure counselling took around 30 minutes. This is longer than the time stated in NHS information on IUS fittings, which states that ‘the appointment takes about 15 – 20 minutes’.
27. We acknowledge the delay in the appointment starting, and the need to transfer between treatment rooms, made Mrs I concerned that the procedure may have been rushed. We have not seen that this was the case.
Informed consent, local anaesthetic use, pain, and blood loss
Pre-procedure Discussion
28. Mrs I says there was only a brief discussion prior to the procedure, during which the gynaecologist said ‘I hope you don’t have a low pain threshold’. Mrs I says she told the gynaecologist that she does have a low pain threshold and that is why she was having the procedure done at the hospital, so she could have local anaesthetic.
29. Mrs I says the gynecologist did not inform her that the procedure could cause the level of pain she experienced. She says that by leaving out this information, the gynecologist did not gain her informed consent.
30. The hospital says that it informed Mrs I that the procedure could be uncomfortable, and that she gave verbal consent.
31. We have taken clinical advice on this part of the complaint. Our adviser told us that the article IUCD and IUS – Management, contains the UK standards for this procedure. As part of our consideration of this complaint, we shared our clinical advice with the hospital. It is aware we are using these standards in this case.
32. Our adviser explained the amount of pain caused by this procedure varies significantly between patients and cannot be predicted. Pain can be absent or mild but on occasion may be severe. They said that this should be discussed with the patient prior to the procedure.
33. GMC Guidance on consent states: ‘The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment’.
34. The article IUCD and IUS – Management says: ‘before the device is fitted, patients should be offered advice on the following: The insertion procedure may be uncomfortable; oral analgesia prior to insertion may be helpful’.
35. It goes on to say, ‘Documentation should be made in the case notes of pre- and post-insertion counselling’.
36. We have reviewed the medical records relevant to this part of the complaint. The pre-procedure checklist records that Mrs I gave her verbal consent for the insertion. There is no record of any pre-procedure counselling relating to pain.
37. We have considered that whilst the hospital has told us that it informed Mrs I the procedure could be uncomfortable, it has not given any further detail of the content of this conversation. The gynaecologist has also acknowledged that they should have counselled Mrs I in more detail about her expectation of pain and offered her oral analgesia.
Pain and blood loss during the procedure
38. Mrs I says she experienced extreme pain during the procedure. She says she screamed out and then swore before the gynaecologist asked her to be quiet. She then says she closed her eyes and remained quiet for the rest of the procedure despite the pain.
39. Mrs I says she continued to experience pain for several days following the procedure, although this pain was not as severe as during the procedure itself.
40. She also says that during, and immediately after, the procedure she lost blood and that the gynaecologist stemmed the bleeding using silver nitrate. She describes the bed as being covered in blood following the procedure.
41. The hospital explained that the gynaecologist applied 11mls of Instillagel (local anaesthetic) to Mrs I’s cervix prior to starting the procedure. It also says that to insert the IUS, the cervix has to be held with a sharp instrument, which can sometimes cause bleeding.
42. The gynaecologist says that they do not recall it being a difficult procedure and that they would stop if a patient could not tolerate it. We do not doubt this to be the case. Nor do we doubt Mrs I’s account of the pain she experienced or judge how she reacted to it.
43. We have reviewed the medical records relevant to this part of the complaint. The records show that local anaesthetic gel was used during the procedure as described by the hospital. The safety checklist, which was completed by the nurse after the procedure, does not record any adverse or unexpected incidents.
44. Due to the pain she experienced during the procedure, Mrs I visited her GP two days later. The GP referred her for an ultrasound scan, which she had one week after her visit to the GP. The scan showed that the IUS was correctly sited.
45. The article IUS and IUCD - Management contains the following information says:
· ‘The need for pain relief during insertion should be discussed with the patient’ · ‘Non-steroidal anti-inflammatory analgesia can be taken one hour previously: there is no evidence of significant reduction in pain associated with insertion, although it may help post-insertion discomfort’ · ‘Many operators use local anaesthetic gel on the cervix. There is evidence that this reduces pain associated with tenaculum placement’ (A tenaculum is a surgical instrument, usually classified as a type of forceps. It consists of a slender sharp-pointed hook attached to a handle and is used mainly in surgery for seizing and holding parts, such as blood vessels) · ‘Some operators offer cervical anaesthesia for the procedure’ · ‘Insertion may be offered under general anaesthesia to patients who cannot tolerate the procedure.’
46. We asked our adviser about this part of the complaint. They told us the use of local anaesthetic gel in advance of the IUS insertion is known to reduce some of the discomfort, particularly that of the instrument (tenaculum) applied to the cervix during the insertion procedure.
47. They explained there is no requirement for injectable local anaesthetic to be used during the procedure, but its use should be discussed, particularly if there is a history of failed insertion which has been limited by pain.
48. We have considered that the referral from Mrs I’s GP did not mention that the previous insertion attempt had been limited by pain. This information should have been established during the pre-procedure discussion.
49. Our adviser explained that even with the use of injectable local anaesthetic, the pain of insertion is often not abolished. This is because much of the discomfort arises from the upper part of the cervical canal, which cannot be easily numbed by injectable local anaesthesia. This should be made clear as part of the pre-procedure discussion.
50. We also asked our adviser if the amount bleeding described by Mrs I could be considered ‘normal’ for this type of procedure. The adviser told us that, from the gynaecologist’s account, the bleeding came from contact of the tenaculum with the cervix. They explained that this is not unusual, and the gynaecologist dealt with this correctly using silver nitrate sticks to stem the bleeding.
51. It is clear Mrs I was very distressed by the pain and bleeding that she experienced. Having been referred to the hospital by her GP she expected that the procedure would be pain free, or close to pain free, due to the use of local anaesthetic.
52. We have not seen that anything went wrong during the procedure that caused this. We are satisfied that the gynaecologist used local anaesthetic gel during the procedure and that its use was in line with the relevant guidelines. There are no adverse or unexpected events recorded. The cause of the bleeding experienced by Mrs I is known and is not unusual for this type of procedure. Also, an ultrasound confirmed the IUS was correctly sited.
53. However, there were further options available which could have reduced the pain that Mrs I experienced. These included establishing if she had taken oral analgesics prior to her appointment, discussing and considering the use of injectable local anaesthetic, or doing the procedure under general anaesthetic. These options should have been discussed and that discussion recorded.
54. As part of this discussion, Mrs I should also have been informed that, except for general anaesthetic, none of the pain relief options would guarantee the procedure would be pain free.
Summary
55. We have not seen that anything went wrong regarding the procedure itself.
56. We acknowledge that the hospital informed Mrs I that the procedure could be painful, both the gynaecologist and Mrs I have told us this happened. We are unable to establish how in depth this conversation became and note the gynaecologist has acknowledged she could have counselled Mrs I further in this regard.
57. We also think that the gynaecologist’s use of anaesthetic gel shows they did take action to reduce the likelihood that Mrs I would experience pain during the procedure.
58. However, there is no evidence to show that there was a discussion about Mrs I’s expectation and previous experience of pain, or that the anaesthetic used would not guarantee the procedure would be pain free. There is also no evidence to show that alternative options for managing pain, and the limitations of these, were discussed. This should have happened, and been recorded, in line with the requirements of GMC guidance on consent and the standards outlined in the article IUS and IUD – Management.
59. This is a failing. We consider the impact of this on Mrs I later in this report.
Complaint response
60. Mrs I says the complaint response she received is inaccurate as it refers to general, rather than local, anaesthetic. She also says it failed to mention the two nurses who saw how distressed she was following the procedure.
61. We reviewed the initial complaint email Mrs I sent to the hospital, and their response. In her complaint email Mrs I simply refers to ‘anaesthetic’. In its response the hospital states the gynaecologist ‘cannot recall a conversation regarding the procedure being performed under general anaesthetic and this was not documented in the referral letter’.
62. Our review of these documents also shows that Mrs I did mention two nurses in the initial complaint. This information is included as part of a narrative account of Mrs I’s experience that day. The nurses are not mentioned in the hospital’s response.
63. After it received Mrs I’s complaint, the hospital spoke to her on the telephone and offered to meet her in person to discuss the issues she had raised. Mrs I declined this offer and so the hospital issued a written response. The hospital made a further offer to meet Mrs I in its written response dated February 2020.
64. The NHS complaints regulations say that an organisation should issue written responses to complaints. We note that there is no obligation for a complainant to accept the offer of a face-to-face meeting, although these can often be useful. As Mrs I declined the offer to meet, the hospital was not aware of these issues at the time and has not had the opportunity to respond.
65. Our Principles of Good Complaint Handling state that a public body should ‘Listen to and consider the complainant’s views, asking them to clarify where necessary, to make sure the public body understands clearly what the complaint is about.’
66. We can see that the hospital missed an opportunity to clarify which type of anaesthetic Mrs I was referring to during the phone call that took place prior to sending the written response.
67. We understand Mrs I is concerned that the hospital’s complaint response refers to general anaesthetic and does not mention the nurses. Our view is that, despite mentioning general rather than local anaesthetic, the complaint response does answer the main concerns Mrs I raised in her email. We also think that as Mrs I’s complaint raises clinical concerns about the procedure, it was appropriate not to mention the nurses in the response.
68. Having considered the information above, our view is that there was a shortcoming in the hospital not clarifying the type of anaesthetic. We consider something to be a shortcoming where something has gone wrong but does not fall so far below the standard that we would expect to be called a failing.
Impact
69. Having spoken to Mrs I and read her written complaint, it is clear she was extremely distressed by her experience. She says that if she had known the procedure could cause that amount of pain, she would not have gone ahead.
70. We have seen that the gynaecologist should have had a more in-depth discussion with Mrs I prior to undertaking the procedure. This discussion should have covered Mrs I’s expectation and previous experience of pain, and the options for managing pain and their limitations.
71. Had this happened, Mrs I may have decided either to defer the procedure until she had taken oral analgesia in advance, or to have the procedure under general anaesthetic. This could have led to the pain and trauma she experienced being reduced or avoided.
72. Alternatively, she may have chosen to go ahead with a pain reduction method such as an injectable local anaesthetic. In this case the amount of pain she experienced may have been reduced.
73. We have also considered that, short of general anaesthetic, none of the pain relief options available would have guaranteed the procedure would be pain free. Had Mrs I been aware of this, she would at the very least have found the pain less unexpected. This would have reduced her distress.
74. We understand that the bleeding Mrs I experienced caused her distress. We have not seen that this was caused by something that went wrong during the procedure. As such, this impact cannot be linked to the failings we have identified.
75. Mrs I visited her GP after the appointment and told us that she worked from home for the rest of that week due to pain and trauma.
76. The IUCD and IUS - Management article states that cramping ‘is common for the first 24-48 hours and does not usually persist beyond this’ and that taking oral analgesia one hour prior to the procedure ‘may aid post-insertion discomfort’.
77. We cannot link the visit to the GP, the post-insertion pain, or the need to work from home to the failings we identified. This is because some level of pain is usual following the procedure. Even if a fuller discussion had been had, or a different type of anaesthetic used, we cannot say the post-procedure pain would have been eliminated. If she had taken oral analgesia prior to the appointment, Mrs I may still have needed to visit her GP and work from home.
78. In letters sent to us, the gynaecologist has acknowledged that they should have counselled Mrs I in more detail about her expectation of pain and offered her oral analgesia. The gynaecologist says they have reflected on the issues raised and have amended their practice.
79. The hospital has also told us that it is sorry it misunderstood the reference to anaesthetic and did not mention the nursing staff in the complaint response.
80. We welcome these steps. However, we do not think the action taken by the hospital is enough to remedy the impact these issues have had on Mrs I.