A practice in the North Lincolnshire area

4. Mrs J complains about the treatment which the Trust commissioned an independent provider to provide to her. Specifically, she says during an operation to sterilise her in March 2024, staff at the independent provider used metal clips on her fallopian tubes, instead of cutting them, and she did not consent to this.

5. Mrs J says this caused her significant abdominal pain, bleeding, distress, and a worsening of her anxiety and other mental health conditions. She also says she needs a further operation to have the metal clips removed which has been delayed due to anxiety caused by what happened.

6. Mrs J seeks service improvements and for the Trust to pay her a financial remedy.

7. In September 2022, Mrs J’s GP referred her to the Trust to discuss surgical options for her gynaecological issues. Mrs J asked to be sterilised, which is a permanent type of contraception, where the fallopian tubes are blocked, sealed or cut so sperm cannot meet an egg.

8. The Trust contacted her in late October 2023 and offered her treatment from a different provider via the Digital Mutual Aid System (DMAS) because she had been on the waiting list for over 40 weeks. One of these providers was the independent provider, with which the Trust had a contract at that time. Mrs J agreed to this and selected the independent provider to sterilise her.

9. In early December 2023, a nurse at the independent provider conducted a pre-assessment with Mrs J.

10. A few days later, a consultant gynaecologist surgeon at the independent provider did a pre-surgery review of Mrs J with her over the telephone.

11. In March 2024, a consultant gynaecologist surgeon at the independent provider sterilised Mrs J.

15. Mrs J says when she asked the independent provider to sterilise her she believed the surgeon would cut her fallopian tubes and seal them. She says the surgeon had told her this when they were preparing her for theatre. She says after the operation staff gave her an information leaflet which said clinicians had sterilised her with metal clips and this is not the procedure she had consented to.

16. We are sorry to hear that this made Mrs J’s anxiety significantly worse and that she has suffered with abdominal pains and bleeding since the operation.

17. In its complaint response in April 2024, the independent provider said it expected any issues that need to be considered as part of the planning for the surgical procedure to be discussed at the pre-assessment appointment with the pre-assessment nurse. It said this appointment provides the opportunity for patients to ask questions, explain anxieties and raise any issues that may impact on their surgery. It apologised if this did not happen and that Mrs J was under the impression her fallopian tubes would be cut instead of the less invasive and more common procedure of clipping them. It said the Trust should have passed on this information in the transfer of her notes.

18. GMC’s ‘Good medical practice’ says patients have the right to be involved in decisions and their treatment and be supported to make informed decisions. It says clinicians should give patients clear information in a way they can understand. It also says clinicians should check a patient’s understanding of the information they have been given.

19. GMC’s ‘Decision making and consent’ says, even for routine procedures, clinicians should explain what they are going to do. It says:

‘The exchange of information between medical professionals and patients is central to good decision making. It’s during this process that you can find out what’s important to a patient, so you can identify the information they will need to make the decision.

The purpose of the dialogue is: • to help the patient understand their role in the process, and their right to choose whether or not to have treatment or care • to make sure the patient has the opportunity to consider relevant information that might influence their choice between the available options • to try and reach a shared understanding of the expectations and limitations of the available options.’

20. This guidance also says clinicians must give patients information they want and need including the nature of the treatment and they should keep an accurate record of these conversations.

21. RCS guidance says, ‘Surgeons must ensure that the patient is provided with the information they need to make an informed decision about treatment.’

22. NICE CKS says the clinicians involved in the sterilisation should provide the patient with verbal and written information on the sterilisation procedure.

23. Our adviser explained that blocking the fallopian tubes with small metal clips, called Filshie clips, is the standard method of female sterilisation, unless there is a reason not to. They said established good practice would be for the surgeon to clip the fallopian tubes in the first instance as this involves less surgery than when cutting or removing the fallopian tubes which both carry higher risk of potential complications. Our adviser said a surgeon would not routinely offer different types of sterilisation, and there is no guidance which says they should offer alternatives.

24. However, our adviser said the GMC, NICE and RCS guidance are particularly relevant when a surgeon is going to be placing any medical equipment into a patient, such as Filshie clips. They said, in line with guidance, the surgeon should have discussed what the operation entailed with Mrs J.

25. The notes from the pre-operative assessment with a nurse at the independent provider in early December 2023 identify Mrs J’s mental health conditions and show an assessment of her. There are no details of conversations about what procedure Mrs J would have.

26. A consultant gynaecologist at the independent provider did a pre-surgery review with Mrs J a few days later. The notes indicate Mrs J asked for her ovaries to be removed. We consider this indicates that Mrs J was not clear on what the process of sterilisation is.

27. The consultant told her she would go through the menopause and her mental well-being may get worse if she had her ovaries removed. The consultant followed this up with a letter to Mrs J’s GP. In the letter, they explained that Mrs J wanted to proceed with sterilisation. There is nothing in the notes or letter to suggest that the surgeon discussed what would happen during this procedure.

28. The consent form which Mrs J signed immediately before the procedure in March 2024 says ‘Lap – sterilisation’. This means laparoscopic, otherwise known as keyhole surgery, where the sterilisation is done via small cuts which the surgeon makes in the abdomen. However, the consent form does not include what would specifically happen during the procedure, or even a brief description of this. The consultant listed the risks of the procedure but there is no record that they mentioned the Filshie clips or method of sterilisation.

29. The clinical notes from the operation indicate the surgeon sterilised Mrs J by putting clips on her fallopian tubes.

30. Mrs J asked for and consented to sterilisation, however there is no evidence that the consultant surgeon explained the sterilisation procedure and that they would use Filshie clips.

31. There is no audio recording of the pre-surgery review or the consent process immediately before the surgery and the notes do not indicate what was discussed. As such, we cannot know what the consultant said.

32. However, on balance, when considering what Mrs J tells us and the evidence we have seen, we hold the view that the consultant did not fully explain the sterilisation process, or that Filshie clips would be placed on Mrs J’s fallopian tubes.

33. Therefore, we find the consultant did not act in line with GMC, NICE CKS and RCS guidance because they did not provide Mrs J with the information she needed to give informed consent, or record details of the conversation in the notes. This is a failing.

34. We have carefully considered the evidence to assess what impact this had.

35. We find that this means Mrs J did not give informed consent to the specific type of sterilisation the surgeon carried out. She now has Filshie clips inside her which she did not consent to.

36. Mrs J says she has had bleeding and abdominal pain since the procedure. We are sorry to hear this and we appreciate how distressing this must have been.

37. Our adviser explained, there is a risk of bleeding and pain with any sterilisation procedure. While we have found the surgeon did not explain the procedure to Mrs J, the evidence shows that they did outline these risks. As such, we consider Mrs J was aware of them being possible, irrespective of how the sterilisation procedure would be carried out. We have not seen evidence these symptoms are because she was not told that she would have Filshie clips.

38. Mrs J has previous diagnoses of emotionally unstable personality disorder and anxiety, for which she is on medication. The records from the pre-operative assessment and pre-surgery review show that the independent provider was aware of this.

39. We can understand why Mrs J would be anxious and distressed to find out she has Filshie clips in her when she had not consented to this. We appreciate this has had an impact on her life, and we consider this has affected her more because of her mental health conditions. We can understand why it has made these conditions worse.

40. We are sorry to hear that Mrs J is also anxious that the Filshie clips would be harmful to her when she has MRI scans in the future. We would like to reassure her that Flishie clips are made of titanium which is a metal that is not magnetic. Our adviser confirmed they are not a risk when having an MRI scan.

41. Our adviser said if the surgeon had explained they were going to use Filshie clips and Mrs J had objected, the doctor may have offered alternative options such as a bilateral salpingectomy (removal of the fallopian tubes). They said as this method is not included in national guidance, it is possible they would have referred her on to another consultant for a second opinion or encouraged her to consider another method. Therefore, we consider this was a missed opportunity for the surgeon to reassure her about the use of Filshie clips and she was denied the opportunity to make a fully informed decision about her treatment.

42. If the surgeon had fully discussed and explained the procedure with Mrs J in line with GMC, NICE and RCS guidance, she may have consented to sterilisation with Filshie clips. There is no evidence this conversation took place and, as such we will never know for certain what the outcome of such a conversation would have been.

43. However, at a further gynaecology appointment in April 2025 at the Trust, a consultant reassured Mrs J about the benefits of Filshie clips as a method of sterilisation. Despite this, she continued to tell them she wants her fallopian tubes and the Filshie clips removed.

44. On balance, this shows it is likely she would have refused Filshie clips, even if the surgeon had fully informed her prior to the operation in March 2024. Our view is that it also shows how strongly she feels about having the Filshie clips inside her.

45. In late May 2024, Mrs J’s GP made an urgent gynaecology referral to the Trust. The GP explained Mrs J was tearful during the consultation. They said they had made the referral urgently because of her mental health conditions, that Mrs J is struggling with the fact that clips were used and that she wanted them removed.

46. Mrs J was due to have a bilateral salpingectomy at the Trust in July 2025, however this was cancelled because she had developed epilepsy and is suffering with seizures. The consultant said she is not fit to be put under anaesthetic because of this. They said they can re-list her for the operation when her seizures are under control. We understand Mrs J’s continued anxiety about having the Filshie clips inside her.

47. We appreciate this further operation is Mrs J’s choice. However, the fact she is opting to have this surgery demonstrates how much distress the failings have caused her. We consider she should never have been put in the situation, where the lack of information during the consent process for the initial procedure has caused her such anxiety. Our view is that it is likely Mrs J would not need this second operation if the consultant had obtained Mrs J’s consent in line with the guidance we have referred to.

1. We are sorry to hear how the events Mrs J complains about have caused her significant anxiety and concern. We appreciate this has been a difficult and distressing time for her.

2. We find that the independent provider did not give Mrs J the information she needed to provide informed consent to an operation, and did not keep accurate records of conversations. This means Mrs J has metal clips on her fallopian tubes (which connect the ovaries to the womb) which she did not consent to, and this has caused her significant anxiety and distress.

3. We therefore partly uphold Mrs J’s complaint and make recommendations to put things right.

48. We make recommendations in line with our ‘Principles for Remedy’ which are reflected in the ‘NHS Complaint Standards’. These say organisations should identify instances where things have gone wrong, take responsibility for these and find ways to put things right for those involved. They should learn from complaints to improve services.

49. We expect organisations to take action to compensate people appropriately if they cannot return them to the position they would have been in if the poor service had not occurred. In some cases, a financial remedy will be required and we explain later that we think that is the case here. To decide on a level of financial remedy, we review similar cases where the person has experienced a similar injustice, along with our ‘Severity of Injustice Scale’.

50. We have identified failings when the independent provider failed to provide Mrs J with the information she needed to give informed consent and did not record conversations in the notes. We consider this means Mrs J has Filshie clips in her body, which she did not consent to and this has caused her anxiety, made her mental health conditions worse, so much so that she wants a further operation to rectify this.

51. The independent provider is no longer operating as a business. We acknowledge that the Trust did not provide Mrs J with the care directly and none of the Trust’s clinicians were involved in the treatment Mrs J complains about. However, we are concerned about how the Trust governs the services it commissions and sub-contracts.

52. NHS England’s ‘Standard Contract 2023/2024’ outlines that sub-contracting services will not relieve the provider of any of its obligations and the provider will be responsible for the performance of sub-contractors. In this case, the provider is the Trust.

53. In July 2025, the Trust said it transferred Mrs J to the independent provider via an Inter Provider Transfer (IPT) in late October 2023. It said with an IPT, the responsibility transfers to the receiving provider when they formally accept the patient. It went on to say there was no contract held in the Trust as an IPT does not require a contract; it is a pathway of care.

54. We identified that there was a sub-contract between multiple NHS Trusts, including the Trust, and the independent provider. The Trust acknowledged this in a letter in December 2025.

55. Our concern is that the Trust did not appear to know it had a contract with the independent provider. This indicates that the Trust did not have oversight or governance of the quality of care the independent provider provided.

56. We cannot make recommendations to the independent provider as it does not exist anymore. Instead, we are asking the Trust to reflect on what has happened and tell us how it will ensure the quality and governance of sub-contracting to prevent the same things happen again. The Trust commissioned the independent provider for the service, which it did not provide in line with guidance, and which has had a significant impact on Mrs J. We consider it is the Trust’s responsibility to put things right.

57. With that in mind, we recommend that following this final report the Trust: • pays Mrs J £1,200 within two months, in recognition of the anxiety and distress the failings have caused her • explains what action it will take, or has taken, to address how it will ensure the quality and governance of sub-contracting to prevent the same things happen again. It should do this within three months in the form of an action plan which should be shared with us, Mrs J, and NHS England too.

58. We expect the Trust to send us evidence it has completed all of the recommendations we make in this report. We will check the action plan includes the reason for the failing, what it did or will do differently in future, who is responsible for each action, the timescale for completion, and how it will be monitored.