Hampshire Hospitals NHS Foundation Trust

3. Mr T complains on behalf of his wife, Mrs T, that the Trust incorrectly told Mrs T her left breast implant had ruptured on 18 December 2018. Mr T complains the Trust told Mrs T she needed urgent surgery but did not provide the surgery.

4. Mr T says due to concerns about his wife’s health, they paid for private surgery and the implant was found to be intact. Mr T says his wife had unnecessary surgery and now suffers from anxiety and depression which is being treated.

5. Mr T says he would like the Trust to accept its failings and apologise. He would also like the Trust to reimburse the cost of the private surgery and travel costs which totalled £7,971.

6. Mrs T was referred to haematology (diseases of the blood) on 29 August 2018 with a six-week history of enlarged lymph nodes (organs that help fight infections and diseases) in the left side of her neck.

7. Mrs T had an ultrasound scan (USS) of her neck on 17 September and an MRI of her neck on 17 October. An USS of a neck is used to find problems with thyroid, lymph or salivary glands. An MRI of Mrs T’s neck was requested because the USS did not find the cause of her enlarged lymph nodes.

8. The consultant radiologist reviewed the MRI and USS and suggested the changes were possibly consistent with ruptured breast implants.

9. The results of the scans were discussed with Mrs T on 4 December, and she was referred to a consultant breast surgeon (the consultant) and had an appointment on 18 December. She had another USS of her breasts that day. This USS report confirmed there was evidence that the left implant had ruptured. Based on this USS report, the consultant told Mrs T her left breast implant had ruptured.

10. The consultant recommended that Mrs T had the implants removed as it was likely the problems with her lymph nodes would get worse.

11. Mrs T says she left the appointment with the understanding that the Trust would contact her with a date for surgery. The Trust’s response and clinical records show that Mrs T said she would be back in touch if she wanted the surgery on the NHS. Mrs T called the Trust twice for a date and was told it could not tell her when the surgery would happen.

12. Mrs T was concerned about the impact the ruptured implant could have on her health. As she could not get a date for surgery from the Trust, she looked for private medical care.

13. Mrs T had private surgery on 21 January 2019 to remove the implants. Both implants were found to be intact.

17. The USS report from 18 December says:

‘There is evidence of intra-and extracapsular left implant rupture. There is silicone within the left axillary and supraclavicular lymph nodes.

Right implant appears intact. There is shallow fluid around the medial part of the implant.

No suspicious features.’

18. The consultant reviewed the report from the radiologist. The report found that Mrs T’s implant had ruptured. Based on this report, the consultant told Mrs T her left implant had ruptured and recommended she had the implants removed. They advised that her swollen lymph nodes would only get worse if she did not have them removed.

19. Standard one says:

‘Imaging to check implant integrity Breast implants do not require routine imaging to check the integrity of the implant. If there is clinical concern regarding the integrity, ultrasound should be the first-line tool. If the ultrasound findings are equivocal, or if there is persisting clinical concern, then MRI is indicated.’

20. Our radiology adviser has reviewed all the images and reports. The USS from September and the MRI from October were of Mrs T’s neck. They did not provide any information about her breast implants. They said the USS of Mrs T’s breasts from 18 December 2018 does not show any clear signs that the implant had ruptured.

21. Silicone deposition in the lymph nodes in a woman with breast implants can happen for two reasons, the first being rupture of existing or old implants. Mrs T had a history of implant rupture in the past and silicone in the nodes could have been present since then. Lymph nodes are not routinely taken out when ruptured implants are removed.

22. The second reason is gel bleed. This is when tiny amounts of silicone seep through the undamaged shell. This is due to the semipermeable (material allowing certain substances to pass through it) nature of the implant covering and deposit in the lymph nodes.

23. Radiologists should be aware of gel bleed as implants are not routinely removed because of it. A USS is the first line of investigation when it is suspected an implant has leaked or ruptured. But an MRI of the breast is the most accurate way of assessing the breast implant shell. An MRI should be done unless there is no doubt from a USS that the implant has ruptured.

24. To make sure of fairness and transparency after the Trust commented on the clinical advice we got for this case, we discussed the comments with our radiology adviser two more times. Their advice is unchanged. We are satisfied they have provided advice in line with our clinical standards.

25. Our radiology adviser said there were no definite signs of breast implant rupture in the USS. Mrs T had also had a rupture before, which meant the silicone could have been from then. The Trust radiologist noted the previous rupture in their report, so we are satisfied they were aware of it. In line with standard one, we would have expected the report from the radiologist to recommend Mrs T to have an MRI of her breasts.

26. We know when the private surgeon removed Mrs T’s implant it was intact. Published research (research one and two) show that MRIs are highly accurate when identifying breast implant rupture. We think that had the Trust done an MRI of Mrs T’s breast, it is likely it would have found it was intact.

27. In line with standard one, we consider the Trust did not do the appropriate scans to confirm the diagnosis. The Trust radiologist incorrectly reported on the USS from 18 December 2018. This led to the consultant advising Mrs T that her left breast implant had ruptured.

28. We looked in more detail at the consultation on 18 December as this is when the consultant told Mrs T about the ruptured implant. Standard three says:

‘Clinical assessment History: in women with breast implants symptoms may be incidental or related to the implant, including changes in texture, size or shape; following reconstructive surgery for previous breast cancer there may be concern about recurrence. Record the original reason for the implant (augmentation or reconstruction); the site, i.e. submuscular or subglandular; the nature of any associated reconstructive procedure e.g. latissimus dorsi flap; the date of surgery and type of implant used. If there are symptoms of pain or lump record details as under above protocols.’

29. The clinic letter shows the consultant took an appropriate history, examined Mrs T and recorded the key clinical findings. This is in line with standard three.

30. The consultant confirmed to Mrs T that her left implant had ruptured, but this was based on the report from the radiologist. Breast surgeons work closely with radiologists and rely on their reporting from reviewing the scans.

31. We have not found anything wrong with the consultation on 18 December 2018. The consultant relied on the report from the radiologist and the consultation was in line with standard three.

Impact

32. We considered what impact the failings had on Mrs T. We know Mrs T had private surgery to remove the implant just over a month after the first consultation. We are satisfied that Mrs T would not have had this surgery if the Trust had completed an MRI scan and found the implant was intact.

33. Our Principles of Remedy say organisations should restore complainants to the position they would have been in had the service failure not happened.

34. Mrs T wants reimbursement for the cost of the private surgery and the travel to and from the hospital. The surgery included a breast lift as well as removal of the implants. Mrs T did not have the implants replaced. If Mrs T’s implants were not removed there would have been no need for the breast lift surgery. Both procedures were unnecessary and happened as a direct result of the failing we found.

35. We recognise Mrs T was offered the option of having the implants removed on the NHS and this would have been free. It was Mrs T’s choice to have the operation privately. But Mrs T only made the decision to have this surgery because the consultant had advised her the implant had ruptured and she thought it posed a risk to her health.

36. Mrs T also told us about the emotional impact these events had on her. She says that knowing her health was at risk was extremely distressing and caused her anxiety.

37. We can see from Mrs T’s GP records that she has had depression in the past. Before this matter she was feeling well and was not on any medication. On 6 March 2019, Mrs T had an appointment with her GP about her low mood related to the events of the complaint. Mrs T told her GP she had been unable to get a date for surgery from the Trust. The GP recorded Mrs T’s mood as very low, with occasional suicidal thoughts and she was struggling to sleep. The GP prescribed fluoxetine (an anti-depressant) which she had taken before.

38. We cannot know for sure if there were other factors that contributed to Mrs T’s low mood. We have decided that, on balance, concerns about her health were a large factor in this.

39. These events caused Mrs T a significant level of distress and anxiety which could have been avoided if the Trust had done an MRI scan and found the implant was intact.

1. We understand this has been a difficult time for Mrs T and we are sorry to hear about the circumstances of her complaint. We have found that the Trust failed to do an MRI (a type of scan) of Mrs T’s breasts. As a result, it incorrectly told her the left implant had ruptured and this led to unnecessary surgery, distress and anxiety for Mrs T. We uphold this complaint.

2. We recommend the Trust creates an action plan to stop the same mistake happening again and writes to Mrs T to accept the error and apologise for how she was affected. The Trust should pay Mrs T £7,885 as reimbursement for the cost of the unnecessary surgery and £86 for the cost of the transport to and from the surgery. The Trust should also pay Mrs T £800 in recognition of the unnecessary surgery and distress.

40. In considering our recommendations, we have referred to our ‘Principles for Remedy’. These state that where poor service or maladministration (fault) has led to injustice or hardship, the organisation responsible should take steps to put things right.

41. We are pleased the Trust has worked with us throughout our investigation. It has taken our findings on board and reflected on these.

42. Within four weeks of the date of this final report, the Trust should write to Mrs T to apologise and acknowledge it should have offered her an MRI scan to confirm whether her breast implant was intact. It should also recognise how this led to Mrs T having unnecessary surgery that caused a significant amount of distress and anxiety.

43. Our principles say that organisations should look for continuous improvement and should use the lessons learned from complaints to make sure they do not repeat the same mistakes.

44. In line with this, within four months of the date of this final report, we recommend the Trust creates an action plan to explain the changes it will make to make sure patients with possible breast implant rupture get the correct tests. The action plan should identify who is responsible for each action and the date when it will complete them. Once complete, the Trust should share the action plan with us, Mrs T and the Care Quality Commission (CQC).

45. Our principles also say that organisations should put things right and, if possible, return the person affected to the position they would have been in if the poor service had not happened. If that is not possible, they should compensate them appropriately.

46. We do not have standard amounts that we suggest for specific failings as people are affected differently and have different circumstances. We consider the individual facts of a case when deciding what level of financial payment is appropriate to recommend.

47. We have decided the Trust should reimburse Mrs T with £7,885 for the cost of her surgery. It should also pay her £86 for the cost of travel for the surgery.

48. The Trust should also pay Mrs T £800 in recognition of the unnecessary surgery, distress and anxiety. It should pay these amounts within four months of the date of this report.