Royal Free London NHS Foundation Trust

5. Mrs W complains Royal Free London NHS Foundation Trust declined to replace her leaking breast implant, which was diagnosed in July 2021. The affected breast is asymmetrical to the other side, resulting in self-esteem issues and anxiety due to the feeling of a lump and ‘a crinkle’ in the breast. She is seeking an apology and financial compensation.

6. Mrs W had an NHS-funded breast augmentation in the early 2000s for cosmetic reasons, which required extensive assessment for approval. She explained it was approved she did not develop breasts in puberty due to having very little breast tissue, and this significantly impacted on her self-esteem into her adulthood.

7. Later, she sought a revision due to media coverage about the type of silicone used in the implants, called PIP implants. Her case was put to the Trust’s cosmetic surgery tribunal, and the NHS agreed to remove and replace them.

8. Some years later, Mrs W experienced issues with one of the replacement implants. A different Trust examined her and confirmed it was leaking. It referred her to the Trust for treatment.

9. The Trust declined to replace the implants, only offering to remove them. It said this was in line with the clinical commissioning group (CCG, now called an Integrated Care Board or ICB) policy).

10. Mrs W continued to live with the affected implant, which affected her mental health due to the way it looks and feels. She told us she has undergone three recent mammograms due to fears of cancer due to how the breast feels on examination. She also experiences self esteem issues due to the asymmetry of the breasts.

13. To decide if we should conduct a detailed investigation into a complaint, we first consider whether there are any indications something went wrong with the organisation’s service. If so, we then explore if the organisation would be willing to take further steps to put this right and resolve the complaint.

14. In its response in April 2022, the Trust told Mrs W it could not replace the affected breast implant due to a change in the CCG’s policy (now ICB). It only offered to remove the implant.

15. To explore this complaint further, we queried the current ICB policy on breast prosthesis and removal with the Trust. This is because it says:

‘Breast implants may be inserted during reconstructive surgery for treatment or prevention of breast cancer or for cosmetic purposes. Surgery to remove a breast impact may be used to treat the complications of breast impacts inserted for reconstructive or cosmetic purposes.

16. Clinical indications for removal of breast implants are:

• after implant leakage or rupture • severe capsular contracture (grade III/IV on the Baker classification) This will need to be confirmed by specialist opinion • implants are complicated by recurrent implant infection or seroma • the patient develops BIA-ALCL (breast implant associated anaplastic large cell lymphoma).’

17. This policy confirms implant leakage or rupture is a clinical indication for the removal of an implant. Mrs W’s leaking implant was diagnosed in July 2021.

18. It also says:

‘Only patients whose initial procedure was funded by the NHS should be considered for both implant removal and replacement. In line with the current guidance, patients eligible to have their implant replaced must be informed of the potential risk of BIA-ALCL (a rare type of lymphoma linked to breast implants).’

19. This section implies it is possible that patients whose implants were originally NHS-funded, as in Mrs W’s case, could be eligible for both implant removal and replacement.

20. Whilst this policy is from 2025, it suggested the Trust’s rationale to decline the implant in 2022 may have been incorrect. This is because it had said the ICB’s policy had changed and the only treatment available to patients who had implants for cosmetic reasons on the NHS was removal.

21. We also noted the Trust’s website still includes information about cosmetic surgery tribunals, however there was no evidence that the Trust followed a tribunal process to consider Mrs W’s request from 2021 onwards.

22. We arranged a meeting to discuss this with the Trust. It agreed to offer Mrs W a consultation. This resulted in approval for replacement of the implants, subject to psychological assessment as per the usual tribunal process.

23. Whilst Mrs W is pleased with this outcome, she remained concerned about the length of time taken to achieve this.

24. She asked for an apology to recognise the experience both her and her GP had when needing to repeatedly contact the Trust because the GP’s referrals would not be accepted unless they were marked as ‘removal-only’. She feels she would not have coped emotionally with the experience had it not been for the support of her GP.

25. She also asked for a financial remedy in line with level four of our severity of injustice scale. This was to recognise the extent of the delay and how the issue with the affected implant impacted her emotionally during this time. As stated previously, this included anxieties about possible cancer due to lumps in the affected breast and low self-esteem due to the appearance of the breast.

26. The Trust has agreed to provide an apology and a £2500 financial remedy, which Mrs W has accepted.

27. Our NHS Complaint Standards say organisations should find ‘suitable and appropriate ways to put things right for people who raise a complaint’.

28. In this case, we are satisfied the Trust has acknowledged it did not take appropriate steps to consider Mrs W’s request, as it declined her GP’s referrals. It has now put this right with a consultation. The outcome of this is that the Trust has confirmed Mrs W’s implants can be replaced, subject to psychological assessment. Mrs W expected this step and agreed with it. She understands there could also be clinical reasons why surgery may not be able to go ahead which would be beyond the Trust’s control, such as a health reason.

29. The Trust has also agreed to an apology and financial remedy which has met Mrs W’s expectations. For this reason, we consider this will resolve her complaint. Therefore, we have decided not to take any further action. We would like to acknowledge Mrs W’s persistence in pursuing her complaint despite the significant length of time it was taking her to feel heard. We are pleased the Trust was open to her feedback and to a resolution which recognised this effort.

1. We have carefully considered Mrs W’s complaint about Royal Free London NHS Foundation Trust (the Trust) and its decision not to replace a leaking breast implant which it diagnosed in July 2021.

2. The Trust has acknowledged it did not follow the correct process to consider Mrs W’s request to have her leaking breast implant replaced. Following a clinical consultation, it has confirmed it will now replace both implants, subject to further checks.

3. It apologised for the time Mrs W and her GP spent asking the Trust to accept referrals, only to be turned away. It recognised there was missed communication with Mrs W which meant her further complaint went unanswered, resulting in a delay. It agreed to a £2500 financial remedy for the significant delay these issues caused, which left Mrs W with significant body image issues and anxiety during this time due to the asymmetry and texture of the affected breast.

4. Mrs W has accepted this offer to resolve her complaint, so we have decided not to take any further action.