Part 5 - Complaint about South Devon Healthcare NHS Foundation Trust (the Trust) and the Healthcare Commission (the Commission)
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Complaint about the care and treatment of a patient in relation to a bilateral mastectomy, and complaint about the Commission’s subsequent review
Background to the complaint
In December 2004 Mrs N was referred by her GP for a mammogram which showed that she had small tumours in both breasts. A bilateral mastectomy (surgery to completely remove both breasts) was recommended.
In February 2005 Mrs N attended Torbay Hospital where she was provided with information about her condition. Mrs N discussed the issue of scarring with the Breast Care Nurse and emphasised that the position and cosmetic appearance of the resulting scars were both very important considerations for her. Later that month, the Consultant Surgeon who was to perform the operation gave Mrs N a consent form to sign; however, she had yet to decide whether she would proceed with the proposed surgery and did not sign the form immediately.
In March 2005 Mrs N signed the consent form. She was admitted to Torbay Hospital in early April 2005, and underwent a bilateral mastectomy. When the bandages were removed Mrs N was horrified to discover that, rather than two scars below the breast line, as she had been expecting, she had been left with what appeared to be a single horizontal scar across her chest wall, above her breast line. Mrs N was shocked and extremely distressed by the extent, position and appearance of her scarring and raised her concerns immediately with a member of the Trust’s staff. Mrs N was discharged the next day.
The complaint to the Trust and the Commission
Two days after her discharge Mrs N complained to the Trust in writing about the appropriateness of the surgery and the consent procedure in relation to the nature and extent of potential scarring. The Chief Executive responded to the complaint in September 2005 and said that the bilateral mastectomy was the correct procedure and that the surgeon had acted appropriately.
Mrs N remained dissatisfied and in October 2005 she complained to the Commission which found that the procedure was appropriate and the scarring within normal range. It did, however, find shortcomings relating to consent and asked the Trust to look at those issues (both in terms of reminders to staff about the importance of ensuring that consent forms were completed fully, and giving patients the opportunity to ask questions when there is a time lag between consent being given and an operation carried out) and to inform Mrs N of resulting changes in policy. The Commission, in two replies (February and March 2006) concluded that, despite the shortcomings identified, consent had been obtained on a properly informed basis.
What we investigated
In April 2006 Mrs N complained to the Ombudsman. Our subsequent investigation looked at:
- the Commission’s handling of her case; and
- the standard of care and treatment provided by the Trust in terms of informed consent, and the appropriateness of the procedure.
Mrs N made clear that she had pursued her complaint in order to have it acknowledged that the operation she received was not the one for which she gave consent, not to obtain financial compensation.
We examined all the relevant documentation and obtained specialist clinical advice from a Consultant Breast Surgeon who is also a Professor of Breast Cancer. We also took account of the relevant standards contained in the Department of Health’s ‘Reference Guide to Consent for Examination or Treatment’ (2001) and the General Medical Council’s ‘Seeking patients’ consent: The ethical considerations’ (1998).
What our investigation found
We found that the bilateral mastectomy was an appropriate procedure for Mrs N.
We found that some parts of the consent process were reasonable, insofar as different treatment options were described, nursing staff were involved in the consent-making process, and Mrs N was given the opportunity to reflect before and after making a decision. However, we noted that there was no review of the consent at the time of the admission immediately before the operation. We also concluded that, based on the information given to Mrs N pre-operatively, it would have been reasonable for her to expect two separate scars running horizontally across the lower to middle part of her chest. The fact that Mrs N was not given more specific information about the risks of the procedure impacted on her ability to give fully informed consent. We found that, overall, there were sufficiently serious shortcomings in the consent process to undermine the validity of the consent, with the result that Mrs N was denied the opportunity to decide whether or not to go ahead with the surgery with full knowledge of the potential risk of scarring.
The investigation found that, having reviewed appropriate evidence and sourced appropriate advice, the Commission’s resulting decision that Mrs N’s consent was fully informed was unreasonable, as it did not properly reflect the evidence assessed or clinical advice received.
This caused Mrs N additional inconvenience and distress.
The investigation concluded in February 2008 and we upheld Mrs N’s complaints against both the Trust and the Commission.
Outcome
As a result of our recommendations the Trust and the Commission agreed to apologise to Mrs N for the shortcomings identified in our report and the injustice she had suffered.
In addition to the action they had taken as a result of the Commission’s recommendations, the Trust also agreed to give Mrs N an assurance that lessons had been learnt from her complaint and an explanation of the changes made to prevent such failures being repeated.
