A Dublin woman whose cancer was misdiagnosed was not informed of the fact for nine months after the hospital became aware.
Alison McCormack is one of two women who attended St James's Hospital in Dublin in 2010 and had their breast cancer misdiagnosed.
When Alison noticed a lump in her right breast, she was referred to the breast clinic at St James's Hospital where in September 2010 - following a series of tests - she was diagnosed with DCIS, Ductal Carcinoma in Situ, a localised form of breast cancer.
Speaking in an RTÉ Investigates report which is due to be aired tonight, Alison said, "“The consultant basically said I had DCIS which is ductal carcinoma in situ, she said of all the cancers to get that’s one of the best ones because it’s actually pre-cancerous, it’s Stage 0 cancer. So my surgeon had explained you’re lucky to have DCIS, as in it’s a cancer that is curable by surgery.”
Alison underwent a mastectomy and breast reconstruction but it was decided that further treatment such as chemotherapy was not required.
In October 2012, Alison discovered what appeared to be a lump in her neck and was once again referred to St James's Hospital.
“I saw my own consultant and she said that they’d looked at the biopsy and it was the original breast cancer that was back, it was the DCIS and it had now spread into the lymph nodes of my armpit and up to my neck," Alison said.
"So we were shocked and we couldn’t, we couldn’t understand it and actually she couldn’t understand it either. She basically said it’s very rare for DCIS to come back.”
She spent the following year undergoing a year-long treatment plan including six months of aggressive chemotherapy and had all the lymph nodes in her right arm removed as well as five and a half weeks of radiation.
Alison has been left with lifelong health issues as a result of the treatment including lymphedema which results in severe swelling of her right arm.
Following the treatment, Alison began to wonder why her cancer had returned.
She requested a meeting with St James's Hospital in late 2013 where she was informed for the first time that her cancer had been misdiagnosed.
The hospital then sent Alison a copy of a report into her misdiagnosis revealing that the hospital had been aware of her misdiagnosis since February 2013 but she had not been told.
“Had Alison not pursued the questioning that she was determined to find out about, there is absolutely no way she would ever have learned that were was a mistake on the part of this hospital,” said Rachael Liston, Alison’s solicitor.
The 27 page review confirms that when Alison re-presented in 2012 with a lump on her neck, the hospital reviewed her original pathology slides, which revealed they had actually shown invasive breast cancer – but this cancer had been missed by the pathologist.
But the hospital report reviewing Alison’s care concluded “the error, in either not identifying the small focus or not appreciating that it was in fact invasive rather than in situ carcinoma, was an error that could have been made by any competent pathologist.” And so “... should be characterised as a sporadic human error and did not represent incompetence on the part of the original reporting pathologist.”
St James's Hospital subsequently reviewed a portion of the pathologist’s case load. In all the doctor had analysed over 300 breast cases in 2010 – the year of Alison’s misdiagnosis.
The review looked at every 10th case, as well as a further 9 DCIS cases – that is cases with a pre-cancerous diagnosis similar to Alison’s.
Of the 39 cases reviewed by the hospital, two were found to have been misdiagnosed - including Alison's and another unidentified patient.
Both cases came from the DCIS category only, meaning the pathologist had misdiagnosed two out of nine cases – an error rating in excess of accepted international pathology norms.
As part of a successful legal action taken by Alison against the hospital her case was examined by a number of UK experts – including Professor Ian Ellis, a leading consultant pathologist based at Nottingham City Hospital.
Prof Ellis: “It sounds very small, two out of 39 but these are very, very fundamental and serious errors so they are red flag type of errors.
"And so in my opinion that is of concern. The number of breast cases that he had looked at were a few hundred, that’s not a huge number of cases and certainly if I was asked my opinion on what to do I would recommend a review of all the cases.”
St James's Hospital decided a full review of all breast cases examined by the pathologist was not required.
The pathologist did not work on breast cases alone and during his time at the hospital he analysed specimens on almost 2,700 cases including other specialities.
His performance in these areas has never been examined.
In a statement to RTÉ Investigates St James's Hospital said it "treated the review of her case, which was completed in February 2013 as part of the overall review and shared it with the patient together with other related documents in November 2013 when the review was complete."
The hospital also said it "fully acknowledges that the missed diagnosis error occurred. For this the hospital was and remains unequivocally sorry."
Despite repeated requests from RTÉ Investigates, St James hospital failed to confirm that the second patient has been informed that she was misdiagnosed.
In a statement the hospital said “St. James’s Hospital can confirm that all relevant elements of the patients care were discussed with her at the time of diagnosis and eight years later the patient remains in normal active clinical review.”