A potentially significant number of cervical cancer cases were not subject to an audit examining whether smear results were wrongly interpreted as clear, Health Minister Simon Harris has said.
In the latest development in the growing health care controversy, Mr Harris said the issue related to women who had already been diagnosed with cancer.
On Monday, the HSE confirmed that an audit by CervicalCheck – Ireland’s national screening programme – of 1,482 women diagnosed with cervical cancer since 2008 had found potential errors in 208 cases, meaning the women received clear smear results when in fact a different result should have been flagged.
On Tuesday evening, Mr Harris told the Dail that he had been informed that the cases examined by CervicalCheck did not include all the cervical cancer diagnosis notified to the National Cancer Registry.
The disclosures raises the possibility that more than 208 women have received false negatives.
The majority of those 208 women – 162 – were not initially told of the outcome of the audit. Of the 208, 17 women have since died.
“While CervicalCheck has audited all cases notified to it, I have been informed that a potentially significant number of cases will not have been subjected to an audit of their screening history,” Mr Harris told the Dail.
“Let me be clear, these are not new cases of cancer, nor is it a group of women wondering if they have cancer.
“These are women who have already been diagnosed with cervical cancer and treated as such, but their cases have not been included in a clinical audit.”
He added: “The screening history of these additional cases will be established, and if any of these women were screened through the CervicalCheck programme, their case will be reviewed in further detail with a cytology review where necessary.”
On Tuesday night, the HSE and CervicalCheck offered “deepest apologies to women for any worry caused by the evolving situation around the cervical screening programme and its recent audit process”.
The controversy was triggered by the case of Vicky Phelan, the terminally ill mother whose legal battle cast light on the issue.
Last week Ms Phelan, a 43-year-old mother of two from Co Limerick, settled a High Court action for 2.5 million euro after being incorrectly told in 2011 that her smear test had given a negative result for cancer.
In 2014 she was diagnosed with cancer but only told of the false negative last September.
An independent review of the screening programme has already been launched while the clinical director of CervicalCheck stepped down at the weekend.