Women who underwent gynaecological “exploratory work” without their consent at St Luke’s Hospital, Kilkenny, are being contacted by the hospital group about the incident.
Ireland East Hospital Group is in the process of contacting the five women in relation to the incident, which happened nine months ago. The women are being told they will be briefed on the contents of a report into the matter before it is published.
Minister for Health Simon Harris said on Monday evening that his officials have sought assurances from the hospital group that the women's care needs are being met.
"The Department of Health has been advised by the HSE of a review of hysteroscopy procedures in St Luke's Hospital, Kilkenny. The HSE has stated that the review and its recommendations are being considered by the Ireland East Hospital Group. It is important to await the outcome of this process and the Department is engaging with the HSE in this regard," he said.
Appealing for the privacy of those involved to be respected, Mr Harris said his immediate concern was for the patients involved.
“The HSE has advised that open disclosure has taken place with all patients involved.”
The hospital group says it received the report by gynaecologists Prof Donal Brennan of UCD and Dr William Boyd of the Mater Hospital late last week.
Prof Ray O’Sullivan, the obstetrician at St Luke’s who carried out the tests, has said he did not feel he needed to obtain consent beforehand.
The hospital maintains he should have obtained consent, has sought his suspension and has reported the matter to the Medical Council.
The tests were stopped last September after nursing staff raised concerns over whether the required consents had been obtained from a hospital ethics committee and from the patients themselves.
The tests involved flushing the vaginas of the women with water, inserting a miniature scope for monitoring and measuring the pressure within the vagina. The equipment involved, including tubes and pressure gauges, was brought in from outside the hospital.
Speaking to The Irish Times on Sunday, Prof O’Sullivan said the issue “had more to do with preliminary, exploratory work – as to whether you need consent for that before you engage in an actual clinical trial. It was more technical than anything else”.
Asked if he felt he needed consent, he replied: “I felt I didn’t need consent. I didn’t because we weren’t actually doing the research. We were just seeing if a particular procedure that we were planning on doing as part of the research could be done”.
Stopped the tests
Once the issue became known, the hospital stopped the tests, seized the equipment and informed the patients, who were told investigations into the matter would be completed within weeks.
Prof O’Sullivan stressed that no patients were harmed, adding “they didn’t even know it’s been done”.
“You can’t innovate within the HSE without having to mind your Ps and Qs,” he said.
In a statement, the Ireland East Hospital Group said its chief executive had commissioned a review of “a research study undertaken in Kilkenny Hospital on the hysteroscopy procedure”.
It said the chief executive was carefully considering the review’s findings and any recommendations or actions arising from it would be implemented fully “having regard for due process”.
“Arising from the media coverage of the issue today, IEHG contacted the patients comprehended by the study today to share the findings and to provide information and reassurance.”