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Dáil
‹ Ceisteanna ó Cheannairí - Leaders' Questions

Temple Street spinal implant scandal

Summary

Deputy Murphy raises serious concerns for children with spina bifida and families affected by the Temple Street surgery scandal, including unlicensed springs and reported high complication rates. The Taoiseach says a patient safety review, Medical Council complaint and external expert review are under way, then responds sharply to Murphy’s claim that he warned the Government earlier, saying the information reached the Department through parliamentary questions and was passed to the HSE.

Children with spina bifida have been failed scandalously by this State. Now, their families are faced with the horrifying revelations that some of their children who went through surgeries in Temple Street hospital did not get the care they needed. There were extremely high rates of complications and, most scandalously, three had unlicensed, non-medical-grade springs inserted into them. I spoke to one of the families over the weekend and it would be fair to say they are in absolute turmoil.

They do not feel listened to so far. This scandal is not only about the actions of one surgeon. It is about a governance process that would allow it to happen, and where this would still be happening if it was not for one brave whistleblower speaking out and a journalist who exposed it in an article on The Ditch. Now we have a second external review, after a first internal review and a first external review, essentially because the first external review did not uncover the use of the springs. It took The Ditch to highlight this.

This review must get it right. The families must be at the heart of the process and their views have to be taken on board. The terms of reference have to be amended to include all CHI children's operations. There must be a spinal surgeon on the external review team. The internal review into spinal operations in Crumlin, which has already taken place, must be published.

I want to focus my question on when the Government knew about it. The Minister for Health, Deputy Stephen Donnelly, has been quoted as saying that his Department became aware of it only in August and I do not understand how that can be the case. On 10 May, I asked a parliamentary question to the Minister asking whether all implants used were appropriately licensed. On 25 May, I got an answer from CHI saying that to the best of its knowledge, all spinal implants were CE-approved and licensed appropriately. We now know that this was not the case. Why was the "to the best of our knowledge" there? I asked again in June and got the same answer, without the "to the best of our knowledge".

On 13 July, I asked the Minister for Health how many spring implants had been used in Temple Street hospital, how many had been removed and how many failed in situ. I asked whether they were CE-marked and, if not, what governance process oversaw and permitted their use. That was on 13 July but that is not all. On 5 July, I asked the Taoiseach about this. I spoke to him in the Dáil about the allegations that unlicensed implants had been used in children. The Taoiseach said to me in response that he did not know about it but said he would "let the Minister, Deputy Stephen Donnelly, know that it was raised in the Chamber and get back to the Deputy". I did not hear anything back from the Taoiseach or the Minister.

What did the Taoiseach do after 5 July? I raised this extremely serious allegation with him. He said that he was going to speak to the Minister for Health. Did he tell the Minister about it and, if so, when, and then what action was taken by the Government?

Comment on this
Leo Varadkar The Taoiseach Fine Gael

At the outset, once again I want to take the opportunity to acknowledge that this is a cause of great anxiety for a lot of parents, families and vulnerable children attending these services. A comprehensive patient safety review and assurance process has been commissioned into the paediatric orthopaedic surgery service, and there is a Medical Council complaint that is currently being considered. An expert from the UK, Mr. Selvadurai Nayagam, has been commissioned to lead an external review following identification of a number of specific clinical and patient safety concerns. The concerns related to clinical outcomes of some complex spinal surgery, including what appears to be a higher-than-normal incidence of post-operative complications and infections, as well as two serious surgical incidents.

It is important to say that we do not have all of the facts yet and therefore it is important that we do not jump to any conclusions at this stage. It is why the Minister for Health and the HSE have sought this external review. It was clear that they did not feel that the existing reports were sufficient and they did not, for example, report the use of these non-CE-marked metal springs. It is a matter of concern that this did not come up in the two reviews that were done and which have now been published. As the Deputy knows, two reports, internal and external, have been commissioned. The Minister and chief executive of the HSE made it very clear that the initial position that was adopted by the hospital groups, which was that the reports would not be published, was not acceptable. The Minister for Health will make statements later today and I understand there will also be an Oireachtas joint committee hearing that will allow further discussion of this.

To answer the Deputy's detailed question on when the Government knew, if by "the Government" he means the Cabinet, there has been no Cabinet memo on this so far. There may be one forthcoming. I cannot answer definite questions about timelines within the HSE or the Department of Health but I am sure they can. On the issue the Deputy raised with me, I will have to check. Our standard practice, when something is raised with me in this Chamber on any given day - and many things are - is that it is then passed on to the relevant Minister for a reply.

The Deputy asks a fair question. I first heard definitively about non-medical devices being used in surgery in the past week or so and was shocked.

Comment on this

I told the Taoiseach on 5 July.

Comment on this
Leo Varadkar The Taoiseach Fine Gael

The Deputy did not pass on any detail or information or at least did not pass it to me. Perhaps he did pass it to other people. If he had that kind of information weeks and months ago, and perhaps he did not, he should have passed it on.

Comment on this

I heard the allegation that unlicensed implants were being used in April so I did what was appropriate and asked the Minister if it was happening. The response I got twice from CHI stated it was not happening. I went back to the person who was alleging this to me with more specifics. I came forward with specific parliamentary questions on 13 July about how many spring implants had been used, how many had been removed, how many had failed in situ and so on. At the very latest, the Government or the Minister knew about the issue on 13 July. That is at the very latest. What does the Government do at that point? It does not make sense that the external review did not uncover the use of springs because there is a reference to springs in the internal review. It states it right there. I have checked. There is no legitimate authorised use of springs for these sorts of surgeons. The reference to springs in the internal review should have caused alarm bells to go off in terms of the external review and should have ensured this was investigated.

I want a commitment from the Taoiseach that the external review that is now going to be done will be done properly, which means expanding it to include all CHI operations.

Comment on this

I thank the Deputy. We are over time.

Comment on this

It means there is a spinal surgeon-----

Comment on this

Thank you. We are way over time now.

Comment on this

-----involved in the external review. The Taoiseach can see how it is important that I raised the matter with him on 5 July.

Comment on this

The Deputy is over time.

Comment on this

He is now saying the normal practice would be to pass that on to the Minister-----

Comment on this

The Deputy is over time.

Comment on this

-----and the Minister says he did not know about it until August.

Comment on this
Leo Varadkar The Taoiseach Fine Gael

My understanding is that parliamentary questions were submitted in the Deputy's name in July. The Department of Health was not aware of this at the time and passed on the queries to the HSE. That was how the issue came to light. The allegations were passed on by the Deputy by means of the parliamentary questions. That information was passed on to the HSE. It made inquiries and that was how the information came to light. I do not want to give exact dates because I do not know them for certain and do not want to mislead the Dáil inadvertently.

We will certainly take on board any suggestions that people have in respect of the review. It is important we get it right. If we were to extend the review to deal with all surgery happening at all three sites, it would take a very long time. We are talking appendixes and minor surgery. I am not sure if that is the right approach. This is about spinal surgery and, as far as we know, one surgeon. If we were to expand it to every surgery done by every surgeon in all three major paediatric hospitals, we would not be coming back here with an answer for years and I am not sure that would be the best approach but of course I am not going to rule it out at this point. Having discussed the issue with the Minister, Deputy Stephen Donnelly, yesterday, I have issued an invitation to the advocacy groups to meet us later in the week. There are four and possibly five such groups so it will require some logistical work to get it right. However, I am keen to meet them all together. I am keen to hear what they have to say about the issue and we will take that on board before making any decisions.

Comment on this