Louise O'Reilly (Dublin Fingal, Sinn Fein)
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22. To ask the Minister for Health when his attention was drawn to the side effects and complications of transvaginal mesh implant procedures; the steps he has taken to address and take control of the situation; if he will instruct the HSE to establish a register of women impacted by complications from the procedure; and if he will make a statement on the matter. [48282/17]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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This fairly simple question relates to the complications associated with transvaginal mesh implants. The details of some of the serious complications do not make for easy reading for anyone. Those who have met the people affected by this issue will appreciate that it is serious. This question gives the Minister an opportunity to tell me what he is doing about this matter.

Simon Harris (Wicklow, Fine Gael)
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I thank Deputy O'Reilly for bringing this serious matter to my attention. I have been made aware of concerns about complications arising from the use of transvaginal mesh devices in women. Recent media reports here and elsewhere have highlighted concerns that have arisen for some women. A number of women who had these devices inserted for the treatment of specific medical conditions have reported negative experiences.  It is important for me to say that these devices have been shown to be as effective as more invasive surgery, with the advantages of shorter operating and admission times, a quicker return to normal activities and lower rates of complications. My Department is not aware of any scientific evidence which concludes that these devices are unsafe when used in line with their intended use.  These mesh devices continue to be certified as compliant with EU legislation and have not been removed from the market by regulators in Europe.

As the Deputy will appreciate, there is no such thing as a medical or surgical procedure that does not carry some risk. That is why the Health Products Regulatory Authority monitors the safety of medical devices placed on the market and monitors international data on such matters.  The authority has received six incident reports in relation to these devices, four of which have been received following recent media coverage. Perhaps this suggests that more people are coming forward as they are being made aware of this issue.  It is important that clinical facts and evidence determine the further response I give to the issues raised by the Deputy. I have asked the Chief Medical Officer to provide a report on the issues raised. He has informed me that the engagements he will require with national and international bodies, the professional colleges and others will require some months to complete before he can make recommendations to me. I ask the Deputy to await the completion of that work. I will keep her and the House informed. In the interim, I advise any woman who experiences or suspects that she has experienced such a complication to discuss this with her GP and indeed with the hospital from which she received the implant. I will ask the Chief Medical Officer to undertake the body of work I have mentioned.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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To be honest, I do not think the Minister is taking this matter at all seriously. I asked him when his attention was drawn to this issue. He has advised me that he read about it in the media. It strikes me as odd that his officials have not kept him informed about this problem, especially because multi-party actions in this respect are under way in a number of other countries. We discussed such class actions, as they are also known, in the House last night. I raised this matter over a month ago and I am doing so again today because I think we should all be worried about it. The complications as a result of this device need to be addressed immediately.

I welcome the fact that the chief medical officer will compile a report. It is worrying that we cannot put our hands on the number of these devices that have been used. If we were standing here talking about trans-penile mesh or a men's health issue, we would not be having this conversation. It is outrageous that there is no register of the number of devices that have been used and the women who have used these devices so that at least we would know what the scale of the problem might be. More people are going to come forward as this issue receives more attention.

Simon Harris (Wicklow, Fine Gael)
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I thank the Deputy for raising an important issue. She can do so without the political partisanship she brought to the issue or the suggestion that she has a monopoly on concern for women's health and nobody else gives a damn, which she should really reflect on very carefully. Nobody in this House-----

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I did not use that language.

Simon Harris (Wicklow, Fine Gael)
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The very clear implication that if this was a male rather than a female condition, she would get a different response is utter tripe and the Deputy should reflect on that based on knowing me and all colleagues in this House who take issues seriously regardless of that issue. What I do is follow the evidence and ask the available experts to carry out the necessary studies. I told the Deputy very clearly that the chief medical officer will look into all of the issues that have been raised. He will engage with national and international bodies, professional colleges and others and come back with a series of recommendations. As of today, this device is a regulated device in this country. I have given very clear advice that people can go to their doctors should they have a concern. In terms of having an idea of the number of complaints, the HPRA is able to provide current and up-to-date data on that. I note that last month in the UK, the need for an inquiry was dismissed. I want to follow our own evidence here so that we have the best advice available. Anybody with any concerns should go to their GP.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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Regarding the phrase "give a damn", I do not use language like that in here but I stand over what I said. The issue of women's health has been discussed here time out of number and the Minister is aware of that, as am I. It was not intended to be in any way personal. Of course, I welcome the fact that the chief medical officer will examine this but I would like to hear the Minister say that he will instruct the HSE to compile a register of those people who have used this device. I am learning that it does not know how many women have used it and in what context so we do not know. It would be very helpful if the Minister would instruct the HSE to indicate the numbers who may be involved in this. I have spoken to some of the women involved. They are in constant pain. I believe we have an opportunity to get out in front of this issue rather than chase along behind it as we so often do when issues involving women's health come to the fore.

Simon Harris (Wicklow, Fine Gael)
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That is a contribution with which I can agree fully. I will ask the chief medical officer to ascertain as part of his work how many women have availed of this procedure and the international experience in this regard. This involves talking to regulators and expert bodies in Ireland and abroad. If anybody in this country has experienced any pain, suffering or difficulty as a result of a procedure performed here or abroad, I take that extraordinarily seriously. I will keep the Deputy informed about this. I am happy to liaise with her with regard to any women she is aware of. I make the point that six women have come forward to the HPRA. If there are other women who have experienced adverse impacts, I respectfully ask that they consider coming forward as well, which would be helpful in terms of getting a full sense of the scale of the challenge, in addition to the chief medical officer's work. The very important message we should all send out is that no woman should suffer or be left in pain and if anybody is, they should revert to their GP or the hospital where the device was fitted so they can receive appropriate medical attention.