Simon Harris (Wicklow, Fine Gael) | Oireachtas source

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.

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