Clare Daly (Dublin Fingal, Independent)
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394. To ask the Minister for Health further to Parliamentary Questions Nos. 341, 342, 346, 347 and 348 of 30 January 2018, if his attention has been drawn to a scientific study of 92,246 first time surgical mesh procedures (details supplied). [5742/18]

Simon Harris (Wicklow, Fine Gael)
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As previously indicated to the Deputy, at my request the Chief Medical Officer is preparing a report on the many clinical and technical issues involved in the use of mesh implants in urogynaecological procedures in Ireland. This work involves engagement with national and international bodies, the professional colleges and others. The work is underway and will take a number of months to complete.

The Health Products Regulatory Authority (HPRA) is aware of the information from the UK study referred to by the Deputy. The HPRA continues to liaise closely with European Competent Authorities, including the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), the European Commission and with international regulatory agencies in relation to all international evidence relating to these devices.

The safety of surgical meshes used in urogynecological surgery was reviewed by the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The Opinion of the SCENIHR is is available, together with a summary of the outcome, on the website of the European Commission. The SCENIHR summary outlines that "clinical outcome following mesh implantation is influenced by material properties, product design, overall mesh size, route of implantation, patient characteristics, associated procedures (e.g. hysterectomy) and the surgeon’s experience."

My Department strongly advises that any woman who experiences or suspects that she has experienced a complication associated with transvaginal mesh implant (TVMI) surgery should discuss this with her GP or with the hospital from which she received the implant. My Department also advises that women considering surgery involving TVMIs should thoroughly discuss with their doctors the indications, alternatives (surgical and non-surgical), benefits and risks involved in their personal circumstances.