Louise O'Reilly (Dublin Fingal, Sinn Fein)
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847. To ask the Minister for Health if transvaginal mesh devices underwent testing before coming onto the market here; the details and results respectively of the testing; and if he will make a statement on the matter. [46978/17]

Simon Harris (Wicklow, Fine Gael)
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All medical devices, including transvaginal mesh devices, are certified (CE marked) at European level prior to being placed on the market. For mesh devices as class IIb medical devices the products are certified by independent certification organisations, called notified bodies, who are required to have the necessary expertise to assess different types of device technologies. This EU-level assessment demonstrates that the devices comply with the Essential Requirements of the medical device legislation, including those relating to performance and safety. This certification is based on assessment of relevant testing, technical, pre-clinical and clinical data to demonstrate the technical characteristics and the clinical safety and performance of the device.

The Health Products Regulatory Authority (HPRA) is the competent authority for medical devices in Ireland. In accordance with the EU legislation it does not approve medical devices prior to their being placed on the Irish market, rather it has a post market surveillance role where they monitor the medical devices on the market. The approval of medical devices prior to their being placed on the market is carried out at European level by notified bodies. The HPRA does not have access to the specific details and results of testing conducted on individual devices as this information would normally be held by the EU notified body who certifies the device.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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848. To ask the Minister for Health if he will request the HSE and private surgeons that have implanted transvaginal mesh devices to write to the women involved outlining the possible complications or side effects which are associated with such implants in order that their attention is drawn to issues and they are informed in this regard, in view of the fact that many side effects do not occur until many years later; and if he will make a statement on the matter. [46979/17]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines and medical devices in Ireland.

The HPRA does not routinely collect or maintain information on the number of women in Ireland who have received transvaginal mesh devices or vaginal mesh implants as the HPRA does not have a direct role in approving, licensing or certifying medical devices that are placed on the market in Ireland. They have a post market role where they monitor the medical devices on the market.

The HPRA strongly encourages those who have experienced a safety issue with a medical device, including transvaginal mesh devices or implants, to report it through its medical device adverse incident reporting system. The system is accessible to patients, healthcare professionals or any person who identifies a medical device safety issue. Issues or concerns about a medical device can be submitted through the HPRA website’s or by downloading and completing an which is also available from its website, .

It is important to note that these devices continue to be certified as compliant with relevant EU legislation and have not been subject to specific recall.

The use of transvaginal mesh in a procedure is a clinical decision made by the consultant with the patient, at which point possible complications would be brought to the patients attention