Louise O'Reilly (Dublin Fingal, Sinn Fein)
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845. To ask the Minister for Health the procedure when a device is reported to the Health Products Regulatory Authority, HPRA; if the HPRA has the power to have a medical device removed from the Irish market; if not, the reason therefor; his views on whether this is putting persons at risk; and if he will make a statement on the matter. [46976/17]

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. Its role is to monitor the safety of medical devices and to ensure the manufacturer takes any necessary measures relating to their devices so they can be used safely without posing unnecessary risk to patient or user health. The HPRA has the powers to take all appropriate measures to withdraw devices from the market or prohibit or restrict their being placed on the market or put into service. Under S.I. No. 444/2001 - European Communities (Medical Devices) (Amendment) Regulations, 2001, where the ‘Competent Authority considers that, in order to ensure protection of health and safety or to ensure that public health requirements are observed in accordance with Article 36 of the Treaty of Rome, the availability of any device should be prohibited, restricted or subjected to any particular requirements, it may give a temporary direction to that effect’.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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846. To ask the Minister for Health if there is a database log of complications experienced by women that have been fitted with a transvaginal mesh device; if not, the reason there for; and if he will make a statement on the matter. [46977/17]

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. As the Deputy was previously advised, to date, the HPRA identified two unconfirmed reported incidents in respect of transvaginal mesh devices and vaginal mesh implants.

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,