Dáil Éireann Debate, Tuesday - 7 November 2017
846. Deputy Louise O'Reilly asked 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]
Amharc ar fhreagraThe 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 online reporting system or by downloading and completing an incident report form which is also available from its website, www.hpra.ie
