Dáil Éireann Debate, Wednesday - 18 October 2017
154. Deputy Louise O'Reilly asked the Minister for Health the number of persons who have received a transvaginal mesh implant procedure through the HSE; and if he will make a statement on the matter. [44268/17]
Amharc ar fhreagra155. Deputy Louise O'Reilly asked the Minister for Health the number of transvaginal mesh implant procedures carried out here, by year, in tabular form; and if he will make a statement on the matter. [44269/17]
Amharc ar fhreagra156. Deputy Louise O'Reilly asked the Minister for Health the number of women who received transvaginal mesh implant procedures and who are now taking legal action against the HSE or the State; and if he will make a statement on the matter. [44270/17]
Amharc ar fhreagra157. Deputy Louise O'Reilly asked the Minister for Health when his attention was drawn to the side effects and complications of transvaginal mesh implant procedures; the steps he took to address the situation; and if he will make a statement on the matter. [44271/17]
Amharc ar fhreagraI propose to take Questions Nos. 154 to 157, inclusive, together.
While the detailed information requested by the Deputy may not be available, I have asked the HSE to respond to you directly to provide you with whatever information is available.
In relation to the broader issue, the Deputy may wish to note that the role of the Health Products Regulatory Authority (HPRA) is to protect and enhance public and animal health by regulating medicines, medical devices and other health products.
Most medical devices are initially assessed and approved by a separate organisation called a ‘notified body’ which approves them to be placed on the market. A medical device that has been approved will bear a "CE mark" which indicates it meets the basic requirements for safety and effectiveness under European law. The HPRA is responsible for monitoring the safety of medical devices in Ireland after they are placed on the market.
The HPRA operate a national reporting system for medical devices and encourages users of devices to report incidents or problems associated with their use through the HPRA website or by contacting the manufacturer directly.
