Louise O'Reilly (Dublin Fingal, Sinn Fein)
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504. To ask the Minister for Health if there are persons here affected by problems with permanent contraceptives manufactured by a company (details supplied); and if he will make a statement on the matter. [50965/18]

Simon Harris (Wicklow, Fine Gael)
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My attention has been drawn to the recent media coverage around medical devices regulation and certain medical devices which were or are available to Irish patients

I understand that the Health Products Regulatory Authority (HPRA) has received some incident reports in relation to the Essure contraceptive product, however they have also confirmed that Essure has not been distributed in Ireland since January 2014.

The HPRA has further advised me that the sale of Essure has been voluntarily discontinued across Europe and Bayer has made the business decision to stop distribution in the US by the end of 2018 due to declining sales. The HPRA maintain a dedicated section on their own website to provide information for women who have received this device and for healthcare professionals.

With regard to the wider matter of medical device regulation and safety, a new EU Medical Device Regulation will be implemented over the coming years and will enhance and reinforce the existing regulatory system. The HPRA were one of the strongest proponents of this tightening of Regulation and indeed provided expert advice to the EU during the deliberations of this new Regulation.