AQW 20981/17-22

Ms Paula Bradshaw
Alliance Party
South Belfast

Tabled Date: 25/06/2021
Answered On Date: 07/07/2021
Priority Written: No

Question:
To ask the Minister of Health what advice was given, by its manufacturer Bayer, to Health and Social Care Trusts when Essure was withdrawn from the market in 2017.

Answer:

Following the suspension of the Essure device’s CE mark in 2017, the manufacturer Bayer released a Field Corrective Action (FCA) notice and an accompanying patient information leaflet to their customers, recommending voluntary action to suspend any implantation of Essure devices and quarantine any remaining inventory. The information leaflet for patients advised that the product had a positive benefit /risk profile and that women with the device inserted should have no concern from this decision.

In line with the manufacturer’s recommendations, the Department advised Health and Social Care Trusts that they should quarantine their inventory and suspend use of the Essure Device.

Subsequent to this, Bayer permanently withdrew the device from the market. Bayer’s advice was that this was for commercial reasons and not related to product safety or quality issues.