Bayer ESSURE device for permanent birth control

The sale of the medical device for permanent birth control Essure has previously been voluntarily discontinued in Europe and now Bayer has made the business decision to stop distribution in the US by the end of 2018 due to declining sales. Bayer have communicated that the benefit-risk profile of Essure has not changed and remains positive, and that women who have had Essure inserted for permanent contraception can continue to safely use the device.

The HPRA understands that this device has not been distributed in Ireland since January 2014.

The HPRA would like to advise women who are implanted with this device:

• If you do not have any symptoms, there is no need to have the device removed, or to take any further action.
• If you have any questions or concerns about your Essure implant, or if you suspect that you have encountered an adverse event due to your implant, visit your doctor who will be able to advise you on next steps.
• If you would like to report a suspected adverse event, please complete a medical device incident user report, available on our website at: http://www.hpra.ie/homepage/about-us/report-an-issue/mdiur

The HPRA would like to advise healthcare practitioners:

• Bayer continues to provide information to Healthcare Professionals (HCPs) who have questions about the product. They can be contacted at: Bayer Ltd, The Atrium, Blackthorn Road, Dublin 18; Tel: +353 1 206 3300; Fax: +353 1 2061539; E-mail: info.ireland@bayerhealthcare.com
• If you would like to report a suspected adverse event, please complete a medical device incident user report, regardless of how long ago the implant was inserted, please visit our website at: http://www.hpra.ie/homepage/about-us/report-an-issue/mdiur