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MHRA statement on Essure devices

Advice for women following the decision by Bayer to withdraw the Essure device from the European Market.

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Bayer has advised the Medicines and Healthcare products Regulatory Agency that they are withdrawing the Essure Device from the European Market.

The manufacturer has advised this is a commercial decision and is not related to any safety concerns and the device will continue to be available in the USA. They have also advised there is no need for women to have their device removed.

Patient safety is our highest priority and there is currently no evidence to suggest any increased risk to patient safety. Any women with questions should speak to their GP or healthcare professional.

We encourage any woman who has experienced a complication from her Essure device to report this to us through the Yellow Card scheme, regardless of how long ago the implant was inserted.

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Published 21 September 2017