BfArM - Federal Institute for Drugs and Medical Devices

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Discontinuation of the sale of the CE marked device ESSURE for permanent birth control

Reference: 01647/16

The sale of the medical device for permanent birth control Essure has been discontinued in Europe. The manufacturer Bayer Pharma AG points out that women who have had Essure inserted for permanent contraception can continue to safely use the device.

BfArM has no vigilance reports on this device from the German market. Official investigations from different Competent Authorities have been conducted such as by the

So far, BfArM did not identify the need for corrective actions according to German legal provisions (§ 9 MPSV).

Women who may have received the implant outside Germany may contact their doctor in case of any medical questions. Bayer continues to provide information to Healthcare Professionals (HCPs) and patients who have questions about the product. They can contact Bayer Vital at:

Tel.: +49 800-64-22 937 (Germany),
Tel.: +49 214-30-51 348 (international),
Fax: +49 214-30-51 603 (Mon-Fri 08:00-18:00 hrs),
e-mail: medical-information@bayer.com .

Nevertheless, BfArM would like to point out that provisions for incident reporting (if applicable) are not revoked by the discontinuation of sale.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307 3202 (Non-active medical devices)
Facsimile: +49 (0)228 99 307 5300
E-Mail: md-vigilance@bfarm.de

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