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Orthopaedic Alerts - Implant Recall

Details
By Michelle Llamas
Michelle Llamas
Alerts
06 March 2016

FDA Mandates Essure Black Box Warning, More Safety Studies

Nurse scrolls through tablet info

After months of deliberation, the U.S. Food and Drug Administration announced it is mandating stronger warnings and more studies for Bayer’s controversial Essure Permanent Birth Control device. The decision ignited a social media firestorm among women who say the device caused them severe, permanent injuries and led to hundreds of fetal deaths.

Essure is a permanent birth control device made up of two nickel-titanium coils that doctors implant into a woman’s fallopian tubes. In about 3 months, scar tissue forms, blocking the tubes and preventing eggs from being fertilized. But, tens of thousands of women have spoken out about severe complications linked to the device, including organ perforation, severe pain and ectopic pregnancies.

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Last Updated: 06 March 2016
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