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FDA Restricts Sales of Essure Contraceptive Implant

April 11, 2018

On April 9, 2018, the Food and Drug Administration (FDA) announced it would require Bayer to restrict the sale and distribution of its Essure permanent birth control implant to medical practices that agree to fully inform women about the device’s risks and benefits as specified in newly approved product labeling.

This new labeling, which was approved as a special PMA supplement, includes a patient-doctor discussion checklist that must be reviewed by providers with all patients considering Essure for their method of birth control. The device is used as a nonsurgical alternative to tubal ligation.

In November 2016, the FDA required Bayer to add a boxed warning to the Essure product labeling regarding risks for adverse events associated with the device “including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.”

 

Food and Drug Administration (FDA). FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information [news release]. April 9, 2018. Available at: click here. Accessed April 10, 2018.