Bayer voluntarily stopped selling Essure in the U.S. at the end of December 2018, and health care professionals are required to implant the devices within one year from the date of purchase. As a result, the window on new implantations is expected to close in the U.S., by the end of 2019. All devices that have not been implanted should be returned to Bayer by the end of the year, the FDA said in its latest update on Essure on November 4.
Additionally, according to the FDA 1,002 patients are enrolled in its postmarket surveillance (522) study on Essure as of September 1. The agency previously instructed Bayer to extend the study from three years to five to better understand long-term patient complications associated with the device.
More on the FDA is HERE.
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