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# FDA Releases 1st Essure Adverse Event Spreadsheet
- URL: https://www.fdaweb.com/fda-releases-1st-essure-adverse-event-spreadsheet/
- Published: 2020-08-11T12:00:00.000Z
- Updated: 2026-09-14T16:24:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147405

FDA has released updated information on the adverse event information from the first monthly spreadsheet Bayer is required to submit to the agency on its Essure birth control device. An agency [notice](https://www.fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure?ref=fdaweb.com#reports) (includes a link to the spreadsheet) says Bayer is required to submit the spreadsheets under a 4/24 variance from medical device reporting requirements.

The spreadsheet includes 1,453 reportable events with 53 death reports, 1,376 serious injury reports, and 24 malfunction reports.