Women who used Essure experienced pain, device migration, perforation, heavier periods, breaking of the Essure and a failure to prevent pregnancy. At least 49 people are reported to have died due to their Essure implant Litigation followed.
Essure consists of metal coils that are inserted into the fallopian tubes where they block an egg from implanting. The theory is that scar tissue would form around the implant essentially blocking the tube and preventing pregnancy. Bayer has now released its early adverse event reports, collected from the FDA’s MAUDE data on complications.
Bayer promises to provide quarterly analyses on Essure and the FDA promises to make spreadsheets on adverse events associated with essure, available every month.