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Essure Panel Stresses Need For Patient Follow-Up, But Stressed-Out Patients Say, ‘Recall It’

This article was originally published in The Gray Sheet

Executive Summary

An FDA advisory panel recommended a collection of activities to mitigate risk in the use of Bayer Healthcare’s Essure permanent contraceptive device, but dozens of patients describing hypersensitivity, extreme pain, insert migration, irregular bleeding, ectopic pregnancy and perforation events urged FDA to recall the device.

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