The FDA Asks Bayer To Submit Problems Linked With Essure

The FDA Asks Bayer To Submit Problems Linked With Essure

Introduction

Last week, the U.S. Food and Drug Administration (FDA) issued a letter to Bayer indicating requirements for submitting adverse event reports and postmarket activities associated with Essure, a permanent birth control device sold in the U.S. until 2018.

According to the letter issued, Bayer gets a variance, considering the anticipated volume and nature of the information, which gives the company a year to submit postmarket adverse event reports. The variance was requested by the manufacturer as it was receiving information about problems with the recalled Essure birth control device through social media and other adverse event reports.

The variance is valid for one year unless the FDA extends it, after which the manufacturer will be required to follow the regular adverse event reporting requirements for all Essure-associated reportable events.

The reports received by the manufacturer will be made publicly available by the FDA at pre-specified time points over the next year, starting in July 2020.

Nearly 18,000 lawsuits have been filed against Bayer, each involving similar allegations that the permanent birth control device resulted in painful and debilitating complications.