Essure Devices Discontinued As Per FDA's Guidelines

Essure Devices Discontinued As Per FDA's Guidelines

Introduction

The Food & Drug Administration of the U.S. indicated that all the Essure devices are removed from the market, and the women who had permanently implanted the device are enrolled in a study to evaluate the risk associated with it.

99% of the devices were successfully retrieved from the market by Bayer, and only 10 units are remaining. Besides retrieving the devices, Bayer will study 340 women who implanted the device and compare the results to 788 women who were about to undergo laparoscopic tubal ligation.

The Essure device is used for birth control, but thousands of women suffered complications, including migration injuries, perforation, severe reactions, and other problems, which resulted in the removal of the devices from the market.

Essure is suspended from the market in most of the countries since 2017, but Bayer continued to sell the device in the U.S. until the end of 2018. In July 2018, Bayer announced to remove all the Essure devices from the U.S. market from December 2018.

Bayer is currently facing 18,000 lawsuits nationwide. Worldwide 750,000 women have been implanted with the device, of which 70% are from the U.S. as estimated by Bayer.