Bayer to stop sales of Essure birth control device tied to injuries

Henrietta Strickland
July 22, 2018

A logo of Bayer is seen next to dark clouds at Cologne Bonn airport March 27, 2015.

Essure, a non-surgical sterilization device that is inserted into the fallopian tubes and prevents pregnancy by producing scar tissue that blocks sperm from fertilizing eggs, will no longer be available in the USA after December 31, 2018, Bayer announced in a statement.

Bayer said in a statement that the decision was not related to safety concerns. "This decision is based on a decline in USA sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable", the statement reads.

It said it had informed the U.S. Food and Drug Administration of its decision and would update healthcare providers.

Scott Gottlieb said in a statement Friday the company's decision follows the FDA's patient safety action in April when the agency ordered sales and distribution of Essure be restricted.

Bayer said extensive research by the company and independent medical researchers showed Essure was safe. Over the course of three months following implantation, scar tissue - or a "natural barrier", as Bayer puts it - builds up around the coils, blocking the fallopian tubes and thus the ability of sperm to fertilize a woman's eggs.

On Tuesday, Firmalino and other Essure activists held a daylong protest outside Bayer's US headquarters in Whippany, N.J. As part of it, they broadcast a clip from the forthcoming Netflix documentary about medical device failures called The Bleeding Edge.

Bayer has been accused in lawsuits of knowing the risks associated with Essure and failing to warn sellers, doctors and regulators.

Bayer marketed Essure as the only device able to provide permanent sterilization to women without surgery or anesthesia.

The permanently implanted birth control device was approved in 2002 and given the FDA's strongest safety warning label in 2016, following thousands of complaints from women who said it caused pelvic pain, hair loss, muscle weakness, perforation of the uterus and other issues.

"Seven long years of fighting to get Essure removed from the United States market has finally paid off", said Angie Firmalino, who formed a Facebook group in 2011 called Essure Problems and sparked a grass-roots movement of women advocating against the device.

The FDA said the product saw a 70 percent decline of sales in the US after it added a boxed warning and patient decision checklist to the labeling.

Other reports by Click Lancashire

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