Bayer to phase out Essure birth control device in U.S.

Bayer to phase out Essure birth control device in U.S.

Bayer to phase out Essure birth control device in U.S.

In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits.

Marcus Susen, a Florida-based lawyer representing a number of women who have sued the company, called its decision long overdue, and said it would be up to a jury to decide if Bayer stopped the sale of Essure for commercial or safety reasons. In April, the agency moved further, restricting Essure sales to medical practices that agree to inform patients of the risks involved.

Essure is made of two inch-long flexible metal coils.

The device was developed by Conceptus Inc. and acquired by Bayer in 2013.

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The pharmaceutical giant Bayer announced Friday it would stop selling the Essure birth control device in the United States by the end of the year, handing a symbolic victory to thousands of women who say the implant caused serious health issues and excruciating pain.

Bayer in a statement said the decision was not related to safety concerns.

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 US after December 31, 2018, Bayer announced in a statement.

The announcement comes after years of claims by thousands of American women who used the implant that Essure caused serious problems. "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.

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Dr. Christopher M. Zahn, vice president of the American College of Obstetricians and Gynecologists, said in a statement Friday that the safety data on hysteroscopic sterilization, the fallopian tube procedure by which Essure works, "has not changed".

In February 2016, the FDA required Bayer to conduct a post-marketing study which resulted in the addition of a Boxed Warning and patient decision checklist to the labeling 7 months later.

"I also want to reassure women who've been using Essure successfully to prevent pregnancy that they can continue to do so", Gottlieb said. It was not immediately clear what impact Bayer's decision would have on the studies. This is the last place in the world where Essure was still sold.

On Tuesday, Firmalino and other Essure activists held a daylong protest outside Bayer's USA 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.

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