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Bayer To Stop Selling Essure In USA

Holly Kelly Ennis July 20, 2018

Shouts of joy from tens of thousands of women injured by the Essure sterilization device were heard around the United States moments ago when Bayer announced it would no longer be selling the controversial device by the end of the year.  This brings to an end a protracted battle waged by the grassroots movement, The Essure Problems Group, against the pharmaceutical giant, Bayer, a true David versus Goliath victory.

In a statement Bayer said, "This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable."  Many believe that The Essure Problems Group is primarily responsible for the decline in sales.  According to a Washington Post article, Bayer "stands by the safety and effectiveness of the device, and added that women who currently have Essure in place can continue to rely on it."  The full Washington Post article can be read here. https://www.washingtonpost.com/news/to-your-health/wp/2018/07/20/sales-of-essure-birth-control-implant-halted-by-bayer-u-s-was-last-to-sell-controversial-device/?noredirect=on&utm_term=.d3252d31e105

The United States is the last country in which Essure is being sold.  Last September, "citing commercial reasons," Bayer announced it was ending sales outside of the United States.  The Essure Problems Group helped accomplish this cessation of sales as well, with strong social media protests from Essure Problems Groups in Spain, France, Italy, The Netherlands, Finland and other European countries.

In February, Admins from the Essure Problems Group, Madris Tomes of Device Events and Essure attorney Holly Ennis, met with FDA Commissioner Scott Gottlieb and complained that many women were not being warned about the dangers of the device, despite the Black Box Warning.  In April, the FDA imposed a unique restriction on the product by limiting sales to doctor's offices and medical practices who guaranteed to fully inform women about the products' risks. However, in a letter to FDA Commissioner just delivered yesterday, the Group advised Commissioner  Gottlieb that none of the FDA's mandates were being followed by Bayer nor the implanting physicians.

According to the New York Times, Bayer said its decision was based on declining sales, and blamed "inaccurate and misleading publicity," as a key factor.  The full article can be read at https://www.nytimes.com/2018/07/20/health/bayer-essure-birth-control.html  However, it is believed that Bayer wanted to get out ahead of a powerful and damning documentary regarding Essure and the medical device industry, The Bleeding Edge, which will be released worldwide on Friday, July 27th.  This coupled with the Essure Problems Group holding a rally and a screening of The Bleeding Edge outside of Bayer's New Jersey headquarters this week, may have hastened this announcement.

Whatever the reasons for the withdrawl of Essure from the market, tens and tens of thousands of women are rejoicing today and celebrating their victory in a long and hard-fought battle. Cheers to all the Essure Ladies.

If you or a loved one have been injured by the Essure device, contact Holly Ennis at Ennis & Ennis, P.A., at Holly@ennislaw.com or visit us online at www.Ennislaw.com