Bayer Continues to Deny Adverse Side Effects of Essure Birth Control

Although tens of thousands of women have d documented their adverse experiences with Essure on Social Media, Bayer continues to stand behind Essure's safety and efficacy

Monday, July 30, 2018 - The Essure website has an urgent notice that all doctors and patients contemplating using the Essure birth control device as a family planning tool should read. The news release states that "Bayer has made a business decision to voluntarily discontinue sales and distribution of the Essure System for Permanent Birth Control in the United States after December 31, 2018. The voluntary market withdrawal 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."

Merely taking Essure off of the market was not enough for Bayer. The news release states that the company continues to guarantee that Essure is safe and effective and that the decline in sales is due mainly "inaccurate and misleading publicity about the device." In fact, financial experts estimate that sales of Essure may have declined as much as 90% this year. Bayer claims that independent researchers have conducted studies on over 200,000 Essure women over two decades. Bayer lawyers may have never seen the Facebook Group "Essure Problems" where close to 40,000 women write about the negative, life-altering, adverse side effects of Essure in excruciating detail and without fear of reprisal.

Before finally issuing the voluntary market withdrawal, Bayer and Essure have been, and continue to be, under pressure to take Essure off of the market and to do more testing at the very least. Tens of thousands of complaints have drawn celebrity activist Erin Brockovich, as well as US Congressman Fitzpatrick to lobby for Essure's removal. Their efforts led the FDA to undertake a "post-market" study of Essure starting in February 2016. Essure has been required by the FDA to place a "black box" warning on their packaging. A black box warning is a designation reserved for medical devices that may cause serious injury or death of the patient.

Finally, in April of 2018, the FDA required doctors and patients to fill out a "Patient Decision Checklist" that confirms women understand the device's risks so that they can make an informed decision. According to CNN.com, doctors are not complying with the FDA's requirements and Essure Problems report that more than 90% are not getting the Essure warnings and required questionnaire. Doctors have mostly ignored the FDA's orders and the patients continued to be unaware of Essure's potential side effects.

Pressure on Bayer to remove Essure from the market is in response to the concerns of thousands of women that have filed adverse event reports with the FDA reporting adverse symptoms such as heavy bleeding, crippling body aches, adverse auto-immune reactions, total body rashes, constant, severe pain in their reproductive organs that has left many bed-ridden, nausea, headaches, extreme fatigue and many, many more symptoms. Essure resembles the spring coil in ballpoint pen. The device is inserted into the vagina and placed on the inner walls of the Fallopian tubes where in about three months, sufficient scar tissue develops to prevent fertilization.

Sources:

https://www.forbes.com/sites/tarahaelle/2018/07/27/bayers-removal-of-contraceptive-device-essure-praised-by-activists/#228fb2cd4a23

https://edition.cnn.com/2018/04/09/health/fda-restricts-essure-device/index.html

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