Sunday, August 18th, 2019
Home >> Breaking News >> Bayer to Stop Selling Essure Birth Control

WRIC TV, Essure Protest

Women’s Health Litigation, July 21, 2018~ Essure was approved by the Food and Drug Administration in 2002 and this week, after 16 years on the market and thousands of reports of complications, Bayer AG will finally stop selling the controversial medical device in the U.S.

Bayer will stop selling the controversial Essure implantable birth control device by the end of the year due to a loud and vocal campaign by thousands of women who do not believe it is safe.   So far there are 16,000 lawsuits blaming Essure for perforated uterus and fallopian tubes, several deaths have been reported, including a few infants, attributed to the use of Essure.

For its part, Bayer says the move is a “business decision,” not due to litigation or safety issues. – fewer women want to choose Essure as a method of birth control. Sales have reportedly dropped 70 percent.

Essure, CBS News

Essure is made up of two small coils, comprised of nickel and a polyester like fiber that are placed in the fallopian tubes to prevent conception. The tube causes women to develop an inflammatory response and scar tissue but users report severe bleeding, miscarriage, an autoimmune response, and hair and tooth loss.

Essure has a black box warning on the product package.

Bayes no longer sells Essure in England, Brazil, France and Canada.  The U.S. is the last country where Essure is sold.

The campaign has been a vocal one carried out largely on Facebook. Essure Problems has 36,000 members who repeated requested the Food and Drug Administration recall the device.  That did not happen.

The Washington Post reports Angie Firmalino, of Tannersville, N.Y., who started Essure Problems on Facebook, said upon the announcement that she was “blown away,” but that “it took way too long, but we won.”

Last April, the FDA required Essure sales be limited to doctor’s offices and medical practices noting that from 2002 to 2017 it had received nearly 27,000 reports of complications.  Madris Tomes, who used to work at the FDA and now has an independent company that analyzes data, says the number is closer to 30,000.

How Essure works, classaction.com

Essure was approved by the FDA in 2002 and developed by Conceptus Inc. of California. The German company, Bayer AG, acquired the company in 2013.

Bayer says it is “increasingly concerned with the continued spread of misinformation that may scare women with Essure to seek removal, which can lead to serious and unnecessary surgery, as well as post-operative complications.”

The company plans to enroll participants in a postmarket surveillance study.

LEARN MORE:

Washington Post February 29, 2016, FDA to require “black box” warning, but leaves controversial Essure implant on the market

FDA Activities: Essure
https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452254.htm

Essure Problems on Facebook

https://www.facebook.com/Essure-problems-178631888835781/

YouTube Essure
https://www.youtube.com/watch?v=c3erRsXpGvs

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