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Bayer Announces Essure Will Be Taken Off The US Market

Citing a decline in sales Bayer has decided to pull Essure from the US market

Tuesday, July 24, 2018 - US government regulators and health officials have been notified that Bayer Pharmaceuticals, maker of the Essure Permanent Birth Control Device will be removing Essure from the market in the US at the end of the calendar year 2018. The decision follows actions taken by the FDA that have caused sales of Essure to plummet by 70% this year. Earlier in 2018, the FDA required that Bayer place a Boxed warning on Essure's labeling and also a "Patient Decision Checklist " in order to ensure women contemplating Essure were aware of the seriousness of the risks. According to the US Food and Drug Administration "Essure is estimated to have been used by more than 750,000 patients worldwide since it was first approved by global regulatory authorities. The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen."

The decision to remove Essure comes as the ultimate victory for members of the Essure Problems Facebook group and consumer advocate Erin Brockovich, who with the help of U.S. Rep. Mike Fitzpatrick's have lobbied for Essure's removal from the US market pending further testing of the device. Having received hundreds of complaints from Essure women suffering from serious, debilitating and life-threatening Essure side effects, Fitzpatrick introduced a bipartisan bill before Congress asking the FDA to revoke Essure's approval and halt sales. Essure's adverse side effects have been responsible for women having to have the device surgically removed and having to have partial or total hysterectomies to do so.

Nearly one million women worldwide have had the Essure birth control device implanted in their Fallopian tubes. The Essure device resembles the spring on a retractable ballpoint pen and is interwoven with fibers designed to create inflammation in the underlying Fallopian tube tissue, utilizing the body's natural response of creating scar tissue, encasing Essure device and blocking fertilization. Women are advised that it takes three months for Essure to become effective and women are advised to continue to use their other form of birth control for that period of time. Essure is inserted into the vagina and up into the Fallopian tubes in the comfort and convenience of the doctor's office without requiring admission to the hospital. Essure removal, however, requires dangerous surgery performed under general anesthesia.

Bayer's decision to take Essure off of the market in the United States followed an earlier decision made by the company to discontinue Essure sales in Europe and elsewhere around the globe. Tens of thousands of stories of Essure's adverse side effects have found their way to the "Essure Problems" Facebook group. Stories of Essure's side effects include but are not limited to heavy bleeding, constant pain, migraine headaches, fever, total body rashes from allergic reactions and autoimmune responses. Essure has been known to break free from the Fallopian tubes and migrate to and puncture other female reproductive organs such as the uterus. Essure women normally require a partial or complete hysterectomy to remove the device if in fact it can be found in one piece. Essure often breaks apart making its complete removal complicated or outright impossible and leaving Essure women permanently disabled to one degree or another.

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Onder Law is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.