Women share Essure stories as FDA prepares its ruling

FOX Files
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ST. LOUIS (KTVI) – Any day now, the federal government could announce its evaluation of  the popular birth control device Essure. Fox 2 News gathered 10 women in our studios who said they experienced life-altering complications from the non-surgical, permanent birth control procedure.

The FDA’s website shows more than 5,000 complaints. Women affected testified last September at hearings in Washington D.C. No recommendations have been made since the hearings, but one is expected by the end of February.

A Pennsylvania lawmaker introduced the E-Free Act in congress that if passed would require the FDA to withdraw Essure.

Fox 2 News contacted Bayer, the company that markets Essure. Bayer says it stands by the positive benefit-risk profile of Essure. The statement goes on to say Bayer’s highest priority is patient safety and, “we sympathize greatly with any woman who has experienced problems with Essure.”

UPDATE: This report was updated on February 15, 2016, to clarify Bayer’s public statement as follows: An Essure insert may migrate into the lower abdomen and pelvis and may require surgery for removal.  Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching, and hives.

 

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