I-TEAM Update: New restrictions placed on Essure birth control

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DECATUR, Ill. (WAND) – The FDA is imposing new restrictions on the sale and distribution of the birth control product called Essure.

“Every single woman receiving this device should fully understand the associated risks,” said FDA Commissioner Scott Gottlieb, M.D.  “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”

Essure was the subject of a WAND News I-TEAM report in October 2017.  Women in central Illinois have reported complications with the device from abdominal pain and bloating to blood clots and autoimmune diseases.  Depression, hair and weight gain have also been reported along with painful intercourse. 

Some women are reporting Essure metal coils, which are implanted by a doctor, are piercing fallopian tubes and migrating out of the tubes to other parts of the body.

Among the restrictions is a patient brochure which the doctor implanting Essure must explain to the patient.  The woman must sign the brochure as does the doctor.

Essure is manufactured by Bayer.  It has been removed from the market in every country except the United States.

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