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FDA restricts sales of Essure birth control device

A KARE 11 investigation revealed more than 5,000 women filed grievances with the FDA between 2002 and May 2015 about so-called "permanent'' birth control device called "Essure."

Pain. That was the common thread linking six Minnesota mothers who received a birth control device called, Essure. The six were among thousands of women across the nation who said they suffered extreme complications due to the popular birth control device.

Four years ago, some of the women told us the pain was so serious they had hysterectomies to remove the flexible coils inserted into their fallopian tubes.

Monday, the U.S. Food and Drug Administration restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”.

Dr. James Presthus, an early advocate for Essure, specializes in gynecology and once sat on a medical advisory board for Essure.

“The FDA now is requiring any physician or clinic that is going to be doing an Essure procedure to give the patient a 22 page booklet that goes into detail about the potential problems or complications associated with Essure,” he said. “There is also a three-page consent form where the patient and physician have to both sign it and check off boxes they understand exactly the potential risks and complications.”

Presthus, who stopped offering the service two years ago, said he was not surprised by the FDA’s latest move.

“I feel this is probably a first step toward the FDA requesting that this be removed or Bayer pulling the product from the market,” he said. I have seen a lot of patients that have had problems. Almost in every case they feel like they were not given enough information prior to the procedure. Fatigue. Hair falling out. Joint pain. It is often hard to connect these symptoms with having the Essure procedure.”

A KARE 11 investigation revealed more than 5,000 women filed grievances with the FDA between 2002 and May 2015 about so-called "permanent'' birth control device called "Essure." They complained about unintended pregnancies, miscarriages, and severe pain and bleeding.

On its website, Essure is described as permanent birth control. To learn more, click here.

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