essure fda

FDA reviewing complaints about Essure

Jennifer is a mother of two. She lives in Glendale with her family, including two additional stepchildren. With a full house, she wanted permanent birth control.

She chose Essure. The device consists or two small metal coils which are placed inside each fallopian tube. Scar tissue grows to block conception.

But, even after doctors confirmed her fallopian tubes were fully blocked, Jennifer got pregnant.

“Essure just basically didn’t do its job. And because of that, we had to pay the price. Other women have to pay the price,” said Jennifer.

Jennifer is talking about a group of women sharing their experiences with Essure on Facebook .

Many describe the exact same symptoms like extreme bloating, skin rashes and headaches. They also post pictures, including photos of X-rays that show coils cutting through fallopian tubes and broken coils after they were removed.

There are more than 3,500 women in the group and the number keeps growing.

Patients and doctors also reported these same issues to the Food and Drug Administration. The federal government received a total of 943 adverse event reports about Essure.

Including the first reported death associated with Essure.

Now, a month after our initial investigation, the FDA responded to public pressure.

In a statement posted on their website , the agency states they “reviewed” the complaints and clinical trial documents.

They acknowledge some of the complaints are symptoms included in the Essure labeling, and some that are not.

The FDA states, at this point, its “found no evidence” of “more widespread complications” about Essure and said nothing about it’s status as a defective medical device.

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