Heads up

FDA gives “black box” warning to dangerous contraceptive device

Carrie Hirmer (L) and Chandra Farmer, both testified at a Food and Drug Administration meeting about their experiences using Essure in 2015. (T.J. Kirkpatrick/The New York Times)

The U.S. Food and Drug administration announced this week that it’s requiring the agency’s most dire label — a “black box” classification — to be used on packaging of the birth control device Essure. The warning is used to indicate that there’s significant evidence that a prescription drug can cause life-threatening side effects. Essure is a controversial permanent form of birth control. Between 2002 and 2015, more than 5,000 women have filed grievances with the FDA complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after having Essure implanted. Essure is a prescription device that is non-surgically implanted in a woman’s fallopian tube that eventually causes scar tissue to develop, which prevents sperm from reaching eggs.

In a statement, FDA physician and researcher William Maisel said the FDA action “will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them.” But critics of Essure are saying the FDA hasn’t gone far enough and are calling for a full recall of the device. A Facebook group known as the E-Sisters fired back at the decision in a post on the social media platform, saying, “This is all UNACCEPTABLE.” One member of the group lashed out in a post saying the FDA is acting recklessly with the health of future American women. “I’ve seen autoimmune problems. I’ve seen cancer. I’ve seen suicide. I even seen deaths … We didn’t ask for any of this nor did we know,” the group member wrote. And the “black box” decision is hardly the only criticism the group is leveling at the FDA.

Read the full story at Vocativ.

Related:

Essure contraceptive implant coming under heavy fire

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