FDA Revisits Safety of the Essure Contraceptive Device

The Essure contraceptive device is placed in the fallopian tubes, where it causes scarring that blocks sperm from reaching eggs.

After their third son was born, Tisha Scott and her husband decided they were done having kids. So Scott, 34, of Drakesville, Iowa, decided to get her tubes tied. […]

But instead of undergoing surgical sterilization, Scott’s doctor urged her to try something called Essure — the only available, nonsurgical permanent birth control option approved by the Food and Drug Administration. […]

Scott is among thousands of women who blame Essure for a variety of complications, including pain, heavy bleeding, fatigue, hair loss and depression.

Because of complaints, the FDA has asked a panel of outside experts to take another look at Essure during a public hearing on Thursday.

“This device has been sold to tens of thousands — probably hundreds of thousands — of women as a very safe and easy way to permanently end any concerns about pregnancy,” says Diana Zuckerman, who heads the National Center for Health Research, a Washington-based watchdog group that has been studying Essure. “We know that’s not accurate,” she says.

Zuckerman says that Bayer, the company that makes Essure, didn’t fully inform the FDA about the problems the device can cause when it got the device approved in 2002. And while Essure is supposed to be 99 percent effective, Zuckerman says recent research suggests it may actually fail about 10 percent of the time.

“What we’d like to see is new research that’s carefully monitored that can actually tell us how often women have these serious complications from Essure and how often the product does not work to prevent pregnancy. That’s what we really need,” Zuckerman says. […]

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