FDA revisits safety of the Essure contraceptive device
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.
"As old married people, neither of us was really interested in using condoms for the rest of our life," Scott says. "So that was the decision that we made because we knew that our family was complete."
But instead of undergoing surgical sterilization, Scott's doctor urged her to try something called Essure — the only nonsurgical permanent birth control option approved by the Food and Drug Administration.
Essure is a device comprising two tiny coils made of nickel-titanium alloy. Scott's doctor inserted one into each of her fallopian tubes to permanently block them. Since Essure doesn't require surgery, he said it would be a lot easier, quicker and safer.
"He felt if there was no reason to do surgery then we shouldn't," Scott says.
But almost immediately after the procedure Scott started getting an excruciating burning pain in her back and pelvis. "All of a sudden it hurt to have to move my body to get out of bed, to do anything," she says.
The pain got worse and spread all over her body. Despite two operations and many tests and exams, Scott says she still lives in constant pain.
"It feels like you've been hit by a truck every day of your life," she says. "For me, it's been a nightmare. I mean, this device literally ruined my life."
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.
Officials at Bayer defend the device.
"There's a significant amount of data out there regarding the safety and efficacy of Essure," says Edio Zampaglione, the company's vice president for women's health care.
Zampaglione acknowledges that the device can cause complications, but says they only occur rarely.
"What we believe and feel is that these women represent the small percentage of women who have had a bad experience with it," Zampaglione says. "There's nothing that we do or take in the medical world that is 100 percent adverse-event free," he says.
For most women, Zampaglione says, getting sterilized with Essure is quick, easy, safe and totally reliable. That was the case for Jennifer Jenkins, 33, of Dallas. She got Essure about two years ago during a quick stop at her doctor's office on her way to work.
"I had no problems," Jenkins says. "My husband likes to say the only side effect I've experienced is that I haven't been able to get pregnant, which has been a good thing."
An earlier story on the questions surrounding Essure ran in Shots in July.
— via NPR