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FDA Revisits Safety Of Essure Contraceptive Device

Sep 21, 2015
Originally published on September 21, 2015 8:23 am

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 available, 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.



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DAVID GREENE, HOST:

Today in Your Health, a new superfood craze. That in a moment. We begin with a device thousands of women use for birth control. There is a big debate about how safe it is and how well it works. Here's NPR health correspondent Rob Stein.

ROB STEIN, BYLINE: After their third son was born, Tisha Scott and her husband decided they were done having kids, so Scott, who's 34 and lives in Drakesville, Iowa, decided to get her tubes tied.

TISHA SCOTT: As old married people, neither of us was really interested in using condoms for the rest of our life. And so that was the decision that we made because we knew that our family was complete.

STEIN: But her doctor urged her to try something new, something called Essure. It's two tiny coils he could insert into each of her fallopian tubes to permanently block them. No need for surgery, so he said it would be a lot easier, quicker and safer.

SCOTT: He had this new Essure, and he felt if there was no reason to do surgery, then we shouldn't.

STEIN: But almost immediately after she got Essure, Scott started getting an excruciating burning pain in her back and pelvis.

SCOTT: All of a sudden, it hurt to have to move my body to get out of bed to do anything.

STEIN: The pain got worse and worse and spread all over her body. Despite two operations and tons of tests and exams, Scott says she still lives in constant, terrible pain.

SCOTT: It feels like you've been hit by a truck everyday of your life. And for me, it's been a nightmare. I mean, this device literally ruined my life.

STEIN: Scott is among thousands of women who blame Essure for all kinds of problems - constant pain, heavy, sometimes nonstop, bleeding, fatigue, even depression.

DIANA ZUCKERMAN: 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. We know that that's not accurate.

STEIN: Diana Zuckerman heads the National Center for Health Research, a Washington-based watchdog group that has been studying Essure.

ZUCKERMAN: What we don't know is exactly how often it works, and we don't know exactly how often it causes what can be severe, debilitating, life-changing complications.

STEIN: Zuckerman charges the company that makes Essure didn't tell the FDA about all the problems it can cause when it got the device approved 13 years ago. And Zuckerman says Essure's supposed to be 99 percent effective, but she says recent research suggests it may actually fail about 10 percent of the time.

ZUCKERMAN: 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.

STEIN: Officials at Bayer, which makes Essure, defend the device. Edio Zampaglione is the company's vice president for women's health care.

EDIO ZAMPAGLIONE: There's a significant amount of data out there regarding the safety and efficacy of Essure, and what has been noted and seen in all these studies and analysis is that there's a very consistent reporting, let's say, of the safety and efficacy.

STEIN: Now, Bayer does acknowledge that the device can cause complications but says they occur only in a small percentage of women.

ZAMPAGLIONE: What we believe and feel is that these women represent the small percentage of women who have had a bad experience with it. Every drug that's available in the world, every procedure that is done carries risks as well as benefits. There is no procedure, there's nothing that we do or take in the medical world that is 100 percent adverse-event free.

STEIN: But for most women, Zampaglione says getting sterilized with Essure is quick, easy and safe and totally reliable. That was the case for Jennifer Jenkins. She's 33 and lives in Dallas. She got Essure about two years ago during a quick stop at her doctor's office on her way to work.

JENNIFER JENKINS: I had no problems. My husband likes to say the only side effect I've experienced is that I haven't been able to get pregnant (laughter) which has been a good thing (laughter).

STEIN: The FDA is holding a hearing on Thursday to find out more about Essure, including just how safe and effective it really is. Rob Stein, NPR News. Transcript provided by NPR, Copyright NPR.