02 fda essure contraceptive
2015: Essure sterilization method under fire
01:54 - Source: CNN

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The Food and Drug Administration held a hearing on the Essure sterilization device

Thousands of women complained to the agency about the device

CNN  — 

After giving birth to three children, Kristiana Burrell was thrilled when her gynecologist told her about Essure, a sterilization technique she could do right in the office in just minutes – no operating room, no incisions.

“It sounded terrific,” remembers Burrell, a nurse who lives in Fairview, a town in western North Carolina.

But it didn’t end up that way.

Burrell, who also has three stepchildren, said she became pregnant while using the Essure device, even though at the time she was also using a back-up method of birth control.

That baby, whom she and her husband named Ariel Grace, was born in June, nearly three months early. She never took a breath.

Burrell said her obstetrician blamed Essure for the stillbirth, saying the device’s coil ruptured her amniotic sac, causing Burrell to go into labor prematurely. She said she now needs a hysterectomy because the device has perforated her uterus.

Kristiana Burrell with her baby, Ariel Grace, who died.

“I’m so angry and hurt and depressed,” Burrell said. “We want the FDA to listen to us and take Essure off the market.”

From November 2002 through May 2015, more than 5,000 women complained to the Food and Drug Administration about the sterilization device, saying it caused problems including unintended pregnancies, stillbirths and debilitating pain and bleeding. On Thursday, the FDA held an all-day hearing on Essure, taking testimony from patients and experts, and promising to announce next steps in the near future.

660 reports of unintended pregnancies

From the time Essure went on the market in 2001 through 2010, there were 660 reports to the FDA of unintended pregnancies in the United States, according to a statement released at the hearing by Bayer, which makes the device.

They blamed a third of those cases on the patients. Women are supposed to return to a doctor’s office in three months to make sure the device is working and are supposed to use another form of birth control in the meantime.

Bayer said on its website that the device is 99% effective at permanently preventing pregnancy. Unlike tubal ligations, the procedure is done through the vagina, so there are no incisions in the abdomen.

“The safety and efficacy of Essure is supported by more than a decade of science,” Bayer said in a statement. “We sympathize greatly with any woman who has experienced problems with Essure.”

Some women said the device has worked well for them.

Jennifer Jenkins, a mother of three in Dallas, said the device has freed her from having to take daily birth control pills.

“I’ve had no problems,” she said. “It’s been, in one word, liberating.”

Conflicting studies

Bayer said Essure’s high success rate is based on a study of 449 women, none of whom became pregnant during five years of follow-up. That study was funded by Bayer. In addition, among the three co-authors of the study, one reported receiving a grant from Bayer, another reported receiving consulting fees from the pharmaceutical giant and the third reported being an adviser to the company. The study was published in the Journal of Minimally Invasive Gynecology.

In a report this week in the New England Journal of Medicine, doctors at the Yale School of Medicine accused those authors of using “fuzzy math.”

The Yale authors point out that the study looked only at women who had successful insertion of Essure, as confirmed by a test of their fallopian tubes three months after implantation. It didn’t include pregnancy rates of women for whom the insertions didn’t work.

The authors of the Yale article called for a long-term study to be done by an objective body.

Tara DiFlumeri, a spokeswoman for Bayer, said independent studies have already been done on the device.

“We disagree with many of the assertions in this article,” she said, referring to the Yale report.

But the authors of that report said women aren’t fully aware of the risks they’re taking when they choose Essure.

“When the FDA approved Essure, they moved too quickly on a relatively incomplete set of data,” said Sanket Dhruva, a Yale researcher. “We don’t really know how well it works.”

CNN’s John Bonifield contributed to this report.