Women are voicing complaints to federal regulators and on Facebook about their painful experiences with a permanent birth control device called Essure.
They're describing it in stark terms: "It's a constant pain that doesn't go away," one woman said. "It felt like barbed wire inside of me," said another. "It's excruciating," a third woman said.
Last year, after Becky Beesley of Gilbert, Ariz., decided she did not want any more children, she chose to get Essure birth control.
Essure is marketed as permanent birth control women can use without having surgery. It's meant to be cheaper, easier and safer than a tubal ligation, which involves having the fallopian tubes tied.
During the non-surgical Essure procedure, metal coils are placed inside a woman's fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.
"I had the Essure coils put in and immediately my body rejected the procedure," Beesley said. "My leg started to tremor and I threw up a couple of times."
Within a few months, Beesley started experiencing serious health issues, she said. "I felt like there were little gremlins ... that were just trying to claw their way out."
The pain got so bad, she said she couldn't work; she had to quit her job as a teacher. Eventually, her doctor removed the coils. But she said that didn't end her pain.
Beesley saw several different doctors, she said, trying to find the source of her pain. Eventually, one of them ordered an X-ray.
The X-ray revealed the source of her pain: "There were still pieces of the coil in my uterus," she said.
The only way to get them out was extreme: She had a hysterectomy that removed her reproductive organs.
"It's sad. I try not to cry about it. This has been a really difficult situation for me," Beesley said, fighting back tears.
The Essure coils have been around since 2002. According to the manufacturer, about 750,000 women have had the device implanted to date.
The company that developed Essure, Conceptus, conducted two years of clinical trials before the U.S. Food and Drug Administration approved the device. Bayer Healthcare bought Conceptus last June.
Bayer refused an interview for this story, but provided a statement:
"At Bayer, we care about patients and take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause. Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure's safety, efficacy and cost-effectiveness."
But since 2004, 838 women and doctors filed complaints of 'adverse events' with the FDA.
A look at those records shows:
-- There were 150 complaints where the coils broke or otherwise malfunctioned; even more complaints detail the device moving or puncturing the fallopian tube;
-- Some 91 women reported having hysterectomies to remove the coils.
-- Eighty women reported they became pregnant while using Essure;
Women also are sharing their experiences with Essure on Facebook. They have formed a public page called "Essure problems" to share information about the implant procedure and its potential side effects.
There is also a private Facebook group, where thousands of women are sharing their experiences with Essure. The posts show women, many with the same symptoms, describing severe problems after getting the Essure coils implanted.
Most of the comments and photos detail side effects from an allergy to nickel, which is a component of the coils. Originally, women were advised to test for that allergy before getting Essure, but the manufacturer asked the FDA to remove that requirement a few years ago.
Women in the Facebook group describe extreme bloating, skin rashes and headaches. X-rays show the coils perforated the fallopian tubes of some women. And there are photos of broken coils after they were removed.
Famed activist Erin Brockovich has also started a petition on her website for people to sign who want to voice their dissatisfaction with the product.
"These women didn't sign up to have hysterectomies," Brockovich said. "I don't know what else it takes for us to look at a group of women -- thousands of them -- who are having a problem that maybe something is wrong."
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