Women are coming forward to talk about their experiences with a permanent form of birth control 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," according to another. "It's excruciating," a third woman said.
Last year, after Becky Beesley of Gilbert, Arizona decided she no longer wanted children, she chose to get Essure birth control.
"I had the Essure coils put in and immediately my body rejected the procedure," she said. "My leg started to tremor and I threw up a couple of times."
Within a few months, she started experiencing serious health issues. "I felt like there were little gremlins…that were just trying to claw their way out," she said.
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, that didn't end her pain.
She 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.
Unlike a traditional tubal ligation, Essure is marketed as permanent birth control you can get without having surgery. It's meant to be cheaper, easier and safer than getting your tubes tied.
During the procedure, two metal coils are placed inside the Fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.
It's been around since 2002. According to the manufacturer, about 750,000 have had it implanted to date.
Since 2004, 838 women and doctors filed complaints as ‘Adverse Events' with the Food and Drug Administration.
The investigative team of our sister station in Phoenix, ABC15 , found:
·There were 150 complaints where the coils broke or miss-fired;
·Even more complaints detail the device moving or puncturing the fallopian tube;
·80 women became pregnant;
·91 reported having hysterectomies to remove the device.
Now, women are sharing their experiences with Essure on Facebook. They have formed a public page called "Essure problems" that shares information about the 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 woman after woman, many with the exact same symptoms, telling nightmare scenarios 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.
The Women's Stories
ABC15 Investigators found a dozen women in the Valley who wanted to speak out about Essure. Some were too ill to attend a group interview. Seven made it. They all described Essure as a destructive force in their lives.
"I couldn't function. I couldn't be a mom to my kids. I couldn't work," said Tara Ament of Phoenix.
She had a hysterectomy at the age of 30 to remove the Essure coils.
Crystal Arias, also from Phoenix, was barely 26 when she got a hysterectomy.
"Every time I would sit down, I would feel like something was poking my stomach," said Arias. "I would feel horrible, horrible pain."
Her doctor found one of the coils had partially migrated out of her fallopian tube. Amanda Holt, of Phoenix, had a similar experience.
"One [coil] had migrated and embedded into my abdominal lining. And, the other had perforated my fallopian tube."
Four of the seven women who spoke with ABC15 had hysterectomies. The others were planning on getting them in the future.
"I've been sick for so long, that if what I had to sacrifice was my uterus and my female organs to feel better, I didn't care. I just wanted to feel good," Holt said.
Erin Brockovich Takes Action
This group of women, along with the thousands of others who have spoken out about Essure, has some significant backing: Famed activist Erin Brockovich. We flew to Los Angeles to talk with her about why she took on this issue.
"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."
In 2011, the U.S. Supreme Court ruled that you can't sue the manufacturer of a medical device to which the FDA gave pre-market approval.
"I was just astounded at what I was reading and even more angered that there was just going to be no recourse for these women," Brockovich said.
"You have to look at the numbers of women in front of you, all presenting with the same type of symptoms, from excess bleeding to hysterectomies to getting pregnant," Brockovich said.
The FDA approved Essure after two years of clinical trials. Brockovich said she does not believe Essure should be on the market.
"Women are being harmed. Somewhere we're not being informed appropriately or truthfully," she said.
Brockovich blames the manufacturer for not completing the full study and the FDA for not enforcing it. "If you think there's a problem, get it off the market until you fix it," she said.
To Becky Beesley, it's just a matter of time until Essure does even more harm.
"I really feel like Essure is a ticking time bomb," she said. "You never know what's going to happen or when it's going to happen."
The company that developed Essure, Conceptus, conducted the clinical trials and asked the FDA to remove the nickel allergy testing advisory.
Bayer Healthcare bought Conceptus last June.
Bayer refused an interview for the 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. Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control. A recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements.
All Essure studies that are either planned or active are listed on ClinicalTrials.gov. Bayer is developing the next generation Essure and is in the process of planning the clinical trial program.
Per your question regarding the nickel warning, I want to note that the use of a nickel titanium alloy in Essure remains as a warning in the product label. It can be found on page 1 of the Essure Information For Use insert in the Warnings section. The language is pasted below:
From Warnings Section:
· The Essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives.
In regards to the classification of Essure, the US Food and Drug Administration, not the manufacturer, classifies medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Devices are classified into one of three categories—
Class I, Class II, and Class III.
Class III devices are subject to the highest level of regulatory control. For Class III devices, such as Essure, a premarket approval (PMA) application is required by the FDA before they are marketed. Through the scientific and regulatory review of the PMA application, the safety and effectiveness of Class III medical devices is evaluated by the FDA.
No form of birth control is without risk or should be considered appropriate for every woman. It is important that women discuss the risks and benefits of any birth control option with their physicians.