CLEVELAND - Thousands of women are sharing their stories about serious complications and side effects from Essure.
Essure is marketed as permanent birth control without surgery. It is meant to be cheaper, easier and safer than getting your tubes tied.
During the procedure, metal coils are placed inside the fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.
Minerva resident Amanda Lama was searching for permanent birth control after the birth of her third child. Her doctor recommended the device.
A few months after the procedure, one of the coils fell out. Lama's doctor assured her the fallopian tube was sealed.
About 18 months later, Lama gave birth to her fourth child, a daughter named Bailey.
Months after giving birth, Amanda said her stomach was still swollen and she had developed ovarian cysts.
"The ovarian cysts I developed cause pain. I can't event stand up without pain. I can't sit down without pain," she said.
NewsChannel5 Investigators found there are hundreds of women with similar complaints.
Since 2004, 838 women and doctors have filed reports with the Food and Drug Administration.
Women who have experienced problems with Essure are also sharing their stories 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 have complained about extreme bloating, skin rashes and headaches.
See photos from several Essure patients: http://on.wews.com/HsnHvT WARNING: Images may be considered graphic by some viewers.
X-rays show the coils perforated the fallopian tubes of some women. There are also photos of broken coils after they were removed.
That's what happened to Arizona resident Becky Beesley.
"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.
Eventually, her doctor removed the coils, but that didn't end her pain.
After seeing several doctors, an X-ray revealed the source of her pain: "There were still pieces of the coil in my uterus," she said.
To remove them, Beesley had to undergo 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," she said, fighting back tears.
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.
According to the manufacturer, about 750,000 have had it implanted to date.
Erin Brockovich Takes Action
The thousands of women who have spoken out about Essure have some significant backing. Famed activist Erin Brockovich. Our Phoenix affiliate 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."
When the FDA approved Essure in 2002, it gave the device "preemption status" - that means a women who is injured by it can't sue the manufacturer.
"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.
The FDA declined a request for an on camera review.
A spokesperson sent us this statement:
The FDA has reviewed Essure patient reports of problems (including web-based testimonials)
and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure, Conceptus, Inc. The agency also reviewed the results from the five-year follow-up post-approval study conducted by Conceptus that was required by the FDA as part of the product's 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. (Because the FDA had up to five year follow-up data from the post-approval study, the literature review concentrated on evaluating long-term complications more than five years after placement.)
The FDA takes reports of problems with Essure very seriously and will continue to review them carefully. We will continue to monitor the safety of Essure to make certain that it does not pose an increased risk to public health and safety and that its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.
The FDA approved a 2011 PMA supplement to remove a nickel contraindication because there was no evidence from laboratory (bench) testing data, literature, market history information, and clinical trials to support a contraindication for nickel sensitivity. In addition, clinical trial data has shown that the risk of a sensitivity reaction to the Essure device is less than 1 percent. Currently, the labeling includes a nickel warning.
No form of birth control is 100 percent effective and scientific evidence shows that Essure is a highly effective means of sterilization when health care providers and patients follow the appropriate instructions for use. Essure is also the only non-surgical sterilization choice for women who want permanent birth control.
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 declined a request for an on camera interview for this story, but provided this 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 physician.