What You Need to Know About Essure

By Amie Newman — August 23, 2017

Women report severe pain, hair loss, and heavy bleeding. They share stories of migraines, tooth decay, and brain fog. Some develop life altering autoimmune disorders. More than 35,000 women have joined the Essure Problems private Facebook group to commiserate and offer advice to one another, bonding over these unexpected and often debilitating symptoms.

Essure is a method of permanent birth control that’s been in the crossfire of controversy over the last several years as more women come forward to report symptoms and demand action on the part of its manufacturer, Bayer.

The latest coverage, by author and journalist Jennifer Block in the Washington Post this summer, dives into Essure’s life cycle thus far and the stories of the women who have trusted their bodies to their doctors and the device, only to end up sick and defeated.

Essure is a non-surgical type of sterilization that consists of two small metal coils wrapped around polyethylene terephthalate (PET) fibers inserted through the vagina and into the fallopian tubes. It works when the fibers cause inflammation and eventually scar tissue, blocking the fallopian tubes from allowing an egg to pass through.

The method was praised by the women’s health community when it came to market in 2002, after working its way through a short-term human trial and FDA approval. Until that time, the only way to sterilize women was through surgery. Essure offered what seemed to be a safe, effective, and quick method of permanent birth control.

Since that time, more than half a million women  — mostly in the United States — have used the device.

Consumer Reports notes that although the overall complication rate for Essure is low (according to available data), when women suffer side effects, they are significant:

Just 3 to 4 percent of women who have the device implanted report problems. But according to an independent analysis of the Food and Drug Administration’s database, conducted for Consumer Reports by the company Device Events, within that subgroup the problems are indeed serious. Roughly half of the almost 17,000 adverse-event reports involving Essure indicate that surgery—up to and including full hysterectomy—was needed to resolve the problem.

And, yes, Essure did go through a human trial prior to finding its way to market. But physician researchers from Yale, including Sanket Dhruva, a Yale University cardiologist and researcher of high-risk medical devices, took issue with the one-year human trial:

A short-term study “might be okay if it’s a medication that you take for a week,” he says. “But we’re talking about a device that’s going to be implanted in a million people for the rest of their lives.”

“We all know the most rigorous data in clinical medicine is through randomization,” control groups and follow-through, he says. Ideally, he explains, the researchers would have given 1,000 women Essure and another 1,000 women laparoscopic sterilization and followed them for five years to compare rates of pregnancy, complications, hysterectomy and repeat surgeries. Without a real-time comparison, he says, “we just didn’t have the data.”

In 2015, Diana Zuckerman, President of the National Center for Health Research (NCHR), wrote about the problems with Essure for Our Bodies Ourselves. NCHR decided to investigate the issue after hearing from women with severe symptoms as well as women who became pregnant with Essure. While the FDA web site reported that the device was  99.8 percent effective, with “very few side effects,” NCHR was troubled by what they found when they dug deeper:

The “Ah-ha” moment came when several women told us that they had participated in clinical trials the FDA used as the basis for its approval. They told us that their reports of unrelenting, debilitating pain and other serious side effects were not included in the clinical trial data. Why? They said they were told by the doctors and nurses involved in the studies that the side effects were not caused by the device.

The FDA did hold a hearing that year, after outcry and activism from the women on the Essure Problems Facebook page. Among the problems women experienced were chronic pain, fatigue, and hair loss. These are all potential allergic or autoimmune reactions to nickel. And, yes, nickel is the metal found in Essure:

According to Peter Schalock, a Boston-area dermatologist who has published extensively on metal hypersensitivity, reactions to implanted devices can include rashes or eczema, chronic inflammation and chronic pain, all of which are among the adverse events reported by Essure women.

Schalock and several experts in immunology or toxicology expressed concern at the 2015 FDA hearing that the nickel in Essure could be triggering allergic or autoimmune reactions, in which the immune system overreacts and attacks healthy cells. In addition to the issue of nickel, he and other physicians have raised concerns about the PET fibers used to incite the inflammatory response: “Maybe the inflammatory state goes a little wild,” Schalock told me. “The question is what’s driving it. Is it the Essure, or is the Essure waking up some sort of predisposition to autoimmune disease?”

In response to the hearing, in 2016, the FDA ordered Essure to issue a “black box” warning to alert women to the possible side effects which includes “device migration, perforation, persistent pain and “suspected allergic or hypersensitivity reactions.” Essure also needs to conduct another clinical trial, similar to what Dhruva described above and here, the results of which won’t be known until 2023.

Essure is designed to be permanent, and removing it can be difficult and cause additional complications.  It’s important to remove the coils from the insert intact. The Essure Problems website provides guidance on finding a ob/gyn who is knowledgeable about and experienced with removals.


14 responses to “What You Need to Know About Essure”

  1. I have had similar problems from another Bayer product RHOgam which Is administered to women with RH – blood type to protect them and their next baby from having a blood type reaction to one another. Problem is they did not check doner plasma to see if it matched and if not matched it causes a life long autoimmune problem and likely death for some. I mention because Essure is also a Bayer product. Bayer has locked up and or prevented research that could reveal the problem with RHOgam in an effort to market to the WHO Heath markets similar to Essure. They figure it’s a small % so no one will care or know. There are a % of women all over the world impacted by Bayer products, and there is no help or justice for them. Many may not know the problems they are having are related to the Bayer product they used.

  2. Have we learned nothing about how the birth control pill was foisted on us as guinea pigs and suffered the consequences. The chemical companies are not feminist! and do not operate in the interests of the population. Profit-motive is their only mantra.

  3. I am so glad they took this off the market! I am currently working with a group called The Rebecca Project For Justice with helped to get that off the market, We are now in a fight to get Depo Provera off the market Due to all the horrible side effects some just like Enssure. My oly child died from Depo Provera In 2013 19 days after giving birth. She suffered a host of side effects prior to her death but it was Inter Cranial Pressure that caused her to suffer two massive brain bleeds and a stroke. Bre was on Depo consistantly for 5 years with no one warning us that she should be off after 2 years. My gbaby is doing great. Help me ladies get this drug off the market. Email if you have anyquestions rochellerussell927@gmail,com

  4. Yes I have use depo only three month and stop since then I haven’t had my period am geting to two month I have had a test but negative I am so worried what has happen

  5. Essure is a nightmare. It can cause inflammation which can cause cancer. I am questioning how many of us who suffers from essure and cancer is due to essure.

    • I hate Essure. Its ruined my life. I can not heal right even after i got it removed! 1 yr later my gums are still bleeding no reason and i hve an infection that doctors cn not help me with! 3 years of this battle is exhausting mentally, emotionally, physically. FDA approved! Yea right bunch of careless people approving stuff

    • May I ask what kind of cancer? I had a hysterectomy to remove the essure 6 months after placement due to allergic reaction. This was in 2016. In 2020, I had thyroid cancer. I just found out that the Dr who did my hysterectomy did not remove the measure in my right fallopian tube. I just had my ovaries removed and it was found then. I have had severe debilitating pain and fatigue the last few years and no one can tell me why. I am now trying to figure out if my cancer was due to the essure.

      • I had Essure in 2010 and in 2016 I was diagnosed with breast cancer. On paper, I was low-risk. I was under 30, with no family history. I wonder how many women who had/have Essure were diagnosed with cancer. I had a hysterectomy in 2016 as well.

    • I had a tubal removal then the doctor realized it was embedded in my uterus ripped it out had to slice me open to stop bleeding another few months after I had a full hysterectomy I now have chronic ibs and just diagnosed with lupus oh and btw I was allergic to nickel I got it before the test was made mandatory to nickel fuckers !!!

  6. Essure – the crappy product that keeps giving (in negative ways). I hate you so much Bayer. You sicken me – watch the Bleeding Edge to see how dodgey our medicial system is.

  7. I have gone years with horrible bleeding horrible cramping became pre menopausal. Then had uterine cancer had total hysterectomy. I have had severe ibs. Brain fog. Thought I was losing my mind. Panic attacks anxiety headaches lower immune system. Constantly tired no energy.

  8. I had essure inserted in either August or September of 2015. I was only 26 with one child so, when I asked my OB/GYN to have my tubes cut, tied and burnt she made me sign my life away for one lol but, said that she doesn’t perform that procedure and basically told me the only one she would perform is the essure method. So, after reading her short little pamphlet and possibly watching a short video I had the procedure booked. Once inserted I was told to come back in three months to have them checked to make sure scar tissue was forming properly. After that check up on them I was not informed of needing to ever have them rechecked periodically or of any problems that was and obviously still arising from this procedure. I have had some things that were possibly linked to the procedure but, in all honestly I am not sure what all possible side effects and issues that this device could possibly be causing. It’s very hard to find information on everything that could be possibly linked to this device and if they ever need to be rechecked.

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