Victims of severe side effects from Essure, which attractively touted itself as permanent birth control, pushed for its removal from the shelf. That did not happen. However, after 32 deaths and multiple lawsuits against Essure’s manufacturer, the U.S. Food and Drug Administration did act. Still, congressional legislators are being pressured to force the FDA to do more about the coiled device which is implanted into the fallopian tubes.
Attention to Deadly Implant Received Celebrity Endorsement
Women, calling themselves E-sisters, came forward with emotional stories about their experience with Essure, spearheaded by environmental activist, Erin Brockovich. Brockovich stepped into the national spotlight fighting for clean water and restitution for residents in California who were poisoned by Pacific Gas and Electric Company in the 1990’s. In recent years, she has expanded her focus to include damaging medical devices and prescription drugs. The stories were compiled in coordination with a law firm where Brockovich acted as consultant and public spokesperson.
Previewing FDA Review and Response to Harmful Essure Side Effects
After receiving more than 10,000 adverse reaction reports and following numerous lawsuits against Bayer for the device, the FDA slapped a black box warning on Essure. More on that later in this article.
A shocking number of women reported migration. This occurs when the coiled device gets dislodged from its implanted location and moves into, and damages, the uterus. Others reported serious infections from the procedure to implant Essure. Hair loss, swelling, blistering rashes, and even triggering autoimmune diseases were noted. Many women needed a hysterectomy as soon as their 20’s. The nationwide average among all women ranges from the early to late 40’s.
Most importantly, the FDA was advised that complications from Essure resulted in the death of 32 women.
Essure Marketed As Safe Alternative to Invasive Sterilization
Essure was recommended to patients by doctors as the safe alternative to an invasive procedure called tubal litigation, where the woman has her Fallopian tubes (the tubes that carry eggs from the ovaries to the uterus) clamped and severed.
Patient: Essure Caused Unbearable Pain, Suffering – Device Migrated to Intestine, Stomach
A woman, identified only as “Kathryn” on Brockovich’s Essure reporting web site, shared her story on the aftermath of her Essure fallopian tube implant (modified slightly for space).
My husband and I knew we only wanted one child so after my daughter was born I spoke to my doctor about having my tubes tied. He said that they had a new procedure called Essure which was better (in his opinion) and after hearing that it didn’t require a hospital stay, no anesthesia, no cutting and the recovery time was just a day I was sold on it. If only I had done my research.
I had Essure implanted in October 2014. I went back for the dye test (to make sure my tubes were sealed) in February 2015 and was told the coils had fallen out of my tubes. I was devastated thinking about how I would have to have another surgery (tubal ligation) to make sure I didn’t get pregnant again. I asked my doctor if I needed to have the coils removed and he said they were very soft and small and wouldn’t cause any problems. I believed him. My husband stepped up and had a procedure done to save me from surgery…or so we thought.
In April 2015, my menstrual cycle finally returned but it was much heavier than ever before and the cramps were unbearable. I attributed this to my body having changed after having the baby.
In August 2015, I started having severe lower back pain to the point that I couldn’t stand or sit for extended periods of time without having trouble standing up or walking afterwards. Holding my daughter hurt even more! Not being able to hold my daughter – the only child I was ever going to have – killed me inside. It never crossed my mind that this pain was caused by Essure. My menstrual cycle was all messed up- some months I wouldn’t have a period which led me to think my husband’s procedure failed also, other months it was so heavy I thought I might bleed to death!
In October 2015, I began having sharp, stabbing pains on the right side of my pelvic area. They would bring me to my knees in tears. This pain continued daily. I couldn’t play with my daughter because I was constantly in pain. My daughter was now walking and I was missing out on it. My days were spent suffering through the pain so I could play with my daughter, lying in bed nauseous from the pain pills or passed out from the pain pills. I began to suspect this pain might be caused by Essure and wondered where those coils were. I was still having problems with my menstrual cycle.
In November 2015, I began having the same stabbing pain on the left side along with menstrual-like cramping. I don’t know when the headaches began but I was having 2-3 each week. Towards the end of the month is when this strange mucous-like discharge appeared. I was in constant pain, crazy periods and now this odd discharge. I was miserable and so unhappy with the “life” I was living. It was taking a toll on the relationship with my daughter, my marriage and my self-esteem.
In January 2016, I brought this all up to my doctor but he refused to believe any of it was caused by Essure because it was small and soft and blah blah blah. He ran all kinds of tests but nothing looked or felt wrong. He mentioned that he could do an exploratory surgery. If he found anything wrong, he would fix it and do a tubal (remember I asked for that in the beginning?). I thought it over because the whole point of getting Essure was to avoid another surgery not to mention I couldn’t afford another surgery but I decided to go for it. So we scheduled surgery for February.
I had surgery in February and they found the right coil had migrated. It was lodged in my intestine and scraping my stomach! They removed it. I was told the other coil was still in my Fallopian tube but farther in than it was originally placed. So, did it fall out of my tube like they told me when I did the dye test? Did it fall out and then wiggle its way back in? I was beginning to doubt my doctor and questions kept rising. I was pain free for about a week which was probably only because of the pain meds and then the pain on the left got worse. All of my other symptoms were still there. I was depressed and didn’t want to do anything.
In March, I returned to my doctor because the pain was increasing in severity and all of the other symptoms continued. My doctor, still refusing to believe Essure was the culprit, recommended I wait another month to see if the pain went away. That next month was filled by logging daily journal entries of my pain and researching.
One month later, I told my doctor I wanted the remaining coil removed. His staff said he would contact me with suggestions. While I waited for his plan, I did more of my own research and discovered that my best option to have the remaining evil little coil removed was a hysterectomy. We began discussing that hysterectomy. But I had hoops to jump through before they could schedule the surgery (tests, x-rays, insurance approval). They brought in a consultant/special specialist because my doctor and his peers couldn’t tell where the remaining coil actually was! Oh, how I wish I had done my research sooner!!
Finally, insurance approved my surgery and a date was set. I was lucky that Essure didn’t destroy my ovaries and I was able to keep them to avoid hormone replacement. I had the surgery, and all of my symptoms are gone! It is a night and day difference, and I am mending the relationship with my husband. My daughter is happy I can play with her again. The smile on my face is because I’m not in pain. I have a renewed sense of strength, knowing that I didn’t give up. Now I want to do what I can to stop others from making the same mistake I did in getting Essure.
I thought I was saving myself money on a less expensive procedure. After 2 additional surgeries and multiple doctor visits it has cost me over $20,000! I thought I wouldn’t have to have a hysterectomy. I thought Bayer cared about the people they make their products for. I was wrong!
New Essure Label, Black Box Warning
FDA officials added new guidelines for the labeling of Essure. They include the addition of a boxed warning (known as a black box warning). Also, a Patient Decision Checklist must be provided prior to implantation. Both are intended to support counseling of the patient, and ensure a full understanding of the benefits and risks associated with Essure.
When discussing Essure, the provider must use specific wording to explain what to expect during and after the procedure. They are directed to “clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal.”
Providers also ensure the patient understands that while the devices may appear similar, Essure is different than a traditional IUD. An IUD is implanted in the uterus and Essure is implanted in the fallopian tubes. More on how that difference is important below.
What Is Essure, and How Does It Work?
Essure is a permanently implanted birth control device that is not intended to be removed. Its flexible coils are made of metals, including nickel and titanium. Those sensitive or allergic to nickel or other metals should discuss this allergy with their health care provider.
To implant Essure, the provider inserts flexible coils into the Fallopian tubes. In about three months, tissue forms around the inserts, blocking sperm from reaching the eggs and preventing pregnancy.
One of the most important things to know about Essure is that it’s not immediately effective in preventing pregnancy. Another form of birth control must be used for at least three months after the device is implanted.
After three months, women must undergo an X-ray test so their provider can verify if the device is placed correctly and blocking the Fallopian tubes. The test results will help the provider decide whether Essure can be relied upon alone and alternative birth control stopped.
In contrast, an IUD uses several mechanisms of birth control to disturb sperm, the ovum, and a fertilized egg. It is also a reversible implant.
What Are the Benefits and Risks of Essure?
This is the general information provided by the manufacturer, separate from the details identified earlier in this article. Implanting Essure is typically done in a doctor’s office. This procedure doesn’t require an incision and can be done without general anesthesia.
Some women who use Essure have reported serious complications, including:
- poking through the Fallopian tubes or uterus
- persistent pain after the procedure (including pain for weeks or months after the procedure)
- change in menstrual cycles (bleeding patterns)
- symptoms similar to those of allergic reactions
- symptoms similar to those in autoimmune diseases, such as joint pain and fatigue
- needing surgery to remove the device
Patient Information on Boxed Labeling for Essure
See the Essure Information Booklet released by Bayer with the new label.
*** UPDATE: The United States Congress reports it is taking up a new bill requiring the FDA to revoke its approval of Essure, led by Rep. Michael Fitzpatrick.