Essure is a permanent contraceptive coil embedded in more than 750,000 women worldwide. Initially regarded as a breakthrough in birth control, Essure has debilitated women with a series of painful complications.
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The Next Steps
|Essure complications can cause chronic pain, excessive bleeding, unintended pregnancies other serious safety concerns.||Researchers found a more than ten-fold higher occurrence of re-operation during the first year after Essure implantation.||Protests against Essure are growing, with powerful advocates like Erin Brockovich and Congressman Mike Fitzpatrick joining the fight.||Support programs for Essure survivors have become abundant.|
Table of Contents
What is Essure?
Available as an alternative to traditional birth control, Essure is a permanent contraceptive system comprised of two metal coils. The flexible coils, which are implanted in a woman’s fallopian tubes, are made from a combination of stainless steel, nickel titanium, and polyethylene fiber materials.
Manufactured by Bayer HealthCare, Essure exists in 23 countries including the United States, Canada, Europe, Australia, Latin America, and the Asia Pacific. The pharmaceutical company has distributed an estimated 1 million systems worldwide.
Essure is touted as a safe and effective option for permanent sterilization because it doesn’t require surgery or anesthesia. But after 14 years on the market, the dangers of the device have been increasingly exposed.
Essure has been linked to more than 10,000 complaints. Now, women surviving Essure are uniting, calling on advocates, and creating a chain of campaigns spreading across the country.
Studies + Science
The Essure system is the first permanent birth control option outside of surgical sterilization. Tubal litigation, which was the standard method for years, requires costly incisions and general anesthesia. Meant to be a safe but simple process, Essure is said to offer minimal invasion and quick recovery.
How Essure Works
Essure coils are inserted into the fallopian tubes with a catheter. The procedure takes about 10 minutes. Many patients are on their feet and engaging in normal day-to-day activities within the week.
But insertion is only the beginning. Essure embeds itself in the tubes, building scar tissue that’s meant to hold it in place. Over three months, the coils become part of the body. Eggs still release during ovulation, but sperm cannot fertilize them because they are reabsorbed.
Essure Side Effects
Essure has been linked to thousands of injuries. Post-market surveillance indicated that a number of side effects could occur in the first year of Essure use, including:
|Major Essure Complications||Common Essure Side Effects||Additional Essure Side Effects|
Coil breakage and fragmentation
Perforation of fallopian tubes
Chronic pain (6,989)
Heavier, irregular periods (3,210)
Weight fluctuations (2,088)
Cramping / Bloating
While studies show that Essure is 99.83 percent effective, the Food and Drug Administration (FDA) received 631 reports of pregnancies:
- 150 live births
- 96 ectopic pregnancies
- 43 elective terminations
- 155 other pregnancy losses
- 204 unindicated birth or loss
The New York Times reported that Dr. Aileen Gariepy, an assistant professor of obstetrics, gynecology, and reproductive sciences at Yale School of Medicine, found that nearly one in 10 women with Essure would get pregnant within 10 years.
“[This is] a much higher rate than that among women who undergo tubal ligation,” according to the Times.
Revision and Removal
A study conducted by researchers at Cornell University in New York included 8,048 of whom were treated with hysteroscopic Essure-style sterilization and 44,278 with standard sterilization.
“The study found that women who’d had hysteroscopic treatment were 10 times more likely to need a repeat operation within a year – equalling around 1 in 50 women,” according to an article published by the U.S. National Library of Medicine.
And while there are numerous Essure side effects, the emotional impact is deep. Women have described the effects of Essure as “hellish” and “life-ruining.” Removal of the device is often described as the only option to feeling natural and pain-free.
Women discussing Essure in a BBC article shows that a common difficulty to removal is getting a doctor on your side. Often women will require a full hysterectomy. Many women will not feel relief until the Essure — and their uterus — has been removed. For some, it may take years to find the right doctor, have their symptoms acknowledged and withdraw the invader.
The FDA first approved Essure to permanently prevent pregnancy in 2002. Essure was classified as a class III, high-risk device. Originally approved under Conceptus, Inc., Essure was sold to Bayer for $1.1 billion in 2011.
Recent media, agency and advocate investigations have brought attention to Essure, questioning the safety testing that led to approval and evaluating how much the manufacturer knew about the drug’s dangers.
Clinical Trial Controversy
A consumer rights group called Public Citizen sent a letter to the FDA on February 20, 2015. In the letter, Public Citizen made allegations that the manufacturer altered medical records of trial participants to reflect favorable data, less pain, and certain birth dates.
Some examples of the allegations against the manufacturer include, but are not limited to:
- Failed to report 8 perforations
- Failed to notify the FDA of their internal Excel file containing 16,047 entries of complaints since 2011
- Using non-conforming material in the manufacturing of Essure
- Failing to use pre-sterile and post-sterile cages
- Manufacturing Essure for three years without a license to do so
The device was fast-tracked to the market, but complications experienced by many of the women involved in the study weren’t publicized until eight years later. The New York Times investigation found data complications that may have altered the results of the study. The FDA agreed to investigate the complaints.
FDA Takes Action
During the 14 years that Essure birth control has been on the market, there have been nearly 10,000 complaints. In September 2015, an FDA Advisory Committee met to discuss the safety of Essure. The agency also discussed how to support informed decision-making by patients.
The meeting resulted in four key actions:
Bayer must conduct a postmarket surveillance study to obtain more data about Essure’s benefits and risks.
Black Box Warning
A Black Box Warning and Patient Decision Checklist will be added to the product labeling.
“A boxed warning with safety statements to better communicate to patients and providers the significant side effects or adverse outcomes associated with these devices and information about the potential need for removal.”
“A Decision Checklist with key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider their sterilization options.”
“Overall, 35.1% of the observed CRF modifications were favorable to the device.”
During the meeting, Essure activists gathered for a hunger strike that took place outside the FDA headquarters in Silver Spring, Maryland. This strike is one of many examples of advocacy against the birth control system.
A number of governmental and non-governmental advocates are now working to inform women about the dangers of Essure permanent birth control.
Ariel Grace’s Law
Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) have been fighting alongside survivors of Essure in an attempt to spread awareness about the device’s dangers, protect women and hold the manufacturer’s legally liable.
Fitzpatrick has created a bill, H.R.5403, known as Ariel Grace’s Law. The law is named after Ariel Grace, who was stillborn because of Essure failure. Essure is linked to the death of four women, and Ariel is one of nearly 300 unborn children.
“Ariel Grace’s Law resolves this injustice by allowing victims to seek legal recourse and ensures medical device manufacturers are incentivized to maintain the safest and most effective products for all patients,” Fitzpatrick wrote.
Essure Removed from U.S. Markets
Two days prior to the release of Netflix’s hard-hitting documentary “The Bleeding Edge,” Bayer finally removed Essure from U.S. markets. However, the device will still remain on sale until Dec. 31, 2018.
Join the Movement
Essure not only affects the safety of women and unborn children, it diminishes their quality of life. Every day, women implanted with Essure face bleeding, fatigue, depression, weight gain and severe abdominal pain.
Consumer advocate Erin Brockovich, who became a household name following the biopic film starring Julia Roberts, has joined the fight against Essure. Brockovich has launched a website encouraging women to share their stories about the device.
Brockovich has been featured in the media campaigning about the dangerous coil in an effort to spread the word and help women get justice. In an interview with BBC, she discussed how Essure is perforating uteruses, colons, and stomach lining.
“Some women have whole body scans,” she said. “They don’t know where it is, because it’s just floating free in the body.”
Online Communities: Essure Problems Facebook Group
Social media platforms have become a haven for women overcoming Essure side effects. Through Facebook groups and digital forums, survivors can connect, share Essure side effects and provide some comfort. The term ‘E-sisters’ has emerged as a way to identify and unite with others.
In these digital meeting places, some have argued that the FDA warning and checklist aren’t enough. Essure activists want the device off the market for good, which is reflected by the hashtag #banEssure.