Essure

What is Essure?

Formerly 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 until it was removed from the global marketplace in 2018. The pharmaceutical company has distributed an estimated 1 million systems worldwide.

Essure was 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 was the first permanent birth control option outside of surgical sterilization. Tubal ligation, 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 have offered 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:

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:

1. Post-market Data
   Bayer must conduct a postmarket surveillance study to obtain more data about Essure’s benefits and risks.
2. 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."
3. Patient Checklist
   "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."
4. Misconduct Evaluation
   "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.

Erin Brockovich

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.