Essure: The Permanent Birth Control Device That Caused Permanent Harm

A "Permanent Solution" That Created Permanent Problems

Essure was marketed as a revolutionary breakthrough in contraception — a minimally invasive, non-hormonal, permanent birth control device. Manufactured by Conceptus and later acquired by Bayer, Essure consisted of two small metal coils inserted into the fallopian tubes, where scar tissue would form to create a natural barrier against pregnancy. It was FDA-approved in 2002 and offered as an outpatient alternative to surgical tubal ligation.

For hundreds of thousands of women, however, Essure became anything but a solution.

The Devastating Side Effects

Women who received Essure reported severe and debilitating side effects: chronic pelvic pain, abnormal bleeding, device migration into the abdominal cavity, perforation of the uterus and fallopian tubes, nickel allergy reactions (the coil contains nickel), autoimmune reactions, and in some cases, unintended pregnancies. Many women required surgical removal of the device — a complicated and sometimes dangerous procedure.

Despite thousands of adverse event reports filed with the FDA, Bayer continued marketing Essure for years. A grassroots advocacy movement, amplified by the 2018 Netflix documentary "The Bleeding Edge," brought widespread attention to the device's dangers and the FDA's response failures.

Regulatory Action and Market Withdrawal

In 2018, under mounting pressure from patient advocates and regulators, Bayer announced it would stop selling Essure in the U.S. The FDA required a black box warning — its most serious — and restricted sales to facilities that provided detailed patient counseling. Bayer maintained the withdrawal was a business decision, not a safety one, but the distinction rang hollow to affected patients.

The Litigation and Settlement

Bayer faced approximately 39,000 lawsuits related to Essure and agreed in 2020 to pay $1.6 billion to settle the majority of claims. The settlement represented one of the largest medical device settlements in U.S. history. The Essure litigation highlighted critical gaps in medical device regulation, where the FDA's 510(k) clearance pathway — which allowed Essure to reach the market without clinical trials — was widely criticized as insufficient for ensuring patient safety.

The Essure case continues to drive legislative efforts to reform the medical device approval process and ensure that patients — particularly women — are given complete information about implanted devices before consenting to procedures.