Essure Birth Control Problems

Thousands of women have experienced severe problems with Essure, a permanent birth control device made by Bayer HealthCare and Conceptus Inc.

What is Essure?

Essure is promoted as an easy outpatient 10-minute procedure for women who want to be sterilized but don’t want to undergo surgery or anesthesia with a traditional tubal ligation (getting one’s “tubes tied”).

Essure Birth Control Problems

Essure side effects can be devastating for a woman’s long-term health and quality of life. In September 2015, the FDA published a report (PDF) ahead of an advisory meeting to discuss the safety of Essure.

The FDA looked at data from over 5,000 reports of side effects, dozens of studies, and case reports. Some of the most serious problems associated with Essure birth control include:

• Chronic / persistent pain: May occur when Essure is positioned improperly, perforates organs, migrates, or causes an allergic reaction.
• Changes in vaginal bleeding: More heavy, prolonged, or frequent bleeding is a common side effect
• Nickel allergy / hypersensitivity: Essure coils contain nickel-titanium (Nitinol), which could cause allergic reactions, itching, and hives. At least 10% of women are allergic to nickel. The original label for Essure recommended a skin-test, but this was removed in 2011.
• Perforation: Essure can migrate and puncture the fallopian tubes or the uterus.
• Migration in the abdomen: Essure can move in the body and lacerate abdominal organs, including the bowel or bladder.
• Pregnancy: Women who get pregnant despite Essure are more likely to have a life-threatening ectopic pregnancy or miscarriage.

Surgery May Be Necessary to Treat Essure Problems

Women who experience problems with Essure birth control may decide to undergo a hysterectomy. In cases where Essure punctures the fallopian tubes and migrates into the abdomen, doctors must remove it surgically.

A study published in the British Medical Journal in 2015 found a 10X increased risk of needing follow-up surgery when comparing Essure and tubal ligation (2.4% vs. 0.2% risk). Many of these surgeries were performed to alleviate complications like “device migration or incompatibility after surgery.”

Essure Problems May Lead to Pregnancy

Bayer advertises Essure as more than 99% effective at preventing pregnancy. While this may be true with “perfect use,” in the real world Essure does not always work perfectly. Doctors sometimes insert it too far or not far enough. In other cases, the fallopian tube does not scar over completely and an egg can still be fertilized.

In August 2014, Contraception published a study comparing the rate of pregnancy in women who got Essure instead of a tubal ligation. After 10 years, researchers estimated that up to 9.6% of women could get pregnant despite Essure — more than 4X the risk after tubal ligation.

Conceptus Accused of Hiding Problems With Essure Birth Control

When Essure was approved in 2002, it was given “fast-track” status because it was the only non-surgical sterilization device on the market. The manufacturer, Conceptus Inc., was required to follow rigorous scientific protocols when studying Essure. In exchange, Essure was given Pre-Market Approval (PMA), which protects Conceptus from lawsuits under a federal law known as preemption.

Women who were injured by Essure have not been able to file lawsuits or seek compensation. In 2013, the first lawsuits challenging the validity of Essure’s PMA were filed. Conceptus is accused of falsifying medical records, using defective materials, failing to report adverse events, and making false claims about the safety of Essure.