Essure, a permanent form of birth control that was considered a contraceptive breakthrough at the time of its release, has been linked to many Essure health problems in recent years.

Women who have been implanted with the small and flexible coil have complained of side effects and complications including, but not limited to: abdominal pain; heavier menses and/or menstrual irregularities; bleeding; headache; fatigue; and weight fluctuation.

However, there are more adverse side effects reported as Essure health problems. These may include device incompatibility, device migration or breakage, allergic reactions to nickel, fallopian tube perforation and unintended pregnancies.

Women allege that they were never warned about these serious side effects and complications associated with Essure.

Essure Health Problems

Essure became approved by the U.S. Food and Drug Administration (FDA) in 2002, but since then there have been over 4,500 adverse event reports reported to the FDA.

The device was approved through the administration’s fast-track review system because it provided not only an alternative for women to surgical sterilization (aka getting ones’ tubes tied) but also because it provided quicker time for recovery. However, concern now grows that Essure was approved before sufficient and adequate medical device testing could be done to affirm the device’s efficacy and safety for women.

According to Essure birth control lawsuits, moreover, allegations include that Essure’s approval was based on questionable studies and that the device should have never been approved to begin with without further study.

Unfortunately, many women who have looked for another option to surgical procedures chose Essure as a permanent birth control option. According to the FDA, over the past several years they have seen the growing and increasing number of adverse event reports being reported concerning Essure. The reported adverse events “include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions.”

In many cases, women have needed to undergo Essure device removal because of Essure health problems.

What is the Essure device?

Essure is a permanent form of birth control comprised of a small and flexible coil that becomes implanted into a woman’s fallopian tubes during a non-surgical procedure. It is made up of nickel and titanium alloy. Once implanted, scar tissue develops around the coils covering them during the next three months. At this point, it creates a barrier thereby preventing pregnancy.

Women implanted with the Essure device are later evaluated by their physicians to ensure that they are no longer able to get pregnant.

Essure lawsuits allege that Bayer, the device’s manufacturer, knew about the device risks but instead covered them up. However, despite Essure health problems, the product continues to remain available to consumers. To note, since Essure’s introduction the FDA has made several changes to the product’s labels, including adding a new nickel sensitivity warning in 2011, a warning regarding the device’s ability to cause chronic pain and device migration in 2013, and in 2016 a “black box” warning was added to the device’s label.