An Essure birth control lawsuit alleges that the manufacturer knew of the dangers the device posed but concealed evidence from the FDA, doctors and patients.

According to the plaintiffs, the Essure birth control device originated with Conceptus Inc., a pharmaceutical company that was in hundreds of millions of dollars of debt in 1998.

Coming up with a new, easier way for permanent contraception was intended to provide cash flow that the company needed, the plaintiffs say.

Bayer acquired Conceptus in 2013.

What Is Essure Permanent Birth Control?

The Essure permanent birth control has been marketed as a quick and easy alternative that offers irreversible results with no down time.

Two small metal and fiber coils are inserted into the fallopian tubes, which are reached through the vagina.

Over the course of three months, scar tissue grows around the coils, blocking the fallopian tubes to stop the eggs’ release.

The device sounds simple, but the list of possible complications is lengthy.

Essure Birth Control Lawsuit Alleges Coverup

More than 750,000 women have been implanted with Essure, and thousands say they have suffered side effects that have adversely affected their lives.

Between Jan. 1, 2008 and Dec. 6, 2010, Conceptus received a minimum of 16,581 complaints regarding Essure.

Only 182 of these complaints were reported to the FDA, the plaintiffs say. None of the reported complaints mentioned organ perforation.

According to the lawsuit, Conceptus concealed the complaints to the FDA because if the problems became public knowledge, sales would drop drastically.

Bayer bought out Conceptus in 2013 for $1.1 billion. The Essure birth control lawsuit says, “Bayer continued illegally hiding the true safety risks of Essure.”

MedWatcher App Gave Victims a Voice

The FDA started using an app called MedWatcher in 2013. This new app gave consumers the ability to directly report adverse events to the FDA rather than to the manufacturer of any drug or medical device.

Women also started to communicate on Facebook on a page called “Essure Problems.”

Hearing these women’s demands, the FDA held a meeting in September 2015 for the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to gather information and hear concerns from experts and patients regarding Essure.

Soon after that hearing, Cornell University researcherrs published a study in the British Medical Journal that showed women with Essure were ten times more likely to require a corrective operation than those who had received traditional tubal ligation.

The FDA concluded it would require a detailed black box warning for Essure. Black box warnings are given to cover only the most dangerous adverse events.

Essure Problems Include Degrading Materials, Device Migration

According to the Essure lawsuit, Conceptus and Bayer allegedly knew the following problems could occur with Essure permanent birth control:

• The stainless steel used in Essure is passivated, which means it is chemically treated to make it less reactive. The material used in Essure can become unpassivated, which leads to rusting

• Essure permanent birth control coils contain nickel. The Centers for Disease Control and Prevention estimates that between 10 and 20% of the population is allergic to nickel.

• Symptoms of an allergic reaction after implantation can include itching, rashes, and in some cases, painful inflammation throughout the body. These types of Essure side effects are attributed to nickel allergy.

• The lead-free solder could have traces of lead in it.

• The galvanic action (corrosion) between the metals used to create Essure could become a constant irritation to some patients.

• The plastic used in the surfacing of the coils is made of PET plastic, which is known to degrade and leach toxins when it reaches a temperature of 65 degrees. When it releases these toxins into the human body, the plastic can cause chronic inflammation and possible autoimmune responses.

• Essure coils could migrate into the abdominal cavity.

If you or someone you know has received Essure birth control and suffered any side effects, you could be eligible for compensation through an Essure birth control lawsuit.

The Essure Birth Control Lawsuit is Case No. 1622-CC09870 in the Circuit Court of the City of St. Louis State of Missouri.