Numerous consumers recently filed a lawsuit against Bayer, alleging that Essure complications due to design defects are common with the permanent birth control device.

Plaintiffs have filed a joint lawsuit against Bayer US LLC and Bayer Healthcare LLC, alleging that they experienced a variety of Essure complications after being implanted with the permanent birth control device.

Essure is a permanent birth control device which was approved by the U.S. Food and Drug Administration (FDA) in 2002. At the time of approval, Essure had the potential to be a historic, non-surgical alternative to tubal ligation.

Essure is comprised of two coils which are inserted into the fallopian tubes. Over the course of several months, scar tissue is supposed to build up around the coils which blocks any ovulation.

Instead of becoming a historical improvement to medical care, however, alleged Essure complications made the device a historical failure. Complaints of Essure side effects began to surface shortly following the release of the device. Reported Essure complications include a nickel reaction, chronic inflammation and pain, device breakage, device migration, and organ perforation.

Plaintiffs in the lawsuit include women who have experienced these Essure complications.

Plaintiff Complaints

Plaintiff Keisha W. says she was implanted with the Essure device in August 2011. After being implanted with the device, she says she began to experience severe Essure complications including “abdominal and back pain, menorrhagia, dysmenorrhea, irregular menstrual cycles, anemia, bloating, and frequent urinary tract and vaginal infections.” Allegedly as a result of her persistent Essure complications, Keisha had her uterus and fallopian tubes surgically removed in March 2017.

Many other women participating in the lawsuit also had to undergo surgical intervention after experiencing severe Essure complications. Some women’s post-surgery reports showed that only one Essure coil was found upon removal, leading some to believe that the other Essure coil is still in their bodies.

Plaintiffs in the lawsuit claim that Bayer intentionally concealed reports of Essure complications and submitted false information to the FDA in order to keep their defective device on the market. “Bayer did this in an effort to maintain the impression that the Essure device had a positive risk/benefit profile and to guard sales,” the complaint claims.

However, this alleged tactic would not save Essure. Women affected by Essure complications spent years lobbying against the device, urging the FDA to remove it from the market. In April 2018, the FDA initiated new restrictions on the device, requiring doctors to implement a patient checklist informing them of the risks for Essure complications.

In July 2018, Bayer announced that it would cease U.S. sales of Essure, citing declining sales.

Although Essure will longer be sold in the U.S. effective Dec. 31, 2018, no recall was ever initiated for the device. Plaintiffs aim to hold Bayer accountable for allegedly concealing the facts relevant to their device and the prevalence of Essure complications.

The Essure complications lawsuit seeks compensatory damages, economic damages, non-economic damages, punitive damages, court costs, and attorneys’ fees.

The Essure Complications Lawsuit is Case No. 2:18-cv-01142-MPK in the Court of Common Pleas of Allegheny County, Pennsylvania.