A Pennsylvania woman filed an Essure lawsuit against Bayer Healthcare Pharmaceuticals claiming the company concealed knowledge of device migration and used deceptive tactics to market Essure.

Plaintiff Susan S. had the Essure birth control device implanted between October and November 2010 and claims that Bayer’s defective design of the Essure device caused the device to migrate from her uterus, causing her to suffer from bladder infections, severe pelvic pain, and severe bleeding. As a result, according to her lawsuit, Susan had to undergo a hysterectomy to remove the Essure device in April 2014 due to the Essure complications.

The Essure lawsuit also accuses Bayer of fraudulently concealing adverse reports of migrations and perforations from not only Susan but also from the FDA.

Essure Complications

When Essure hit the market 13 years ago, the contraceptive was considered a major innovation for women who didn’t want to have more children. However, serious side effects, similar to reported Mirena IUD complications, have prompted an FDA investigation.

Essure is manufactured by Bayer Healthcare Pharmaceuticals. It received FDA fast-track clearance in 2002, because it offered the first alternative to surgical sterilization and promised a quick recovery. It is the only non-hormonal birth control option that doesn’t require a skin incision for women who want permanent birth control.

Soft flexible inserts are placed into the fallopian tubes, which carry the eggs from the ovaries to the uterus. After about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, preventing conception.

A total of 943 reports of adverse events related to Essure were reported from its approval through Oct. 25, 2013.

Women who have been harmed by the Essure device are urging the FDA to take it off the market and warn the public about its potentially serious side effects. Several have pursued Essure lawsuits, claiming the device seriously injured them.

In total, the FDA has received more than 4,000 reports of serious complications related to the device.

Essure Lawsuits

Women who receive an Essure birth control implant for pregnancy prevention may be at risk for side effects like device migration and perforation of internal organs. If you or a loved one has taken Essure and experienced severe side effects, you may be eligible to file an Essure lawsuit.

The Essure Lawsuit is Case No: 2:14-cv-07318-ER in the U.S. District Court Eastern District of Pennsylvania.