A recent Essure lawsuit claims that the birth control implant caused serious health problems including excessive bleeding.

Plaintiff Katrina H. was reportedly implanted with the Essure device in February 2013. The success of the implant was confirmed in an HSG test, but Katrina reportedly started experiencing issues afterward. Her symptoms allegedly included unusual bleeding, pain and cramping, and unusual periods.

Due to these “severe and problematic issues”, Katrina was allegedly forced to undergo a hysterectomy and the removal of her fallopian tubes in March 2017.

Katrina argues that Bayer’s representations failed to sufficiently warn her of the issues associated with the Essure device and instead lead her to believe that the implant was safe and effective.

Essure is a permanent birth control implant composed of two coils which are inserted into the fallopian tubes, the structures which connect the egg releasing ovaries to the uterus.

Once in the fallopian tubes, the Essure coils are designed to elicit a response from the body which creates the growth of scar tissue over the course of three months. This scar tissue is supposed to block the fallopian tubes, preventing eggs from reaching the uterus and being fertilized. 

Although the devices held high hopes of being a nonsurgical alternative to tubal ligation, the side effects of the implant have reportedly made Essure too dangerous for use.

Women implanted with Essure reportedly experienced serious side effects including bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain, miscarriage, and ectopic pregnancy.

Despite a large number of women reporting these issues to Bayer, the company allegedly failed to warn consumers and instead concealed the issue from the public and the Food and Drug Administration (FDA).

“Defendants concealed and altered the medical records of its own trial participants to reflect favorable data,” the Essure lawsuit claims. “Specifically, Defendants altered medical records to reflect less pain than was being reported during the clinical studies for Essure and changed the birth dates of others to obtain certain age requirements that were needed to go through the PMA process.”

“Subsequently, Defendants failed to disclose this and concealed it from Plaintiff and her implanting physicians.”

In July 2018, Bayer announced that it would no longer be selling Essure in the United States – citing declining sales and the conclusion that Essure business in the country was “no longer sustainable.”

The move was touted as a win by Essure advocates who had publicly called out Bayer for allegedly failing to warn consumers about the risks associated with the birth control implant system. Thousands of women banded together in groups such as the “Essure Problems” group on Facebook to complain about the issue and work together to demand action from the FDA.

In 2016, the FDA added a black box warning to the implant’s labeling and ordered Bayer to conduct more studies. In February 2018, further regulatory action was taken when the agency ordered that only doctors who guaranteed that patients were being warned of side effects could sell Essure.

The Essure Lawsuit is Case No. 2:18-cv-05347-CFK in the U.S. District Court for the Eastern District of Pennsylvania.