Essure problems have prompted yet another lawsuit against Bayer, alleging that the company’s permanent birth control is defective.

Plaintiff Jennifer D., and her husband Bryan D., recently filed a lawsuit against various Bayer subsidiaries alleging that Essure problems caused her various injuries. Jennifer was implanted with Essure in 2010, but the device allegedly migrated from its original position and caused her injuries. She and Bryan say her injuries took a toll on their relationship.

The Essure device is a permanent birth control intended to act as a non-surgical alternative to tubal ligation. The system is composed of two metal coils which are placed into the fallopian tubes through a non-surgical procedure. Over the course of several months, scar tissue is supposed to form around the coils and block the passage of eggs from the ovaries.

However, Jennifer claims that the device is subject to a variety of Essure problems including migration, perforation, breakage, and corrosion, all of which can wreak havoc on the body. Some patients have experienced additional Essure problems related to the nickel content in the device’s coils.

Jennifer also argues that Bayer was fully aware of Essure problems experienced by their consumers but chose to conceal the facts and heavily promote their device as safe and effective. Conceptus, the original company which developed Essure and that was later acquired by Bayer, allegedly failed to follow regulations set out by the U.S. Food and Drug Administration (FDA) when seeking approval for the device, leading to a variety of citations and warnings.

From 2002 to 2003, Conceptus was allegedly cited for a variety of violations including failure to provide complete data, failure to provide the FDA with reports, failure to document Essure problems and failure rates, and more. In 2011, Conceptus was issued a violation because “MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury if the malfunction were to recur.” The Essure problems in question occurred several times in 2010 and reportedly included perforation of bowels, breakage of Essure, and migration.

Jennifer claims that, instead of addressing Essure problems and working to be more ethical, the defendants concealed the nature of the device and heavily marketed their product. Bayer allegedly reported efficacy rates for Essure at 99.6% when the device is less effective than tubal ligation.

The FDA eventually took “actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with” Essure in 2016. New documentation, warnings, and patient checklists were required so that consumers could fully understand Essure problems and risks they may be exposing themselves to.

Following FDA regulatory actions, Bayer announced that it would no longer be selling Essure in the United States by the end of 2018. Bayer maintains that this move is not related to the safety of Essure and instead was driven by market factors.

The Essure Problems Lawsuit is Case No. 2:18-cv-04251-JP in the United States District Court for the Eastern District of Pennsylvania.