In an investor report released in October 2018, Bayer stated that they were currently facing lawsuits from over 18,000 women who used the Essure device. In these suits, plaintiffs allege personal injuries including hysterectomy, perforation of the uterus and/or fallopian tubes, pain, bleeding, weight gain, nickel sensitivity, depression, and unwanted pregnancy. For these allegations, they are seeking compensatory and punitive damages. To date, the suits remain individual cases and have not been rolled into a Multi-District Litigation (MDL) or been given class-action status.

Further adding fuel to the fire is a citizen petition from Koch Parafinczuk and Wolf, P.A. released in 2015. The document concluded that there is evidence that Conceptus, the Essure manufacturer, failed to report many of the adverse events they had knowledge of and fraudulently altered trial patient records to show only favorable information.

In December 2018, FDA Commissioner Scott Gottlieb, M.D., released a statement stating they had received more than 15,000 adverse effect reports related to Essure and they had ordered Bayer to complete a five year follow up study on the long term effects of Essure on the women who have used it despite their decision to withdraw it from the market. In so many words, he meant to indicate that the FDA’s concerns stand and that they would be watching Bayer closely.

While no major cases or verdicts have been made available to the public yet, by the companies own admission in 2017 Essure losses cost Bayer upwards of $413 million. Bayers financial records report €391 million in “Impairment” losses connected to Essure. Their statement about discontinuing Essure for business reasons may be accurate, but their statement about standing by its efficacy and safety appear disingenuine in light of these financial reports.

One legal fight that has managed to make it into the news is that of Kristiana Tweed Burrell, a woman who claims that she suffered a stillbirth and then underwent a hysterectomy due to complications from the Essure device.

Bayer appealed the decision to hear the case in its court of origin, North Carolina, and instead move it to a federal court. Their reasoning was that although the case seeks relief under the laws of North Carolina, there is a bigger question of whether or not Bayer complied with federal regulations and therefore, the case should be heard in a federal court. However, a three-judge panel of the 4th U.S. Circuit Court of Appeals denied Bayers motion.

Still the question remains about why Bayer ultimately decided to remove Essure from the market if they believed it to be safe and effective? Could it be an attempt to cut the potential for future losses after devastating reports from the FDA and patients became public? As a matter of fact, prior to FDA intervention, Essure lawsuits totaled a mere 3,000 compared to today’s whopping 18,000.