Bayer Corp. faces a lawsuit from several plaintiffs alleging they sustained injuries caused by Essure.

A group of 73 plaintiffs have joined in a lawsuit against Bayer Corp. alleging that they had serious injuries caused by Essure. The plaintiffs claim that Bayer failed to meet FDA reporting standards, failed to report known defects to the FDA and failed to comply with federal marketing laws.

Essure is a birth control device intended cause permanent sterilization via occlusion of the fallopian tubes. The Essure micro-inserts are anchored into the fallopian tubes where they then cause the formation of scar tissue.

The scar tissue permanently blocks the fallopian tubes which leads to sterilization. Three months following implantation, patients are supposed to receive a confirmation test to make sure the inserts are in the correct location and that the fallopian tubes have been completely occluded.

The plaintiffs in the case argue that Essure causes serious damage to the body. “The device migrates from the tubes, perforates organs, breaks into pieces, and/or corrodes wreaking havoc on the female body,” the lawsuit alleges. All 73 plaintiffs in the lawsuit allege that they sustained serious and permanent injuries caused by Essure.

According to the lawsuit, failure of device materials can lead to injuries caused by Essure. The lawsuit mentions specific metals such as nitinol, lead, and steel which can either degrade or cause the body to attack the implant.

Bayer allegedly testified at an FDA hearing that a skin patch test is not reliable for predicting a nickel reaction with the device, but allegedly continued to tell patients and doctors that it was sufficient.

The lawsuit also alleges that Essure is not as effective as it was marketed to be. According to the lawsuit, “the efficacy rates for Essure are 99.6%; in reality, studies show that the chances of becoming pregnant with Essure are higher than with tubal ligations and higher than the rates reported by Bayer to the FDA at the public hearing.”

Bayer allegedly marketed Essure as equivalent to tubal ligations, which does not coincide with the efficiency rates given in the lawsuit.

The lawsuit alleges that Bayer altered clinical data in order to report positive conclusions to the FDA. Specifically, the plaintiffs allege that Bayer “altered medical records to reflect less pain then 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.”

According to the Essure lawsuit, the FDA intervened in Bayer’s dishonest actions and is requiring a black box warning, a new patient decision checklist and a post-market study. However, these actions do not benefit patients who have already allegedly sustained injuries caused by Essure.

The lawsuit accuses Bayer of negligence, breach of warranty, misrepresentation and failure to warn. The plaintiffs seek a trial by jury, damages in excess of $75,000 each, court costs and attorney’s fees.

The Essure Injury Lawsuit is Case No. 2:18-cv-00836-BMS in the U.S. District Court for the Eastern District of Pennsylvania.