Despite removing the device from the U.S. market, Bayer faces yet another lawsuit alleging severe side effects of Essure sterilization.

Plaintiff Melissa G. says she was implanted with the Essure device in May 2014. Shortly after the procedure, Melissa allegedly started to experience  side effects of Essure including severe migraines, pelvic pain, and cramping. She reports that the side effects of Essure allegedly became so “severe and problematic” that she was forced to undergo a hysterectomy in January 2018 to remove the Essure device from her body.

“Plaintiff recalls reviewing a brochure for Essure that promoted the device as a safe and effective form of permanent birth control,” the side effects of Essure complaint argues. “Plaintiff relied on Defendant’s misrepresentations in the Essure brochure as to the safety and effectiveness of Essure and, based thereon, decided to undergo the implantation of Essure.”

“Plaintiff would not have chosen to undergo the implantation of Essure had she not relied on Defendant’s misrepresentations as to the safety and effectiveness of Essure as a permanent birth control device,” the Essure lawsuit adds.

Essure is a permanent birth control device comprised of two metal coils. The coils are placed into the fallopian tubes through an in-office procedure. Over the course of several months, scar tissue build up in the fallopian tubes around the coils. This is supposed to stop eggs from reaching the uterus after being released by the ovaries.

Because Essure had the potential to provide a non-surgical alternative to tubal ligation, the U.S. Food and Drug Administration (FDA) fast-tracked the approval process and gave the device conditional premarket approval. The approval had a variety of conditions including training for physicians, reporting on adverse reactions to the FDA, and more.

However, Bayer allegedly failed to follow through on these requirements set out in their conditional approval. Melissa claims that countless women like her suffered from side effects of Essure but Bayer failed to inform the FDA. Instead, the company allegedly concealed severe, adverse reactions including perforation of internal organs.

In February 2016, the FDA announced that it would be taking new actions to help the public stay informed about the side effects of Essure and the risks. Specifically, the agency required a new black box warning, a patient decision checklist, and a new post market study.

However, Melissa claims that these actions were “too late” to warn her and other patients of the side effects of Essure. She also argues that, had Bayer followed the law and complied with federal regulations, patients like herself would have been informed and could have made an educated choice about their health. Instead, countless women were allegedly exposed to debilitating side effects because they were not sufficiently warned.

Melissa aims to hold Bayer accountable for allegedly failing to warn consumers about the risks associated with their product.

The Essure lawsuit seeks compensatory damages, economic damages, non-economic damages, specific damages, punitive damages, exemplary damages, court costs, and attorneys’ fees.

The Essure Side Effects Lawsuit is Case No. 2:18-cv-05364-CDJ in the U.S. District Court for the Eastern District of Pennsylvania.