A recent Essure lawsuit was filed in November 2016 on behalf of dozens of women across the country. Filed in Alameda County Superior Court, the claim alleges each of these women suffered complications due to Essure failure. These women claim that they were not warned against Essure failure and device complications.

The Essure lawsuit names Bayer HealthCare as the defendant, alleging the manufacturer failed to send many of the injury reports to the FDA. The plaintiffs’ lawyers stated that not only is this required by law, but that the company did this to withhold vital Essure safety information from doctors and patients.

The Essure birth control product is the only non-surgical female sterilization option in the United States, and it has become one of Bayer’s premier contraceptives. The product consists of two metal coils that are implanted in each fallopian tube, in which the tissue swells around it and ultimately prevents sperm-to-egg fertilization.

Essure was originally developed in 2002 by Conceptus Inc., but has since been acquired by Bayer Healthcare. Since its approval, thousands of women have had the device implanted and have experienced success, but some have also reported serious cases of Essure failure.

Some of the complications reported include auto immune disease, pain, unusual bleeding, unplanned pregnancies, miscarriage, and the formation of abscesses and tumors.

Overview of Essure Failure Lawsuits

The women involved in the Essure lawsuit have also experienced debilitating complications, which led to them to filing legal action against the manufacturer.

According to the claim, the coils can actually rust inside the patients, while other women suffered allergic reactions due to not being aware that the device was made of nickel. The plaintiffs’ attorneys expressed frustration over these cases of Essure failure, as these women face both physical and mental pain when they report complications.

“The doctors don’t believe them. The insurance companies won’t pay for removal. They get shuffled around to all these different specialists and they are desperate to have the surgery and have these devices removed,” the attorney said. The attorney also stated that the Essure warning label initially contained a warning for nickel content; Conceptus eventually had it removed.

“This FDA label decision will further strengthen our competitive advantage and leadership in the permanent birth control market, and we are pleased that we were able to secure it,” the company’s CEO at the time stated.

The women and their attorneys are confident in their Essure lawsuit, stating that a fair amount of Essure failure reports did not make it to the FDA. Even though it was Conceptus facilities that allegedly failed to submit the Essure failure in 2010 and 2013, the lawsuit names Bayer Healthcare as the primary defendant, as they purchased and market the Essure device.

Investigators found over 15,000 Essure injury reports were never submitted to the FDA, incurring federal violations. Bayer HealthCare representatives stated that they take all cases of potential Essure failure seriously and the company makes it a point to work with the FDA.

At this point in time 23 Essure lawsuits in the litigation process have either been dismissed or significantly diminished in allegations including cases pending in California federal and state courts.