Thousands of women in the U.S. have filed lawsuits against Bayer in relation to Essure. They cite issues ranging from pain, perforation and nickel sensitivity to depression, device migration and unwanted pregnancies.
Bayer has thus far used a defense known as federal preemption in the face of these lawsuits. The company argues that it should not be held liable — effectively, the company contends it has immunity — due to the fact that a federal agency, the FDA, approved the use of Essure.
In June 2016, Rep. Michael Fitzpatrick (R-Penn.) and Rep. Louise Slaughter (D-N.Y.) introduced legislation that sought to amend a section of the Federal Food, Drug and Cosmetics Act to essentially waive such federal protections for manufactures. The bill died prior to reaching the House floor.
But in August of 2016, a California judge ruled that a collection of Essure lawsuits — nearly a dozen suits, representing women “in the multiple hundreds” — could proceed against Bayer. Those cases, as well as numerous others around the country, are ongoing.
Bayer maintains that the FDA-approved product is safe for use for a majority of women.