The Essure System was first submitted to the FDA in April of 2002 as a form of permanent birth control by Conceptus, which was subsequently bought by Bayer. The FDA gave the system approval in November of that same year. The Essure system consists of nickel-titanium and stainless steel coils, which are wrapped in polyethylene terephthalate and inserted into the fallopian tubes. The devices cause irritation to the area, developing fibrous scar tissue which creates a blockage, preventing the descent of eggs. The FDA imposed several requirements on the maker, including an adequate, physician training program and a warning label concerning information about failure and success [...]

Lawsuits totaling more than 900 have been filed in California against Bayer Healthcare for serious side effects caused by their contraceptive device Essure. Until early this month Bayer has successfully kept the door locked against more than 40,000 complaints related to Essure but a ruling by a judge in California may have smashed down that door. Judge Winifred Smith of the Superior Court in Alameda County granted a motion in the beginning of October to coordinate 55 cases filed against Bayer. At the same time, she sided with the plaintiffs against Bayer concerning pre-emption. Bayer contended that plaintiffs were not allowed to file suit under federal [...]