Hailed as the next generation of contraception, Essure consists of implantable coils that are permanently inserted via a catheter into the fallopian tubes, to prevent pregnancy. It has been on the market since 2002. Thousands of women across the US have had the coils implanted, and subsequently joined support groups on social media to discuss the side effects and medical problems they believe are caused by the device. The most common side effects include pain, hemorrhaging, headaches, menstrual irregularities, weight fluctuation, device migration and suspected nickel allergy. Some women have reportedly had a hysterectomy or other procedures to remove coils.
The decision, by Judge Winifred Y. Smith in Superior Court of California, County of Alameda, found that the women’s claims were not expressly or impliedly pre-empted under federal or state law. Bayer claimed immunity, asserting the plaintiffs, and similarly situated women, are barred from bringing claims against it due to federal pre-emption law, because Essure is a Class III medical device that was approved by the FDA in 2002, and therefore immune from lawsuits brought by the victims of the device.
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In February 2016, the FDA announced it will require Bayer to conduct a clinical study, implement a patient decision checklist to make sure potential users of Essure understand the risks of the product, and add a black box warning to Essure's labeling. A black box warning is the FDA's highest warning level and indicates that a product may cause serious injuries or death.