82 E-Sisters File Lawsuit in California Against Bayer Over Essure
05/03/2016 - More than 80 women injured by the controversial Essure birth control device filed suit today in the Superior Court of California, County of Alameda. The case was filed as a Complex Designation Litigation case and should be transferred to one Judge who will likely hear all similar Essure cases. The women allege the Essure device caused them severe health problems including abdominal pain, severe cramping and bleeding, migraines, allergic reactions, device migrations and perforations and autoimmune issues. This suit is one of a handful of suits against pharmaceutical giant, Bayer regarding Essure and comes following the FDA’s announcement last month that it will be requiring the company to issue new “Black Box” warnings. The proposed warnings, which the agency reserves for the strongest safety warning, is open for public comment until May 3rd. The complaint contained allegations of Strict Products Liability-Failure to Warn and Manufacturing Defect, Negligent Failure to Warn, Negligence in Training, Negligence in Manufacturing, Negligent Representation and Breach of Express Warranty.
Each of the plaintiffs maintaining the lawsuit against Bayer was implanted with Essure, sustained injuries and was forced to undergo surgical procedures, some multiple procedures, to have the devices removed. The significant complications suffered by these plaintiffs include migration, hysterectomy, abdominal pain, pelvic pain, back pain, bloating, weight gain, mental haziness, heavy menstrual bleeding, irregular menstrual cycles, perforated organs, autoimmune issues, hair loss, tooth loss, headaches and other complications. All of the plaintiffs were advised by their physicians that Essure was a non-surgical procedure at least as effective of other forms of birth control. The plaintiffs were not warned about the serious and significant complications and injuries that could result from the Essure device.
The Essure device is a four-centimeter coil placed into each fallopian tube to prevent pregnancy by causing severe inflammation creating a total blockage of the fallopian tubes. The coil contains nickel, which some women are unknowingly highly allergic. The coil also contains polyethylene (PET) fibers, which irritate and inflame the tubes, causing scar tissue to form over the coils, blocking subsequent fertilization. Unfortunately the PET fibers which create the irritation to form the scar tissue, often cause the body to fight what it deems to be an infection or foreign body, creating a host of other problems from autoimmune disorders, neurological problems, kidney, adrenal and thyroid disorders and even cancer. The coils often become dislodged, perforating the fallopian tubes, uterus, colon or other internal organs.
The FDA has received nearly 10,000 adverse event reports regarding complaints concerning Essure. Inspections of the Conceptus manufacturing facility revealed thousands of other Essure-related complaints, which were never reported to the FDA. Holly Ennis, one of the attorneys filing the complaint stated, “It is clear that Bayer violated federal law in the manufacturing, distribution and implanting of the Essure devices. Thousands of women have paid the price for these violations and it is time these wrongful acts were adjudicated.”
The Essure victims were filed in one complaint by the law firms of Ennis & Ennis, P.A., Fleming, Nolen & Jez, LLP and local counsel, Walker, Hamilton & Koenig, LLP .