August 11, 2016 — A group of 98 women who were injured by Essure have filed a single lawsuit accusing Bayer of downplaying the risk of severe side effects.
The lawsuit was filed on July 25 in Madison County Circuit Court against Bayer HealthCare, LLC (Case No. 16-L-1046).
On August 2, California Superior Court Judge Winifred Smith allowed 11 Essure lawsuits involving 14 women to move forward, according to MassDevice.
Until now, lawsuits have been preempted by a federal law related to FDA-approved labeling, which essentially gives Bayer immunity. That immunity has been under attack by advocates like Erin Brokovich.
The FDA has also issued a number of warnings about Essure. After the agency received over 5,000 complaints, Bayer was ordered to place a “Black Box” warning label on Essure.
The women say Essure caused severe health problems, including severe pain, bleeding, headaches, allergic reactions, implant migration, perforations, and more. Most of the women had surgery to remove Essure, and some required a complete hysterectomy.
Essure is a non-surgical sterilization coil that is implanted into the fallopian tube. It prevents pregnancy by causing severe inflammation and a total blockage of the fallopian tubes, which prevents sperm from fertilizing an egg.
The problem is that the coils contain nickel, which is one of the most common metal allergies. The coils are also coated in polyethylene (PET) fibers, which are designed to cause irritation and inflammation. The coils can also break and perforate the fallopian tube, uterus, intestines, or other organs.