November 19, 2014 — Nearly 2,500 lawsuits have been filed by women who were injured by Mirena, a contraceptive IUD made by Bayer HealthCare that can allegedly perforate a woman’s uterus, migrate into the abdomen, and require surgery to remove.
There are 1,089 lawsuits pending in a federal Multi-District Litigation (MDL), according to an update (PDF) from federal judges overseeing the litigation. The first “bellwether” trials are scheduled to begin in March 2016.
In New Jersey state court, another 1,250 lawsuits are pending before Judge Brian R. Martinotti.
All of the women in this growing litigation accuse Bayer of downplaying risk information linking Mirena with spontaneous uterine perforation. The label on Mirena only includes warnings about uterine perforation during insertion, despite thousands of reports describing perforations months or years after insertion.
Complications include chronic pain, scarring, adhesions, infections, embedment or erosion into the uterus, infertility, and even intestinal perforations. After Mirena migrates into the abdomen, the only way to remove it is with surgery. Unfortunately, many women were misdiagnosed because their doctors were unaware of the side effect and assumed it had fallen out.
At least 9 additional lawsuits have been filed by women who were diagnosed with Intracranial Hypertension (high pressure inside the skull), a rare brain disease that can cause chronic headaches and vision loss. The first studies linking levonorgestrel-releasing IUDs and intracranial hypertension were published in the 1990s, but Mirena does not have warnings about this risk.