February 27, 2014 — At least 1,036 Mirena lawsuits have been filed in New Jersey state court and a federal litigation in New York, and the litigation continues to grow rapidly as more women come forward to seek justice for injuries, including spontaneous uterine perforation, migration, infection, and other complications that resulted in removal of Mirena.
According to a case list (.PDF) issued on February 19, there are 408 lawsuits in the Mirena Multi-District Litigation (MDL No. 2434, In re: Mirena IUD Products Liability Litigation). The MDL was established in April 2013 in the U.S. District Court for the Southern District of New York before Judge Cathy Seibel.
In addition, a case list (.PDF) provided by the New Jersey Superior Court confirms 628 Mirena lawsuits in Bergen County, before Judge Brian R. Martinotti.
The Mirena Intra-Uterine Device (IUD) is a small piece of T-shaped plastic that is implanted in the uterus, where it prevents pregnancy by slowly releasing hormones over five years. It was first approved in 2000. In 2009, the same year the FDA expanded approval of Mirena to treat women with heavy menstrual bleeding, the agency sent a warning letter to Bayer for advertisements they said made misleading claims about the benefits and risks of Mirena.
Since 2008, the FDA has received at least 5,000 reports of Mirena migrating out of place — in some cases moving completely out of the uterus. Although Bayer provides warnings about the risk of migration and uterine perforation during implantation procedure, many of these events occurred several months or even years after the IUD was implanted.