The lawsuit, filed on January 2 in the Superior Court of New Jersey Law Division, Morris County, names Bayer Healthcare Pharmaceuticals, Inc., which manufactures Mirena®, as the defendant. The suit alleges that the Mirena® intrauterine device (IUD) perforated the woman’s uterine wall and migrated outside the uterus, causing severe and permanent physical injuries. According to the lawsuit, the plainiff suffered emotional distress and economic losses, and needed to undergo laparoscopic surgery to remove the device.
Mirena®, a hormonal IUD, works by releasing the hormone levonorgestrel while it is implanted. According to recommendations, the device can be left in place for up to five years. The plaintiff’s Mirena® IUD was implanted in 2008, and she appeared to tolerate it well, but a 2011 ultrasound revealed that the device was no longer present in her uterus.
The lawsuit alleges that although Bayer warned of the possibility of uterine perforation, it did not warn the plaintiff and other consumers of the possibility of spontaneous migration and the serious consequences that could result. Mirena® has been in use since 2002 when it received approval from the U.S. Food and Drug Administration (FDA). In that time, the device has been associated with a variety of serious adverse events including perforation of the uterine wall, embedment of the device in the uterine wall, ectopic pregnancy, streptococcal sepsis, and Pelvic Inflammatory Disease (PID). A number of lawsuits have recently been filed against Bayer over alleged Mirena® injuries.