National law firm Parker Waichman LLP has filed a lawsuit on behalf of an Arizona woman alleging that the Mirena® intrauterine device (IUD) perforated her uterus and migrated outside the uterus, forcing the plaintiff to undergo laparoscopic surgery to remove the device.
The lawsuit was filed on January 2, 2013 in the Superior Court of New Jersey Law Division, Morris County (case no. MRS L-0041-13). Bayer Healthcare Pharmaceuticals, Inc. has been named as the defendant. The lawsuit alleges that the plaintiff suffered severe and permanent physical injuries, substantial pain and suffering, and economic loss as a result of using Mirena®.
The Arizona woman’s Mirena® IUD was inserted in 2009 and, initially, she appeared to tolerate the device well. Neither she nor her doctor had reason to believe that the device had perforated her uterus until the doctor was unable to locate the device during a 2011 ultrasound. A CT scan of the pelvis revealed that the Mirena®IUD had perforated the uterus and moved outside the uterus. The woman required laparoscopic surgery to retrieve the device.
The Mirena®, a small, t-shaped intrauterine device, releases the hormone levonorgestrel to prevent pregnancy; the device can be left in place for up to five years. But if the IUD does not remain in place in the uterus, an unintended and possibly dangerous pregnancy can result. In addition to unintended pregnancy, serious adverse reactions have been reported to the U.S. Food and Drug Administration (FDA) since the device’s approval in 2000. These include: ectopic pregnancy (a pregnancy in which the fertilized egg grows outside the uterus); pregnancy with Mirena® in place; group A streptococcal sepsis; Pelvic Inflammatory Disease (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix.
In 2009, Bayer was reprimanded by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) for overstating the benefits, while failing to mention the risks, of Mirena® in the company’s “Simple Style” program, a social network marketing campaign aimed at “busy moms” seeking effective birth control that’s easy to use.