A woman Implanted with a Mirena® IUD is suing Bayer, the maker of the device, alleging that the IUD perforated her uterus and necessitated surgery to remove the IUD. The lawsuit was filed by the national law firm, Parker Waichman LLP, on behalf of the Florida woman and charges that the Mirena® IUD caused substantial injuries
According to the complaint, the woman’s Mirena® IUD birth control migrated from its intended position, perforating her uterus and forcing her to undergo surgery to remove the contraceptive device. The lawsuit was filed on November 5, 2012 in the Superior Court of New Jersey Law Division, Morris County (Civil Action No. MRSL-2723-12), and names Bayer Healthcare Pharmaceuticals as the defendant.
According to the complaint, the woman received the Mirena® IUD in 2008 and, by July 2010, she suffered from pelvic pain. The strings attached to the device could not be located, and the IUD itself could not be found though an ultrasound. The woman underwent laparoscopic surgery in December 2010 to remove the IUD.
The lawsuit is also alleging a number of damages on behalf of the woman, including severe and permanent physical injuries, pain and suffering, and economic losses in the form of medical expenses and lost wages.
The Mirena® IUD, a long-term form of birth control, is a plastic device that is attached to two strings and is inserted into the uterus for up to five years. While implanted, the IUD releases the synthetic hormone, levonorgestrel. According to the lawsuit, Bayer admits that it is not sure exactly how Mirena® works to prevent pregnancy.
The lawsuit also alleges that Bayer has not warned the public about the spontaneous migration of the Mirena® IUD. The label only warns that the device may migrate if the uterus is perforated during insertion, although the plaintiff’s experience contradicts this notion, given that she had no symptoms of migration until two years after the device was implanted. According to the complaint, the women had well tolerated the initial procedure; neither she nor her doctor had any reason to suspect that her uterus was perforated until she began experiencing pelvic pain.
Bayer has been scrutinized in the past over the way in which it has marketed Mirena. In 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) determined that certain claims made by the company’s “Simple Style Program,” which marketed Mirena® to “busy moms,” were unsubstantiated. The agency said that, among other things, the program failed to mention side effects such as weight gain, acne, and breast tenderness.