We have been blogging heavily about an increasing number of lawsuits against Bayer Healthcare Pharmaceuticals--maker of the Mirena IUD, a t-shaped plastic device inserted into a woman's uterus intended to provide long term (up to five years) contraception.
In a nutshell, women across the country have experienced severe complications after Mirena has migrated from its intended position in the uterus and perforated the uterus and sometimes other parts of the body. When this occurs, it typically requires surgery to remove the device. Bayer's label warns that perforation may occur upon insertion. However, the label does not warn doctors (who then never have a chance to warn their patients) that sometime after proper insertion, Mirena can "spontaneously" migrate and perforate the uterus and end up somewhere in a woman's abdominal cavity
Recently, we posted that one of Bayer's defenses in a South Carolina case in federal court is that spontaneous migration is "biologically implausible." Thus, Bayer is claiming migration (which, in turn, frequently leads to perforation) simply does not occur.
However, a variety of sources points otherwise. In addition to adverse events reported to the FDA and to Bayer, in June 2010, Bayer wrote letters to inform healthcare practitioners and the public in Canada of important safety information about Mirena. Specifically, the letter to the public warns that "Uterine perforation may occur as MIRENA® is being inserted or after the insertion with limited symptoms." (emphasis added). If Bayer is claiming Mirena does not migrate, or move, after insertion, why would it warn of post-insertion perforation at all?
And if this warning was provided to the public and to doctors in Canada nearly three years ago, why didn't Bayer warn of the same in the United States? Bayer's label currently only warns that perforation may occur upon insertion. The label includes no warning of migration and post-insertion perforation. According to Bayer, nearly 2 million women in the U.S. currently have MIrena.