Hundreds of Lawsuits Filed by Mirena Users Alleging Organ Perforation, Other Injuries
Hundreds of lawsuits have been filed against the maker of Mirena alleging that the contraceptive can migrate from its original position after implantation and cause serious side effects including organ perforation and hemorrhages.
More than 400 cases involving Mirena are currently pending in federal court, according to the Judicial Panel on Multidistrict Litigation’s most recent statistics report. These lawsuits allege that Mirena is dangerous and defective, and carried risks that weren’t properly conveyed to both patients and doctors. In some women, the device can allegedly embed itself in the uterus or migrate from its original position, causing problems including infections, scars, organ perforation, adhesions, hemorrhages and intestinal obstruction. Furthermore, if a woman becomes pregnant while fitted with Mirena, she may be at risk for an ectopic pregnancy (one which occurs outside of the womb), miscarriage and infertility, the lawsuits claim.
Some of the plaintiffs claim that they chose Mirena after attending a “Mirena party,” which marketed the device to “busy moms” and stressed the IUD’s convenience. At these parties, a nurse and a Bayer representative would read from a script that said Mirena did not require any routine and would make women “look and feel great.” The FDA, however, found that these claims were misleading and sent Bayer a warning letter regarding these “parties.” According to the FDA, the device did require some sort of routine to ensure that it was protecting women from unwanted pregnancies, and Bayer lacked scientific evidence supporting the claim that the IUD would improve how women looked and felt. Furthermore, the FDA noted that women in clinical trials reported other side effects that directly contradicted these claims, including decreased libido, depression, weight gain and abdominal/pelvic pain.
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