September 22, 2014 — A lawsuit has been filed by a woman who says Bayer’s Mirena intrauterine device (IUD) perforated her uterus and migrated into her rectum, according to Courthouse News.
According to the complaint, the plaintiff received the IUD in July 2012. In September, she had a positive pregnancy test. The ultrasound “did not show an IUD in the uterus or pelvis,” and she miscarried soon after.z
One month later, she had surgery to locate the IUD. An extensive search of her liver, spleen, and stomach were unsuccessful. Finally, the IUD was located and removed after a rectal exam.
Bayer HealthCare is facing nearly 2,000 lawsuits from women who were injured when Mirena spontaneously migrated and punctured the uterus. Mirena has been linked to reports of intestinal perforation, but this may be the first lawsuit to describe an IUD migrating to the rectum.
Many women in the litigation accuse Bayer of downplaying risk information about spontaneous uterine perforations after Mirena is implanted. The current Prescribing Information warns only about the risk of uterine perforations during the implantation procedure.
When an IUD migrates into the intestines, it must be removed surgically. Otherwise, it is possible that a fistula, infection, sepsis, or other complications will develop.
Hundreds of lawsuits against Bayer have been consolidated in a federal Multi-District Litigation (MDL No. 2434) in the U.S. District Court for the Southern District of New York, where they are overseen by Judge Cathy Seibel. Last month, lawyers selected 12 cases that may be selected for so-called “bellwether” trials. The first trial is tentatively scheduled for March 2016.