September 22, 2014 — Bayer HealthCare is facing nearly 2,000 lawsuits involving the Mirena intrauterine device (IUD), but Courthouse News has reported what may be the first lawsuit involving a rectal perforation.
The IUD was inserted into the plaintiff’s uterus in July 2012. Two months later, she had a positive pregnancy test. When she went to the doctor, an ultrasound “did not show an IUD in the uterus or pelvis.” Soon after, she suffered a miscarriage.
The next month, she underwent extensive examinations to locate the missing IUD. Despite surgery, her doctor was unable to find the IUD in her liver, spleen, or stomach. The IUD was finally located after a rectal exam.
In recent years, Bayer has been accused of concealing risk information linking Mirena with spontaneous uterine perforations. The Prescribing Information carries warnings about uterine perforations during the insertion procedure, but hundreds of women have been injured when Mirena spontaneously migrated into their abdomen — sometimes months or years after the initial insertion procedure.
It is not uncommon for an IUD in the abdomen to damage intestines, but rectal perforations are rare. This complication must be treated with surgery to remove the IUD and repair damage to the intestines. Without treatment, it can rapidly lead to life-threatening complications like sepsis, infection, or a fistula.
Bayer is facing hundreds of lawsuits in a Multi-District Litigation (MDL No. 2434) in the U.S. District Court for the Southern District of New York. In August, plaintiffs’ attorneys selected a group of 12 cases as candidates for the first “bellwether” trial, which will be used to help determine the outcome of other cases in the litigation. The first trial is tentatively set for March 2016.
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