May 2, 2014 — Nearly 2,000 women have filed a Mirena lawsuit for uterine perforations or ectopic pregnancy, according to Bayer AG, the manufacturer of Mirena.
According to the stockholders report:
“Mirena™: As of April 8, 2014, lawsuits from approximately 1,810 users of Mirena™, an intrauterine-system providing long-term contraception, had been served upon Bayer in the U.S. Additional lawsuits are anticipated. Plaintiffs allege personal injuries resulting from the use of Mirena™, including perforation of the uterus or ectopic pregnancy, and seek compensatory and punitive damages.”
Bayer is accused of failing to warn about the risk of spontaneous uterine perforation. In some cases, the complication occurred months or even years after Mirena was implanted. Some women were misdiagnosed because doctors assumed Mirena had fallen out when they were unable to locate the IUD.
Plaintiffs allege that Mirena can erode through the uterine wall, puncture the uterus, and even migrate into the abdomen. When this occurs, Mirena will fail to protect against pregnancy. About half of all pregnancies with Mirena are ectopic pregnancies, which occur outside the womb.
Ectopic pregnancy is life-threatening for the mother. The growing fetus cannot survive outside the womb. As it grows, it can rupture internal organs where is is growing (fallopian tubes, cervix, etc.) and cause severe bleeding, organ damage, and sepsis. About 40% of ectopic pregnancies cause infertility.