May 2, 2014 — Bayer AG has reported that nearly 2,000 women have filed Mirena lawsuits against the company for complications like uterine perforation and ectopic pregnancy.
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.
Plaintiffs allege that Bayer has failed to warn about the risk of spontaneous uterine perforation, a complication that may occur when the T-shaped Mirena erodes through the uterine wall.
In some cases, Mirena migrates outside the uterus and into the abdomen, where it can only be removed with surgery. If this complication occurs, Mirena may fail to protect against pregnancy. About half of all pregnancies that occur with Mirena are ectopic pregnancies.
Ectopic pregnancy is a rare but life-threatening condition that occurs when a fertilized egg implants and grows outside the uterus. Almost all ectopic pregnancies occur in the fallopian tubes, which connect the ovaries and womb.
Unfortunately, the fetus cannot survive unless it is in the womb. As it grows, it may cause severe organ damage, bleeding, and shock. The condition requires emergency medical treatment. Only about 60% of women who have an ectopic pregnancy are able to get pregnant again.