A Pennsylvania woman has filed a Mirena lawsuit against Bayer Pharmaceuticals alleging that the drugmaker failed to properly warn patients about the risk of side effects caused by the device. Mirena is a hormonal IUD that is placed inside the uterus by a doctor and left in place to provide contraception for up to five years.
According to the lawsuit filed by Tricia Prendergast, the warning label for Mirena that was published by Bayer failed to alert users that they could face an increased risk of having the IUD become embedded in their body, ectopic pregnancy, hysterectomy, and other side effects. According to the case filed by her Mirena attorney, Prendergast was forced to undergo surgery to have the IUD removed from her body after suffering side effects and complications from the device.
Health officials in both the U.S. and Canada have warned about the dangers posed by the side effects of Mirena. In June 2010, a Mirena warning issued by Health Canada alerted IUD patients that they could face an increased risk of uterine perforation from Mirena, which could lead to infertility or require the IUD to be surgically removed.
In October 2009, the Food and Drug Administration warned that 50% of women who become pregnant with Mirena suffer an ectopic pregnancy. Becoming pregnant while taking Mirena can also increase the risk of other side effects, including miscarriage and infertility.