The Food and Drug Administration has received more than 70,000 complaints about the hormonal intrauterine device Mirena since 2000, according to records released by the health agency. Studies have linked the IUD to potentially fatal health problems as well as complications during pregnancy.
According to records released by the FDA under the Freedom of Information Act, the agency has received thousands of complaints involving severe pain, dislocation of the IUD, uterine perforation, or migration of the device outside the uterus. Many of these complications required surgery to repair internal injuries or to have the Mirena IUD removed.
Researchers have also linked Mirena to an increased risk of complications during pregnancy. About half of all women who become pregnant while using Mirena will experience an ectopic pregnancy in which the fetus develops outside the womb, making the pregnancy unviable. Mirena may also cause miscarriage, septic abortion, or permanent infertility among pregnant women.
More than four dozen Mirena lawsuits have been filed in federal court on behalf of women who suffered complications from the IUD. Lawsuits against Mirena have alleged that the manufacturer of the IUD failed to properly warn women about the health risks of the IUD while overstating the effectiveness of the device.