The Food and Drug Administration has reported that the agency has received more than 45,000 reports of complications linked to the hormonal intrauterine device (IUD) Mirena. Mirena was approved for sale by the FDA in 2000 and is currently the online hormonal IUD on the market in the U.S.
According to the FDA’s Mirena side effects report, the agency received over 1,400 reports of cases involving the migration of the IUD, which can place women at risk of uterine perforation or other conditions. More than 6% of the adverse event reports received by the FDA involved Mirena complications that required hospitalization or surgery.
Both the FDA and Health Canada have sent warnings about Mirena to Bayer, the manufacturer of the IUD, concerning the serious complications that have been linked to the device. In addition to the risk of uterine perforation linked to Mirena, patients who use the IUD may also be at risk of developing other serious side effects, including migration of the device, pregnancy complications, infection, perforation of other organs or blood vessels.
Women who were treated with Mirena and have suffered serious complications from the device have filed lawsuits against Bayer. These Mirena lawsuits have accused the company of intentionally misleading patients about the risk of complications from the IUD.