July 16, 2013 — Bayer HealthCare is facing 105 Mirena lawsuits in a federal Multi-District Litigation (MDL #2434). All complaints involve allegations that Bayer failed to adequately warn women about the risk of spontaneous migration of the Mirena IUD (intra-uterine device), which can puncture a woman’s uterus and migrate into the abdominal cavity. Lawsuits have been centralized in the U.S. District Court for the Southern District of New York before Judge Cathy Seibel.
One of the most recent complaints was filed by Lourdes Gonzales. She was implanted with the Mirena IUD in 2009. In June 2011, it began migrating inside her body and perforated her cervix. She required surgery in July to have Mirena removed, which caused her to suffer pain and financial losses. Furthermore, the lawsuit alleges that she now suffers from permanent complications, including scarring and a risk of placenta accreta.
Lawsuits claim that Bayer never warned about the risk of spontaneous migration and uterus perforation. The label only warns about the risk of uterine perforation during the implantation procedure, which is when most perforations occur. Additionally, when Mirena migrates spontaneously, it can increase the risk of ectopic pregnancy and becoming embedded in the uterine wall.
Mirena is an intrauterine contraceptive device that is made of flexible plastic in a T-shape. The device slowly releases hormones into a woman’s uterus to reduce the risk of pregnancy. It was approved by the U.S. Food and Drug Administration (FDA) in 2000, and is now used by more than 2 million women.
Since 2000, the FDA has received more than 70,000 complaints about the Mirena IUD. Since 2008, nearly 5,000 complaints involve “device dislocation” and 1,300 complaints involve uterine perforations. In many cases, the complication causes severe pain and may require surgery to remove from the body.