Mirena is an intrauterine contraceptive device (IUD) first approved in January of 2000. The Mirena IUD is implanted into the uterus to prevent contraception and control menstruation. It is recommended that the IUD be removed after five years. Mirena is recommended only for women who have had at least one child.
The IUD was originally approved to prevent contraception. In 2009, it was also approved to aid in the control of menstruation. Mirena obtained approval under section 505 (b) of the Food Drug and Cosmetic Act. It is not regulated as a medical device by the FDA because it dispenses medication.
Women who use Mirena are at risk of the IUD spontaneously migrating outside of the uterus, perforating the uterine wall. The Mirena label, which has been modified slightly in May of 2014, does not provide adequate warning of the risk of migration and perforation. Attorneys are looking for injuries demonstrating device migration necessitating surgical removal or resulting in uterine perforation.