Mirena is a T-shaped intrauterine device (IUD) that is implanted directly into the uterus and can remain there for up to five years while it provides contraceptive protection. Mirena prevents pregnancy by releasing the hormone progestin (levonorgestrel) which prevents sperm from entering the uterus by thickening the cervical mucous. It also thins the lining of the uterus which decreases the chances that a fertilized egg will implant and grow.
Bayer’s popular intrauterine device (IUD) Mirena has recently been linked to a number of serious side effects, the most severe of which is perforation of the uterus. In a large number of recipients, Mirena has been reported to migrate from its original position after being inserted, perforating the uterus or embedding itself in the womb. In either case, the woman must undergo painful revision surgery to remove the Mirena IUD.
Earlier in 2009, Bayer received a warning letter from the FDA regarding other forms of Mirena marketing that were misleading because they make representations about the efficacy of Mirena but failed to communicate any risk information.
All advertisements for drugs and/or medical devices must include risk information. Failing to disclose the most common side-effects misleadingly suggests the drug or device is safer than it actually is.