Women across the country have begun filing lawsuits against the pharmaceutical giant Bayer Healthcare Pharmaceuticals, Inc., alleging they have suffered severe injuries from Bayer's Mirena intrauterine device (IUD).
Mirena is a small, t-shaped plastic device that is inserted into a woman's uterus by a healthcare practitioner. It releases a synthetic hormone called levonorgestrel to prevent pregnancy. It is intended to work for up to five years. After five years the daily dose of the hormone it releases is reduced to half and the IUD should be removed.
Mirena was originally approved by the U.S. Food & Drug Administration (FDA) in 2000 for contraception. In 2009, the FDA approved Mirena for heavy menstrual bleeding. Since its arrival, Mirena is estimated to have been implanted in 2 million women in the U.S. and 15 million women worldwide.
Recently, the Judicial Panel on Multidistrict Litigation agreed to consolidate Mirena cases in the U.S. District Court for the Southern District of New York under Judge Cathy Seibel for coordinated pretrial purposes. The litigation continues to grow as more and more women are filing lawsuits against Bayer.
Many of the lawsuits claim that the device migrated, or moved, from its intended position in the uterus and perforated the uterus, cervix or other internal organs. Women suffering from this type of complication typically have to undergo surgery to remove the IUD. These injuries can also lead to additional types of complications such as sepsis.
Other women claim that the Mirena embedded in their uterus, also requiring surgery to removed the device. Jones Ward is also investigating a possible link between Mirena and pseudotumor cerebri, a serious condition that develops when cerebrospinal fluid builds up the skull and creates increased pressure on the optic nerve.