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.
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.
In New Jersey, another consolidated litigation has formed under Judge Martinotti. Both consolidated litigations are seeing more lawsuits filed and have begun the preliminary stages.
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 lawsuits claim that Mirena became embedded in the uterus, also requiring surgery to remove the device. To read more about Mirena's injuries, click here.
Additionally, Jones Ward is investigating whether a severe brain condition, known as pseudotumor cerebri, is related to the hormone released by Mirena (levonorgestrel). Pseudotumor cerebri (PTC) develops when cerebrospinal fluid in the brain is not released at the same time it accumulates, leading to increased pressure in the skull. It typically presents with blurred vision and severe, migraine-like headaches, as well as other symptoms that frequently manifest in patients with increased cranial pressure.