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Ohio Woman Sues Bayer Over Mirena IUD Migration

On July 12, 2013, a lawsuit complaint was filed with the U.S. District Court for the Eastern District of Pennsylvania regarding the controversial Mirena IUD. The plaintiff, an Ohio woman, is suing Bayer Pharmaceuticals for damages in excess of $150,000. She alleges the contraceptive device migrated, causing pain and suffering, and putting her at risk of future health complications. It is the latest Mirena IUD migration lawsuit to hit Bayer, and comes amid growing publicity surrounding potential side effects that were allegedly not disclosed by the manufacturer.

The plaintiff was implanted with the Mirena IUD in January 2009. Before undergoing the procedure, her doctors explained the risks and benefits of using the device. But according to the court documents, it was “impossible” for doctors to adequately discuss the level of risk because Bayer had not informed them of the true likelihood of perforation, migration and embedment in the uterine wall. Physicians say they would never have have advised the plaintiff to use the device had they known the true extent of Mirena side effects.

The plaintiff stated she “would not have elected to have the Mirena IUD implanted if she knew of the true risks.”

By the summer of 2011, tests showed that the device had migrated, perforating the plaintiff’s cervix. In July of the same year, she was forced to undergo revision surgery, which has left her with scarring and an increased risk of placenta accreta, a potentially life-threatening obstetric condition which causes the placenta to bind with the uterine wall.

In addition to the physiological difficulties suffered by the plaintiff, the Mirena IUD migration lawsuit says the plaintiff experienced “financial loss” and describes the device as “unreasonably dangerous.” It goes on to describe Bayer’s production and marketing of the Mirena IUD as displaying a “wanton and reckless disregard for public safety.”

Thousands of complaints lodged with FDA

Designed to give women five-year protection from unwanted pregnancies, the intrauterine device releases the hormone levonorgesterel, which thickens cervical mucus and prohibits the transfer of sperm – although Bayer admit they are not fully sure of how Mirena actually works. When it was first approved in 2000, the Mirena IUD was marketed as a safe form of long-term contraception.

To date, nearly 50,000 “adverse event” reports have been submitted to the FDA regarding the Mirena IUD. The complaints cite complications ranging from device expulsion and perforation of the uterus, to pelvic inflammatory disease and ectopic pregnancy.

According to the most recent data, around 36% of the adverse event reports filed related expulsion of the device. Around 10% related to migration of the device, and 8% to vaginal bleeding. Hospitalization was required in around 6% of cases, and the device is implicated in at least 50 deaths.

Mirena IUD migration lawsuit filings

More than 50 women have filed a Mirena IUD lawsuit in federal courts. There are approximately 110 lawsuits pending in New Jersey and other state courts across the United States. With over 10 million women having been implanted with the device, legal experts expect the number of lawsuits to rise significantly.

Dozens of lawsuits have been consolidated into a Mirena IUD multidistrict litigation (MDL no. 2434), due to be heard before Judge Cathy Siebel in the Southern District of New York.