Several Canadian women have filed lawsuits against Bayer alleging the company did not adequately warn that its Mirena intrauterine device could cause serious injuries. The lawsuits mirror concerns of hundreds of other plaintiffs in the United States.
In 2013, Health Canada, the country’s drug regulator, received 52 reports of uterine perforations involving the Mirena IUD. Perforations have caused tissue or organ damage. There were also reports that the device migrated from its intended position in the cervix to other parts of the abdomen.
Surgery is often required to remove the renegade Mirena IUDs. In some cases women have had to undergo hysterectomies, leaving them sterile.
One Canadian woman who has filed a Mirena IUD lawsuit against Bayer claims she suffered severe abdominal cramping a year after being implanted with the device. The pain was so debilitating she could not walk and could barely get out of bed. When she went to have the device removed, doctors could not find it with an ultrasound. During surgery, doctors found her Mirena IUD near her hip bone.
In July 2008, the U.S. Food and Drug Administration (FDA) required Bayer to update the label of the Mirena IUD to include the warning: “Delayed detection of perforation may result in migration outside the uterine cavity…” Health Canada did not make the same requirements of Bayer, thus Mirena IUDs sold in Canada do not include the warnings.
Source: CTV News