A 33-year-old woman who used the Mirena Intrauterine Device (IUD) for birth control for about six months developed a serious bone disease that left her disabled. The Mirena IUD was considered the primary source of her condition, according to researchers with AdverseEvents.
According to the case study filed with the Food and Drug Administration (FDA) Adverse Event Reporting Program, the woman developed avascular necrosis in her hips and right shoulder shortly after being implanted with the IUD. After the device was removed, the necrosis did not spread to her right shoulder. (Avascular necrosis tends to affect parallel joints.)
The woman had four surgeries in 2012 – three for core decompression and one hip replacement. She spent six months in a wheelchair and had to learn how to walk again. The condition is thought to have been an autoimmune response that led to blood loss in the bones.
There have been more than 47,000 adverse events reported with the Mirena IUD since it hit the market in 2000. Avascular necrosis is a highly unusual response. Most negative side effects associated with the Mirena IUD include device expulsion or dislocation, hemorrhaging, and abdominal pain. The device has also been associated with an increased risk for ectopic pregnancy, organ perforation and infection. In some cases, surgery and/or hospitalization was required.
Several women have filed lawsuits with Bayer Healthcare, maker of the Mirena IUD, claiming they were not adequately warned of the risks associated with the device.