More than 70,000 Reports of Mirena IUD Adverse Effects Detailed in FDA Records
The U.S. Food and Drug Administration (FDA) received 70,072 reports of adverse effects associated with the Mirena intrauterine device (IUD) between the device’s approval for use as a form of birth control in 2000 and April 2013, according to recently released FDA records. Many Mirena IUD complications have been serious, resulting in the need for emergency surgery and removal of the device.
The FDA records in question were acquired through a Freedom of Information Act (FOIA) request and reported by a variety of media sources. The records regarding Mirena IUD adverse effects are more than 13,000 pages long and can be viewed here.
The records detail 4,775 instances of women who reported dislocation of a Mirena IUD and subsequent embedment of the device in the uterus or migration of the device outside of the uterus. The FDA adverse effects complaints also list 1,322 cases in which women suffered uterus perforation due to migrating Mirena IUDs.
Injuries stemming from Mirena IUD can be severe, painful and life-changing. Emergency surgeries, including appendectomy and hysterectomy procedures, are sometimes necessary; some women are left unable to have children.
More than 220 lawsuits have been filed in state and federal courts against Bayer Healthcare Pharmaceuticals, which manufactures Mirena IUD. Among the charges faced by Bayer are that the company did not provide physicians and patients with adequate warnings regarding the risks of Mirena IUD use.