An investigative report by WXYZ News in Michigan revealed that the U.S. Food and Drug Administration has received nearly 60,000 complaints regarding the Mirena birth control intrauterine device (IUD) since 2008.
Despite the reported problems, the FDA has not taken steps to has not change its position on Mirena’s safety. More than 70,000 complaints have been received since 2008.
In recent years, as popularity of Mirena increased, the FDA compiled some 59,073 complaints related to Mirena since 2008. The most serious of the adverse events include 4,775 women who reported dislocation of the device — which means the IUD was embedded in the uterus or migrated outside of the uterus, in some cases into the abdominal cavity. Reported side effects have also included uterine perforation and potentially dangerous vaginal hemorrhaging.
The Mirena IUD is a plastic device that is a hormone eluding device implanted into the uterus to prevent pregnancy.
WXYZ reporter Heather Catallo obtained the reports using a Freedom of Information Act (FOIA) request. It includes more than 13,000 pages of detailed complaints.
According to WXYZ more than 220 lawsuits have been filed in federal and state courts seeking damages for Mirena-related injuries.