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Rhode Island medical practices were using unapproved Mirena devices

April 1st, 2015

Seven Rhode Island medical practices reached an intrauterine device (IUD) settlement with more than 700 women after they installed unapproved versions of the Mirena IUD. The practices will pay over $5 million, and roughly $3,800 to each woman who received an unapproved birth control device believing it was an IUD approved by the U.S. Food and Drug Administration.

The Mirena IUD is a birth control device that gives off an artificial hormone after being inserted into the uterus. Women in the Rhode Island lawsuit who received a device received a version of the Mirena IUD (or the ParaGard IUD) that was not approved for sale in the United States. Court records indicate that some doctors noticed the unapproved IUD didn’t deploy in the same manner as those that were approved by the FDA, but inserted them anyways.

More than 70,000 Mirena complaints have been filed to the FDA by women who received one of the devices and suffered severe side effects. Manufacturer Bayer AG faces thousands of Mirena lawsuits alleging that the device caused severe complications, including bleeding, pain and tissue damage when the device perforates the uterus and travels to other parts of the body.


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