Mirena® is an intrauterine device (“IUD”) that releases a synthetic progestogen to prevent pregnancy. It is inserted into the uterus by a healthcare provider and is approved to remain in the uterus for up to five (5) years after insertion. The Mirena® IUD was approved by the Food and Drug Administration (FDA) in late 2000 for intrauterine contraception. In 2009, the FDA also approved Mirena for the additional indication of heavy menstrual bleeding. Data indicates that more than 2 million women in the United States use the Mirena® IUD.
Chimicles & Tikellis is now investigating claims against the manufacturer of Mirena® (Bayer Healthcare Pharmaceuticals) as evidence suggests that the Mirena IUD may migrate and perforate the uterus. Once it does, it can become lodged in the abdominal cavity and/or perforate other organs such as the bowel, liver, spleen, etc. In this event, surgical repair is often necessary to remove the IUD. Mirena’s label is inadequate as it only warns for migration or perforation during the insertion/initial time period, but does not advise users of this potential occurrence at a later point in the product’s 5-year life span.
For more information about this case or to add your experience to our database, click on the Email Us about this Case button, below.
[accordion-item id=”item-1″ title=”Email us about this Case”]
[accordion-item id=”item-2″ title=”Alert me to Case updates”]
[widgets_on_pages id=”Email Alerts”]