Is the Mirena IUD a Safe Choice for Women?
Mirena is one of only three intrauterine device (IUD) contraceptives available for use in the United States. The federal Food and Drug Administration (FDA) approved Bayer Healthcare Pharmaceuticals, Inc.’s New Drug Application for Mirena in December 2000. Over the past decade, it is estimated that Mirena has been used by millions of women in the United States and more than 15 million women worldwide.
The Mirena IUD is a small T-shaped device, measuring 32 mm in both the horizontal and vertical direction, made up of flexible plastic that is inserted into the uterine cavity by a trained health care provider during a regular office visit. A thin tail-string hangs from the bottom of the IUD into the upper vagina, so the device can be removed by a clinician and checked periodically by the user.
Mirena works by releasing a hormone called levonorgestrel into the uterus in order to provide birth control, for up to a period of five years. In 2009, Mirena was also approved for and has been prescribed to help treat women who experience
heavy menstruation cycles.
Although the exact science behind what levonorgestrel does once released into the uterus is still unknown, it is believed that Mirena prevents pregnancy by thickening cervical mucus to prevent sperm from entering the uterus, inhibiting sperm movement, and/or thinning the lining of the uterus.
Recently, a number of lawsuits have been filed against Bayer alleging that the Mirena IUD has spontaneously migrated and/ or perforated the uterine wall. While Mirena’s label indicates that it can perforate the uterus during the initial insertion period (four to six weeks), Mirena’s label fails to warn about the serious risk of spontaneous migration of the IUD after the initial time frame.
In the past few years, the FDA has issued Bayer two warnings for overstating the efficacy of Mirena while failing to adequately convey information related to its risks.
However, despite these FDA warnings and the vast MedWatch Adverse Event reports concerning the Mirena becoming embedded, migrating, and/or perforating the uterine wall, the IUD’s label continues to be void of any warnings related to these very serious medical events.
Once the Mirena IUD has migrated or perforated the uterine wall, it can travel throughout the abdominal cavity or other bodily areas. Women have discovered the Mirena IUD in a number of areas such as the bowels, intestines, spine, hip and pelvic area.
Unfortunately surgery, sometimes in the form of a hysterectomy, is often needed in order to properly remove the IUD once it has migrated. If a Mirena user experiences pain related to the device, it is recommended they seek immediate medical attention and undergo a physical examination, and, if necessary, a diagnostic test, to confirm that it remains in the proper location.
Women who are using the Mirena IUD should be mindful of the risk of spontaneous migration after it is initially inserted. As a result, women should follow up with their health care providers regularly to ensure that the IUD remains in the proper location.