Mirena IUD Lawsuits: Device Ranks High for FDA Searches
With Mirena IUD lawsuits being filed in courts around the country, it’s perhaps not surprising that the device is ranking high among searches conducted on the U.S. Food & Drug Administration’s (FDA) website. This may be due, in part, to concerns women have about potential Mirena side effects, including uterine perforation and spontaneous device migration.
The Mirena IUD is a small, plastic t-shaped birth control device that is inserted into the uterus by a healthcare professional, where it can stay in place for five years. Now used by more than 2 million women, Mirena was first approved by the U.S. Food & Drug Administration (FDA) in 2000 as a contraceptive. In 2009, the agency gave Bayer Healthcare Pharmaceuticals clearance to sell Mirena as a treatment for heavy menstrual bleeding for women who wish to use an IUD as their method of birth control.
Mirena is now used by some 2 million women. What’s more, the Mirena IUD is growing in popularity, and most experts expect that trend to continue. In fact, the American College of Obstetricians and Gynecologists (ACOG) recently recommended Mirena as a first-line method of birth control for teenagers and young women.
FDA Mirena Searches
According to the FDA, Mirena was the 17th most-searched-for-term on the agency’s website from August 2012 through October 2012. Only two other medical products outranked Mirena on the FDA’s list of popular search terms – metformin (a diabetes drug), and acetaminophen.
Considering that 2 million women are using the Mirena IUD, it’s not surprising that the device would generate a good deal of interest on the FDA website. However, it’s likely that some of the searches were prompted by concerns about Mirena side effects. According to a recent report from AdverseEvents.com, well over 45,000 adverse event reports naming Mirena have been made to the FDA since the device first came on the market in 2000.
Mirena IUD Lawsuits
A growing number of women are filing Mirena lawsuit alleging Bayer downplayed the risks of serious injuries, including spontaneous device migration that occurs long after implantation. Many of these side effects have the potential to endanger a woman’s fertility, and even her life. For example, if the Mirena IUD migrates from its original location, it may become embedded in the uterine wall, or cause a uterine rupture. The device may even migrate outside of the uterus and into the abdominal cavity. If any of the above occurs, there is a risk that even more serious complications will develop, including:
- Erosion of nearby tissue
- Inflammation of the membrane that the abdominal cavity and internal organs (Peritonitis)
- Intestinal perforations or obstruction
- Pelvic Inflammatory Disease
- Uterine perforation
- Embedment in the uterine wall
- Ectopic pregnancy
Many legal experts agree that the litigation surrounding Mirena could be large. This apparently includes Bayer’s own attorneys, who in August petitioned the New Jersey Supreme Court to establish a consolidated litigation for all MIrena lawsuits pending in the state in Superior Court in Middlesex County.