Bayer Pharmaceuticals, Inc. is facing litigation concerning its Mirena intrauterine device (IUD). In addition to thousands of lawsuits concerning Bayer’s birth control pills Yaz and Yasmin, for which the company has already paid over $400 million in settlements, Bayer is now defending lawsuits alleging the Mirena IUD caused women serious injuries.
According to a recent report, a total of 16 cases have been filed in the New Jersey Superior Court, Morris County. Each case claims that Bayer overstated the benefits of the device while understating the side effects and failing to warn about the risks. Bayer is currently seeking to centralize the litigation in New Jersey.
FDA Approves Mirena in 2000
The FDA approved the Mirena IUD device in 2000. Prior to that, the device had been marketed for 10 years in Europe.
Mirena is a small, T-shaped, plastic device inserted by a trained healthcare professional into the uterus to prevent pregnancy. While in the uterus, it gradually releases the hormone levonorgestrel into the body, where it reduces the chances of pregnancy for up to five years. The device itself also disrupts the egg and sperm to discourage pregnancy.
In 2009, the FDA approved Mirena for the additional use of treating heavy menstrual bleeding. In the primary clinical trial submitted to the FDA, women using Mirena showed a statistically significant reduction in menstrual blood loss.
At the time of the second approval, the FDA noted that the most serious adverse events reported included ectopic pregnancy (where the fertilized egg grows outside the uterus), intrauterine pregnancy (pregnancy with the Mirena in place), pelvic inflammatory disease, embedment of the device into the uterine wall, and perforation of the uterine wall or cervix.
Reports of Serious Mirena Side Effects
Other post-marketing reports have indicated that Mirena may also be associated with additional side effects. For example, the device may migrate outside the uterus causing scarring and other complications. This type of migration can also result in organ perforation or the device becoming embedded in the uterus or into another organ. In these cases, surgery is typically needed to remove the device. Such surgeries have been reported to affect a woman’s ability to have children in the future.
In addition, women have reported experiencing abscesses, infertility, intestinal perforations or obstructions, infections, and erosion of adjacent areas, such as the vagina.
Women Filing Mirena IUD Lawsuits
More women have been coming forward to seek compensation for their Mirena IUD injuries. Lawsuits allege that Bayer failed to properly study the device to be sure of its risks and side effects before releasing it onto the market. Plaintiffs also claim the company failed to adequately warn patients and doctors about the risks, and over-promoted the benefits through its “Simple Style” program, which claimed Mirena increased intimacy and helped women look and feel great.
The first Mirena IUD lawsuit was filed on April 12, 2012, on behalf of an Ohio woman. Her complaint alleged that she required a hysteroscopy to remove the device. Considering over two million women have used Mirena in the U.S., many more injured women may be coming forward with complaints in the near future.
