Mirena Birth Control Lawsuits

FDA Warnings to Bayer

Bayer, the maker of the device, has been warned for shady business tactics promoting Mirena.

In March 2009, the Food and Drug Administration issued a warning to Bayer Healthcare Pharmaceuticals regarding three of their products, one of which was Mirena. In the warning, the FDA cites misleading sponsored web links.

Specific complaints regarding Mirena include the oversimplification of the product, incomplete product statements, and failure to identify a specific patient population (women who have at least one child).

At the end of December 2009, the FDA administered a warning to Bayer about their script for a "live consumer-directed program," stating that the program overstated Mirena's efficacy, included unsubstantiated claims, false/misleading presentations, and minimized risks.

What is Mirena?

Mirena, a product of Bayer Healthcare Pharmaceuticals, is an intrauterine device, or a type of birth control that is placed inside the uterus. The Food and Drug Administration (FDA) originally approved Mirena for patient use in 2000 and again approved it in 2009 for use to treat women with heavy menstrual bleeding.

Mirena Danger Signs

Like all forms of birth control, Mirena comes with its own list of side effects, including pain or bleeding soon after the device is placed. Occasionally, the device is expelled. Some users may experience depressed mood or migraines, and even fewer may experience weight increase, pelvic pain, or anemia. However, some women have experienced far worse symptoms.

Some women have experienced uterine perforations (tears) when the Mirena IUD moves from the uterus into the abdomen; it can potentially tear the intestines or other organs and/or cause infection. Several surgeries may be required to remove the IUD, resulting in scarring, uterine damage, or infertility. Perforation can occur months after the IUD is first inserted.

Other women report that the hormone—synthetic progestin hormone—that the device releases causes brain injuries through brain swelling. Some women may contract pelvic inflammatory disease (PID), which can cause infertility. Ectopic pregnancies, a dangerous form of pregnancy, occur in half of women who become pregnant while using the IUD.

Lawsuits are being filed over these additional dangers and the lack of warnings on the product label. Bayer may have known the risks and yet put out a dangerous product. If you have received the Mirena IUD and you've experienced any of the above symptoms, you may be eligible for substantial compensation.