Bayer's Mirena intrauterine system (IUS) is marketed as a top-of-the-line of birth control method for women who have had at least one child and prefer a long-term form of birth control.
However, in the past year, women all over the country have begun reporting suffering serious injuries. Migration of the device from the uterus leading to perforation of the cervix, uterus, and other parts of the body is among the most serious.
Mirena first arrived on the U.S. market in 2000. In 2009 the FDA approved it for heavy menstrual bleeding, as well as for contraception. Bayer's website reports that it has been implanted by an estimated 2 million women in the U.S. and 15 million worldwide.
The device is intended to be implanted by a doctor in a woman's uterus. It releases 20 mg of the hormone levonorgestrel each day, which prevents pregnancy. Once implanted, Mirena is intended to provide long-term contraception (for up to five years).
Mirena's label warns physicians that it may perforate the uterus upon insertion. It does not warn, however, that Mirena may migrate, or move from its intended position in the uterus, to other parts of the body.
The problem may be caused by the fact that levonorgestrel, in combination with the Mirena's t-shape and its intended position in the uterus, may caused a woman's uterus to thin, making it more susceptible to perforation. Once Mirena perforates the uterus, it can travel to essentially anywhere within the abdominal cavity.
When it migrates, it may perforate internal organs, or become lodged in the fallopian tube. Typically, a woman may feel severe abdominal cramps when the device migrates and perforates the uterus. Many women can't find the strings attached to the IUS (which they should always be able to find if Mirena is still in its proper place). If a woman seeks medical attention, a physician may have to use an xray or an ultrasound to even find the device.
Mirena migration and perforation can cause severe injuries and unfortunately, women may not be aware of exactly what is going on. Some women suffer from these injuries for months or even years before seeking medical attention.