Mirena is a t-shaped plastic (polyethylene) intrauterine device (IUD) that is inserted directly into a woman’s uterus by her healthcare provider. Mirena also has strings attached to it that hang down from the plastic reservoir, which are supposed to provide easy retrieval and removal. Mirena is approved by the U.S. Food & Drug Administration for use for up to five years. Mirena is indicated for contraception and to treat heavy menstrual bleeding. It is recommended to women who have had at least one child.
Although Mirena has been inserted in an estimated 15 million women worldwide (2 million in the U.S.), Mirena’s manufacturer does not know exactly how the IUD works. Mirena contains a reservoir that holds and releases the hormone levonorgestrel at a rate of 20 micrograms per day. According to Mirena’s manufacturer—Bayer HealthCare Pharmaceuticals, Inc.—there are numerous mechanisms with Mirena that work to prevent pregnancy, including:
- Thickening of the cervical mucous, to prevent sperm from entering the uterus;
- Inhibiting sperm movement;
- Thinning of the uterine lining; and
- Possibly stopping the release of eggs from the ovary
The Mirena IUD is inserted by a doctor into the “fundus” or top of the uterus. This is its proper position. Mirena’s label asks that patients follow up with their doctor within 4-6 weeks of insertion so the doctor can do an examination and ultrasound to ensure Mirena is properly placed. Although considered a medical device, Mirena is regulated by the FDA as a drug, because of its use of levonorgestrel.
Mirena was approved for use in the U.S. on December 6, 2000. Mirena’s indication for heavy menstrual bleeding was not approved until September of 2009.
What Are The Risks of Mirena?
There are numerous serious risks associated with Mirena, including ectopic pregnancy (pregnancy outside of the uterus), intrauterine pregnancy, which can result in septic abortion and may lead to death, increased risk of miscarriage, sepsis, premature labor and delivery, Group A streptococcal sepsis (a severe bacterial infection), pelvic inflammatory disease, irregular bleeding and amenorrhea, ovarian cysts, and breast cancer.
Mirena also comes with risks due to displacement or embedment. Mirena or its strings may become embedded in the uterine wall, which often requires surgery to remove. Mirena may move around or “migrate,” which can result in uterine perforation. If Mirena perforates through the uterus, it can travel throughout the abdominal cavity causing damage, tearing, and scarring. Perforation also typically requires surgery to locate and remove Mirena.
What Are The Claims About Mirena?
Women across the country have been injured—sometimes severely—because of Mirena’s tendency to migrate, perforate through the uterus, or become embedded in the uterine wall. Mirena’s label only warns doctors that it may cause perforation upon insertion. Mirena’s label does not warn that Mirena can spontaneously migrate and perforate the uterus, sometimes even years after insertion.
The Mirena IUD can also become embedded in the uterine wall, which Bayer claims “in some cases, surgical removal may be necessary.” Unfortunately, embedment is an all too common occurrence, and typically requires surgery to remove.
If you or a loved one has suffered any of the injuries above Please contact Jamie Sheller Esq. for a free consultation at 1 800 883 2299