The medical device attorneys at Heninger Garrison Davis are investigating potential lawsuits on behalf of users of the Mirena IUD. A large number of women have been diagnosed with a condition called Pseudotumor Cerebri (PTC) or Intracranial Hypertension (IH or IIH) while the Mirena device was implanted. This condition has symptoms of terrible headaches and increased pressure in the head and brain. It also impacts vision. Many times surgery is required to alleviate symptoms. If you were diagnosed with this condition while the Mirena was implanted, please contact our firm for a free evaluation.
What is Mirena?
The Mirena IUD (Intra-Uterine Device) was introduced by Bayer and approved by the FDA in 2000. It was originally approved as an intrauterine contraceptive, and later as a treatment for heavy menstrual bleeding in women who gave birth.
Mirena is a T-shaped form of birth control that is implanted into the uterus during a doctor’s office visit. It works by slowly releasing the chemical progestogen levonorgestrel into the uterus. Mirena is indicated for intrauterine contraception for up to 5 years. At that point, the system should be replaced if continued contraception is desired. Mirena is only recommended for women who have had at least one child.
More than 2 million women throughout the U.S. have used Mirena since it was introduced in December 2000, and popularity continues to rise.
Mirena Side Effects
Since its approval, serious Mirena side effects have included ectopic pregnancy, intrauterine pregnancy (a pregnancy in the uterus with the IUD in place), group A streptococcal sepsis, pelvic inflammatory disease (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix. Other common Mirena side effects include irregular spotting or bleeding, headaches, ovarian cysts, vaginitis, painful menstruation, pelvic pain, and breast tenderness.
The drug label on the Mirena IUD states that using the device might cause the following side effects:
Perforation — The Mirena IUD can puncture the uterine wall, leading to other complications.
Migration — The Mirena IUD can shift and move to a part of the woman’s body outside the uterus.
Infertility — About half of all pregnancies that occur to women with a Mirena IUD are ectopic pregnancies (that is, they occur outside of the uterus). This condition is usually fatal to the fetus and might result in infertility.
Infection — The Mirena IUD can cause infections including Group A streptococcal sepsis (GAS), massive and possibly fatal bacterial infection that can occur within days of the device’s implantation.
Mirena Removal — The Mirena IUD is designed to be safely removed by applying gentle traction on the threads with forceps. The arms are designed to fold upward as it is withdrawn from the uterus. In some cases, complications may require more invasive procedures to remove Mirena, especially if it has become embedded in the uterus or migrated. Surgery for Mirena removal, may result in permanent complications, and in some cases, may impact a woman’s ability to have children in the future.
Pelvic Inflammatory Disease (PID) – A condition that women should be evaluated for before receiving a Mirena IUD.
Embedment – Sometimes the Mirena IUD becomes embedded in the uterus and requires surgical removal.
FDA receives over 45,000 reports of Mirena complications
The FDA received a total of 45,966 adverse event reports associated with Mirena IUD between November 1, 1997 and June 30, 2012. Among these cases, the most common complaints included device expulsion, device dislocation and vaginal hemorrhage. More than six percent of the women who filed complaints needed surgery that required hospitalization to correct the side effects associated with this problematic birth control device.
The FDA has previously warned Bayer about the marketing of Mirena, which failed to disclose safety risks while claiming the devices could help “busy moms” with intimacy and make them “look and feel great.”
In New Jersey state court alone, there are at least 16 lawsuits alleging the Mirena IUD caused serious injuries, including perforations to women’s uteruses. In August 2012, Bayer moved the New Jersey Supreme Court to centralize those cases into one multicounty litigation proceeding in Middlesex County.
In late 2012, still other Mirena IUD injury claims were filed in federal courts in Ohio and California. The Ohio plaintiff is seeking monetary compensation, including punitive damages, for injuries she suffered as a result of her Mirena IUD perforating her uterus, migrating, and becoming embedded near her liver.
If you or a loved one suffered serious complications, including device expulsion, device dislocation and vaginal hemorrhaging, following usage of a Mirena IUD, you may be eligible to file a personal injury lawsuit seeking compensation for your injuries or injuries of a loved one. To learn more about the legal options available to you, please contact the Mirena lawyers at Heninger Garrison Davis for a free evaluation.
Even if you feel you are not ready to file a suit, consult one of our qualified lawyers as soon as possible so that you will know your options. We do not charge any fees upfront. In fact, we will only charge attorney’s fees if we obtain a financial settlement for you. If you don’t win, we won’t get paid a legal fee. Call us today for your free case evaluation 1.800.241.9779.