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.
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, contact our firm at (304) 845-9750 for a free evaluation.
As of April 2018, Bayer signed a settlement for $12.2 million to resolve approximately 4,100 lawsuits related to Mirena IUD claims.
What is Mirena?
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.
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 birth control device.