By: Namra Ajmal
Women are coming forward due to significant physical injury from Mirena; many women have experienced adverse side effects such as a dislocated IUS. Besides minimal effects (i.e. sepsis, PID, weight increase, and depression), very serious complications occur such as uterine perforation (lesion on the uterine wall) and migration.
Because of these injuries, an application has been made to the Supreme Court of New Jersey, through the Acting Administrative Director of the Courts, requesting designation of all New Jersey state-court litigation involving the contraceptive device sold under the trade name Mirena® for centralized management. The application includes a request that the litigation, if designated for centralized management, be assigned to Middlesex County.
Mirena is a T-shaped intrauterine contraceptive system approved by the FDA in 2000. The small plastic T-shaped device functions by releasing synthetic female sex hormone called levonorgestrel as the active ingredient. Mirena intrauterine system is a long acting birth control method that usually lasts up to 5 years. Mirena IUS (intrauterine system) is not to be confused with the older intrauterine devices (IUD), which were copper and did not release hormones.
Recently, extrauterine migration of the intrauterine system has become a fatal threat. Extra uterine migration is usually the result of IUS expulsion, or by perforation of the uterine wall (both stated in the warning). In many cases, emergency surgical intervention is needed or else dangerous outcomes such as infertility, and perforation of the abdominal area or bladder area can occur.
According to Mirena side effect labels, nearly 5% of the women using this contraceptive experience expulsion. Expulsion is when the intrauterine system moves or migrates from its fixed location inside the uterus, causing discomfort, severe pain, bleeding, and no prevention against pregnancy. Doctors mistakenly believe it has been expelled, however in actuality, it remains in the woman’s body. If there is an uncertainly whether the device remains within the uterus or has been expelled successfully, an X-Ray must be done to rule out the possibility of IUS migration towards other organs. Complains of abdominal pain, heavy or irregular vaginal bleeding, and abnormal tenderness around the abdominal and vaginal area should be reported for further investigation on the condition/placement of the IUS.
Due to Mirena intrauterine system’s efficacy failures, IUS users have reported ectopic pregnancies. Ectopic pregnancies occur as a result of expulsion or perforation, the migration of the device no longer prevents pregnancy. If a woman becomes pregnant while using Mirena, major risks and dangers such as miscarriage, infertility, and even death can occur if medical attention is not acquired immediately. If the device remains in the female’s uterus during pregnancy, the IUS can perforate the amniotic sack that will lead to defective birth, as the device will remain within the fetal membrane.
Bayer HealthCare Pharmaceuticals, the manufacturer of Mirena has a history of producing defective contraceptive methods, such as YAZ, also known as Yasmin birth control pills. Many YAZ birth control pills side effects included fatal clot injuries. Bayer has also been repeatedly fined for improper advertisements and deceptive marketing. Our firm currently represents over 50 women who have suffered injuries while using YAZ and Yasmin. As stated above, the litigation cases assigned to Middlesex County in New Jersey will pressure Bayer HealthCare Pharmaceuticals to take accountability for producing defective devices.