In a new Mirena pseudotumor cerebri (PTC) lawsuit filed in U.S. District Court for the Southern District of New York on June 15, 2018, plaintiff Kelly R. alleges she experienced unanticipated side effects associated with Mirena. Mirena is an intrauterine device (IUD) which is a t-shaped coil placed inside the womb of an adult female to prevent pregnancy.

These Mirena IUD complicationspurportedly led her to suffer considerably. Kelly is a resident of Watertown, S.D.

The purported Mirena IUD complications stem from its internal reservoir containing 52 mg of levonorgestrel. According to the lawsuit’s factual section, 20 pg of levonorgestrel is systemically released into the patient’s system and is the substance that is responsible for contraception.

Levonorgestrel is a synthetic form of progesterone—a human hormone that has involvement in the menstrual cycle and pregnancy from conception to birth.

While it is not known for certain how the Mirena IUD actually prevents pregnancy, it is believed that levonorgestrel changes the permeability of the cervical mucous—making it thick and difficult for live sperm to negotiate. It also thought to inhibit sperm travel and thin the lining of the womb.

The History of Mirena and Its IUD Complications

The Mirena IUD, developed and produced by the Bayer Co., was approved by the U.S. Food and Drug Administration in 2009 for birth control purposes. It was recommended for use in women that also had issues with unusually heavy bleeding during their menstrual cycles. It has been quite popular around the world with global usage totaling approximately 15 million women.

Mirena’s label mentioned the possibility of developing a condition known as transient cerebral ischemia (TCI) caused by inadequate blood flow to the brain in some takers, but never warned of IUD complications such as PTC. While TCI is often brought on by a blood clot, PTC can cause similar symptoms, but the diagnosis remains elusive.

PTC is caused by an overproduction of cerebral spinal fluid which causes increased pressure in the cranial cavity. The fluid is not reabsorbed at a fast enough rate and can lead to migraines, seeing double, the temporary inability to see or other disruptions in the visual field. It is usually accompanied with dizziness and/or vertigo.

A patient usually undergoes radiological imagery tests such as X-rays, CAT scans, and MRIs prior to having a lumbar puncture to evaluate the level of CSF present. This is because physicians need to be sure there are no actual masses on the brain contributing to the symptoms of the individual.

The Plaintiff’s Experience of Mirena IUD Complications

According to this Bayer lawsuit, 33-year-old Kelly had the Mirena IUD inserted for contraceptive purposes in 2008 when she was 23. Within a year of its implantation, Kelly started to experience IUD complications, such as severe migraine headaches, that she would not immediately associate with the device until later.

She was diagnosed with PTC in 2010 and continued to suffer from symptoms, remaining ignorant of the potential connection between the device and the condition. She had the Mirena IUD removed in 2012.

According to her claim, it wasn’t until she heard of PTC IUD complications from other Mirena product liability litigants that she linked her experience with the device.

The IUD Complications Lawsuit is Case No. 1:18-cv-05409-PAE-JLC in U.S. District Court for the Southern District of New York.