A 35-year old woman has filed a lawsuit against Bayer Healthcare et al. alleging the company has been manufacturing and selling a defective long term birth control product known as Mirena.

Plaintiff Candice S. files the complaint in U.S. District Court for the District of New Jersey.

Mirena is an implanted hormonal intrauterine device, or IUD, that is used for long-term birth control. The device is a T-shaped frame made of plastic. It releases progestin, a synthetic steroid hormone, which then condenses and coagulates cervical mucus and prevents sperm from reaching an egg.

According to the Mirena complications lawsuit, Candice alleges that the device’s label “does not sufficiently warn about non-stroke neurological conditions such as pseudotumor cerebri (‘PTC’), also known as idiopathic intracranial hypertension (‘IIH’).”

Idiopathic intracranial hypertension occurs when there is increased pressure inside the skull. It is believed to come from increased levels of CSF, or cerebrospinal fluid.

Candice alleges that she had Mirena inserted into her body in April 2011. She says that decision was made upon the defendant’s patient information booklet and other representations made by the defendants.

She contends that the representations made by the manufacturers did not, however, mention the risks involved in planting the birth control device despite “a known link between levonorgestrel and PTC/IIH.”

After the birth control device was placed, she says she began to experience double vision and extreme headaches.

She was soon diagnosed with IIH/PTC and believed that her diagnosis was allegedly caused by her Mirena implantation. She then had the device removed in October 2015.

Mirena Complications

Mirena is one of several hormonal IUDs approved by the U.S. Food and Drug Administration. Known primarily for its use as a contraceptive, Mirena also thins the lining of the uterus and partially suppresses ovulation.

CSF is a colorless, clear fluid that acts as a safeguard and cushion for the brain.It is known to provide immunological and mechanical protection to the brain within the skull. By increasing CSF in the brain, however, the condition known as pseudotumor cerebri or idiopathic intracranial hypertension may occur. The symptoms of this diagnoses imitate symptoms of a brain tumor, as it also increases pressure levels in the skull.

Although the cause of psudotumor cerebri, or idiopathic intracranial hypertension, is unknown, it is believed to be caused by the increased levels of CSF, often occurring due to buildup and an obstruction that prevents proper drainage of the fluid. The brain is known to repeatedly produce more CSF and that constant reproduction is routinely reabsorbed into the bloodstream unless it becomes obstructed and unable to drain out properly.

Mirena complications include elevated risks of developing intracranial hypertension. Some of the symptoms include feeling dizzy or nauseated, difficulty seeing to the side, seeing light flashes, and vision loss affecting one or both eyes.

Other Mirena complications include migraines, dizziness, headaches, changes in vision, nausea and/or vomiting, neck stiffness, depression, forgetfulness, problems walking, and ringing in the ears.

The Mirena Complications Lawsuit is Case No. 2:17-cv-03744-SDW-LDW, in the U.S. District Court for the District of New Jersey, Newark Division.