A woman has filed a lawsuit against Bayer over the side effects of Mirena.

Mirena is an intrauterine device (IUD) placed in the uterus as a birth control method. A synthetic progestin hormone called levonorgestrel (LNG) is released by Mirena for up to five years after implantation.

Plaintiff Aliya Q. says she received a Mirena IUD in February 2007. In October 2011, she says, she was diagnosed with pseudotumor cerebri, also known as intracranial hypertension. Pseudotumor cerebri is a severe and potentially irreversible brain condition that can result in the patient becoming permanently blind.

Studies show Mirena may lead to pseudotumor cerebri. Symptoms include migraine-like headaches, double vision or blurred vision, temporary blindness, blind spots or other visual aberrations. These symptoms imitate the pressure that a tumor would place on the optic nerve, which is why it is called a pseudotumor.

Patients sometimes experience dizziness, ringing in the ears, a stiff neck, depression, nausea or vomiting, and problems walking. Forgetfulness and depression might occur, as well.

Effects of Mirena and of some birth control pills include pseudotumor cerebri. Mirena contains only the synthetic progestin hormone levonorgestrel, but no form of estrogen. Spikes of levonorgestrel might lead to increased hormonal side effects, including pseudotumor cerebri.

According to the Mirena lawsuit, Bayer allegedly should have known that levonorgestrel causes or contributes to the development of pseudotumor cerebri.

Dangerous Side Effects of Mirena

Sudden weight gain is among the common effects of Mirena, and it’s also a risk factor of developing pseudotumor cerebri. Aliya’s lawsuit contends Bayer should have known the link between sudden weight gain was a precursor to pseudotumor cerebri but did not warn patients, doctors or the health care community.

“Mirena is defective and unreasonably dangerous because it releases and exposes patients long-term to levonorgestrel, which is known to cause, contribute to, and/or trigger the development of IIH/PTC,” said the side effects of Mirena lawsuit.

Aliya further alleges that Bayer failed to warn her that the Mirena problems included severe risks of brain injury and blindness.

Pseudotumor cerebri results when the body’s normal absorption of cerebrospinal fluid is interrupted. Instead of being reabsorbed back into the bloodstream, the fluid builds up and causes pressure, much like a brain tumor would.

The body creates cerebrospinal fluid as a cushion to protect the brain and spinal cord. The fluid is constantly produced and reabsorbed into the bloodstream in regular cycles. Why the side effects of Mirena include interrupting this cycle is not currently understood.

The patient can receive a lumbar puncture to relieve the excess fluid and have it tested for infection. A hollow needle is inserted into the lumbar area, drawing out the over-accumulated cerebrospinal fluid. Patients with pseudotumor cerebri caused by Mirena and no other pathological issues will see normal test results.

The Side Effects of Mirena Lawsuit is Case No. 1:18-cv-06003-PAE, in the U.S. District Court for the Southern District of New York.