Plaintiff Stephanie S. has filed a products liability lawsuit against the manufacturers of Mirena due to alleged adverse health effects and Mirena IUD side effects.

The lawsuit is filed in New York federal court, naming Bayer Healthcare Pharmaceuticals, Inc. as defendant.

Stephanie claims she had a Mirena IUD implanted in April 2007. She alleges that within a few weeks, she began to suffer from “leg numbness, vision loss, and right-sided facial tingling and numbness.”

By November 2007, Stephanie had been diagnosed with papilledema and pseudotumor cerebri, a condition that mimics the symptoms of a brain tumor. She had her Mirena IUD removed that month.

Stephanie’s claim is filed as part of a large multidistrict litigation, or MDL, centered on allegations that the Mirena IUD causes the condition pseudotumor cerebri, or PTC.

The Mirena product is a levonorgestrel-releasing intrauterine system. Levonorgestrel is a female hormone which is allegedly known to cause biological changes in a female’s cervical mucus or uterine lining. By causing such changes, the Mirena device reduces the chance of conception.

The Mirena plastic device, which is inserted into the female’s uterus, slowly releases the hormone throughout a 5- year period.

Stephanie’s Mirena lawsuit, however, says many women have reported serious Mirena IUD side effects. These severe adverse health side effects include extreme dizziness, mood changes, weight gain, breakthrough bleeding, loss of an interest in sex, puffiness in ankles, feet, hands, or face, and jaundice.

According to the Mirena IUD side effects lawsuit, reports of risks of developing the non-stroke neurological condition of pseudotumor cerebri, or PTC was allegedly unknown to the plaintiff and many other women.

PTC is also known as idiopathic intracranial hypertension, or IIH. According to reports, it is a condition that occurs when the pressure inside the skull increases. Roughly 200,000 cases of PTC are reported annually, and the condition is treatable by a medical professional.

According to the Mayo Clinic, pseudotumor cerebri include several signs and symptoms. Some of these symptoms include: blurred or dimmed vision; nausea, vomiting, or dizziness; difficulty seeing to the side; double vision; seeing light flashes; moderate to severe headaches; and may also include brief episodes of blindness.

The Mayo Clinic says that individuals who possess the condition to pseudotumor cerebri “experience progressively worsening vision and may eventually become blind.” Other medical conditions resulting from the diagnosis of pseudotumor cerebri include: lupus; kidney disease; uremia; Addison’s disease; blood-clotting disorders; and polycystic ovary syndrome.

According to the Mirena lawsuit, patients claim the Mirena label had made no mention or indication of the alleged risks in developing PTC/IIH — despite the existence of medical evidence that there is a link between levonorgestrel and PTC/IIH.

Stephanie claims that the defendant’s promotional and marketing activities led her to believe “that Mirena is safe and fit for its intended uses, that it did not produce severe side effects, including IIH/PTC, and that it was adequately tested.”

The Mirena lawsuit further contends that “Mirena does not conform to these express warranties and representations because Mirena is not safe or effective and may produce serious side effects…”

The Mirena IUD Side Effects Lawsuit is Case No. 1:17-cv-05345, in the U.S. District Court for the Southern District of New York.