Another recent intracranial hypertension lawsuit has been filed by a woman against the makers of the Mirena intrauterine device (IUD), Bayer Healthcare Pharmaceuticals, Inc. over allegations that the device caused her to suffer from severe adverse side effects and complications.

Plaintiff Gabrielle H. filed the intracranial hypertension lawsuit in New York federal court, demanding jury trial.

According to the intracranial hypertension lawsuit, Gabrielle is a resident and citizen of New Albany, Ind. She says that she had the Mirena IUD inserted into her body without any complication on May 8, 2008.

She says that prior to the device’s insertion, she read up on the device from Bayer’s “Patient Information Booklet” that they provided to her. From that, she says that she relied on Bayer’s representations of Mirena and their disclosures that the device was safe and effective for use.

However, soon after the Mirena IUD was implanted, Gabrielle says she began to experience side effects such as nausea, blurred vision, dizziness, and severe headaches. After seeking treatment for the symptoms, she was diagnosed with papilledema by her physician–the condition where increased pressure in or around the brain causes part of the optic nerve within the eye to swell up.

After undergoing a lumbar puncture, she was ultimately diagnosed by her physician with pseudotumor cerebri, or intracranial hypertension. On March 18, 2013, she says she had the Mirena IUD removed.

According to the intracranial hypertension lawsuit, Gabrielle “has been permanently injured and has incurred or will incur past and future medical expenses, has experienced or will experience past and future pain and suffering, has incurred or will incur lost wages, and is subject to an increased risk of future harm.”

The intracranial hypertension lawsuit was filed on multiple counts including negligence, design defect, failure to warn, strict liability, breach of implied warranty, breach of express warranty, negligent misrepresentation, fraudulent misrepresentation, and fraud by suppression and concealment.

Overview: Mirena IUD

The Mirena IUD is a t-shaped device that becomes inserted into a woman’s uterus and acts as a contraceptive device preventing pregnancy. Once the t- shaped device is inserted it can remain in place for five years.

Many women decided to become implanted with device because of its convenience and ease. However, many are now reporting that they have suffered severe adverse side effects, including the development of pseudotumor cerebri (PTC), also known as Idiopathic Intracranial Hypertension (IIH).

According to intracranial hypertension lawsuits, Bayer misrepresented the severe adverse side effects that may come about from being implanted with Mirena.

According to the Mayo Clinic, pseudotumor cerebri occurs when there is pressure inside the skull, also known as intracranial pressure. The symptoms of pseudotumor cerebri mimics those of a brain tumor, but no tumor is actually present.

According to the Mayo Clinic, symptoms of pseudotumor cerebri may include:

• Double vision
• Difficulty seeing to the side
• Blurred or dimmed vision
• Vomiting, dizziness, or nausea
• Ringing in the ears that “pulses in time with your heartbeat”
• Moderate to severe headaches
• Back, neck, and shoulder pain

The Intracranial Hypertension Lawsuit is Case No. 1:18-cv-04067-UA, in the U.S. District Court for the Southern District of New York.