A new Mirena pseudotumor cerebri lawsuit alleges Bayer failed to properly warn women about the side effects of the Mirena IUD.

Plaintiff Ashey M. is holding Bayer Healthcare Pharmaceuticals, manufacturers of the Mirena Intrauterine Device (IUD), liable for injuries she sustained after being implanted with the product—a decision she says she made in reliance upon the information presented by the pharmaceutical giant.

According to the lawsuit, Ashley engaged the services of her OB-GYN physician to insert the Mirena IUD as a chosen method of birth control on Feb. 24, 2014.

Within the next four months, the plaintiff says she experienced a bizarre array of symptoms such as sensitivity to light, blurry, unfocused vision and loss of ability to see at night, headaches and neck pain along with periods of dizziness, short-term memory loss, and unexplained weight gain.

After undergoing a lumbar puncture, Ashley says she was diagnosed with pseudotumor cerebri. She says that on the day the diagnosis was made, the IUD was not considered to be a possible cause.

She was treated in an ongoing fashion for her pseudotumor cerebri with two medications known as Diamox and Furosemide for a year and two months prior to having the device removed in August 2016, the lawsuit says.

What is Mirena Pseudotumor Cerebri?

Mirena pseudotumor cerebri is so named because the symptoms of the disorder act like a brain tumor without actually being one. Frequently, a patient suffering from the associated symptoms must have the presence of a brain tumor ruled out by a medical team by undergoing Magnetic Resonance Imaging (MRI) and CT scans.

The cause of the symptoms that largely affect vision, head, neck, and balance are related to increased production of cerebro-spinal fluid (CSF) and the pressure the excess build-up in the skull cavity causes.

Normally, the body absorbs any excess CSF produced. But for sufferers of pseudotumor cerebri, this absorption isn’t enough to avoid painful symptoms. The increased amount of CSF often puts additional pressure on the optic nerve leading to visual disturbances. Migraine headaches and a ringing in the ears known as tinnitus can often accompany the visual interruptions.

The Mirena IUD

The Mirena IUD is a polyethylene T-shaped device that contains levonorgestrel—a synthetic progesterone. It releases a small amount everyday and is believed to thicken cervical mucus, preventing sperm penetration and movement, thereby preventing pregnancy. While the complete mechanism of action isn’t entirely known, the Mirena IUD is intended to be effective for up to five years after implantation.

Ashley is holding Bayer liable for presenting the Mirena IUD birth control device as effective without properly warning her or the medical community about side effects such as Mirena pseudotumor cerebri.

The lawsuit says that the labeling in the U.S. doesn’t mention increased risk of non-stroke neurological conditions related to use of this IUD. The labeling does warn against use by patients with a history of migraine.

Ashley is asking for a trial by jury and is bringing ten causes of action against the defendants, including Fraud by Suppression and Concealment, Fraudulent Misrepresentation, Failure to Warn, and Design Defect.

The Bayer Mirena IUD Lawsuit is Case No. 1:18-cv-04821 in U.S. District Court for the Southern District of New York.