A lawsuit has been filed in New York by a patient who says she was never told about the dangerous and devastating side effect of Mirena, intracranial hypertension.

The plaintiff, Darnesia F., has filed the lawsuit against Bayer HealthCare Pharmaceuticals. She says that she was prescribed the unreasonably dangerous and defective product Mirena that caused her to develop intracranial hypertension.

Intracranial Hypertension

Intracranial hypertension, also called pseudotumor cerebri, is a condition that occurs inside a person’s skull when the cerebrospinal fluid level inside the brain becomes elevated. This causes more pressure inside the brain because the fluid is not being released or absorbed at the appropriate rate.

Patients with this condition will typically develop symptoms that mirror migraine like headaches, including double vision, blind spots, blurred vision, and other visual challenges. These visual symptoms are often directly related to the higher level of pressure on the patient’s optic nerve. Furthermore, patients may also experience audio side effects including ringing in the ear, also known as tinnitus.

Intracranial hypertension can be a very painful medical condition that causes a patient to miss time at work and suffer through costly and painful medical treatments.

More often than not, this intracranial hypertension condition is diagnosed for a Mirena user after a spinal tap or lumbar puncture is performed that allows a physician to identify the level of cerebrospinal fluid in the patient’s skull. The first diagnostic test used by doctors who are evaluating a patient with migraine like symptoms is usually a CT scan or an MRI to rule out a blood clot in the brain or an actual tumor.

Certain types of treatment for the condition of intracranial hypertension are invasive and come with their own set of risks. While a lumbar puncture might give some short term relief to a patient who is suffering from this condition, it does not completely cure the condition itself. A lumbar puncture has also been associated with problems like bleeding, back pain or headache.

The plaintiff in the lawsuit says that it is the responsibility of the manufacturer to warn her and other users of the side effects of the Mirena device that they could develop intracranial hypertension or pseudotumor cerebri as a result of using the device as intended.

Mirena became an extremely popular birth control device when it first came out on the market, but the plaintiff in this lawsuit and many other plaintiffs allege that the manufacturer put profits over the goal of safety and left many patients exposed to unnecessary risks.

When a medical device is associated with dangerous side effects, the label may not be updated until numerous patients have come forward to file complaints and adverse event reports. Patients who report problems can help to raise red flags for further clinical trials and investigation.

The Mirena Intracranial Hypertension Lawsuit is Case No. 1:18-CV-04768-UA filed in the United States District Court for the Southern District of New York.