A woman has filed a pseudotumor cerebri lawsuit against Bayer Healthcare Pharmaceuticals and its related companies alleging that the birth control device known as Mirena caused her significant personal injury.

Plaintiff LaShonda R., a 27-year-old woman, states that she began using Mirena around March 2012 when she was 22 years old. She alleges that in April 2014, she was diagnosed with pseudotumor cerebri, leaving her permanently injured. She has suffered physically and emotionally and has incurred or will incur lost wages as a result of her condition, her pseudotumor cerebri lawsuit states.

Pseudotumor cerebri is also known as idiopathic intracranial hypertension. Idiopathic referrers to the lack of a definitive cause for the condition, which is high pressure within the cranium, or brain, as a result of increased cerebrospinal fluid. The term pseudotumor refers to the fact that the symptoms associated with the condition mimic those of a brain tumor.

Common symptoms of pseudotumor cerebri include severe headaches or migraines, blurred vision, double vision, temporary blindness or blind spots in the visual field and other visual aberrations. When visual symptoms are present, typically the optic is involved and there is increased pressure placed upon the structure. Papilledema, or swelling of the optic disc, is also common.

Additionally, tinnitus, or ringing in the ears, is a common symptom. A diagnosis of pseudotumor cerebri is typically made after a spinal tap or lumbar puncture is performed. Digital imaging of the brain is also used to rule out any actual tumors that may be present, as well as blood clots or any other abnormalities in the brain.

Mirena is a form of birth control that is internally placed within a woman’s uterus during a visit to her physician. The birth control device contains a steroid reservoir that releases synthetic progesterone into the body each day. In addition to serving as an intrauterine contraception device, the devices also FDA approved to treat heavy menstrual bleeding in women.

According to the pseudotumor cerebri lawsuit, Bayer admits “’[i]t is not known exactly how Mirena works,’” but the pharmaceutical company “suggests that Mirena may thicken cervical mucus, thin the uterine lining, inhibits sperm movement and reduced sperm survival to prevent pregnancy.” The device can be used for up to five years before it is replaced, and is recommended for women who have had at least one child.

The pseudotumor cerebri lawsuit states that the labeling and packaging for Mirena does not make any mention of the possibility of patients developing pseudotumor cerebri as a result of Mirena use.

As a result of her injury, LaShonda has filed a products liability lawsuit against the makers of Mirena and has brought forth allegations of 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.

LaShonda has also alleged Bayer has violated unfair and deceptive trade practices laws. She is requesting judgment against the Defendants, punitive damages, compensatory damages, attorneys’ fees and any additional relief deemed just and proper by the Court.

The Pseudotumor Cerebri Lawsuit is Case No. 1:17-cv-03676-PAE, in the U.S. District Court for the District of New Jersey, Newark Division.