A new Mirena pseudotumor cerebri lawsuit has been filed alleging that the levonorgestrel IUD causes high intracranial pressure.

Plaintiff Erendira C. filed a complaint against Bayer Healthcare Pharmaceuticals Inc alleging that she developed Mirena pseudotumor cerebri after using the intrauterine birth control device.

Mirena is an IUD which releases levonorgestrel, a synthetic form of progestogen, to prevent conception. Although the exact mechanism of progestogen and levonorgestrel is unknown, a fact allegedly admitted by Bayer, the hormones are thought to thicken cervical mucus which inhibits sperm movement.

The device can be inserted into the uterus during an office visit and is effective for five years, although it is not suggested for women that have not had a child. The Mirena IUD was approved in 2000 as a birth control device and in 2009 as a treatment for heavy menstrual bleeding.

Erendira says she had the Mirena inserted in August 2013 with no complication. In May 2017, however, she was diagnosed with pseudotumor cerebri, allegedly caused by the Mirena IUD. She argues that her patient information booklet, which she relied on for information, contained no warning of the possibility that she may develop pseudotumor cerebri (PTC).

What is PTC?

Pseudotumor cerebri is a condition involving an abnormal amount of cerebrospinal fluid in the skull. The excess of fluid builds up and causes increased pressure, mimicking the symptoms of a brain tumor. Symptoms of pseudotumor cerebri include migraines, tinnitus, blurred vision, double vision, temporary blindness, blind spots, and other visual problems.

The visual side effects of pseudotumor cerebri are thought to result from increased pressure on the optic nerve. Failure to diagnose and treat pseudotumor cerebri may lead to permanent damage to the optic nerve, resulting in vision loss or partial blindness. There is no treatment to reverse such damage.

Although the device’s label contains a warning for transient cerebral ischemia, also known as a “mini-stroke,” the Mirena pseudotumor cerebri lawsuit argues that “Mirena’s label does not sufficiently warn about non-stroke neurological conditions such as pseudotumor cerebri, also known as idiopathic intracranial hypertension.”

According to the Mirena pseudotumor cerebri lawsuit, scientists have linked levonorgestrel with an increased risk of pseudotumor cerebri. The synthetic hormone can bond with a wide range of hormone receptors, which is thought to induce a reaction in the body resulting in high levels of cerebrospinal fluid.

Although pseudotumor cerebri has been linked to levonorgestrel, the exact mechanism is not understood.

Despite the scientific evidence and many other levonorgestrel birth controls containing warnings for pseudotumor cerebri, the Mirena’s packaging and patient information booklet contain no information or warning about PTC. The Mirena pseudotumor cerebri lawsuit argues that Bayer should have included a warning in their booklet and on their labels so patients and physicians could be informed and prepared.

Erendira accuses Bayer of negligence, design defect, failure to warn, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, and fraud by suppression and concealment. The Mirena pseudotumor cerebri lawsuit seeks a trial by jury, compensatory damages, punitive damages, court costs, and attorneys’ fees.

The Mirena Pseudotumor Cerebri Lawsuit is Case No. 1:18-cv-02814-PAE-JLC in the U.S. District Court for the Southern District of New York.