A Mirena pseudotumor lawsuit has been filed by a woman who claims the birth control device is dangerous.

Bayer’s Mirena is an intrauterine device (IUD) in the shape of a “T” that is inserted into the uterus for birth control. Mirena releases a synthetic progestin hormone known as levonorgestrel for up to five years.

Plaintiff LaShonda R. opted for Mirena and had the device inserted in March 2012. In April 2014, she was diagnosed with pseudotumor cerebri (PTC), increased pressure in the skull caused by a buildup of cerebrospinal fluid. The condition is also known as idiopathic intracranial hypertension (IIH). This led to her filing a Mirena pseudotumor lawsuit.

Pseudotumor ceerebri causes symptoms much like a brain tumor would cause, which is why it is called a “pseudotumor.” Symptoms include migraine-like headaches accompanied by blurred or double vision, temporary blindness, blind spots, or other visual disturbances.

Vision symptoms are the result of increased pressure on the optic nerve. Permanent blindness can occur if the condition is not correctly diagnosed and treated in time.

Even though there is no way to reverse permanent optic nerve injuries caused by increased intracranial pressure, relief from the built up fluid is possible through a lumbar puncture. A doctor inserts a hollow needle into the lumbar area to draw some of the excess cerebrospinal fluid from the patient.

Diagnostically, this procedure can allow the fluid to be tested to rule out infection or inflammation in the fluid. Patients with pseudotumor cerebri will have fluid that tests normal.

LaShonda’s Mirena pseudotumor lawsuit says, “In severe cases, therapeutic shunting, which involves surgical insertion of a tube to help drain cerebrospinal fluid from the lower back or from the skull, is recommended.”

Mirena Pseudotumor Lawsuit Alleges Risks Were Known

Mirena is marketed as a “low” or “no” hormone device that provides “stable” levels of levonorgestrel, or LNG. But according to LaShonda’s Mirena lawsuit, the drug’s labeling doesn’t describe LNG levels in a way that relates to the risk f pseudotumor cerebri.

LNG taken by itself greatly decreases the sex hormone binding globulin (SHBG), which can cause the hormonal effects of LNG to become stronger. “LNG’s propensity to suppress SHBG, where, as with Mirena, it is used alone, increases the risk of systemic hormonal side effects, including IH/PTC,” alleges the Mirena pseudotumor lawsuit.

Bayer’s “failure to describe the suppressive effects of LNG upon SHBG levels” and the company’s “description of systemic exposure to LNG are calculated in a manner which obfuscates and confuses healthcare practitioners and consumers who seek to compare hormonal exposure and systemic effects while on Mirena with that of other hormonal contraceptives.”

When LNG is bound to SHBG, it is hormonally inactive. When unbound or “free,” LNG can cause progestogenic effects.

The Mirena pseudotumor lawsuit says that “[t]he appropriate measure of systemic LNG exposure is the amount of free, unbound and hormonally active LNG present in blood serum or blood plasma.” In practice, “total LNG levels (which include both bound and unbound LNG) are misleading when compared to combination hormonal contraceptives that contain both LNG and an estrogen (most commonly, ethinyl estradiol.)”

The Mirena pseudotumor lawsuit alleges that women might have “total serum levels of LNG far outside the maximums provided for various time points in Mirena’s label” and that these elevated levels can result in increased risks of Mirena side effects such as pseudotumors.

The Mirena Pseudotumor Lawsuit is Case 1:17-cv-03676-PAE in the U.S. District Court for the District of New Jersey, Newark Division.