A woman has filed suit against Bayer, the maker of the Mirena IUD birth control that allegedly led to her pseudotumor cerebri diagnosis.

Plaintiff Katherine S. claims she received a Mirena IUD implant in December 2009. After receiving the implant, she claims, she started to experience headaches and vision problems, including intermittent loss of her peripheral vision.

Katherine says she underwent a CT scan in October 2016 that revealed no abnormalities. A day after the CT scan, she alleges she was admitted to the emergency room after her optometrist found optic disc swelling and she then received a pseudotumor cerebri diagnosis. 

Doctors performed a diagnostic lumbar puncture to evaluate her intracranial pressure, which is usually seven to 15 mm in adults. Katherine’s intracranial pressure allegedly was 43 mm. She received a pseudotumor cerebri diagnosis and underwent removal of the Mirena IUD.

Pseudotumor cerebri (PTC) is the elevated intracranial pressure that occurs when cerebrospinal fluid builds up in the skull. The condition is called “pseudotumor” because the symptoms mimic those of a tumor. The condition is sometimes known as idiopathic intracranial hypertension (IIH).

Reason for Pseudotumor Cerebri Diagnosis

Mirena releases synthetic progestogen levonorgestrel (LNG) directly into the uterus as part of its birth control method.  According to Katherine’s lawsuit, LNG has been linked to pseudotumor cerebri diagnosis since the 1990s when the synthetic hormone was used in the Norplant birth control system. A warning was added to Norplant in 1993 that users should be aware of early symptoms, including a headache and visual disturbances.

Despite thousands of lawsuits filed against Norplant by women who allegedly obtained a pseudotumor cerebri diagnosis, Katherine’s lawsuit says Mirena’s label is devoid of any warning of the condition.

The pseudotumor cerebri diagnosis lawsuit alleges that because Mirena’s label does not warn of the possibility of the condition, once a patient’s healthcare provider rules out other causes of migraines or vision problems, the healthcare provider will not typically know or advise a patient with the pseudotumor cerebri diagnosis to have Mirena removed.

“Mirena is defective and unreasonably dangerous because it releases and exposes patients long-term to levonorgestrel, which is known to contribute to and/or trigger the development of IIH/PTC,” alleges the pseudotumor cerebri diagnosis lawsuit.

The complaint says that instead of warning women about the risks of using Mirena, Bayer began a consumer-directed advertising campaign called Mirena Simple Style Statements Program, a live presentation they say they designed for “busy moms.” A Simple Style program was presented in the home of a consumer by a representative from “Mom Central,” a social networking website.

The Simple Style script allegedly indicated that Mirena could help women “look and feel great.” The Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) purportedly contacted Bayer in 2009 regarding the Simple Style program because the claims of looking and feeling great were “unsubstantiated.” The DDMAC allegedly also noted that weight gain, acne, breast pain, and decreased libido were all potential Mirena side effects.

The Pseudotumor Cerebri Diagnosis Lawsuit is Case No. 1:18-cv-04018-PAE-JLC and is part of the Mirena MDL, In re: Mirena IUS Levonorgestrel-related Products Liability Litigation (No. II), in the U.S. District Court for the Southern District of New York.