A woman has filed a Mirena lawsuit after the intrauterine birth control system caused her to develop pseudotumor cerebri.

Plaintiff Alfreda B. says she had her first Mirena IUD implanted without complications in 2009. In November 2014, she had the original Mirena removed and another one inserted. In January 2015, she claims, she began to have difficulties with the device’s placement, which necessitated its removal and the implantation of another Mirena IUD.

After that third Mirena was placed, Alfreda claims she began to experience “headaches, with associated neck, back and shoulder pain, dizziness, tinnitus, as well as vision problems including blurriness, diplopia (double vision) and vision loss,” leading her to file this Mirena lawsuit.

A neurologist soon diagnosed her with pseudotumor cerebri, an alleged complication of her Mirena implant. Pseudotumor cerebri, also known as intracranial hypertension, is a condition that occurs when a patient’s cerebrospinal fluid becomes elevated. Normally, the fluid is released and absorbed by the body.

Pseudotumor cerebri is so named because the pressure inside the skull acts like a tumor but is not a real tumor. The pressure is caused by excess cerebrospinal fluid that has not properly been absorbed by the body. Increased pressure from this fluid can cause migraine-type headaches with visual disturbances because of increased pressure on the optic nerve.

Patients also might hear a ringing or “whooshing” noise in their ears, a condition known as tinnitus.

Pseudotumor cerebri is most often diagnosed after a lumbar puncture is performed, allowing the cerebrospinal fluid to be evaluated. When infection or inflammation in the fluid is ruled out and the fluid appears normal, pseudotumor cerebri is diagnosed as the problem.

Anywhere from five to 15 millimeters of mercury is considered normal intracranial pressure.

According to the Mirena lawsuit, Alfreda “underwent a diagnostic lumbar puncture to evaluate increased cranial pressure, with an opening pressure of 25 cm” in November 2017.

Mirena Lawsuit Alleges Permanent Injuries Suffered

Despite the fact Alfreda had the Mirena implant removed in September 2016, she claims she still suffers from permanent injuries, according to the Mirena lawsuit.

Mirena’s manufacturer, Bayer, advertised Mirena as a birth control device that could help women “look and feel great,” something the company promoted as The Simple Style program.

The literature allegedly did not indicate that Mirena could cause adverse side effects such as weight gain, acne, breast pain or pseudotumor cerebri.

The Mirena lawsuit says that despite Bayer having a large amount of information linking Mirena’s active hormone levonorgestrel with pseudotumor cerebri, the company “placed Mirena into the stream of commerce with wanton and reckless disregard for the public safety.”

Mirena’s maker should have known that the Mirena IUD could cause the possibly irreversible brain condition known as pseudotumor cerebri and that it could lead to permanent blindness.

The Mirena Lawsuit is Case No. 1:18-cv-01839  and is part of the Mirena MDL, In re: Mirena IUS Loveonorgesterel-related Products Liability Litigation (No. II), MDL No. 2767, in the U.S. District Court for the Southern District of New York.