A woman has filed a lawsuit against Bayer, alleging that unwarned Mirena IUD side effects include pseudotumor cerebri, also known as intracranial hypertension.

Plaintiff Stephanie C. alleges she had the Mirena inserted in July 2013 at her doctor’s office. After the device was inserted, Stephanie allegedly began experiencing severe Mirena IUD problems including intense headaches, blurry vision, eye pressure, loss of vision, and tinnitus.

Stephanie says she had the Mirena removed in July 2015 but allegedly continues to experience problematic side effects.

The Mirena IUD is a birth control device which is inserted into a woman’s uterus where it then releases levonorgestrel, a synthetic form of progesterone. Levonorgestrel is used in birth control methods to thicken cervical mucus and inhibit sperm movement. However, Stephanie’s lawsuit claims that levonorgestrel can cause Mirena side effects including pseudotumor cerebri.

Pseudotumor cerebri, also known as idiopathic intracranial hypertension, occurs when excess cerebrospinal fluid creates increased pressure in the skull. This buildup of pressure can cause tumor-like symptoms including severe migraines and vision problems. Although reducing pressure can relieve symptoms, permanent damage to optic nerves cannot be treated. Treatment is therefore often focused on preventing further vision loss and future relapses of pseudotumor cerebri.

Stephanie argues that these Mirena IUD side effects are caused by the levonorgestrel contained in the device. The complaint claims that levonorgestrel serum levels in the blood can vary dramatically between people, with high levonorgestrel levels allegedly causing Mirena IUD problems. Bayer allegedly does not warn their consumers that serum levels may vary, resulting in inaccurate labeling and prescribing information, Stephanie argues.

“As a result, Mirena’s label is insufficient, inadequate, and inaccurate, as it fails to inform healthcare practitioners and patients of the full scope of the wide variability of LNG serum levels between individuals in a useful or informative manner,” the lawsuit states.

Stephanie aims to hold Bayer accountable for allegedly misleading their consumers. The complaint argues that the company doesn’t properly portray the outcomes, serum levels, and Mirena IUD side effects. Many other women have had negative experiences with Bayer. 

“Defendant fraudulently misrepresented that such side effects could not or would not occur due to the low systemic hormonal effects of Mirena by representing Mirena as releasing a low amount of hormone directly into the uterus, representing that hormone levels are stable and without peaks and troughs, and representing that the amount of hormone is less than other hormonal contraceptives,” the complaint states of the allegedly misleading portrayal.

Stephanie accuses Bayer of negligence, design defect, failure to warn, strict liability, breach of warranties, negligent misrepresentation, fraudulent misrepresentation, and fraud by suppression and concealment. The Mirena IUD side effects lawsuit seeks compensatory damages, punitive damages, court costs, and attorneys’ fees.

The Mirena IUD Side Effects Lawsuit is Case No. 1:18-cv-06130-PAE-JLC and is part of the Mirena MDL, In re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), MDL No. 17-MD-2767, in the United States District Court for the Southern District of New York.