A South Carolina woman is joining her new Mirena lawsuit to a larger multidistrict litigation, claiming that she suffered from intracranial hypertension from Mirena and that the drug makers did not inform patients about the risks of severe side effects.

Plaintiff Kimberly M. is filing her products liability lawsuit against defendant Bayer HealthCare, the makers of her Mirena intrauterine device used to prevent pregnancy.

What is Intracranial Hypertension from Mirena?

Mirena is a commonly used IUD, or intrauterine device, that prevents pregnancy in women of childbearing age. It is a “T” shaped device that is placed by a physician inside the uterus of a patient. This IUD slowly releases a hormone, levonorgestrel which helps in the prevention of pregnancy.

The Mirena IUD is made of polyethylene and has been approved for use in the United States as a contraceptive since the year 2000. Additionally, the U.S. Food and Drug Administration approved Mirena for the treatment of heavy menstruation symptoms in 2009.

Currently, 2 million women use Mirena and it has been used by 15 million patients worldwide.

Bayer admits, according this lawsuit, that they do not know exactly how Mirena works, but they suggest that levonorgestrel might thicken cervical mucus and make the uterine lining thing. This can inhibit sperm movement and make it less likely that sperm survive, thus preventing pregnancy.

Mirena is intended to stay implanted for five years, as the release of the hormone occurs slowly over time.

However, Mirena can come with certain serious side effects. Intracranial hypertension from Mirena is a condition in which pressure inside the skull is increased. Intracranial hypertension from Mirena is also known as pseudotumor cerebri.

The use of Mirena has been connected with an elevation of cerebrospinal fluid in the skull higher than the normal range. Normally, cerebrospinal fluid is produced and then is reabsorbed back into the body. Those patients who suffer from intracranial hypertension from Mirena see an increased level of this that cannot be efficiently reabsorbed into the body.

The pressure in the skull is heightened, and this mimics symptoms of a brain tumor. This condition, intracranial hypertension from Mirena, can even lead to vision loss. Women who suffer from this experience a variety of symptoms including headaches, migraines, dizziness, vomiting, nausea, changes in vision, problems with walking, a whoosing in the ears, depression, forgetfulness, and neck stiffness.

The multidistrict litigation, or MDL, that Kimberly’s lawsuit is joining claims that intracranial hypertension from Mirena occurs as a result of the negligence of the drug makers. Kimberly and other plaintiffs allege that the drug makers failed to properly test the Mirena IUD and that they should have discovered the possibility of serious risks associated with their product.

The lawsuit claims that “despite an increasing number of adverse events, including reports of intracranial hypertension, blindness, papilledema, and increased intracranial pressure, Defendants have made no effort to warn physicians, the healthcare community, or patients of the risk of developing IIH/PTC with Mirena.”

Additionally, Kimberly has brought forth counts of design defects, failure to warn, strict liability, breach of implied warranty, breach of express warranty, negligent misrepresentation, fraudulent representation and fraud by suppression and concealment.

This Mirena Lawsuit is Case No. 1:17-cv-06296-PAE in the United States District Court for the Southern District of New York.