A North Carolina woman says she would not have chosen the Mirena IUD if she had been better informed about a link between Mirena and IIH, or idiopathic intracranial hypertension.

Plaintiff Keshia B. joins a growing multi-district litigation against Bayer Pharmaceuticals, the maker of Bayer, claiming that the device’s marketing as a “low hormone” birth control is misleading, because the device’s metabolic effects cause fluctuations in hormones that can result in serious side effects that were not disclosed to patients and medical professionals.

Keshia claims that she had the Mirena birth control device, an intra-uterine device, implanted in her body around August 2010. Allegedly, the device was installed without complications, but claims that she began experiencing vision issues and headaches after having the device implanted. She claims that around May 15, 2015, she was diagnosed with optic neuritis.

Keshia goes on to state that she had the birth control device removed around Oct. 19, 2015. In December of the same year, she allegedly complained of a pressure build up behind her eyes, and was diagnosed with optic nerve swelling.

She claims that she then had an MRI on Dec. 11 as a follow-up to her diagnosis. At this point, she allegedly was diagnosed with pseudotumor cerebri, also known as idiopathic intracranial hypertension, as well as a swelling of the optic nerve.

Keshia then claims that she had to undergo treatment to treat the pseudotumor cerebri. Allegedly, these medical issues were caused by her use of Mirena.

Keshia’s Mirena and IIH lawsuit claims that Keshia read the accompanying literature and warnings in advance of having the Mirena device implanted, but she says none of the information she was given warned that the side effects she experienced, including intracranial hypertension.

Keshia claims that though the device is marketed as a low hormone birth control, the body metabolizes the levonorgestrel, the hormone that is released by the device, in such a way that it has drastic effects on the body, causing side effects including IIH.

Allegedly, the metabolic effect of the drug was not sufficiently researched before it was released into the market. In support of this claim of insufficient research, Keshia points to the fact that Bayer admitted that it does not know entirely how Mirena works to prevent pregnancy. According to the Bayer Mirena class action lawsuit, Bayer “suggests that Mirena may thicken the cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy.”

Additionally, the Mirena side effects class action lawsuit claims that Bayer knew that the device could have negative impacts in the area of cranial pressure, blood flow and other side effects. Allegedly, the device is not recommended for patients who have “migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.”

Keshia claims that, based on this warning, Bayer should have researched Mirena’s effects on all patients, and the possibility of the device causing transient cerebral ischemia, stroke, or intracranial hypertension, as well as the relationship between Mirena and IIH.

The Mirena and IIH Lawsuit is Case No. 1:18-cv-04859-PAE-JLC, in the U.S. District Court for the Southern District of New York.