A new Mirena IUD hypertension lawsuit has been filed against Bayer, alleging that the company sold the birth control device knowing that it could cause a dangerous condition known as intracranial hypertension.

Plaintiff Courtney S. recently filed a Mirena IUD hypertension lawsuit against Bayer, claiming that the birth control device caused her to develop intracranial hypertension, an allegedly unwarned side effect of the IUD.

Courtney says she had the Mirena implanted in February 2011. After implantation, she allegedly experienced Mirena IUD hypertension symptoms including migraines, blurry vision, and pulsatile tinnitus. Due to these symptoms, she had the device removed in September 2011 but allegedly has continued to suffer from side effects.

The Mirena was approved by the U.S. Food and Drug Administration (FDA) in 2000 as a birth control device. In 2009, its official uses were expanded, and the FDA approved the device for the treatment of heavy menstrual bleeding.

The device is inserted into the uterus during an office procedure and releases levonorgestrel, a synthetic form of progesterone. After it is inserted, the Mirena is effective for up to five years.

According to Bayer, “it is not known exactly how Mirena works.” However, it is believed that the release of levonorgestrel causes a thickening of cervical mucus and a thinning of uterine lining, making it difficult for sperm to move and decreases their survival rate.

According to the Mirena IUD hypertension lawsuit, the device may cause intracranial hypertension, also known as pseudotumor cerebri, an allegedly unwarned side effect. Intracranial hypertension is a condition involving an excess of cerebrospinal fluid, resulting in increased pressure in the skull.

The condition’s symptoms mirror those of a tumor, including severe headaches and vision problems. Courtney argues that this condition develops due to the release of levonorgestrel.

“Defendants knew or should have known that Mirena®, and specifically, the synthetic progestin levonorgestrel, causes and/or contributes to the development of [intracranial hypertension], a severe and possibly irreversible brain condition,” the Mirena IUD hypertension lawsuit states.

The Mirena IUD hypertension lawsuit claims that levonorgestrel can limit sex hormone binding globulin (SHBG), allowing for uncontrolled levels of levonorgestrel in the blood and resulting in more pronounced hormonal side effects.

Due to uncontrolled levels of the hormone, levonorgestrel is allegedly more likely to lead to the development of intracranial hypertension in Mirena users.

“The synthetic hormone released by Mirena, levonorgestrel, causes or contributes to the development of [intracranial hypertension], increases the risk of developing [intracranial hypertension], and/or worsens or exacerbates [intracranial hypertension],” the Mirena IUD hypertension lawsuit states.

Courtney also claims that Bayer did not sufficiently warn patients and physicians about the risks of Mirena IUD hypertension. Other levonorgestrel birth control methods allegedly contain warnings for intracranial hypertension, but the Mirena reportedly does not.

Courtney aims to hold Bayer accountable for her injuries due to allegedly unwarned Mirena IUD hypertension. The lawsuit seeks compensatory damages, punitive damages, court costs and attorneys’ fees.

The Mirena IUD Hypertension Lawsuit is Case No. 7:18-cv-04810 and is part of the Mirena MDL, In re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), MDL No. 2767, in the United States District Court for the Southern District of New York.