Bayer faces a lawsuit alleging that their popular IUD can cause Mirena intracranial hypertension.

Plaintiff Tashena E. filed her lawsuit against Bayer alleging that she was diagnosed with Mirena intracranial hypertension after using their IUD.

The Mirena is an IUD which releases the hormone levonorgestrel as a contraceptive. Levonorgestrel is a synthetic progesterone which thickens cervical mucus, inhibiting sperm movement.  The Mirena is intended for women with heavy menstrual bleeding and can stay in the uterus for up to five years. The Mirena was approved by the FDA in 2009. The labeling contains warnings for use in patients with migraines, focal migraines, or other symptoms indicating transient cerebral ischemia.

Tashena says she had the Mirena IUD implanted in March 2011. While using the Mirena IUD, she began experiencing severe headaches, dizziness, tinnitus, and papilledema. In 2014, she was diagnosed with intracranial hypertension, which she believes was caused by the Mirena IUD. Her Mirena IUD was removed in 2017.

Intracranial hypertension, also known as pseudotumor cerebri, involves elevated intracranial pressure which causes symptoms similar to a tumor. Pseudotumor cerebri is thought to be caused by an excess of cerebrospinal fluid in the spine and skull, resulting in high intracranial pressure. Pseudotumor cerebri can be detected through imaging techniques such as an MRI by a physician.

Patients with Mirena intracranial hypertension have symptoms including migraines, headaches, blurred vision, double vision, temporary blindness, blind spots, and other visual problems.

Mirena intercranial hypertension is allegedly caused by levonorgestrel, the hormonal component of the Mirena IUD. Levonorgestrel allegedly affects the amount of cerebrospinal fluid in the body, which can cause Mirena intracranial hypertension.

Tashena’s lawsuit alleges that other levonorgestrel implants include warnings that pseudotumor cerebri has been reported with usage of those methods. The lawsuit alleges that the Mirena should contain additional warnings, and that to not include those warnings is a breach of federal law.

The Mirena intracranial hypertension lawsuit argues that Bayer knew that the Mirena had the potential to cause pseudotumor cerebri and “concealed the dangers and health risks from Plaintiff, physicians, pharmacists, other medical providers, the FDA and the public at large”.

Tashena believes that Bayer had a duty to consumers and medical professionals to disclose all the risks associated with the Mirena IUD and that by omitting Mirena intracranial hypertension as a side effect, they induced consumers to use the Mirena under false pretenses. “[Bayer] fraudulently misrepresented that Mirena caused few, if any, adverse reactions and side effects, and fraudulently misrepresented that Mirena would not lead to neurologic side effects, including the development of IH/PTC,” the lawsuit states.

Tashena accuses Bayer of negligence, design defect, failure to warn, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, fraud, and violation of state consumer fraud laws. The lawsuit seeks a trial by jury, damages, court costs, and attorneys’ fees.

The Mirena Intracranial Hypertension Lawsuit is Case No. 1:18-cv-01987-UA in the U.S. District Court for the Southern District of New York.