Mirena birth control side effects have prompted a lawsuit against Bayer, alleging that the company knew about the possible side effects but did not warn consumers.

Plaintiff Tristyn A. recently filed a lawsuit against Bayer Healthcare Pharmaceuticals Inc., Bayer Pharma AG, and Bayer OY, alleging that the drug manufacturer knew that pseudotumor cerebri was one of the Mirena birth control side effects.

The Mirena is an IUD which releases a synthetic form of progestogen known as levonorgestrel. The device is inserted into the uterus in a simple procedure that can be done during an office visit, although the device is not suggested for women who have not had children.

The synthetic hormone released by the device affects the reproductive system to prevent conception for up to five years. Although the exact mechanism of progestogen and levonorgestrel is unknown, a fact allegedly admitted by Bayer, the hormones are thought to thicken cervical mucus which inhibits sperm movement.

In July 2012, Tristyn says she had the Mirena inserted by her provider. After she had the device placed, she alleges she began experiencing headaches, vision problems, neck pain, shoulder pain, back pain, and tinnitus (ringing in the ears).

In July 2016, Tristyn visited a vision specialist complaining of double vision. The doctor concluded that she may have potential pseudotumor cerebri, and she was referred to an ophthalmologist. She later had multiple MRIs and a lumbar puncture to diagnose her with pseudotumor cerebri. In February 2017, Tristyn removed the Mirena device.

Pseudotumor cerebri is a condition involving an excess amount of cerebrospinal fluid in the skull. The symptoms of the condition, caused by a high intracranial pressure, mimic the symptoms of a brain tumor. Symptoms of pseudotumor cerebri include migraines, tinnitus, blurred vision, double vision, temporary blindness, blind spots, and other visual problems.

The visual side effects of pseudotumor cerebri are thought to result from increased pressure in the skull placing pressure on the optic nerve. Failure to diagnose and treat pseudotumor cerebri may lead to permanent damage to the optic nerve, resulting in irreversible vision loss or partial blindness.

In her lawsuit, Tristyn argues that pseudotumor cerebri was caused by the Mirena but was not included in the list of possible Mirena birth control side effects.

“Defendants negligently misrepresented that Mirena does not have the propensity to cause or contribute to [pseudotumor cerebri] or hormonal side effects generally,” the lawsuit states.

Tristyn aims to hold Bayer accountable for not disclosing all of the potential Mirena birth control side effects. She claims that, since she was unaware of all of the Mirena birth control side effects, she could not make an informed decision about whether to have the Mirena inserted.

Tristyn 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 lawsuit seeks compensatory damages, punitive damages, court costs, and attorneys’ fees.

The Mirena Lawsuit is Case No. 1:18-cv-04323-PAE 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.