Plaintiff, Katelynn H., has filed a products liability lawsuit against Bayer Healthcare Pharmaceuticals, Inc., alleging personal injuries, severe adverse side effects and complications suffered as a result of her being prescribed and using Mirena.

According to the Mirena complications lawsuit, the product is a levonorgestrel-releasing intrauterine system.

The plaintiff is a resident and citizen of Colorado Springs, Colorado, while the defendant’s principal place of business is in Whippany, New Jersey.

Mirena is an intrauterine device, or IUD, that is inserted by a physician or healthcare practitioner. It is a T-shaped polyethylene frame used for contraception and requires a prescription.

According to the Mirena complications lawsuit, the U.S. Food and Drug Administration approved Mirena in December 2000. More than 2 million women use Mirena throughout the U.S. today.

The Mirena complications lawsuit asserts that the Mirena intrauterine system releases a hormone or synthetic progestogen, levonorgestrel, directly into the uterus for use as a contraceptive.

However, although the Mirena complications lawsuit maintains that the defendants warned that the Mirena product should be used with caution, it did not sufficiently warn about “non-stroke” neurological conditions such as pseudotumor cerebri (“PTC”), also known as idiothatic intracranial hypertenstion (“IIH”).

According to the Mirena complications lawsuit, the defendants made no indication of the potential risks involved in developing PTC/IIH, despite the known link between levonorgestrel and PTC/IIH.

The Mirena complications lawsuit maintains that, “upon information and belief, defendants did no clinical testing of Mirena and its known link to the development of IIH/PTC, despite over a decade of literature indicating further testing regarding levonorgestrel and IIH/PTC is needed.”

The Mirena complications lawsuit maintains that psedutumor cerebri or idiopathic intracranial hypertenstion is a condition that develops that causes increased pressure in the skull resulting from elevated levels of a person’s cerebrospinal fluid. Essentially, the fluid within the skull increases and is not released and absorbed at a quick and proper rate.

According to the Mirena complications lawsuit, the plaintiff had inserted Mirena into her body in May 2014. Allegedly, she relied on an information booklet provided by the defendant that iterated common side effects and other complications that may result from its use.

However, after Mirena was inserted and placed, the Mirena complications lawsuit maintains that she “began experiencing headaches, vision problems including floaters and blind spots in her vision, sharp pains in the base of her skull, and associated nausea and vomiting.”

In July, she was admitted into the emergency room complaining of headaches and blurry vision. In August 2015, she had her Mirena IUD removed and that month was diagnosed with pseudotumor cerebri.

The following counts are being filed against the defendant: 1) Negligence, 2) Design Defect, 3) Failure to Warn, 4) Strict Liability, 5) Breach of Implied Warranty, 6) Breach of Express Warranty, 7) Negligent Misrepresentation, 8) Fraudulent Misrepresentation, and 9) Fraud by Suppression and Concealment.

The Mirena Complications Lawsuit is Case No. 1:17-cv-05965-UA, in the U.S. District Court for the Southern District of New York.