A woman has filed a lawsuit in New Jersey federal court alleging that the Mirena IUD birth control device cause her to develop intracranial hypertension and led to personal injury.

Plaintiff Jade L. filed her Mirena IUD hypertension lawsuit against Bayer Healthcare Pharmaceuticals raising safety concerns about the birth control option and stating how it personally harmed her.

Mirena is a contraceptive device that is implanted within a woman’s uterus by a physician during a regular office visit. The device is a T-shaped plastic frame that contains a reservoir that holds synthetic progesterone that is released daily into the woman’s body.

Mirena became approved by the FDA in December 2000 as a contraceptive device, and in 2009, the FDA approved the device to treat heavy menstrual bleeding in women who choose to use intrauterine devices as their preferred method of contraception. Currently, over 2 million women in the United States alone are implanted with Mirena.

The Mirena lawsuit states, “Defendants admit, ‘[i]t is not known exactly how Mirena works’ ” but suggest that Mirena may thicken cervical mucus, thin the uterine lining, inhibits sperm movement and reduce sperm survival to prevent pregnancy. The device may stay in place for up to five years before it must be replaced and it is recommended to be used in women who have already had at least one child.

According to the Mirena IUD hypertension lawsuit, the device should be used with caution in patients who have “migraine, focal migraine with asymmetrical visual loss or symptoms indicating transient cerebral ischemia” and that the device should be removed if those symptoms appear for the first time after the woman has the device implanted.

“Mirena’s label does not sufficiently warn about non-stroke neurological conditions such as pseudotumor cerebri (“PTC”), also known as idiopathic intracranial hypertension (“IIH”),” the lawsuit states.

The type of hypertension Jade states that she developed after Mirena was implanted is idiopathic intracranial hypertension. Hypertension refers to an increased pressure, and intracranial means that is happening within the brain, while idiopathic means that they do not have a specific cause identified.

This increased pressure in the skull happens because an individual’s cerebrospinal fluid level becomes elevated. This causes the fluid to build up in the person’s skull because it does not properly drain and become reabsorbed.

The term pseudotumor cerebri is used because the condition of intracranial hypertension behaves like that of a tumor although no tumor is found.

The symptoms linked to Mirena IUD hypertension in the brain include “symptoms of severe migraines or migraine-like headaches with blurred vision, diplopia (double vision), temporary blindness, blind spots, or other visual deficiencies.”

The visual problems result because there is increased pressure on the optic nerve, and often, patients develop papilledema, or swelling of the optic disc.

Treatment of the condition includes frequent lumbar punctures to release the pressure, weight loss or medications such as Diamox, which has its own potential side effects. Shunts are placed for extreme cases of Mirena IUD hypertension.

The lawsuit states that synthetic progesterone levonogestrel has a known link to intracranial hypertension, but the company made no mention of the association between the two.

Jade had her device implanted in July 2011 at approximately age 21. She says she later developed “intense headaches, blurred vision, and intermittent black spots in her peripheral vision, visual loss, and dizziness.”

Jade sought treatment in May 2014 and was diagnosed with intracranial hypertension approximately one month later. In September 2015, Jade had her Mirena IUD removed by another physician.

Jade brings forth a number of counts against Bayer including negligence, design defect, failure to warn, strict liability, breach of implied and express warranties, negligent misrepresentation, fraudulent misrepresentation, fraud by suppression and concealment and requests punitive damages.

Jade is seeking a jury trial and seeks an award of compensatory and punitive damages, judgments against defendants, fees and costs and any additional relief deemed appropriate by the Court.

The Mirena IUD Hypertension Lawsuit is Case No. 2:17-cv-03745, in the U.S. District Court for the District of New Jersey, Newark Division.