In a new Mirena lawsuit, a Maryland woman faults Bayer for failing to warn her about the risk of a painful condition associated with the Mirena IUD.

Plaintiff Daphne H. says she was implanted with a Mirena birth control device in June 2005. She later began to suffer from headaches.

In April 2009, she sought treatment for complaints of pressure headaches and vision changes.

She was initially diagnosed with papillary edema, or swelling of the optic nerves. But  after a round of imaging studies and a diagnostic lumbar puncture, she was diagnosed with pseudotumor cerebri.

Pseudotumor cerebri, also known as idiopathic intracranial hypertension, is a condition caused by an excess of cerebrospinal fluid. The extra fluid creates pressure inside the skull.

The name pseudotumor cerebri comes from the fact that the condition’s symptoms mimic those of a brain tumor without there being any actual tumor present.

Patients with pseudotumor cerebri typically suffer from severe migraine or migraine-like headaches and alterations of vision such as blind spots, blurred vision, double vision, and temporary blindness.

The Mirena IUD

According to Daphne’s Mirena lawsuit, Mirena is an intrauterine device that releases 20 micrograms per day of the contraceptive medication levonorgestrel. The device consists of a T-shaped polyethylene frame and a steroid reservoir that holds the device’s supply of medication.

The implant is designed to be implanted by a doctor and remain in the woman’s uterus for up to five years.

Mirena has been on the U.S. market since it was first approved by the FDA in 2000 for use as a contraceptive. It has since been approved as a treatment for heavy menstrual bleeding in women who use intrauterine contraception.

It’s estimated that Mirena is used by more than 2 million in the U.S. and more than 15 million worldwide.

Mirena Lawsuit Says Bayer Failed to Issue Proper Warning

In her Mirena lawsuit, Daphne takes issue with specific language on the package labeling that addresses symptoms similar to what she suffered.

The labeling for Mirena says it should be used with caution in patients who have “Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.”

Daphne believes this warning is “specifically designed to caution healthcare providers about a possible increased risk of transient cerebral ischemia or stroke with Mirena use.”

What that language fails to do, she says, is offer a proper warning about the risk of pseudotumor cerebri.

According to Daphne, the labeling for Mirena makes no mention of pseudotumor cerebri or idiopathic intracranial hypertension, despite what she says is a known link between levonorgestrel and that condition.

Other levonorgestrel-dispensing devices like Norplant have borne a warning about the risk of pseudotumor cerebri from as far back as 1993, Daphne says.

Bayer, however, downplayed or covered up the risk of pseudotumor cerebri associated with levonorgestrel in an attempt to portray Mirena as a low- or no-hormone contraceptive, Daphne claims.

The result, she says, is that patients and their doctors have been misled about the risk of pseudotumor cerebri associated with Mirena. Had she been better informed, she says, she never would have agreed to be implanted with a Mirena IUD.

The Mirena Lawsuit is Case No. 2:16-cv-01418 in the U.S. District Court for the District of New Jersey.