After receiving a Mirena intrauterine device (IUD) for long-term birth control, a Texas woman indicates that she developed severe headaches, vision problems and permanent papilledema due pseudotumor cerebri, which involves a build up of fluid pressure around the brain.

In a complaint (PDF) filed against Bayer Healthcare in the U.S. District Court in the Southern District of New York on July 7, Alyssa Johnson indicates that the manufacturer failed to warn consumers and the medical community about the risks associated with the Mirena IUD.

Johnson, 34, says that the birth control was implanted in May 2014 without complication. However, she was diagnosed in July 2015 with idiopathic intracranial hypertension (IIH), which is also known as pseudotumor cerebri (PTC). The fluid pressure around the brain caused swelling of the optic nerves, known as papilledema from Mirena, which has left Johnson with severe headaches and vision problems, which are expected to be permanent.

IIH/PTC is a serious medical condition, which has been linked to other birth control products. However, Mirena warnings failed to provide any indication that users may experience problems, or that they should seek immediate medication attention if vision issues or headaches develop.

While the fluid pressure around the brain can often be treated, if permanent optic nerve damage is suffered due to PTC/IIH, women may be left with blindness or other long-term complications.

The lawsuit indicates that Bayer knew or should have known that the Mirena could cause PTC/IIH.

“Despite the rarity of PTC/IIH, women who use levonorgestrel-containing products, like the Mirena® IUS, more commonly develop the disorder,” the lawsuit states. “The synthetic hormone released by Mirena, levonorgestrel, causes or contributes to the development of PTC/IIH, increases the risk of developing PTC/IIH, and/or worsens or exacerbates PTC/IIH.”

Johnson’s claim joins a growing number of Mirena IUD lawsuits filed in federal courts nationwide, each raising similar allegations that women may have avoided serious injuries if adequate information had been disclosed to consumers and the medical community.

In late April 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all cases brought by women diagnosed with PTC/IIH from the Mirena birth control implant, centralizing the claims before U.S. District Judge Paul A. Englemayer in the Southern District of New York.

As Mirena lawyers continue to review and file claims for women nationwide, it is expected that the size and scope of the litigation will continue to grow over the coming weeks and months.

As part of the coordinated pretrial proceedings, it is expected that Judge Englemayer will establish a bellwether program, where a small group of cases will be prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Tags: Bayer, Birth Control Device, IIH, Mirena, Papilledema, PTC, Vision Loss