Mirena IUD Problems Resulted in Diagnostic Lumbar Puncture Due to Fluid Pressure on Brain, Lawsuit Alleges

According to allegations raised in a product liability lawsuit over problems with a Mirena IUD, an Illinois woman indicates that she required a diagnostic lumbar puncture due to intracranial pressure caused by the levonorgestrel-releasing birth control implant. 

The complaint (PDF) was filed by Christina Ray in the U.S. District Court for the Southern District of New York last week, alleging that Bayer Healthcare failed to adequately warn about the risk that women may experience increased fluid pressure on the brain, known as pseudotumor cerebri (PTC) or idiopathic intracranial hypertension (IIH), after the Mirena IUD is implanted.

The Mirena IUD is a t-shaped device implanted into the uterus during an out-patient procedure, which is designed to provide protection against pregnancy for up to five years. The intrauterine device releases the progestin levonorgestrel, which has previously been linked to a PTC/IIH risk in other birth control products, such as the Norplant. However, the Mirena warnings failed to adequately warn women and doctors about the importance of monitoring for symptoms after the IUD is implanted.

The lawsuit alleges that the lack of information provided by Bayer resulted in the prolonged use of the Mirena IUD, delaying the diagnosis of PTC/IIH, and increasing the risk of permanent vision loss and other health problems.

“Despite a wide body of information available to Defendants regarding the connection between levonorgestrel and PTC/IIH, Mirena’s label is devoid of any warning regarding PTC or IIH,” Ray’s lawsuit states. “[B]ecause Mirena’s label is devoid of any warnings of PTC or IIH, once a patient’s healthcare provider rules out transient cerebral ischemia or stroke as a cause of symptoms of migraine and/or asymmetrical visual loss, the healthcare provider will not typically know or advise a patient with PTC to remove Mirena, which causes or contributes to the development and/or progression of PTC/IIH.”

Ray, 30, was first implanted with the Mirena in January 2010 and had one reinserted again in March 2015. However, she began experiencing headaches and vision problems that were not diagnosed until she underwent a diagnostic lumbar puncture in February 2016.

The Mirena IUD was removed shortly afterward, however the lawsuit indicates that Ray has been left with permanent injuries.

Ray’s complaint joins a growing number of similar Mirena IUD lawsuits filed nationwide by women who suffered intracranial hypertension or pseudotumor cerebri, often resulting in vision loss and other injuries associated with damage to the optic nerve caused by the fluid pressure around the brain.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings in April 2017, centralizing all cases involving pseudotumor cerebri or intracranial hypertension complications from Mirena IUDs before one judge in the Southern District of New York.

There are currently more than 200 complaints pending before U.S. District Judge Paul A. Englemayer as part of an MDL, or multidistrict litigation. However, as Mirena injury 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.