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According to allegations raised in a product liability lawsuit filed by a 26 year old woman, side effects of the Mirena IUD birth control implant caused a false brain tumor, known as pseudotumor cerebri, which resulted in severe headaches, vision problems and other permanent injuries.
The complaint (PDF) was filed by Kelsey Ramm in the U.S. District Court for the District of New Jersey on May 3, alleging that Bayer Healthcare failed to warn that the Mirena IUD may cause a dangerous build of fluid pressure around the brain.
Mirena is an intrauterine device (IUD), which is implanted int the uterus to provide protection against pregnancy for up to five years. The T-shaped implant releases the hormone levenorgestrel, which has been linked to the development of a serious medication condition known as pseudotumor cerebri (PTC) in other birth control products. Yet, Mirena warnings failed to indicate that users may be at risk.
Ramm indicates that she had a Mirena inserted into her body in June 2013, by her healthcare provider at Planned Parenthood in Beaverton, Oregon. She indicates that she later began to develop intense headaches, blurred vision, double vision and dizziness, seeking medical treatment in May 2015.
After she was initially diagnosed with papilledema, Ramm was eventually referred for diagnostic testing and evaluation for a false brain tumor, which resulted in a diagnosis in June 2015 of pseudotumor cerebri (PTC), which is sometimes referred to as idiopathic intracranial hypertension (IIH).
About a year later, in June 2016, Ramm had her Mirena IUD removed, but indicates that the fluid pressure from the false brain tumor left her with permanent injury.
“Defendant knew or should have known that Mirena, and specifically, the synthetic progestin levonorgestrel causes and/or contributes to the development of IIH/PTC, a severe and possibly irreversible brain condution that can also lead to permanent blindness,” according to the complaint. “Despite an increasing number of adverse events, including reports of intracranial hypertension, blindness, papilledema, and increased intracranial pressure, Defendants have made no effort to warn physicians, the healthcare community, or patients of the risk of developing IIH/PTC with Mirena.”
The case joins a growing number of Mirena false brain tumor lawsuits filed in recent months by women who have suffered symptoms of pseudotumor cerebri, each raising similar allegations that plaintiffs may have avoided severe and potentially life-long problems from permanent optic nerve damage if the drug maker had provided warnings about the importance of removing the device once symptoms of the fluid pressure first appeared.
Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, earlier this month the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all Mirena IUD PTC/IIH claims filed in federal courts nationwide be transferred to the U.S. District Court for Southern New York before District Judge Paul A. Engelmayer for coordinated pretrial proceedings.
There are currently more than 100 product liability lawsuits pending over Mirena pseudo-brain tumor injuries. In addition, as Mirena injury lawyers continue to review and file cases over the coming months and years, it is ultimately expected that hundreds, if not thousands, of cases will be added to the litigation in the coming months and years.