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After experiencing intense headaches and blurred vision caused by a build up of fluid pressure around her brain, an Ohio woman indicates that she was diagnosed with papilledema and pseudotumor cerebri (PTC) triggered by a Mirena IUD implant received for long-term birth control.
The complaint (PDF) was filed eariler this month by Sara Marie Wessel in the U.S. District Court for the District of New Jersey, alleging that Bayer failed to adequately warn women and the medical community about the potential side effects of Mirena birth control.
The Mirena IUD is marketed as a “hassel free” form of birth control, involving a T-shaped plastic implant placed into the uterus, which release the progestin levonorgestrel to prevent pregnancy for up to five years.
Wessel indicates that a Mirena IUD was implanted in July 2012, and she began suffering headaches, blurred vision and other symptoms caused by a build up of fluid pressure around the brain, known as pseudotumor cerebri (PTC) or ideopathic intracranial hypertension (IIH). The condition is also often associated with a diagnosis of papilledema, or optic disc swelling caused by the increased intracranial pressure.
“There is currently no treatment to reverse permanent injury to the optic nerves caused by increased intracranial pressure. Because of this, treatment of PTC or IIH is focused on halting visual loss that has already occurred,” the lawsuit states. “Although PTC or IIH is considered reversible in some patients, it may take years before normal pressure is maintained. it also may be irreversible in some cases.”
The case joins growing number of similar Mirena lawsuits over papilledema and pseudotumor cerebri (PTC) filed by women nationwide, each involving similar allegations that plaintiffs could have avoided long-term damage if Bayer had provided better warnings about the risk associated with the IUD birth control.
Exposure to levenorgestrel in other birth control products has been linked to problems with pseudotumor cerebri, but no Mirena warnings were provided about the potential risk associated with Bayer’s IUD implant, or the importance of doctors monitoring patients for signs of sudden headaches, vision problems or other signs of the dangerous build up of fluid around the brain.
While the fluid pressure on the brain caused by pseudotumor cerebri from Mirena can often be resolved via a lumbar puncture or the use of a brain shunt, many women have been left with permanent damage to the optic nerve, which can lead to life-long symptoms.
In several other countries, including South Africa and Hong Kong, warning information provided by Bayer indicate that papilledema is a possible side effect of Mirena. However, the same information and warnings were provided women in America or the U.S. medical community. Plaintiffs allege that this failure to warn prevented users and doctors from promptly recognizing the symptoms of pseudotumor cerebri or papilledema from Mirena, which may have allowed women to avoid long-term optic nerve damage.
Amid a growing number of Mirena pseudotumor cerebri cases brought throughout the federal court system against Bayer, a request was filed last year with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the cases before one judge. However, that request was rejected, so Wessel’s claim and others filed by other women nationwide are proceeding without coordinated pretrial proceedings.
In addition to problems with pseudotumor cererbri, Mirena IUDs have also been linked to reports of the IUD perforating the uterus or moving out of position, causing severe internal injuries for many women.