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The pseudotumor cerebri (PTC) side effects of the Mirena IUD allegedly caused a Minnesota woman to suffer papilledema, intense headaches, blurred vision, nausea and other symptoms associated with the build up of fluid pressure around the brain, according to a new lawsuit.
The complaint (PDF) was filed earlier this month by Mandy Mitlyng in the U.S. District Court for the District of Minnesota, indicating that Bayer Healthcare failed to adequately warn consumers and the medical community about the risk of pseudotumor cerebri induced papiledema that has been linked to their popular birth control implant.
Papilledema involves swelling of the optic disc that can produce severe headaches, vision problems and other complications. It is typically caused by increased intracranial pressure, and may be a side effect of pseudotumor cerebril (PTC), which is a risk associated with Mirena IUD birth control.
Mitlyng indicates that she began suffering symptoms of pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH), after the Mirena IUD was implanted as a form of long-term birth control in April 2010.
In June 2013, Mitlyng sought medical treatment after she began suffering intense headaches, blurred vision and nausea associated with migraine-like headaches. She was diagnosed with pseudotumor cerebri and papilledema in July 2013.
As a result of the complications, Mitlyng has undergone a lumbar puncture to reduce the pressure, and has had repeated trips to the hospital as a result of the Mirena complications, the lawsuit indicates.
While the fluid pressure on the brain caused by pseudotumor cerebri and papilledema from Mirena can often be resolved via a lumbar puncture or the use of a brain shunt, it is important that the birth control implant be removed. However, many women have been left with permanent damage to the optic nerve due the failure to identify the cause of their problems, which can result in life-long symptoms.
Mitlyng’s complaint states that Bayer has failed to adequately warn the medical community about the risks assocaited with the Mirena IUD implant, or about the importance of consumers and physicians monitoring for signs of papilledema.
“[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,” the lawsuit states.
In several other countries, including South Africa and Hong Kong, Mirena IUD warning information provided by Bayer indicates that papilledema is a possible side effect of the birth control. However, the same information and warnings were not provided women in America or the U.S. medical community.
Mitlyng’s case joins a growing number of Mirena IUD lawsuits over pseudotumor cerebri, each raising similar allegations that the failure to warn prevented users and doctors from promptly recognizing the cause of papilledema, headaches or vision problems, which may have allowed women to avoid long-term optic nerve damage.