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Bayer faces a product liability lawsuit brought by a woman who claims that the side effects of the Mirena IUD caused her to suffer a severe medical condition known as pseudotumor cerebri, or PTC, involving a dangerous increase in fluid pressure on the brain, which resulted in severe headaches, pain, nausea, ringing of the ears and a host of vision problems.
The complaint (PDF) was filed by Anna Conley in the U.S. District Court for the District of New Jersey on October 28, indicating that women and the medical community were not provided with adequate warnings about the risk of severe and potentially debilitating PTC problems from Mirena IUD birth control implants.
PTC, which is also sometimes referred to as idiopathic intracranial hypertension (IIH), involves a build up of cerebrospinal fluid in the skull, which poses a medical emergency and often results in permanent damage to the optic nerve.
Conley indicates that she had a Mirena IUD implanted in January 2007, to provide long-term birth control for up to five years. However, the lawsuit claims that shortly after the device was placed in her uterus, she began to suffer severe headaches, ringing in the ears, dizziness, blurred vision, double vision and general vision loss, as well as pain in the neck, shoulders and back.
The Mirena PTC complications resulted in the need for six lumbar puncture procedures to alleviate the growing pressure on her brain, but the device was not removed until April 2011, several years after she was diagnosed.
“Upon information and believe, because 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 vision loss, the healthcare provider will not typically know or advice a patient with PTC to remove Mirena, which causes or contributes to the development and/or progression of PTC/IIH,” according to the complaint.
Conley’s case joins a growing number of Mirena IUD lawsuits over 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.