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According to allegations raised in a product liability lawsuit recently filed against Bayer, an Arizona woman suffered severe pseudotumor cerebri problems from a Mirena IUD, after the birth control implant caused a dangerous build up of fluid around the brain.
The complaint (PDF) was filed by Daniella Pavelka in the U.S. District Court for the District of New Jersey on July 19, indicating that the condition required placement of a brain shunt to drain her cerebrospinal fluid.
Mirena IUD is a form of long-acting birth control, involving a T-shaped implanted that is placed into the uterus for up to five years, releasing the progestin levonorgestrel. Although exposure to levenorgestrel has been linked to problems with pseudotumor cerebri in other birth control products, Pavelka indicates that Bayer failed to warn women or the medical community that the risk may be linked to side effects of Mirena as well.
Pavelka is currently 28 years old, and indicates that she had a Mirena IUD implanted in April 2013. Shortly after it was placed, Pavelka indicates that she began experiencing severe headaches, blackouts, blurred vision and other problems.
Only a few weeks after the IUD was implanted, Pavelka was diagnosed with pseudotumor cerebri, which is a medical condition involving a build up of fluid pressure on the brain, which can lead to permanent damage to the optic nerve, causing vision problems, headaches and other ailments.
As a result of the condition, Pavelka indicates that she has been prescribed several diuretics, undergone several lumbar punctures, MRI and CT scan procedures, and ultimately had a shunt placed to drain fluid away from her brain. However, she indicates that she has been permanently injured due to the Mirena pseudotumor cerebri problems.
“Unfortunately, therapeutic shunting procedures have high failure and revision rates and often require several repeat or revision surgeries,” the lawsuit states. “Additionally, a patient’s shunt may need frequent adjustment, which may also require surgical intervention, to find the right setting for a particular patient’s needs.”
Growing Mirena Pseudotumor Cerebri Lawsuits
The case is one of a growing number of similar Mirena IUD lawsuits over pseudotumor cerebri (PTC) filed in recent months, each allege that Bayer withheld information from women and the medical community about the risk that levonorgestrel released by the implant may cause the sudden buildup of pressure on the brain.
Lawsuits allege that this prevented users and doctors from promptly recognizing the symptoms of PTC, which may have allowed women to avoid long-term optic nerve damage.
In several other countries, including South Africa and Hong Kong, warning information provided with the Mirena IUD indicate that papilledema is a possible side effect. However, Bayer has not given women in America or the U.S. medical community the same information.
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 Pavelka’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. There is a separate multidistrict litigation (MDL) established for Mirena migration injury lawsuits, which currently includes about 4,000 complaints pending before U.S. District Judge Cathy Seibel in the Southern District of New York, where a small group of “bellwether” cases are being prepared for early trial dates.