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According to allegations raised in a recently filed product liability lawsuit over the Mirena IUD, the birth control implant caused a woman to suffer severe headaches, vision loss and other complications associated with side effects of pseudotumor cerebri, which involves a buildup of fluid pressure on the brain.
The complaint (PDF) was filed by Cattie Kessler in the U.S. District Court for the District of New Jersey on May 9, alleging that Bayer Healthcare Pharmaceuticals failed to adequately warn women and the medical community about the potential link between Mirena and pseudotumor cerebri (PTC), also referred to as idiopathic intracranial hypertension (IIH).
The intrauterine device (IUD) is a small, T-shaped implant designed to prevent pregnancy for up to five years, releasing the progestin levonorgestrel, which has been linked to reports of pseudotumor cerebri problems in other birth control products. However, the Mirena warnings failed to adequately warn women that the IUD birth control may cause a dangerous buildup of pressure on the brain, which can cause permanent damage to the optic nerve and other side effects.
Kessler indicates that she received a Mirena implant in October 2010. At the time, there were no signs of complications with the IUD. However, in April 2013, she began experiencing severe headaches, vision loss, numbness of the extremities, tinnitus, nausea and fatigue.
About four months later, Kessler was diagnosed with papilledema, which is a medical condition involving swelling of the optic nerve. Following a number of scans and a lumbar spinal tap to relieve the pressure and rule out other causes of the fluid buildup on the brain, Kessler discovered that she was suffering pseudotumor cerebri side effects from the Mirena IUD.
The case is one of a growing number of Mirena IUD lawsuits filed over pseudotumor cerebri filed in recent months, which each allege that Bayer failed to adequately warn about the risk that levonorgestrel released by the implant may cause the sudden buildup of pressure on the brain.
In several other places around the world, 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 Kessler’s claim and others filed by other women are proceeding without coordinated pretrial proceedings.
In addition to problems with pseudotumor cererbri, Mirena has 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.