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In a product liability lawsuit recently filed against Bayer Healthcare, a Georgia woman alleges that side effects of a Mirena IUD birth control implant caused her to develop a medical condition known as pseudotumor cerebri (PTC), resulting in severe headaches, vision damage and other problems caused a build up of fluid pressure on her brain.
The complaint (PDF) was filed by Jaclyn Spett in the U.S. District Court for the District of New Jersey on May 27, alleging that the drug manufacturer failed to adequately warn women and the medical community about the potential link between Mirena and pseudotumor cerebri, which is also known as idiopathic intracranial hypertension (IIH).
Mirena is an intrauterine device (IUD) that is marketed for long-term birth control, involving a T-shaped implant that is placed in the uterus to prevent pregnancy for up to five years. The device releases the progestin levonorgestrel, which has previously been linked to pseudotumor cerebri problems. However, the Mirena warnings provided in the United States failed to disclose that women receiving the implant may suffer permanent optic nerve damage and other side effects from this build up of cerebrospinal fluid around the brain.
Spett indicates that she received a Mirena IUD in September 2013, and only a few months later she began to experience cluster headaches, blurred vision, nausea, dizziness and vision problems when bending over.
In April 2014, she was diagnosed with papilledema, or swelling of the optic nerve. She underwent diagnostic tests, including CT scans and MRI, as well as a diagnostic lumbar puncture to rule out other causes of the pressure on her brain, before being diagnosed with pseudotumor cerebri from the Mirena IUD. As a result of the complications, she had the Mirena implant removed in June 2014.
The case is one of a growing number of Mirena IUD lawsuits filed over pseudotumor cerebri side effects in recent months, which each allege that Bayer withheld information about the risk.
In several other countries outside the United States, 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.
“Defendants failed to adequately warn Plaintiff or her physicians of the increased risk of developing IIH/PTC with use of Mirena and failed to warn that Mirena should be immediately removed once Plaintiff is diagnosed with IIH/PTC and/or papilledema, and/or suffers characteristics, symptoms, or manifestations of IIH/PTC and/or papilledema,” Spett’s lawsuit states. “Despite Defendants’ knowledge of the risks associated with levonorgestrel-releasing implants, including the development of IIH/PTC, Defendants did not adequately conduct pre-market and/or post-market testing to account for the risks.”
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 are currently about 4,000 Mirena migration injury lawsuits pending throughout the federal court system, which are currently centralized 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.