Mirena IUD Pseudotumor Cerebri Problems Led To Cluster Headaches, Blurred Vision: Lawsuit

The side effects of a Mirena IUD implanted in a North Carolina woman for long term birth control allegedly caused her to suffer a dangerous medical condition known as pseudotumor cerebri (PTC), which resulted in cluster headaches, blurred vision, nausea, dizziness and other problems associated with the build up of fluid pressure on the brain. 

The complaint (PDF) was filed by Abigail Michel in the U.S. District Court for the District of New Jersey on June 3, alleging that Bayer Healthcare failed to adequately warn about the risk of Mirena IUD pseudotumor cerebri problems.

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 a risk of pseudotumor cerebri in other birth control products. However, the lawsuit indicates that Mirena warnings failed to adequately warn women that the IUD birth control implant may cause a dangerous buildup of pressure on the brain, which can cause permanent damage to the optic nerve and other side effects.

Michel began suffering cluster headaches, blurring vision, nausea and dizziness, which was later diagnosed as papilledema and possible pseudotumor cerebri (PTC), which is also commonly referred to as idiopathic intracranial hypertension (IIH). She was diagnosed with the condition in September 2013, after undergoing an MRI and a diagnostic lumbar puncture, and the Mirena IUD was removed in November 2013. However, the lawsuit indicates that she has been left with permanent problems from the Mirena IUD as a result of optic nerve damage caused by the build up of pressure around the brain.

“Defendants failed to adequately and properly test the Mirena both before and after placing it on the market,” the lawsuit states. “A prudent seller in the exercise of ordinary care would and should have discovered and foreseen the dangerous and defective condition of Mirena and its potential to cause severe conditions, including PTC/IIH, when placing the product on the market.”

The case is one of a growing number of similar Mirena IUD lawsuits over pseudotumor cerebri problems filed in recent months, which 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/IIH, 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 Kessler’s claim and others filed by other women 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.