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Global healthcare giant Bayer is facing a new slate of federal lawsuits over the wildly-popular hormonal IUD Mirena. Thousands of women have already blamed Mirena for severe uterine perforations and ectopic pregnancies, but an additional group of patients has stepped forward to link the intrauterine device to pseudotumor cerebri, a rare and deeply-troubling brain condition that can lead to permanent vision loss.
Mirena Lawsuits Seek Multi-District Litigation
More than 100 women have filed pseudotumor cerebri lawsuits against Bayer, noting that Mirena’s warning label makes no mention of this debilitating brain disorder. As many patients have learned with shock, the synthetic hormone used in Mirena has been linked to cases of pseudotumor cerebri (or “intracranial hypertension”) for nearly 25 years. In fact, a previous birth control implant based on levonorgestrel was pulled from the market after thousands of women reported debilitating side effects, including pseudotumor cerebri.
As Harris Martin reports, attorneys have now moved to see these Mirena lawsuits consolidated, asking the Judicial Panel on Multi-District Litigation to transfer cases filed in federal courts to the US District Court for the Southern District of Mississippi. If granted, the motion would centralize all federal lawsuits in which patients allege that:
“levonorgestrel, a potent synthetic hormone, contained in the Mirena levonorgestrel-releasing intrauterine system, caused them to develop conditions which manifested as increased intracranial pressure or intracranial hypertension.”
A previous request for centralization, which involved only nine pseudotumor cerebri lawsuits, was denied in 2014. Today, plaintiffs are more hopeful, since the number of Mirena lawsuits has only continued to grow over the past three years.
Usted puede acceder más información sobre esta litigación en Español por visitando nuestra página de demandas de Mirena por lesiones de pseudotumor cerebral.
What Would MDL Mean For Mirena Plaintiffs?
Consolidation would allow plaintiffs’ attorneys to share resources, crafting legal strategies together, rather than being forced to work on similar cases in isolation. Existing pseudotumor cerebri lawsuits are currently scattered across seventeen different jurisdictions and legal observers believe that thousands of women may eventually file suit against Bayer.
To learn more about Multi-District Litigation, and why it may provide plaintiffs with more benefits than class action, click here.
Concerns Over Hormone Go Back Decades
More than 20 years ago, medical researchers found evidence that Norplant, a levonorgestrel-releasing birth control implant, was causing cases of pseudotumor cerebri. In a 1995 New England Journal of Medicine report, doctors from an Oregon university and the World Health Organization described the strange cases of two young women, aged 16 and 19, who had developed intracranial hypertension only months after receiving Norplant.
Even stranger? Norplant’s manufacturer, Wyeth Laboratories, had already warned patients about this risk, clearly noting “intracranial hypertension” under the Precautions section of the implant’s warning label. By 2001, numerous references to the condition, along with synonyms like “pseudotumor cerebri,” could be found on Norplant’s labeling information.
Canadian Study Links Mirena To Pseudotumor Cerebri
Similar cautionary statements have not yet appeared on the labeling for Mirena. But new research has revived old concerns, putting the long-term safety of Mirena into doubt.
In a 2015 review of FDA adverse event data, researchers at the University of British Columbia discovered a “higher than expected” number of reports linking Mirena to cases of intracranial hypertension (another name for pseudotumor cerebri). Using statistical analysis, the researchers concluded that Mirena users could be up to 78% more likely to be diagnosed with pseudotumor cerebri than members of the general population.
The researchers also found an increased risk for papilledema, which may be intracranial hypertension’s most significant side effect. As pressures inside the skull increase, key structures in the optic nerve can begin to swell, leading to visual disturbances and progressive vision loss. This condition, known as papilledema, can eventually cause permanent blindness. Expert medical witnesses for Bayer have dismissed the study’s results as “erroneous and misleading.”
What Is Pseudotumor Cerebri?
Women have been filing pseudotumor cerebri lawsuits involving the Mirena IUD for over three years. In their complaints, patients describe experiencing startling and life-altering side effects within months of receiving the device. Most patients report migraine headaches and confusion, along with memory loss, cognitive difficulties and strange changes in visual perception. These are all symptoms of pseudotumor cerebri, the Mayo Clinic reports.
Most cases will never be fully explained, although the medical community’s leading theory suggests that pseudotumor cerebri may ultimately be caused by excessive cerebrospinal fluid that surrounds the brain. By increasing intracranial pressure, pseudotumor cerebri can stress the optic nerves that transmit visual information, leading to the disorder’s most notable symptoms:
- Headaches (usually beginning behind the eyes and worsening with eye movement)
- Ringing in the ears (usually pulses in rhythm with heartbeat)
- Blurry and double vision
- Transient episodes of total vision loss
- Nausea and vomiting
- Confusion and dizziness
- Neck and shoulder discomfort
Thankfully, pseudotumor cerebri is not fatal, but the condition can lead to life-altering adverse consequences. Left without proper treatment, patients with the brain disorder can experience progressive vision loss and eventually be left blind. In some troubling cases, the condition’s symptoms can recur, even after month or years of remission.
How Is Intracranial Hypertension Diagnosed?
Rare and poorly-understood, the brain condition closely mimics the symptoms caused by a brain tumor, but is caused instead by an abnormal increase of pressure inside the skull. Unfortunately, the nonspecific symptoms of intracranial hypertension lead to a startling number of misdiagnosed cases.
In diagnosing the condition, doctors generally refer to the Modified Dandy Criteria, a system used to distinguish cases of idiopathic intracranial hypertension from other causes of raised cranial pressure. The Dandy Criteria, first developed by neurosurgery pioneer Walter Dandy, has been used since 1937:
- Signs and symptoms – headache and papilledema, a swelling of the optic disc
- Physical exam – ruling out signs of localized neurological injury
- MRI or CT – ruling out presence of brain tumors and blood clots
- Spinal tap – high intracranial pressure, but no cerebrospinal fluid abnormalitis
There is, however, much controversy within the medical community over these criteria. In fact, there is little agreement on how cases of intracranial hypertension should be defined in the first instance, thanks in large part to the condition’s often-mysterious origins.
Who Gets Pseudotumor?
Women who are obese and under the age of 44 live at an increased risk of developing intracranial hypertension. While around 1 to 2 of every 100,000 people in the general population will experience pseudotumor cerebri, the condition is more common in obese women, affecting anywhere from 4 to 21 in 100,000 women with excessive body fat.
How Does Mirena’s Synthetic Hormone Work?
Mirena is an intrauterine device (IUD) that slowly releases the synthetic hormone levonorgestrel. While researchers aren’t quite sure why levonorgestrel prevents pregnancy, several plausible theories have been suggested. As the US National Library of Medicine notes, doctors usually ascribe the hormone’s contraceptive effects to one of three possible explanations:
- preventing ovulation (release of egg from ovary)
- preventing sperm from fertilizing egg
- thickening uterine lining to prevent fertilized egg from implanting
Mirena is a T-shaped plastic implant, inserted into the uterus during a relatively short OB / GYN appointment. While the insertion itself can cause severe pain for a number of weeks, most women will become used to the device fairly quickly. After implantation, Mirena begins to release its synthetic hormone, levonorgestrel, which is a manufactured version of the naturally-occurring hormone progestin. Clinical trials have shown that Mirena is more than 99% effective at preventing pregnancy for up to five years, after which the implant must be replaced.
Levonorgestrel is one of several active ingredients used in many combination birth control pills, including emergency contraceptives like Plan B.