Certain types of hormonal birth control, including oral contraceptives and popular birth control implants, like Mirena IUD, have been linked to an increase in the amount of cerebrospinal fluid in the skull, which can result in a debilitating neurological condition called pseudotumor cerebri. A growing number of women across the country are now pursuing legal claims against the makers of Mirena IUD and other hormonal birth control devices, over devastating brain injury complications like pseudotumor cerebri. If you believe you have been adversely affected by side effects of female birth control, including pseudotumor cerebri, consult a skilled product liability lawyer as soon as possible to explore your possible compensation options. With a knowledgeable birth control injury attorney on your side, you can ensure that your legal rights are protected, and seek fair and timely reimbursement for your losses.
Pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH), or benign intracranial hypertension, is a condition characterized by excessive levels of cerebrospinal fluid in the skull that leads to increased pressure on the brain without an obvious cause. In people suffering from pseudotumor cerebri, which literally translates to “false brain tumor,” symptoms typically mimic those of a brain tumor and may include vision loss, migraine headaches, vomiting, problems walking, and pulsating sounds inside the head. In many cases of pseudotumor cerebri, there is pressure on the optic nerve, which can cause serious eye injuries and blindness that may become permanent.
The symptom most often associated with idiopathic intracranial hypertension is a headache, which occurs in 92% to 94% of all cases, and is typically a generalized, throbbing headache that is worse in the morning. Headaches caused by PTC can be made worse by any activity that further increases the intracranial pressure, even something as simple as sneezing or coughing. Another common symptom of IIH is pulsatile tinnitus, a whooshing sensation in one or both ears that occurs in sync with the pulse. In some patients, pain caused by pseudotumor cerebri may also be experienced in the neck or shoulders.
The exact cause of pseudotumor cerebri or idiopathic intracranial hypertension remains unknown, but the neurological condition is believed to be associated with the buildup or poor absorption of cerebrospinal fluid back into the bloodstream. Cerebrospinal fluid is constantly being produced by the brain and absorbed into the bloodstream, and the fluid acts as a cushion to protect the brain and spinal cord from injury. However, when there is too much cerebrospinal fluid in the skull, it can put dangerous pressure on the brain and optic nerve, and cause symptoms that mimic those of a brain tumor.
According to medical experts, pseudotumor cerebri can only be diagnosed “if there is no alternative explanation for the symptoms,” and diagnosis typically involves a brain scan to rule out other causes of the patient’s symptoms, and a lumbar puncture. While the condition can affect any age group, PTC is most common in women between the ages of 20 and 40, especially those with obesity. In cases where women suffer symptoms of pseudotumor cerebri while using Bayer’s controversial Mirena IUD, levonorgestrel appears to be the only shared risk factor present. Between 2000 and 2014, more than 70,000 adverse event reports were submitted to the FDA involving complications from Mirena, and more and more common are Mirena injury reports involving IIH or PTC side effects.
Even though pseudotumor cerebri isn’t an actual brain tumor, it is still a potentially serious medical condition that can result in lasting injuries. Some people who present with symptoms of pseudotumor cerebri, for example, experience progressively worsening vision, and may eventually become blind. In order to prevent permanent vision loss, regular eye exams and checkups are typically recommended, so that any eye problems can be treated before they progress. Treatment for PTC may include discontinuing the use of hormonal birth control, surgical placement of a shunt to redirect fluid from the brain, or a spinal tap to remove fluid and alleviate pressure on the brain. Unfortunately, even if symptoms of pseudotumor cerebri have resolved with treatment, they can recur months or even years later, without warning.
Pseudotumor cerebri is a debilitating neurological condition, and a growing body of research has linked the use of certain types of birth control to dozens of cases of PTC resulting in symptoms like severe headaches and progressive vision loss possibly leading to permanent blindness. In 1995, a study published in the New England Journal of Medicine found a connection between intracranial hypertension and the use of birth control products containing the hormone levonorgestrel, which includes Bayer Pharmaceuticals’ widely-used intrauterine device (IUD), Mirena. The researchers involved in the study identified 56 cases of pseudotumor cerebri among women prescribed the Mirena intrauterine birth control device.
More recently, in 2014, the use of Mirena IUD was linked to the development of PTC side effects in women using the intrauterine birth control device to prevent pregnancy. That same year, Bayer Healthcare was hit with nine product liability lawsuits accusing the manufacturing company of downplaying the link between Mirena IUD and severe brain injuries, including idiopathic intracranial hypertension, benign intracranial hypertension and pseudotumor cerebri. Unfortunately, many women using oral contraceptives or intrauterine birth control devices have no idea they may be facing an increased risk of pseudotumor cerebri or idiopathic intracranial hypertension just by using the popular medical products.
The symptoms of pseudotumor cerebri or idiopathic intracranial hypertension can be devastating, and women using hormonal birth control who suffer from the neurological disorder may experience a throbbing headache, nausea, vomiting, vision problems, blindness and other serious complications from the condition. For women who used Mirena IUD or another levonorgestrel-based birth control device, and have since been diagnosed with PTC or IIH, compensation may be available to cover the cost of medical bills, emotional trauma, loss of income due to the inability to work, and the need for ongoing care. With more and more studies and FDA adverse event reports tying birth control devices like Mirena IUD to a risk of pseudotumor cerebri, it is important to know your rights. Contact a knowledgeable product liability lawyer today to discuss your compensation options.
In an effort to reduce the incidence of pseudotumor cerebri among users of Mirena IUD and other pharmaceutical drugs or medical devices, the FDA has issued numerous warnings regarding the potential for certain products to increase the risk of intracranial pressure and PTC. Although the FDA has yet to issue an official warning about the potential for Mirena IUD to cause brain injuries in users, the agency has included warnings of idiopathic intracranial hypertension risks on the labels of other levonorgestrel-containing birth control implants, including Norplant, another hormonal contraceptive device used to prevent pregnancy in women.
Hormonal birth control drugs and devices aren’t the only products that have been linked to a risk of pseudotumor cerebri though. In October 2011, the FDA updated the warning label for the antibiotic drug Cipro (ciprofloxacin) to include a risk of central nervous system effects or disorders, including increased intracranial pressure or pseudotumor cerebri. Earlier that same year, the FDA had notified consumers and doctors about new safety information identified by the agency’s Adverse Event Reporting System, including a potential risk of PTC from other fluoroquinolone antibiotics, like Levaquin (levofloxacin) and Avelox (moxifloxacin).
As a result of mounting research linking pseudotumor cerebri and hormonal birth control products like Mirena IUD, Yaz and Yasmin, a growing number birth control lawsuits have been brought against Pfizer, Bayer, and other manufacturing companies on behalf of women who allege that the drug makers failed to provide adequate warnings to consumers and the medical community about the potential for their products to cause serious neurological injury. As a result of the expanding Mirena PTC litigation, a panel of federal judges was petitioned to centralize the litigation in May 2014, but the judges denied the petition saying there weren’t enough cases. Since then, the number of pseudotumor cerebri cases brought against the makers of birth control products has only grown.
Lawsuits brought against the makers of levonorgestrel-containing birth control products like Mirena IUD allege that the manufacturing companies made and sold a defective product, failed to adequately research the safety and effectiveness of their product, downplayed the risk of serious side effects associated with their birth control product, and failed to provide adequate warnings to consumers and the medical community about the potential for their product to cause pseudotumor cerebri and other devastating complications in users. The makers of such birth control products are accused of negligence, fraud and failure to warn.
In September 2015, a Florida woman brought a pseudotumor cerebri lawsuit against Bayer Healthcare, alleging that the company’s Mirena IUD birth control caused her to suffer severe migraine headaches, vision problems, cognitive problems and memory loss indicative of idiopathic intracranial hypertension. A number of other product liability lawsuits have been brought against the makers of hormonal birth control, like Mirena IUD, on behalf of consumers across the country who have been diagnosed with pseudotumor cerebri, idiopathic intracranial hypertension or another severe neurological condition.
As more information comes to light about the potential connection between certain levonorgestrel-containing birth control products, like Mirena IUD, and neurological problems indicative of pseudotumor cerebri or idiopathic intracranial hypertension, product liability lawyers are investigating injury claims filed on behalf of women across the country, who believe they have been harmed by side effects of their birth control. If you have been diagnosed with pseudotumor cerebri, and you believe Mirena IUD or another birth control product to be the cause, contact an experienced product liability lawyer today for legal help. You may have grounds to file an injury lawsuit against the company responsible for manufacturing the birth control drug or device, in order to pursue the financial compensation you deserve for your injuries, medical bills, and pain and suffering.