Sunshine Coast Mum Almost Killed by Botched Contraceptive Operation, News.com.au - April 2018: click here to read the full article.
Have you or a loved one used the Mirena IUD and been diagnosed with Pseudotumor Cerebri? You or your family may qualify for compensation. Click the button to the right to learn more and get in touch with our attorneys today.
Mirena IUD Linked to Pseudotumor Cerebri
PTC was linked to birth control as far back as 1995, when the New England Journal of Medicine published a study suggesting that the serious neurological condition may be caused by the use of birth control pills and contraceptive implants containing the synthetic hormone levonorgestrel, like Bayer’s Mirena intrauterine device. The researchers involved in the study highlighted 56 cases where Pseudotumor Cerebri complications occurred in women implanted with the IUD "Norplant", a levonorgestrel-releasing implant that is no longer on the market. More recently, findings presented at the 2015 meeting for the Association for Research in Vision and Ophthalmology suggested that “exposure to a [levonorgestrel-releasing intrauterine system] was significantly associated with the development of [idiopathic intracranial hypertension],” and that the use of Mirena IUD is “disproportionately more common among IIH patients than non-IIH patients.”
The Mirena intrauterine device (IUD) itself has been linked to development of pseudotumor Cerebri (PTC). But despite this growing body of research, many women across the country have no idea that their birth control pill or implant may put them at risk for Pseudotumor Cerebri and other devastating side effects, and this is due in large part to the fact that Bayer and other manufacturing companies have downplayed or concealed these risks from consumers, in an effort to protect their product and their reputation. In the meantime, pseudotumor Cerebri or idiopathic intracranial hypertension allegedly linked to birth control products like Mirena IUD, Yaz, and Yasmin have led to product liability lawsuits brought against the drug and device manufacturing companies, due to the fact that these risks were never disclosed to the public.
Lawsuits Over IUD Side Effects
The Mirena MDL regarding device perforation and injury was wiped out by a judge in 2016, but litigation regarding the IUD’s link to Pseudotumor Cerebri is currently ongoing and an MDL for these cases was achieved in early 2017.
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.
What is Mirena?
Mirena is a type of long-lasting, reversible birth control known as a hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. It is a small, T-shaped device, also known as an IUD, or intrauterine device that is placed into the uterus. The Mirena intrauterine device (IUD) contains levonorgestrel, a female hormone that can cause changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Mirena contains 52 mg of levonorgestrel (LNG). Initially, LNG is released at a dose rate of approximately 20 mcg/day. This rate decreases progressively to half that value after 5 years. Meanwhile the levonorgestrel intrauterine device may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. If the device embeds in or perforates the uterine wall, your doctor may need to surgically remove the device. This product has also been linked to numerous other side effects, including the painful occurrence of Pseudotumor Cerebri or idiopathic intracranial hypertension.
What is Pseudotumor Cerebri?
The term Pseudotumor Cerebri is also known as a “false brain tumor,” and the term describes a severe neurological condition characterized by symptoms that mimic those of a brain tumor when no actual tumor is present. Pseudotumor Cerebri is also called benign intracranial hypertension (BIH) or, when there is no apparent cause of the condition, idiopathic intracranial hypertension (IIH), and the neurological condition occurs when the pressure inside the skull increases for no obvious reason. PTC can occur in all age groups, including adults and children, but is most common in obese women of childbearing age.
The fact that women of childbearing age appear to be more susceptible to pseudotumor Cerebri side effects is alarming, considering this is the target population for hormonal oral contraceptives and birth control implants like Mirena IUD. Research has also shown that the use of hormonal birth control implants like Mirena IUD is disproportionately more common in patients diagnosed with Pseudotumor Cerebri or idiopathic intracranial hypertension.
Possible Causes of PTC
While the causes of Pseudotumor Cerebri, or idiopathic intracranial hypertension, are not well understood, it is believed that the increased cranial pressure characteristic of the neurological disorder may be related to the buildup or poor absorption of cerebrospinal fluid. According to a growing body of research, certain medications can increase the risk of developing this condition, with birth control being one of the most common, particularly oral contraceptives and birth control implants that contain the synthetic hormone levonorgestrel (the hormone contained in the Mirena IUD, in addition to numerous other forms of birth control).