Mirena – Much More Than A Headache
Bayer, a multibillion-dollar pharmaceutical company, and manufacturer of the Mirena intrauterine device (IUD), has a history of deceiving the public with regard to the safety of its products. In fact, in 2009, Bayer received two warnings from the FDA that its television and internet advertising involving its Mirena IUD was misleading.
Sadly, thousands of women have fallen victim to Bayer’s false and misleading advertising surrounding its medical devices, including Mirena. In April of 2017, approximately 50 cases filed against Bayer were centralized in a MultiDistrict Litigation or “MDL”, in the United States District Court, Southern District of New York. This particular MDL is a consolidation of all federally-filed cases involving women who were diagnosed with intracranial hypertension (“IH”) after having been implanted with the Mirena IUD. There are now over 600 Mirena cases pending in the MDL and the count continues to grow as more women learn that they were deceived by Bayer and that their injuries are actually the result of their Mirena IUD.
In case you are unfamiliar with the term, intracranial hypertension, it is usually a permanent medical condition where the body is unable to release and/or absorb cerebrospinal fluid (“CSF”) at the proper rate. Consequently, the level of CSF continues to rise, and with nowhere to go, the excess fluid starts to cause parts of the brain to shift into other compartments, compressing and squeezing the parts and nerves already within that space. This squeezing pressure can lead to horrific and debilitating symptoms, including but not limited to: severe migraines or migraine-like headaches with blurred vision; diplopia (double vision); temporary blindness; blind spots; a “whooshing” or ringing in the ear, also known as tinnitus; nausea; vomiting; and dizziness. But perhaps most alarming is when this shift within the brain causes the optic nerve to become pinched, also referred to as papilledema, which, if not treated quickly, can result in the permanent loss of vision.
There is currently no treatment to restore eyesight in patients having suffered vision loss caused by IH. Although IH is considered reversible in some patients, it may take years before normal pressure is maintained. In a vast majority of cases, IH is irreversible and those patients will suffer from recurring IH for the rest of their lives. Treatment of IH may include frequent lumbar punctures and/or medication. In severe cases of IH, therapeutic shunting, which involves surgical insertion of a tube to help drain cerebrospinal fluid from the skull or lower back, is recommended. Unfortunately, therapeutic shunting procedures have high failure and revision rates and often require several repeat or revision surgeries. A second type of surgery, a brain stent procedure, involves the insertion of metal stents, positioned to decompress portions of the veins within the brain that have become restricted due to the increased pressure.
The Mirena IUD is designed to slowly release the hormone, levonorgestrel, a synthetic form of progestin, to prevent pregnancy. However, the hormonal changes caused by levonorgestrel have also been linked to causing IH in women. Nevertheless, the label affixed by Bayer to the packaging of each Mirena IUD fails to warn prescribers of this risk. As a result, doctors are unable to make their patients fully aware of the risks and side effects associated with use of the device. Even more, because Bayer has failed to fully educate the medical community about these risks, doctors have not known to monitor their patients for IH symptoms, nor have they known to connect their patients’ IH symptoms with the use of the device, leaving many women to believe that there is no apparent cause for their injuries. While the Mirena labeling does warn of headaches, that warning is unequivocally insufficient as IH is clearly much more than a run of the mill headache.
The Yost Legal Group believes Bayer should be held accountable for its deceptive and misleading marketing practices. If you or a loved one has been diagnosed with intracranial hypertension after being implanted with the Mirena IUD, The Yost Legal Group may be able to help. Our team of experienced legal professionals is here to offer you free, individual consultation. We serve as the voice of our clients to hold Big Pharma accountable and obtain the justice each one so rightfully deserves. Call The Yost Legal Group (1-800-YOST-LAW) today. Let us be your voice.