Hundreds of pseudotumor cerebri lawsuits have been filed by women who used Mirena and developed migraine headaches, vision loss, blindness, and more. Bayer, the manufacturer of Mirena, is accused of failing to warn about the risk.
Mirena FDA Warning Label
The label on Mirena does not include warnings about severe neurological side effects, such as intracranial hypertension or pseudotumor cerebri. Mirena lawsuits accuse Bayer of failing to warn women and doctors about the risk of these devastating side effects. This may delay diagnosis until a woman has suffered permanent vision loss.
What is Mirena?
Mirena® is an intrauterine device (IUD) for birth control. It is inserted into a woman’s uterus by a healthcare professional during an office visit to prevent pregnancy for up to 5 years. Mirena is a T-shaped device that releases 20μg/day of levonorgestrel to act as a contraceptive. Mirena contains a total of 52 mg of levonorgestrel.
Who Makes Mirena?
Mirena was developed by Bayer Pharma AG and it is currently sold by Bayer Healthcare Pharmaceuticals Inc. in the United States. The FDA approved Mirena for sale in the U.S. in December 2000. In 2009, the FDA approved Mirena for the treatment of heavy menstrual bleeding. Over 2 million women in the U.S. currently use the Mirena IUD.
How Does Mirena Work?
Bayer admits that it “is not known exactly how Mirena works,” but studies suggest that the hormone levonorgestrel acts in several ways to reduce the odds of fertilization or the implantation of a fertilized egg. Mirena thickens the cervical mucous, thins the uterine lining, inhibits sperm movement, and reduces the chances that sperm will survive.
Does Mirena Cause Headaches?
About 10% of women who use the Mirena IUD experience headaches, and some experience debilitating migraines, according to clinical studies. Therefore, Mirena should be used with caution in patients who have a history of migraine headaches, focal migraines with vision loss, and other symptoms of transient cerebral ischema.
What Should I Do?
The label also recommends considering removing Mirena if patients develop migraine headaches or vision loss for the first time after getting Mirena. Unfortunately, the symptoms of transient cerebral ischemia are very similar to pseudotumor cerebri — and the longer this condition goes untreated, the higher the risk of permanent blindness.
What is Pseudotumor Cerebri?
Pseudotumor Cerebri is a condition that causes progressively higher pressure inside the skull when there is too much cerebrospinal fluid. The fluid builds up and is not released or absorbed properly, putting pressure on the brain — just like a growing brain tumor, but it is not actually a tumor.
Symptoms of Mirena Pseudotumor Cerebri
- Pain in the neck, shoulder or upper back
- Blindness or blind spots
- Vision loss
- Blurry vision
- Double vision
- Optic disc swelling (papilledema)
- Ringing in the ears, buzzing, or “whooshing” sound (tinnitus)
- Nausea, vomiting
How is Pseudotumor Cerebri Diagnosed?
Pseudotumor cerebri is frequently diagnosed with a lumbar puncture (“spinal tap”). The doctor will insert a needly into the spine and remove cerebrospinal fluid. Normal pressure is between 5 and 15 mmHg. Pressure above 15 mmHg may lead to a diagnosis of pseudotumor cerebri. The lumbar puncture may immediately relieve some symptoms — or it may cause excruciating back pain, headache, or bleeding.
What if Diagnosis is Delayed?
A growing number of pseudotumor cerebri lawsuits have been filed by women who suffered permanent vision loss or blindness as a result of delayed diagnosis. The problem is that many women suffer irreversible side effects of pseudotumor cerebri. Mirena lawsuits accuse Bayer of failing to warn about the risk. There is no treatment to reverse damage to the optic nerves caused by increased intracranial pressure.
Does Levonorgestrel Cause Pseudotumor Cerebri?
Levonorgestrel has been linked to pseudotumor cerebri for decades. In 1991, a levonorgestrel-releasing birth control implant called Norplant® became available in the U.S. In 1993, Wyeth Pharmaceuticals updated the label to warn about reports of women who developed intracranial hypertension and pseudotumor cerebri.
Mirena does not include similar warnings, although it is a very similar to Norplant. Unlike Bayer, Wyeth also recommended contacting a healthcare professional if you experience headaches or vision problems, and removing Norplant if these symptoms develop.
Study Links Levonorgestrel and Pseudotumor Cerebri
In 1995, the New England Journal of Medicine published several reports of women who developed pseudotumor cerebri after using Norplant. The authors concluded that levonorgestrel was likely what caused elevated intracranial pressure. They also recommended screening patients for pseudotumor cerebri and removing any levonorgestrel implants in patients who developed increased intracranial pressure.
Study: Mirena Linked to 78% Higher Rate of Intracranial Hypertension
In June 2015, a study published in Drug Safety linked Mirena with a 78% higher-than-expected number of reports of intracranial hypertension. Mirena was also linked to a 50% increased number of reports of papilledema (optic disc swelling) in the FDA Adverse Event Reporting System database from January 2004 to September 2013.
Women File 36,000+ Pseudotumor Cerebri Lawsuits
In the mid-1990s, over 36,000 women filed pseudotumor cerebri lawsuits for Norplant injuries. In response to poor sales, Wyeth pulled Norplant off the market in the U.S. in June 2002. Despite a huge amount of evidence linking levonorgestrel and pseudotumor cerebri, Mirena does not have any warnings on the Prescribing Information.
$50 Million Pseudotumor Cerebri Lawsuit Settlement
In August 1999, the parent company of Wyeth Pharmaceuticals paid a $50 million settlement to over 36,000 women who experienced pseudotumor cerebri, intracranial hypertension, headaches, irregular menstrual bleeding, nausea, depression, and other side effects from Norplant — or about $1,500 to every woman who filed a lawsuit.
Pseudotumor Cerebri Mirena Lawsuits
For consumers to collect big payouts in lawsuits, they must be able to prove that they suffered permanent side effects. In the case of Norplant, most of the side effects went away when it was removed. Doctors were also aware that they should consider removing Norplant when a women developed headaches or pseudotumor cerebri.
Doctors May Not Be Aware of the Risk
Mirena is different. Headaches are a common side effect of Mirena, experienced by up to 10% of women. Headaches are also the most common symptom of pseudotumor cerebri — and yet doctors are not being warned to check women for intracranial hypertension or pseudotumor cerebri. Mirena lawsuits have been filed by many women who were not diagnosed until they had permanent vision loss or blindness.
Can Mirena Cause Blindness?
Pseudotumor cerebri can cause papilledema, a condition that can lead to blindness. It occurs when increased intracranial pressure in the brain causes swelling in part of the optic nerve inside the eye. At first, papilledema may not cause any symptoms — but as pressure increases and the optic nerve becomes more damaged, patients experience headaches, nausea, blurry vision, double-vision, vision loss, and permanent blindness.
Can I File a Lawsuit?
Women who were diagnosed with pseudotumor cerebri while using Mirena should talk to a lawyer about filing a lawsuit against Bayer. As of January 2018, over 400 pseudotumor cerebri lawsuits nationwide have been centralized in the U.S. District Court for Southern New York under Judge Paul A. Engelmayer — In RE: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II) — Case MDL No. 2767.