Mirena IUD – Birth Control Device
Note: The Relion Group attorneys are not currently taking cases on this lawsuit.
Did you suffer severe headaches after having the Mirena IUD birth control device implanted?
The Mirena IUD and other birth control options have been linked to an abnormal elevation of cerebrospinal fluid in the skull, resulting in a neurological condition known as pseudotumor cerebri or idiopathic intracranial hypertension. This medical condition increases pressure in the skull, mimicking symptoms of a brain tumor.
Bayer is facing over 100 lawsuits for allegedly downplaying the link between Mirena and neurological side effects, including pseudotumor cerebri (PTC). This serious condition can cause permanent brain damage, vision loss, or blindness.
What is a Mirena IUD?
Mirena is an intrauterine device (IUD) designed to prevent pregnancy. A small “T” shaped device is implanted into the uterus and can last up to five years, with the suggested flexibility of removal at any desired time.
An estimated 2 million American women have a Mirena, a T-shaped intrauterine device (IUD) that contains the hormone levonorgestrel, a type of progestin, which is released over time.
The device can remain in the body providing birth control for up to five years. Like other IUDs, Mirena claims to be over 99 percent effective at preventing pregnancy. Levonorgestrel is also taken orally in emergency contraception to prevent pregnancy after unprotected sexual intercourse.
IUDs with levonorgestrel work mainly by making it difficult for sperm to fertilize an egg. Mirena slowly releases 20 mcg of the synthetic hormone into the uterus each day. Birth control pills, in comparison, typically release 150 mcg into the body daily.
Levonorgestrel has a long history of use in many approved hormonal products in the US. These uses include both contraception and menopausal therapy.
FDA warning for Mirena
In 2009, the FDA sent Bayer two warnings about Mirena, including a warning that their television commercials were misleading and a warning that their internet advertisements were misleading.
As of June 2017, nearly two-hundred lawsuits have been filed alleging Mirena caused their intracranial hypertension. These cases are different from the perforation and migration cases that have been filed over the past few years.
The settlement amounts themselves would be confidential and determined by a number of factors, including the court’s ruling and the strength of the evidence, such as expert witness testimony.
In April 2017, the journal Neuro-Ophthalmology published “An Estimation of the Risk of Pseudotumor Cerebri among Users of the Levonorgestrel Intrauterine Device.” This study reviewed extensive medical records from databases and found that Mirena users were over seven times more likely to develop pseudotumor cerebri. This study is by far the largest and most thorough analysis of the risk of intracranial hypertension among Mirena users, and is compelling evidence of an association between the IUD and brain injuries.
What Is Idiopathic Intracranial Hypertension / Pseudotumor Cerebri?
When a person has symptoms of a brain tumor, but no actual tumor, doctors refer to it as idiopathic intracranial hypertension (IIH). Idiopathic means “a disease that arises spontaneously or with no known cause,” intracranial means “within the skull,” and hypertension means “high blood pressure.” Doctors sometimes call it pseudotumor cerebri (PTC). Pseudotumor means “false growth” and cerebri means “of the skull.”
Symptoms of Pseudotumor Cerebri
Here are the most common symptoms of Pseudotumor Cerebri (PTC) and Idiopathic Intracranial Hypertension (IIH):
- Neck, shoulder, or back pain
- Blurry vision
- Buzzing or ringing sound in the ears (tinnitus)
- Double vision
- Nausea, vomiting
- Vision loss
The most common symptoms include visual loss, brief instances of blindness, a ringing of the ears with the beating of the heart, and a headache that begins behind the eyes. Many times, these eye problems are caused by papilledema, a swelling in the optic disc caused by increased blood pressure in the skull.
Unfortunately, many of these symptoms can become permanent, even after the drug or hormone that caused the condition is removed.
Most of the pending U.S. federal cases have been consolidated in a multidistrict litigation proceeding for common pre-trial management in New York.
These do not include approximately 1,230 cases that were dismissed in July 2016 by a judge who excluded the plaintiffs’ expert witnesses, whom the judge said were not qualified to testify that Mirena could cause secondary perforation.
Many of the cases pending in state court are consolidated in multicounty litigation in New Jersey.
As of January 23, 2017, five Canadian lawsuits relating to Mirena seeking class action certification had been served upon Bayer.
Bayer says it intends to defend itself vigorously.
Mirena® is registered trademark of Bayer.