Mirena Lawsuit – Idiopathic Intracranial Hypertension
Mirena is an intrauterine device (IUD) for women that has been linked to causing Idiopathic Intracranial Hypertension (also known as, pseudotumor cerebri), a devastating neurological disorder that can lead to irreversible vision impairment and even brain damage.
What is an IUD?
An IUD is a form of birth control many women use because of its convenience and reliability in preventing pregnancy. It is a small, flexible device shaped like a T which is implanted in the uterus. IUD’s are known as the most effective birth control methods on the market. They are considered a long-term solution because they can be left in the uterus for up to five years.
An IUD is a readily removable device should a woman pursue pregnancy after having it in. However, the reliability of this method of birth control might not outweigh the chance of severe complications.
Mirena Side Effects
A Mirena IUD has been known to migrate or perforate once inserted, which causes severe pain and sometimes requires surgery. Thousands of women across the country have filed lawsuits against Bayer HealthCare Pharmaceuticals for experiencing the debilitating side effects of Mirena. But among the most controversial side effects are neurological complications caused by the IUD, leaving women who only wanted a safe form of birth control in devastating conditions.
What is Mirena Idiopathic Intracranial Hypertension?
Among the side effects caused by Mirena is Idiopathic Intracranial Hypertension also known as “IIH” which mimics the symptoms of a brain tumor. IIH is characterized by a severe buildup of pressure on the brain and in its most severe form, can cause brain damage. Studies have shown the hormonal medication contained in the Mirena IUD, levonorgestrel, has been linked to causing Idiopathic Intracranial Hypertension.
Warning signs and symptoms of IIH:
- Vision impairment
- Blurred vision
- Tinnitus (ringing of the ears)
- Nausea or vomiting
It is important you reach out to your physician if any of the above symptoms occurred following the implantation of the Mirena IUD. The risk of developing IIH or PTC is nonexistent on the warning label for Mirena. Lawyers handling Mirena lawsuits have accused Bayer of concealing this information from consumers which put women at risk of side effects they didn’t know were a possibility.
In late 2016, plaintiff Kristy Collins filed a Mirena lawsuit against Bayer for experiencing Idiopathic Intracranial Hypertension from her Mirena implant. In the court documents, she claims she had the device removed in 2011 but less than three years later was diagnosed with Idiopathic Intracranial Hypertension. She fears the damage to her optic nerves associated with Idiopathic Intracranial Hypertension is most likely irreversible. She received three lumbar punctures to relieve the pressure on her brain, but the likelihood of reversing her complications are near impossible.
Collins attributes her Idiopathic Intracranial Hypertension diagnosis in direct correlation to the Mirena device she previously had implanted. Nowhere on the product label, dispensing information or guidance booklet did it mention a possible link between Idiopathic Intracranial Hypertension and Mirena, though Bayer is alleged to have known about this and kept it under wraps from the consumer market.
Manufactured by Bayer HealthCare Pharmaceuticals, Mirena was approved by the U.S. Food and Drug Administration in 2000 but has since received nearly 70,000 injury reports by women. Even in 2009, the FDA warned Bayer about their marketing methods, citing they were misleading to the public about the efficacy of Mirena.
Mirena lawsuits allege that Bayer:
- Knowingly designed, produced and sold a defective product
- Failed to research or warn the public about dangerous side effects
- Concealed the dangerous side effects
- Engaged in false and misleading marketing
- Misrepresented the benefits of the device
- Breached implied and expressed warranty
- Failed to issue a recall once information came to light about the complications
Various Mirena lawsuits across the country all have one thing in common: they all indicate that Bayer failed to provide adequate warnings about the potential for (i) Idiopathic Intracranial Hypertension and (ii) pseudotumor cerebri complications from Mirena.