Bayer is facing hundreds of lawsuits alleging that Mirena, a popular contraceptive, contains hormones that can potentially cause pseudotumor cerebri (PTC) and other severe neurological side effects. Bayer is accused of downplaying information about this serious side effect.
Hundreds of Mirena Pseudotumor Cerebri Lawsuits
In 2014, a group of plaintiffs has asked federal judges to establish a Multi-District Litigation (MDL) to centralize 9 lawsuits involving pseudotumor cerebri (PTC) and/or idiopathic intracranial hypertension (IIH) linked to Mirena. In 2017, a federal judge approved a MDL for more than 100 women who suffered PTC after using Mirena. The Mirena MDL is overseen by U.S. District Judge Paul A. Engelmayer in the U.S. District Court for the Southern District of New York.
Mirena and Pseudotumor Cerebri
Mirena is a T-shaped intrauterine device (IUD) that prevents pregnancy by slowly releasing the hormone levonorgestrel. The Prescribing Information for Mirena does not include warnings about neurological side effects, such as PTC. However, the use of levonorgestrel is contraindicated in patients who have a history of PTC/IIH. Due to Bayer’s failure to warn about this severe side effect, women who were injured have filed lawsuits against the drug-maker.
What is Pseudotumor Cerebri?
Pseudotumor cerebri (PTC) is a serious medical condition that occurs when pressure inside your skull increases. This puts pressure on your brain, similar to the effects of a brain tumor. It is also known as idiopathic intracranial hypertension. PTC can also put pressure on the optic nerve, which can cause vision loss.
Experts believe PTC is caused by an increased amount of cerebrospinal fluid. Treatment may involve medications that reduce the production of cerebrospinal fluid or surgery. Doctors may need to use a long, thin tube called a shunt to help drain away excess cerebrospinal fluid.
- Neck, shoulder, or back pain
- Blurry vision
- Buzzing or ringing sound in the ears (tinnitus)
- Double vision
- Nausea, vomiting
- Vision loss