Plaintiff Shahira O., a Los Angeles County resident, has filed a Mirena pseudotumor cerebri lawsuit against Bayer Healthcare Pharmaceuticals, Inc., for personal injuries resulting from having been inserted with the levonorgestrel intrauterine system, also known as Mirena.

Levonorgestral is a female hormone designed to prevent pregnancy. It is thought that the hormone causes changes in the uterine lining and cervical mucus in a female. By doing so, it makes it more difficult for sperm to reach an egg and for fertilization to occur.

Mirena is a plastic device that contains the hormone levonorgestrel. The plastic device is inserted into the uterus and it slowly releases the hormone for up to 5 years.

According to the lawsuit, there are several adverse health effects, however, that may result from using a Mirena IUD.

Some reports indicate that adverse health effects include severe cramps or pelvic pain, extreme dizziness, jaundice, mood changes, breakthrough bleeding, weight gain, puffiness in face, hands, or ankles and feet and mood changes, including loss of interest in sex.

The lawsuit further purports, however, that the Mirena label had not adequately warned about non-stroke neurological conditions such as Mirena pseudotumor cerebri, or PTC.

Pseudotumor cerebri, or PTC, is also known as idiopathic intracranial hypertension, or IIH. The condition occurs when pressure inside the skull increases for no obvious reason, but the lawsuit indicates that Mirena may have caused the development of Mirena pseudotumor cerebri.

The symptoms of the development of Mirena pseudotumor cerebri include signs such as blurred vision, nausea, vomiting, or dizziness, difficulty seeing to the side, brief episodes of blindness and moderate to severe headaches.

According to the Mirena pseudotumor cerebri lawsuit, “Mirena label makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH.”

The plaintiff also maintains that, “upon information and belief, defendants did no clinical testing of Mirena and its known link to the development of IIH/PTC, despite over a decade of literature indicating further testing regarding levonorgestrel and IIH/PTC is needed.”

The Mirena pseudotumor cerebri lawsuit iterates that the failure to diagnose PTC or IIH may lead to blindness or permanent vision loss.

Additionally, “there is currently no treatment to reverse permanent injury to the optic nerves caused by increased intracranial pressure. Because of this, treatment of PTC or IIH is focused on halting visual loss that has already occurred.

Plaintiff Shahira O., a 24-year-old, alleges that she developed PTC/IIH after use of Mirena. She claims that she had the product inserted in August 2016 and that with the insertion of the device, she suffered no immediate complication.

However, roughly around October 2016, she was diagnosed with Mirena pseudotumor cerebri, as she had been suffering and experiencing intense headaches, blurred vision, dizziness, and double vision.

The Mirena pseudotumor cerebri lawsuit alleges that “plaintiff’s IIH/PTC was caused and/or triggered by her Mirena, and/or her Mirena contributed to plaintiff’s development of IIH/PTC.” She later had the Mirena IUD removed in October 2016.

The Mirena pseudotumor cerebri lawsuit states, “As a result of the injuries she suffered as a result of the defective and unreasonable dangerous Mirena IUD, she has been permanently injured and has incurred or will incur past and future medical expenses, has experience or will experience past and future pain and suffering, has incurred or will incur lost wages, and is subject to an increased risk of future harm.”

The Mirena Pseudotumore Cerebri Lawsuit is Case No. 1:17-cv-04918, in the U.S. District Court for the Southern District of New York.