A Mirena side effects lawsuit has been filed within the recently-formed Mirena multidistrict litigation (MDL) that is currently in progress against Bayer. The MDL was established in April 2017; currently there are 190 cases that have been consolidated in New York federal court.

Plaintiff Chavon P., a New York resident, filed her Mirena side effects lawsuit against Bayer Healthcare Pharmaceuticals, Inc. and its related companies after suffering personal injury from the birth control device. Mirena is an intrauterine system, also known as an IUD, that is inserted by a woman’s physician during a regular visit.

The Mirena IUD contains a steroid reservoir that holds a total of 52 mg of levonorgestrel (LNG), which releases into the body at the rate of 20 µg per day. Levonorgestrel is a prescription medication used as a contraceptive. The hormone is suggested to thin the lining of the uterus and thicken cervical mucus as well as to inhibit the movement of sperm and reduce its survival in order to prevent a woman from becoming pregnant.

Implanted into the woman within seven days of the first day of her menstrual cycle, the Mirena IUD can remain there for up to five years. If a woman desires Mirena IUD contraception past five years, the old device is removed and a new one is inserted. It is recommended to be used in women who have had at least one child and can be inserted once a woman passes at least six weeks post-partum.

The labeling of Mirena indicates that the device should be considered for removal if patients develop “Migraine, focal migraines with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia,” the Mirena side effects lawsuit states. Transient cerebral ischemia causes the disruption of blood flow in the brain and is often described as a “mini-stroke.”

However, the Mirena side effects lawsuit states, “Mirena’s label does not sufficiently warn about non-stroke neurological conditions such as pseudotumor cerebri (“PTC”), also known as idiopathic intracranial hypertension (“IIH”).”

With pseudotumor cerebri, the cerebrospinal fluid levels become elevated in the skull which causes increased pressure. The additional fluid is not released and absorbed properly, causing fluid to build up in the skull. This can cause severe migraines to develop, along with double vision, blurry vision, blind spots, transient blindness or other visual issues. Ringing in the ears, or tinnitus, is also common.

The term pseudotumor refers to the fact that the condition behaves like a brain tumor, though no tumor is actually present. The condition is typically diagnosed after a spinal tap or lumbar puncture is performed. Imaging of the brain is also conducted to rule out an actual tumor, blood clot or other issues.

For some patients, pseudotumor cerebri is irreversible; for others, it can be reversed but may take years before optimal pressure is maintained. There is also a possibility that it may recur throughout a patient’s life. Treatment for the condition includes weight loss, frequent lumbar punctures and/or medication. A shunt may also be placed to relocate excess cerebrospinal fluid.

The Mirena side effects lawsuit states that the patient information booklet for the product “misleads consumers, and misled Plaintiff, into the belief that serum levels of LNG are always extremely low, and that Mirena causes little to no systemic or hormonal side effects.” However, women with PTC have been affected by LNG’s action in raising hormones that result in increased intracranial pressure.

Chavon had her device implanted in March 2014 and began experiencing severe headaches, vision problems, including blurry vision, transient visual obscurations, tinnitus, nausea and/or dizziness. She sought treatment and had an MRI completed which indicated normal results. Her symptoms persisted and she had another MRI along with a lumbar puncture and she was ultimately diagnosed with pseudotumor cerebri.

Chavon has brought forth a number of counts in her Mirena side effects lawsuit against the manufacturer including negligence, design defect, failure to warn, strict liability, breach of implied warranty, breach of express warranty, negligent misrepresentation, fraudulent misrepresentation and fraud by suppression and concealment.

The plaintiff is seeking a jury trial in order to be awarded compensatory and punitive damages, attorneys’ fees and costs and any additional relief deemed just and proper by the Court.

The Mirena Side Effects Lawsuit is Case No. 1:17-cv-05335, and is part of the Mirena MDL, In re: Mirena IUS Levonorgestrel-related Products Liability Litigation (No. II), MDL No. 2767, in the U.S. District Court for the Southern District of New York.