Bayer Healthcare Pharmaceuticals Inc. faces a woman’s Mirena IUD side effects lawsuit alleging she suffered serious complications following the intrauterine system device’s implantation.

Plaintiff Quineisha J. filed the Mirena IUD side effects lawsuit in New York federal court joining growing multidistrict litigation (MDL) against the company. The Mirena IUD side effects lawsuit was filed on June 7, 2018.

According to the Mirena IUD side effects lawsuit, Quineisha is a resident and citizen of Okolona, Miss. She says that she had the Mirena IUD inserted on or about February 2009 without any complications. She says that prior to becoming inserted with the device she relied along with her healthcare provider on Bayer’s representations of the device and that the device was in fact safe and effective for use.

However, she  says she later became diagnosed with pseudotumor cerebri or intracranial hypertension on April 4, 2011. According to the Mirena IUD side effects lawsuit, Quineisha “has been permanently injured and has incurred or will incur past and future medical expenses, has experienced 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 IUD side effects lawsuit was filed on multiple counts 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.

Quineisha demands a trial by jury.

Overview: Mirena IUD Side Effects

Mirena was touted upon its introduction to the market as a device that eliminates the need for women to have to take birth control pills or to suffer from undergoing tubal ligation. The device was approved by the U.S. Food and Drug Administration (FDA) in December 2000 as a form of birth control.

Since then, however, thousands have complained of severe Mirena IUD side effects, and hundreds of women have filed lawsuits. Plaintiffs in these lawsuits call into question the effectiveness and safety of the device. Bayer is currently being accused of concealing the side effects and complications of the device that have ranged from severe pain to bleeding and perforation of the uterus.

In fact, the FDA has allegedly warned Bayer about its representations regarding the Mirena IUD. In April 2009, the agency challenged Bayer for allegedly failing to state that Mirena is primarily recommended for women who had at least one child. Bayer was also accused of failing to warn women that the device is not manufactured to be used indefinitely but that it should only be used for up to five years prior to replacement.

Since Mirena’s introduction, the FDA has received nearly 70,000 injury reports. Additionally, while most lawsuits filed against the company revolve around women suffering from adverse effects such as perforation and device migration, many women have suffered from a complication known as pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension.

The Mayo Clinic states that a pseudotumor cerebri occurs when there is intracranial pressure inside the skull. Symptoms mimic those of a brain tumor, but no tumor is actually present in the brain.

Symptoms of pseudotumor cerebri may include:

• Double vision
• Difficulty seeing to the side
• Blurred or dimmed vision
• Vomiting, dizziness, or nausea
• Ringing in the ears that “pulses in time with your heartbeat”
• Moderate to severe headaches
• Back, neck, and shoulder pain

The Mirena IUD Side Effects Lawsuit is Case No. 1:18-cv-05073, in the U.S. District Court for the Southern District of New York.