Bayer Healthcare Pharmaceuticals, Inc. faces a woman’s recent lawsuit alleging she suffered severe side effects of Mirena IUD after she became implanted with the intrauterine system.

Plaintiff Shari H. files the side effects of Mirena lawsuit in New York federal court joining a growing multidistrict litigation (MDL) against the company. The side effects of Mirena lawsuit was filed on Feb. 15, 2018.

According to the side effects of Mirena lawsuit, Shari, a resident and citizen of Harrisville, Utah, says that she was implanted with the Mirena IUD on or about 2006 at Ogden Clinic Women’s Center located in Ogden, Utah. She says that she relied on Bayer’s “Patient Information Booklet” that was provided to her when she decided to become implanted with the contraceptive device.

However, she says that once the device was implanted she began to experience a number of side effects. She says that she “began experiencing headaches, vision problems including blurry vision and ringing in the ears.”

It was in October 2009 when she says that she underwent a diagnostic lumbar puncture to test for increased intracranial pressure. It was then that she was diagnosed with intracranial hypertension.

According to the side effects of Mirena lawsuit, she says that she “has been permanently injured and has incurred and 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 side effects of Mirena 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. Shari also requests punitive damages and a trial by jury.

Overview: Side Effects of Mirena

Mirena is an intrauterine system that becomes inserted by a healthcare practitioner into a woman’s uterus and acts as a contraceptive device preventing pregnancy. It is a t-shaped polyethylene frame that holds and releases a synthetic progestogen known as levonorgestrel into a woman’s uterus.

The medication acts as a contraceptive, and once the device is in place it can remain there for five years. The device became approved by the U.S. Food and Drug Administration (FDA) in December 2000.

Today, there are more than 2 million women in the U.S. who use Mirena as a contraceptive device. Internationally, it has been used by more than 15 million women.

According to Bayer, however, they state that they are not exactly sure how Mirena works. What is believed to occur is that Mirena may “thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy,” the lawsuit explains.

Accusations against Bayer, however, allege them of falsely representing the safety and efficacy of Mirena. They state that the company failed to report and warn patients of severe conditions associated with Mirena, including the development of pseudotumor cerebri.

The Mayo Clinic defines pseudotumor cerebri as increased intracranial pressure located in the skull. Symptoms of the condition are a lot like that of a brain tumor, but no brain tumor is actually there. Symptoms of someone who has developed pseudotumor cerebri may include some of the following:

• 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 Side Effects of Mirena Lawsuit is Case No. 1:18-cv-04340-UA, in the U.S. District Court for the Southern District of New York.