A 26-year-old woman has filed a Mirena side effects lawsuit against Bayer.

Mirena is an intrauterine device (IUD) that is inserted into the uterus for birth control. Mirena releases a synthetic progestin hormone known as levonorgestrel (LNG) for up to five years.

Plaintiff Aida L. says she received the Mirena birth control implant in May 2015. Within two months, she alleges she began suffering severe headaches, dizziness, vision changes, nausea, cognitive issues and eye pressure.

An MRI done in July 2015 did not show any intracranial abnormalities. But in December 2015, she alleges a diagnostic lumbar puncture proved she had increased intracranial pressure, which measured 33 mmHg. Normal intracranial pressure is between 5 and 15 mmHg.

The pressure was caused by a buildup of cerebrospinal fluid, a condition known as pseudotumor cerebri (PTC) or idiopathic intracranial hypertension, she says.

According to the Mirena side effects lawsuit, “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.”

PTC or IIH is irreversible in some patients. In other patients, years can pass before normal intracranial pressure is maintained.

In mid-January 2016, Aida says she had the Mirena birth control device removed by her doctor.

Mirena Side Effects Lawsuit Alleges Negligence

According to the Mirena side effects lawsuit, more than 2 million women in the United States use Mirena, and more than 15 million women worldwide have received the IUD.

Mirena releases the synthetic progestogen levonorgestrel (LNG) directly into the uterus.

“The synthetic hormone released by Mirena, levonorgestrel, causes or contributes to the development of PTC/IIH, increases the risk of developing PTC/IIH, and/or worsens or exacerbates PTC/IIH,” alleges the Mirena side effects lawsuit.

Bayer knew or should have been aware that Mirena “causes and/or contributes to the development of IIH/PTC, a severe and possibly irreversible brain condition.”

Among the allegations against Bayer are that the company failed to properly test Mirena before introducing it to the consumer market; failed to completely analyze the data it did have from premarket testing; and failed to provide sufficient post-market testing and follow-up of Mirena.

“Despite an increasing number of adverse events, including reports of intracranial hypertension, blindness, papilledema, and increased intracranial pressure, Defendants have made no effort to warn physicians, the healthcare community, or patients of the risk of developing IIH/PTC with Mirena,” laments the Mirena side effects lawsuit.

Bayer has pitched Mirena’s “Simple Style” program as an easy birth control choice for “busy moms” and advertised the product as increasing levels of intimacy, romance and emotional satisfaction between romantic partners.

The Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) said such claims were unsubstantiated and pointed to Mirena’s own package insert that indicates at least five percent of patients in clinical trials experienced a decreased libido after implantation.

The DDMAC also took issue with Mirena’s claims that women would “look and feel great” because many women experience weight gain, acne, and breast pain and tenderness.

“The portion of the Simple Style script regarding risks omitted information about serious conditions, including susceptibility to infections and the possibility of miscarriage if a woman becomes pregnant on Mirena,” says the Mirena side effects lawsuit.

If you or someone you love has been injured by Mirena side effects, you could benefit by seeking legal representation.

The Mirena Side Effects Lawsuit is Case No. 1:17-cv-06935-UA in the U.S. District Court, Southern District of New York.