A woman has filed a Mirena IUD neurological side effects lawsuit against Bayer Healthcare because she says the birth control device severely injured her.

Mirena is an intrauterine birth control system that releases levonorgesterel (LNG), a prescription synthetic progestin hormone, for up to five years after implantation.

Plaintiff Sierra M., now 30, said she had her first Mirena IUD from July 2008 through November 2010.  She claimed she had a new Mirena implanted in December 2011.

In April 2015, Sierra said she was diagnosed with papilledema, which means increased pressure in or around the brain, causing the part of the optic nerve inside the eye to swell. Symptoms include vision disturbances, headache and vomiting.

Sierra said she underwent a lumbar puncture in April 2016. She allegedly was diagnosed with pseudotumor cerebri or intracranial hypertension.

According to the Mirena IUD neurological side effects lawsuit, Sierra had the birth control device removed in October 2017, but allegedly has been permanently injured by Mirena IUD neurological side effects.

Mirena IUD Neurological Side Effects Allegations

According to Sierra’s lawsuit, Mirena’s label fails to identify factors that could influence metabolic clearance rates of the LNG hormone, including prescription and over-the-counter medicines.

LNG also was used in the Norplant birth control system, which consisted of six silicone capsules that contained LNG. These capsules were inserted subdermally in the upper arm as a five-year birth control option.

The New England Journal of Medicine reported in 1995 that several womens’ development of pseudotumor cerebri or intracranial hypertension could be linked to the LNG from their Norplant birth control system. By 2001, Norplant’s warning label included a section regarding intracranial hypertension.

Mirena IUD neurological side effects can allegedly be similar to those of Norplant, but Sierra’s lawsuit accuses Bayer of “overstating the efficacy of Mirena while understating the potential safety concerns.”

Bayer allegedly implemented a consumer-directed marketing venture called “Mirena Simple Style Statements Program” that included a live presentation designed for “busy moms.”

Sierra’s lawsuit says “Simple Style” promoted Mirena as a product that would enhance intimacy, romance and emotional satisfaction between the Mirena user and her sexual partner. Simple Style allegedly told patients they would “look and feel great.”

The Mirena IUD neurological side effects lawsuit says that in December 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) contacted Bayer regarding the Simple Style program. The DDMAC allegedly said Mirena’s “claims were unsubstantiated and, in fact, pointed out that Mirena’s package insert states that at least 5% of clinical trial patients reported a decreased libido after use.”

The Simple Style script allegedly never mentioned the possibility of Mirena IUD neurological side effects or other serious side effects, according to Sierra’s claim.

The Mirena IUD Neurological Side Effects Lawsuit is Case No. 1:18-cv-02885-PAE-JLC in the U.S. District Court for the Southern District of New York.