Mirena IUD Headaches, Blurred Vision Caused by Pseudotumor Cerebri, Lawsuit Alleges

According to allegations raised in a recently filed product liability lawsuit, a Mirena IUD implanted for long-term birth control caused a Texas woman to suffer severe headaches, blurred vision and other problems associated with side effects of pseudotumor cerebri. 

The complaint (PDF) was filed by Amanda Massie in the U.S. District Court for the District of New Jersey on August 9, alleging that Bayer Healthcare failed to adequately warn women and the medical community about the risk that the birth control IUD implanted in the uterus may cause a dangerous build up of fluid pressure around the brain.

Massie, 39, indicates that she originally received the Mirena IUD implant in 2007, which is designed to provide protection against pregnancy for up to five years. In 2013, she had the Mirena IUD removed and replaced. About a year after the second device was placed, she indicates that she began to suffer intense headaches, migraines and blurred vision, which was subsequently diagnosed as idiopathic intracranial hypertension (IIH), more commonly known as pseudotumor cerebri (PTC).

Mirena IUD is a T-shaped plastic implant placed into the uterus, releasing the progestin levonorgestrel to prevent pregnancy. Exposure to levenorgestrel has been linked to problems with pseudotumor cerebri in other birth control products, but no warnings were provided about the potential risk with Mirena, or the importance for monitoring for signs of sudden headaches, vision problems or other signs of the dangerous build up of fluid around the brain.

Pseudotumor cerebri from Mirena can cause ringing in the ears, damage to the optic nerve and other health problems. The issue is often addressed via a lumbar puncture to lower fluid pressure or through the use of a brain shunt. However, even after the pressure is relieved, women may be left with permanent vision problems and headaches associated with damage to the optic nerve.

Growing Mirena Pseudotumor Cerebri Lawsuits

The case filed by Massie is one of a growing number of similar Mirena pseudotumor cerebri lawsuits filed in recent months, each allege that Bayer knew about the risk, yet withheld important safety warnings from women and doctors in the United States.

“Since December 6, 2000, key opinion leaders and sales representatives have misrepresented Mirena as a low or no hormone contraceptive with few or no systemic effects, and a lower hormone option than other hormonal contraceptives, consistent with Mirena’s labeling,” the lawsuit states.

In several other countries, including South Africa and Hong Kong, warning information provided with the Mirena IUD indicate that papilledema is a possible side effect. However, Bayer has not given women in America or the U.S. medical community the same information.

Lawsuits allege that this prevented users and doctors from promptly recognizing the symptoms of PTC, which may have allowed women to avoid long-term optic nerve damage.

Amid a growing number of Mirena pseudotumor cerebri cases brought throughout the federal court system against Bayer, a request was filed last year with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the cases before one judge. However, that request was rejected, so Pavelka’s claim and others filed by other women nationwide are proceeding without coordinated pretrial proceedings.

In addition to problems with pseudotumor cererbri, Mirena IUDs have also been linked to reports of the IUD perforating the uterus or moving out of position, causing severe internal injuries for many women.