Pseudotumor Cerebri Lawsuit Filed Over Side Effects of Mirena IUD Birth Control

Bayer Healthcare faces a new product liability lawsuit brought by a woman who alleges that side effects of the Mirena IUD caused her to suffer a dangerous buildup of pressure on the brain, known as pseudotumor cerebri. 

The complaint (PDF) was filed by 31 year old Jennifer Santiago in the U.S. District Court for the District of New Jersey on March 24, indicating that she experienced blackouts, severe headaches and vision loss as a result of brain fluid pressure caused by the popular birth control implant.

Santiago received the intrauterine device (IUD) in April 2007, without complication. However, a few years later she began to experience pseudotumor cerebri problems from Mirena, which causes cerebrospinal fluid levels to become elevated and increase pressure in the skull. She experienced symptoms similar to a tumor, with blackout episodes, severe headaches, and loss of peripheral vision.

After experiencing the symptoms, Santiago had the Mirena IUD removed and she was eventually diagnosed with pseudotumor cerebri (PTC); which is also known as idiopathic intracranial hypertension (IIH).

As a result of Bayer’s alleged failure to adequately warn about the link between Mirena and pseudotumor cerebri, Santiago indicates that most doctors remain unaware that the birth control implant may be a potential cause of migraines, vision problems or a buildup of pressure around the brain.

Santiago’s complaint is one of a growing number of Mirena pseudotumor cerebri lawsuits filed against Bayer by women who say the company failed to provide adequate warnings of health risks.

“Defendants did not disclose an unreasonably dangerous condition regarding its Mirena, namely, that hormones in Mirena can cause or substantially contribute to the development of papilledema and/or IIH/PTC,” the lawsuit states. “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.”

Mirena is an increasingly popular form of long-acting birth control, allowing women to avoid pregnancy for up to five years without needing to remember to take a daily pill. However, a number of women have reported experiencing a number of different complications from Mirena.

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

In several other places around the world, including South Africa and Hong Kong, Mirena warning labels include information about the risk that papilledema as a possible side effect of Mirena. However, Bayer has not given women in America or the U.S. medical community the same warning.

Amid a growing number of Mirena pseudotumor cerebri cases brought throughout the federal court system, 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 Santiago’s claim and others filed by other women are proceeding without coordinated pretrial proceedings.

There is a separate multidistrict litigation (MDL) established for Mirena migration injury lawsuits, which currently includes about 4,000 complaints pending before U.S. District Judge Cathy Seibel in the Southern District of New York, where a small group of “bellwether” cases are being prepared for early trial dates.