Mirena Intracranial Hypertension Lawsuit Filed Over Failure to Warn About Side Effect

According to allegations raised in a new lawsuit over Mirena birth control, a Maryland woman alleges that the intrauterine device (IUD) caused her to suffer idiopathic intracranial hypertension; involving a dangerous buildup of fluid around the brain that causes severe headaches and vision problems. 

The complaint (PDF) was filed against Bayer by Daphne Houck on March 11, in the U.S. District Court for the District of New Jersey.

After a Mirena IUD was implanted for long-term birth control, Houck indicates that she sought began to experience “pressure headaches”, which were accompanied by vision loss, blurred vision and photophobia. After seeking treatment for these severe headaches and visual defects, Houck was diagnosed with papillary edema, which involves swelling of the optic nerves.

Doctors conducted an MRI and CT scan to rule out intracranial abnormalities, and Houck underwent a diagnostic lumbar puncture that resulted in the diagnosis of idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri (PTC).

According to allegations raised in the lawsuit, side effects of Mirena caused the intracranial hypertesnion, and Houck claims that Bayer failed to provide adequate warnings for women or the medical community about the potential risk.

“Defendants knew or should have known that Mirena, and specifically, the synthetic progestin levonorgestrel [which is released by the IUD] causes and/or contributes to the development of [idiopathic intracranial hypertension/pseudotumor cerebri], a severe and possibly irreversible brain condition that can also lead to permanent blindness,” Houck alleges in the complaint. “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.”

Houck presents claims for negligence, defective design, failure to warn, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, and fraud by suppression and concealment. She seeks both compensatory damages and punitive damages, which are designed to punish the pharmaceutical company for intentionally withholding important safety information.

Mirena Intracranial Hypertension Problems

The case is one of a growing number of intracranial hypertension lawsuits filed in recent years by women who suffered the condition after receiving the Depo-Provera birth control shot or Mirena implant.

Intracranial hypertension, or pseudotumor cerebri, develops when cerebrospinal fluid levels become elevated. This causes increased pressure in the skull, acting like a tumor. Individuals experiencing this condition often suffer severe migraines, double vision, temporary blindness, and other vision loss symptoms. This may result in swelling of the optic disk, and ringing in the ears known as tinnitus.

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.

As a result of Bayer’s alleged failure to adequately warn about the link between Mirena and idiocranial hypertension, lawsuit note that most doctors have been unaware that the birth control implant may be a potential cause of migraines, vision problems or a build up of intracranial pressure experienced by many users.

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.

In addition to lawsuits over intracranial hypertension, Mirena lawsuits have also been filed by women who have experienced problems where the IUD perforated the uterus or moved out of position, causing severe internal injuries and often resulting in the need for surgical removal.