As we previously noted here, our office has been investigating cases involving alleged injuries arising out of the use of the MIRENA IUD. The manufacturer, BAYER HEALTHCARE PHARMACEUTICALS has emerged as a powerhouse in the manufacture and sale of contraception to girls and women as explored here. With this status the company has found itself involved in major litigation involving their products. As explained here women have come forward with complaints that the MIRENA IUD was embedded in their uterus, perforated their uterus, or migrated to other parts of the body and required surgical removal. the cases were organized into a Multi-District litigation in the Southern District of New York. In fact, as depicted below we participated in one of the very first conferences held in this proceeding in the Southern District of New York. To date, these cases are limited to these discrete injuries. Coordinated lawsuits are also pending in state venues that include New Jersey and are also limited in scope.
Many analyzing adverse events linked to the MIRENA IUD have focused on cases of perforation, migration and embedment with resulting surgery. However, recent reports and a number of lawsuits have been initiated claiming an entirely different injury. This injury is arguably not warned about in the labeling or prescribing information for the MIRENA IUD in the United States. In fact, it is possible that neither victims nor their prescribing physicians have recognized that there could be a correlation between these side effects and diagnosis.
The medical term is pseudotumor cerebri and may also be diagnosed as intracranial hypertension, idiopathic intracranial hypertension or secondary intracranial hypertension. These conditions are associated with tumor like conditions in the brain, cerebral spinal fluid increases that put pressure on the eyes and brain. The conditions may begin as simple headaches, that progress into severe headaches, dizziness, tunnel vision, blurry vision, double vision and the sensation of “whooshing” sounds or heartbeat sounds. The Mayo Clinic lists the following as symptoms associated with pseudotumor cerebri signs:
The exact cause of pseudotumor cerebri is not known. However, with regard to the MIRENA IUD there is growing reason to consider that the levonorgestrel releasing intrauterine system may be the cause or common link. These symptoms may be associated with a diagnosis of swelling of the optic disc, papilledema, which can itself by a sign of a “brain tumor” or pseudotumor requiring medical attention.
Needless to say, these conditions require medical care, treatment and monitoring to avoid complications or potential blindness. Medications may resolve the condition, however sometimes invasive surgery may be required which brings a host of potential risks and complications.
How the MIRENA IUD works is not really known. In fact, this is depicted in materials the manufacturer once used to educate prescribers and consumers that we have highlighted in yellow to underscore our point.
As a result, many consumers have been testing the “theoretical” mechanism of delivery promised by the MIRENA IUD as a form of contraception. Granted, the intrauterine system is approved by the U.S. Food & Drug Administration (FDA), but theory and practice, when combined with clever marketing, raise the potential for many to question the wisdom of long term use of a hormone releasing implant in the form of the MIRENA IUD.