Bayer Healthcare Pharmaceuticals Inc.’s long-term (5 year) birth control product known as Mirena has been linked to a debilitating brain condition that develops when cerebrospinal fluid builds up in the skull and increases pressure on the optic nerve.
Pseudotumor cerebri, or intracranial hypertension, exists when cerebrospinal fluid is not absorbed properly, leading to the increase in pressure. The condition is named for the fact that the symptoms mimic a brain tumor, although no tumor is actually present.
PTC is much more common in women of child-bearing age, and particularly overweight women or those with sudden weight gain. Since Mirena is only prescribed to women of child-bearing age, it is even more important that potential patients are aware of the increased risk of developing PTC with Mirena.
Mirena’s label fails to warn of PTC whatsoever. In fact, other than warning of migraines and headaches, Mirena’s manufacturer fails to even warn of the symptoms of PTC. This failure is dangerous given that prescribing and treating doctors may not realize that the Mirena is the cause of a patient’s PTC, thus, they may not know that it should be removed immediately once a patient develops the condition.
Mirena is a long-term (up to 5 years) reversible birth control in the form of an intrauterine device that also treats heavy menstrual bleeding. Mirena contains a single hormone, called levonorgestrel.
Levonorgestrel has been linked to the PTC condition as far back as the 90s, when another birth control implant called Norplant that also released levonorgestrel changed its drug label to warn of PTC. Although Bayer claims Mirena releases less levonorgestrel and is therefore, less dangerous than Mirena’s predecessor, recent studies show that blood serum levels of levonorgestrel with Mirena use are potentially much higher than what Bayer claims.
Levonorgestrel is a synthetic hormone, and although its natural counterpart, progesterone, has actually been found to reduce brain swelling and edema after traumatic brain injuries, levonorgestrel has been reported to do the opposite. Thus, it is vitally important for patient safety that the hormone be looked at with greater scrutiny.
Patients filing Mirena PTC lawsuits claim Bayer failed to test Mirena appropriately to prevent foreseeable injuries like PTC. In fact, despite pointing the U.S. Food & Drug Administration to studies based on Norplant’s safety and efficacy, Bayer failed to test Mirena to see if it too could cause PTC. Patients also claim that Bayer failed to warn, and continues to fail to warn of the devastating PTC condition, which, if left untreated, can lead to permanent blindness.
The lawyers at Jones Ward PLC are currently evaluating Mirena cases for patients suffering from papilledema or pseudotumor cerebri/intracranial hypertension. For more information, contact attorney A. Layne Stackhouse at email@example.com or 502-882-6000.