Although the FDA has not yet issued a formal warning about the risk of PTC posed by the Mirena IUD®, research has suggested a link between hormonal birth control devices and drugs like the Mirena IUD® and PTC for decades. The FDA has issued numerous warnings regarding the potential for certain products to increase the risk of intracranial pressure. The agency also has directed that warnings regarding idiopathic intracranial hypertension risks be included on the label of other birth control implants that use levonorgestrel, which includes the Norplant® hormonal contraceptive device.
The New England Journal of Medicine published a study in 1995 that found a link between pseudotumor cerebri (intracranial hypertension) and birth control methods that use the hormone levonorgestrel, such as Bayer Pharmaceuticals’ widely prescribed intrauterine device, the Mirena IUD®. Subsequent studies also have linked the condition to birth control pills like Yaz® and Yasmin® that use drospirenone.
In a more recent 2014 study, the Mirena IUD® was linked to the appearance of PTC-related side effects in women who received the intrauterine birth control device as their form of contraception. The same year the study was generated, Bayer Pharmaceutical was the subject of nine PTC product liability lawsuits. These lawsuits alleged that the pharmaceutical manufacturer minimized the link between the Mirena IUD® and the risk of serious brain injuries, including pseudotumor cerebri, benign intracranial hypertension, and idiopathic intracranial hypertension.
Understanding What Constitutes a Pseudotumor Cerebri?
The term “pseudotumor cerebri” (PTC) literally translates as “false brain tumor”. The term is used to refer to a severe neurological condition which manifests symptoms that mimic a brain tumor. This medical condition is also referred to as benign intracranial hypertension (BIH), or idiopathic intracranial hypertension (IIH) if there is no obvious cause of the condition. This neurological condition arises when a patient suffers an increase of pressure within the skull from excessive levels of cerebrospinal fluid inside the skull in the absence of an apparent reason. The increased pressure can mirror the symptoms of a brain tumor, such as difficulty walking, vision loss, pulsating within the head, and vomiting. Because pseudotumor cerebri often causes intense pressure on the optic nerve, women might suffer serious eye injuries or permanent blindness.
Statistics Involving Pseudotumor Cerebri & Hormonal Birth Control
While PTC can occur in a cross-section of people from all age ranges, the condition most typically affects obese women of childbearing age. Because this population comprises a substantial portion of those to whom hormonal birth control methods are marketed, the potential risk of PTC is concerning. Between 2000 and 2014, the FDA received more than 70,000 adverse event reports regarding complications from Mirena with the reports commonly involving side effects associated with PTC or IIH.
Long-Term Consequences of PTC
While PTC does not constitute an actual brain tumor, the condition can still cause potentially devastating injuries. Some patients experience a progressive loss of vision that may ultimately result in blindness. Patients with the condition might be required to obtain regular checkup with an eye doctor so problems can be diagnosed and treated promptly. Women who experience PTC also might require surgery so a stint can be implanted to redirect fluid away from the brain, or a spinal tap that can alleviate intracranial pressure. If you or your loved one develop this condition, you should be aware that it can reoccur even if the symptoms have previously been completely alleviated.
Lawsuits Filed Over Pseudotumor Cerebri-Related Side Effects
Given the developing research linking hormonal birth control products to PTC, such as Yasmin®, Yaz®, and the Mirena IUD®, an increasing number of lawsuits are being filed against Bayer, Pfizer, and other pharmaceutical manufacturers alleging patients were not adequately warned about potential neurological injuries.
Generally, these lawsuits allege that manufacturers of these hormonal birth control products:
- Sold a defective product
- Failed to conduct adequate research regarding the safety and effectiveness of the products
- Downplayed the risk of experiencing serious side effects of these birth control products
- Failed to provide adequate warnings about the risk of PTC and other serious side effects
Free Case Evaluation by a Seasoned PTC Attorney Today
At Stern Law, PLLC, we are currently investigating claims for compensation on behalf of patients who are suffering from symptoms of pseudotumor cerebri after using hormonal birth control drugs and devices. Our compassionate team recognizes the devastating consequences of suffering blindness or neurological injury, so we tenaciously pursue the fullest compensation for our clients. Call Stern Law, PLLC today at 1-844-808-7529, or complete an online contact form for assistance. Click here now for more information on scheduling your free case evaluation with one of our knowledgeable PTC lawyers.