Investigation against General Electric, Bayer and Braco Diagnostics in connection with the manufacture of a gadolinium based contrast solution used in MRI's and/or MRA's, which can cause debilitating skin disorders called Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD).
Gadolinium is a contrast agent solution used during an MRI or Magnetic Resonance Imaging for the purpose of detecting tumors in the body. Although Gadolinium was approved by the US Food and Drug Administration (FDA) in 1988 for use during MRI's, Gadolinium has also been used by physicians during MRA's or Magnetic Resonance Angiographies. Gadolinium is known by several trade names, including Omniscan, manufactured by GE Healthcare; Magnevist, manufactured by Bayer Healthcare Pharmaceuticals; and ProHance, manufactured by Bracco Diagnostics. Two additional Gadolinium solutions include MultiHance and OptiMARK.
These Gadolinium based contrast agents are injected into the veins of the patient so that the physician can view the patient's internal organs, tissues, bones, and/or vessels. Contrast agents containing Gadolinium have been found to cause serious and often times debilitating skin disorders known as Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD). NSF/NFD is a condition that causes swelling, tightening, and thickening of the skin, which sometimes causes not only difficulty in moving one's limbs, but also impossibility in the ability to move. This condition is usually found in patients with kidney disease or renal dysfunction and typically begins to manifest itself between two (2) days and eighteen (18) months after the initial injection of Gadolinium.
NSF/NFD is a progressive disease that can lead to death. Symptoms of this disease include: burning, itching, swelling, hardening and tightening of the skin, red or dark patches on the skin, yellow spots on the whites of the eyes, stiffness in joints and trouble moving or straightening the extremities, pain deep in the hips or ribs, and/or muscle weakness.
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Name (Stock Symbol)
Bayer AG manufactures pharmaceuticals and consumer products.
General Electric Company (GE)
General Electric Company operates as a technology, media, and financial services company worldwide.
Bracco SpA is a pharmaceutical company and a medical device company.
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