MRI problems should have been disclosed sooner
Gadolinium based MRI contrast agents have been linked to the development of nephrogenic systemic fibrosis (NSF) in individuals with kidney insufficiencies. If the manufacturers of these contrast agents had properly conducted studies of their product or analyzed reports and other clinical data, they could have warned earlier about the potential MRI problems. Earlier warnings may have prevented the disabling and painful condition experienced by hundreds, or potentially thousands, of individuals.
>>INFORMATION: MRI Contrast Problems
Gadolinium is highly toxic metal which is used in the MRI contrast dyes because it is drawn to magnetic fields. When injected before an MRI or MRA, the contrast allows the physician to differentiate blood vessels from nearby tissue when interpreting the exam.
The contrast agent is administered as a chelate, which is supposed to protect the body from the toxic free gadolinium. However, individuals with kidney insufficiencies may not eliminate the contrast from their body, and defects in the design of some the contrast agents could allow the gadolinium to separate from its chelate, causing NSF.
Nephrogenic systemic fibrosis (NSF), previously known as nephrogenic fibrosing dermopathy (NFD), is a progressive disorder which is associated with the development of scarring of the skin and connective tissue throughout the body. It can result in a hardening and thickening of the skin, which could be described as leathery, rigid or course. The hard and thick skin can severely restrict movement of the joints, and is painful and extremely disabling. The fibrosis can also effect other internal organs, and in some cases it can lead to death.
>>INFORMATION: NSF Symptoms
WARNINGS ABOUT MRI PROBLEMS
The first written accounts of individuals with kidney problems experiencing a hardening and thickening of their skin following an MRI were published in medical literature in 2000. However, reports indicate that the condition was observed by some doctors as early as 1997.
It was not until 2006 that the first warnings were issued about problems with the MRI contrast agents. In 2006, the FDA warned that physicians should carefully assess the need for gadolinium MRI dye in patients with moderate to end state renal disease due to the risk of NSF. In May 2007, a prominent black box warning was added to the contrast agents, indicating that the serious MRI problems could result for those with kidney insufficiencies.
Since the information about potential problems was released, independent researchers and physicians have been able to evaluate the risk and come up with steps to reduce the chances of NSF developing. In July 2007, the American College of Radiology, added information to their guidelines on MRI safety about the problems and recommended steps that could be taken to reduce the risk of nephrogenic systemic fibrosis if an enhanced MRI is needed for someone with kidney problems.
The companies which make the MRI contrast agents should have designed their products to ensure that the toxic gadolinium is not released into the patient’s body. In addition, they should have conducted research on the impact their product would have on those with kidney insufficiencies and warn about the potential problems.
The lawyers at Saiontz, Kirk & Miles, P.A. are reviewing MRI law suits throughout the United States for individuals who have experienced symptoms of NSF after an MRI or MRA with contrast. Problems could include dark patches, burning, itching, swelling, hardening or tightening of the skin, which usually develops on the arms, hands, legs or feet.
If warnings about the MRI problems had been provided earlier, those who are now suffering from nephrogenic systemic fibrosis may have been able to avoid the devastating condition. If you, a friend or family member are concerned that problems following an MRI or MRA may be related to the gadolinium based contrast agent, determine if you may be eligible for a claim by requesting a free consultation.
