Product Liability

Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), is a serious adverse reaction to the contrast agent used in MRI (Magnetic Resonance Imaging) and MRA scans (Magnetic Resonance Angiography). Typically, that contrast agent, gadolinium-based gadodiamide, affects patients who have a history of reduced kidney function. Weakened or disabled kidneys are unable to process the toxic gadolinium from the body, resulting in NSF.

Most people are able to flush gadolinium out of the body naturally within a short period of time. However, people with kidney dysfunction have difficulty doing so. Gadolinium, if allowed to stay within the body, causes Nephrogenic Systemic Fibrosis (NSF). The symptoms of NSF can appear within days or after several months. Symptoms include the skin becoming tight and rigid on the hands, feet, arms, and legs, making it difficult to bend joints. The skin can be itchy, burning, or painful, also forming raised, discolored bumps. In severe NSF cases, internal organs can be affected, occasionally leading to death.

All confirmed cases of NSF have involved patients who have a history of kidney problems, however NSF is a relatively new disease and its full extent is not yet known. NSF is best diagnosed with a skin biopsy. Symptoms of NSF are similar to another skin-affecting disease known as scleroderma. If you have been diagnosed with scleroderma and have a history of MRIs, MRAs, or other exposure to gadolinium, consult with your physician.

Gadolinium has been used as a contrast agent for MRIs and MRAs over the past 20 years. When it is used for MRA, a larger dose (typically double or triple of the approved MRI dose) is administered. Most cases of NSF occur after MRA. The FDA has not approved any of the 5 gadolinium-based contrast agents (Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance) for use in MRAs.