Nephrogenic Systemic Fibrosis (NSF)

A Man-Made Disease Caused by Gadolinium-Based MRI Contrast Agents

If you have impaired renal function (kidney failure, dialysis patient, kidney transplant recipient, kidney transplant candidate) and received an injection of a gadolinium contrast agent for an MRI, MRA, angiogram/angioplasty, CT scan (CAT scan), fistulogram, or venogram, you may have Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD).

The NSF attorneys/NSF lawyers at DeCarli Law are investigating and litigating NSF lawsuits for people with NSF.  Contact us for a free telephone consultation to learn your legal options.

NSF: A Disease Caused By Gadolinium Contrast Agents in which the Skin and Other Body Tissues Harden

NSF is a disease characterized by the hardening of skin and other body tissues as a result of gadolinium contrast agents breaking down in the human body.  Typically, the skin first begins hardening around the ankles and/or wrists.  The disease is progressive.  The skin hardening usually then spreads, up the legs and arms, and to the torso.  Tissue in joints, muscles and internal organs may harden as well, making the disease potentially fatal.

Many health care providers are not familiar with NSF because it is a relatively new disease.  The first cases of NSF were identified in 1997, and the first published report of NSF cases appeared in 2000.  The link between NSF and gadolinium was only revealed in 2006.

At present, there is no known cure for NSF, and treatments are still in the experimental stage.

NSF Attacks People on Dialysis, with Impaired Renal (Kidney) Function, and Liver Disease

NSF most frequently attacks dialysis patients, kidney transplant patients, candidates for kidney transplant, and people with kidney dysfunction.  This is because gadolinium-based contrast agents are unstable, and if left in the human body too long, begin breaking down.  People with impaired kidney function are at risk because their kidneys often fail to remove the contrast agent before it begins breaking down.  When this happens, the gadolinium ion separates from the rest of the contrast agent and becomes lodged in tissues throughout the body.  Once this happens, it is extremely difficult, if not impossible, to remove the gadolinium from the body.

The key to whether there was a risk of NSF is if there was impaired kidney function at the time the gadolinium contrast agent was injected.  For example, if a patient had a severe kidney infection at the time of the MRI, that person might be at risk, even though they had no previous history of kidney failure or impairment.  On the other hand, if a person's kidneys were working when the contrast agent was injected but failed months later, it is less likely that the contrast agent remained in the body too long.  Also, if you have diabetes or high blood pressure, you may also be at risk, since these conditions can also be associated with impaired kidney function.

Importantly, a gadolinium-based contrast agent alone can cause kidney failure, which in turn places a patient at risk of developing NSF.  Renal failure (kidney failure) is one of the known risks of gadolinium-based contrast agents.  This means that any person's kidneys could fail when injected with the contrast agent.  If a person's kidneys fail after receiving the contrast agent and are not immediately put on dialysis, they are also at risk of developing NSF because their bodies also may not remove the contrast agent before it begins breaking down. Thus, even someone who had no kidney problems before receiving the contrast agent could potentially develop NSF.
          LEARN MORE about how gadolinium-based contrast agents cause NSF

What are the Symptoms of NSF?

Common symptoms of Nephrogenic Systemic Fibrosis (NSF) include:

• Swelling, thickening and tightening of the skin, especially on the legs or arms;
• Skin is hard, and feels “woody” or "leathery";
• The skin has an "orange peel" appearance;
• Hair loss on the affected area of the skin;
• Joints contract and become inflexible, especially the hands, wrists, elbows or feet, ankles, knees;
• Yellow papules in the whites of the eyes;
• Severely affected people may be unable to walk or close their hands.

NSF symptoms can appear as early as two days after injection of a gadolinium-based contrast agent, and up to 18 months later.  NSF is frequently unrecognized or misdiagnosed.  When there are no skin symptoms, NSF is rarely diagnosed.  Common misdiagnoses when skin symptoms do appear are scleroderma, scleromyexedema, fibromyalgia, and rheumatoid arthritis.

Photographs of NSF Symptoms

The appearance of NSF skin symptoms varies greatly.  Below are how the skin symptoms manifested on one patient diagnosed with NSF:

Swelling; joints contract and become inflexible	Thickening and tightening of the skin
Skin is hard and feels woody or leathery	Yellow papules in the eye
Loss of mobility

Diagnosis of Nephrogenic Systemic Fibrosis (NSF)

Currently, the only way to diagnose NSF is to have a physician, preferably a dermatologist, take a biopsy from an affected area of the skin.  It is crucial that the biopsy be taken from an affected area of the skin because only those areas show the tell-tale signs of NSF in the fat tissue below the skin.  Also, if the biopsy taken does not reach below the bottom layer of the skin, it will not show the signs of NSF.  Assuming a biopsy is properly taken from an affected area of the skin, it then must be specifically tested for NSF, by a pathologist familiar with the disease.
          LEARN MORE about how NSF is Diagnosed

No Cure for NSF and NSF Treatments Still Experimental

At present, there is no cure for Nephrogenic Systemic Fibrosis (NSF). Further, treatments for the symptoms of NSF are still at the experimental stage. However, research on possible treatments is promising.
          LEARN MORE about NSF Treatments

Was Gadolinium Used For Your Treatment?

A gadolinium-based contrast agent is always administered intravenously.  If you drank the contrast agent for your treatment, rather than having it injected, you did not receive a gadolinium-based contrast agent.

In 1988, Magnevist (gadopentetate dimeglumine) became the first gadolinium-based contrast agent approved for use in the United States.  This means that if you were injected with a contrast agent before 1988, it did not have gadolinium and there was no risk of developing NSF.

Product Names and Manufacturers of Gadolinium Contrast Agents

Since 1988, the FDA has approved seven gadolinium-based contrast agents for use in magnetic resonance imaging (MRI), all of which are subject to the FDA warning. These are:

       Omniscan, manufactured by GE Healthcare.

       Magnevist, manufactured by Bayer Healthcare.

       OptiMARK, manufactured by Mallinckrodt.

       MultiHance, manufactured by Bracco.

       ProHance, also manufactured by Bracco.

       Eovist, also manufactured by Bayer Helathcare, and

       Vasovist (new name Ablavar), manufactured by Lantheus (formerly Epix).

Importantly, with the exception of Vasovist, gadolinium contrast agents are only approved for use in MRIs. Nevertheless, common unapproved uses include magnetic resonance angiography (MRA), angiogram/angioplasty, CT scan, fistulogram, and venogram.

The risk of developing NSF from unapproved uses is even greater than for an MRI because unapproved uses often use significantly larger doses of the contrast agent. This places an even greater strain on the kidneys because there is more gadolinium to be removed from the body -- and consequently increases the chances of the contrast agent breaking down in the body before it is completely removed.

In theory, all brands of gadolinium-based contrast agents have the potential to cause NSF, especially for people on dialysis or with any significant level of kidney function impairment at the time the contrast was injected. This is because if not removed from the human body, gadolinium-based contrast agents will eventually break down, releasing free gadolinium into the body.

The Most Dangerous Contrast Agents: Omniscan, Magnevist, and Optimark

Three brands of gadolinium-based contrast agents are far more likely to cause NSF because they are less stable, and therefore more likely to break down in the in the human body. These more dangerous brands are Omniscan, Magnevist, and OptiMARK.
                                                                LEARN MORE ABOUT OMNISCAN
                                                                LEARN MORE ABOUT MAGNEVIST
                                                                LEARN MORE ABOUT OPTIMARK

The Food and Drug Administration (FDA) Warns of the Risk of NSF

The Food and Drug Administration (FDA) recognized the danger to kidney patients from gadolinium-based contrast agents, and issued warnings in 2007.  The FDA ordered manufacturers to place a "black box warning" on gadolinium-based contrast agents, which is the greatest step the FDA can take short of ordering a product to be completely recalled from the market. The FDA also ordered manufacturers to send letters to health care providers to warn them of the risks of gadolinium-based contrast agents.

Links:  FDA Alert

           Dear Healthcare Professional Letter

NSF Lawsuits

If you have NSF, you can sue the drug manufacturers because they failed to warn both you and your doctors that gadolinium-based contrast agents could cause NSF.  The manufacturers of gadolinium-based contrast agents knew NSF was a risk for kidney and liver patients, but did not disclose this to doctors and patients. The manufacturers concealed this risk. The manufacturers only warned doctors and patients after they were ordered to do so by the FDA.

Because of the manufacturers' concealment of the dangers of their drugs and their failure to warn of the side effects, many lawsuits have been filed against the manufacturers of gadolinium-based contrast agents. If you have been exposed to these drugs and are suffering from NSF/NFD symptoms, please contact the NSF attorneys/NSFlawyers at DeCarli Law to learn about your legal rights and possible compensation.

Contact DeCarli Law for a free consultation if you or a loved one may have developed NSF or NFD.

We represent all individuals suffering from NSF or NFD in a gadolinium lawsuit (or NSF lawsuit or MRI lawsuit) on a contingency basis.  This means you pay no legal fees unless we win compensation in your case. For a free no obligation consultation, please call toll free at 1-800-401-4720 or fill out our short online contact form.  A Gadolinium NSF lawsuit attorney will contact you to answer any of your questions.

There are never any legal fees or expenses unless you receive compensation.