MRI Health Risks: The Danger in the Discovery

Washington, DCThe largely man-made disease most closely associated with the use of gadolinium-based contrasting agents in MRI procedures is just a little more than 10 years old, and is a horrific affliction--called NSF or NFD--that is characterized by the thickening, and the hardening of skin—effectively entombing the victim.

When Nephrogenic Fibrosing Dermopathy (NFD) was first discovered in 1997, it was thought to affect the skin, and underlying tissues only. But that was before a patient, who died 11 months after the onset of NFD, was found to have sustained hardening of tissues and organs deeper down. Autopsy revealed fibrosis and calcification of the psoas muscle, renal tubules and testes. What's more, microscopically most of the diaphragm had been replaced by fibrous tissue with extensive vascular and extravascular calcium deposit.

Pretty serious stuff. From that day in 2003 forward, NFD (also referred to as NSF)was updated to Nephrogenic Systemic Fibrosis to reflect an updated understanding of the disease process.

The MRI connection is through the use of gadolinium contrasting agents that are commonly used for both MRI and MRA procedures. However, to understand the risk, is to understand what gadolinium really is:

A rare earth element that is used as a contrasting agent for Magnetic Resonance Imaging, thanks to its powerful paramagnetic properties. In its free state, gadolinium is highly toxic. However, when chelated the element's water solubility is enhanced and toxicity is reduced, rendering it safe for use with MRI under most circumstances.

However, there are exceptions. One is with MRA, or Magnetic Resonance Angiography, which requires up to three times the level of gadolinium needed for MRI. It is for this reason that the US Food and Drug Administration (FDA) does not approve gadolinium-based contrasting agents for use with MRA.

The other concern relates to patients with weak, or malfunctioning kidneys. In patients with normal renal functionality, the gadolinium chelates are excreted through the kidneys soon after the procedure, normally without difficulty. It is for this reason that the use of gadolinium, an element that is not found naturally in the human body, is thought to be both safe and effective for most people.

However, for kidney patients it is an entirely different story. For them, the gadolinium chelates are not excreted quickly enough. When that happens the chelates break down, and the free gadolinium remains within, and circulates through the body, leading to NSF / NFD in numerous patients. Some patients exhibited the symptoms of NSF / NFD two, to four weeks after having an MRA. One patient reported burning, and a reddening of the upper and lower extremities one day after receiving an MRA. That patients was later diagnosed with NSF / NFD, for which there is no known cure.

The FDA began taking a position on the suspected link between gadolinium contrasting agents and the onset of NSF / NFD after 25 cases of the affliction had been reported to the agency as of June 2006. That number had grown to 90 by Christmas, prompting the FDA to update its advisory.

As of now, the five gadolinium-based contrasting agents approved by the FDA for MRI, are NOT approved for MRA due to the higher levels (up to three times higher) of gadolinium inherent with MRA. That goes for everyone. As for patients with weak kidneys or renal failure, it is important for physicians to carefully explain the risks of having an MRI or MRA, given what we now know. Patients should be screened for kidney dysfunction before an MRI or MRA is administered, and it has been recommended that kidney patients who consent to an MRI should have dialysis immediately thereafter, in an effort to rid the body of the potentially toxic gadolinium.

It has been reported that NSF / NFD has not been found in any patient who had not been exposed to gadolinium.

It is also telling that NSF / NFD had not been seen, or identified prior to 1997, a time when MRI imaging was just getting a foothold in health care. While the technology had been around for a while, costly MRI machines were just coming into hospitals and regions willing to spend the money.

Thus, a correlation between the proliferation of available MRI units in hospitals around the globe, the rise in the number of MRI and MRA procedures for disease detection, and the spike in cases of NSF / NFD.

That tells you something right there…

On February 27th of this year, the United States Judicial Panel on Multi-District Litigation issued a transfer order in the Gadolinium Contrast Dyes Products Liability Litigation. All federally filed cases will be assigned to the Northern District of Ohio, and will be heard by Judge Dan A. Polster.