A growing number of people are becoming afflicted with an incurable, man-made disease that is related to a common medical procedure performed every single day in this country, a KCRA 3 investigation has found. Sarah Fracella is one the victims.
The 38-year-old Santa Barbara resident said what happened to her is “devastating.”
The issue involves magnetic resonance imaging scans that include the use of a contrast dye containing gadolinium.
For people with healthy, functioning kidneys, the risk of using the element gadolinium to pinpoint potential health problems in MRI scans is zero.
“Gadolinium is extremely safe,” said neuroradiologist David Seidenwurm at Radiological Associates of Sacramento.
But, for people with kidney disease, the use of gadolinium poses a significant health risk. The risk is so significant that the Food and Drug Administration issued a warning for gadolinium this year.
Dr. Philip LeBoit of the University of California, San Francisco first discovered this problem. The disease is called nefrogenic systemic fibrosis, or NSF.
“It can have severe toxic effects,” LeBoit said.
The concern is that the chemicals that surround the gadolinium and make it safe for use in the human body are in some cases breaking down. For those patients with weakened kidneys, they cannot sufficiently rid the body of the gadolinium. That has led to toxic effects for an estimated 500 to 1000 people so far.
Dr. Shawn Cowper of Yale University estimates the risk of contracting the disease at 5 percent for kidney patients.
To date, there is no known treatment for NSF. The disease can lead to a debilitating hardening of the skin.
For Sarah Fracella, the skin on her hands has hardened so much that she cannot open a bottle on her own. She also has trouble sitting and walking. In more extreme cases, NSF has attacked internal organs. NSF has also proven fatal.
KCRA3 has learned that the Burg Simpson law firm in Denver, Colo., is already investigating dozens of potential lawsuits.
Attorney Peter Burg alleges that GE Healthcare, the manufacturer of OMNISCAN, one of the most widely used gadolinium-based dyes, “knew or should have known that this product was inherently dangerous and ultrahazardous to humans.”
When contacted, GE Healthcare said it does not comment on pending litigation.
As for Fracella, she said she is telling her story as a warning to others. She wants to make sure anyone with weakened kidneys is aware of the risk of this disease before they accept the use of a gadolinium-based dye in their body.
“It’s been the hardest thing I’ve ever had to deal with in my life,” she said.
November 26th, 2007