If she knew then what she knows now, Sarah Fracella would not have undergone an MRI.
“I don’t think there’s been a day in the last, probably, two years that’s gone by that I haven’t cried at least once about this,” said Fracella, 38, of Santa Barbara, whose skin is hardening painfully into something that looks startlingly like marble.
Fracella is one of as many as 1,000 people worldwide who have contracted a debilitating, incurable and sometimes fatal disease called nephrogenic systemic fibrosis, or NSF, from the dye that is used in millions of magnetic resonance imaging scans every year.
For most people, dyes based on gadolinium – the magnetic ion blamed for the condition – are safe, said David Seidenwurm, a neuroradiologist with Radiological Associates of Sacramento. But for people with severe kidney problems, the ion can poison the patient by causing collagen to build up in tissues.
The Food and Drug Administration asked manufacturers in May to include a so-called black-box warning on gadolinium-based products, saying patients with kidney problems could develop NSF after a single exposure. In addition to severe thickening of the skin, leading to immobility, the disease is also known to affect the liver, the lungs and the heart.
Few alternatives to dye for MRIs
The specific cause of NSF is not yet understood, but researchers at Yale University reported that in more than 95 percent of the cases they had surveyed, patients were exposed to a gadolinium-based dye two to three months before the onset of the disease.
Shawn E. Cowper, a dermatologic pathologist at Yale who first identified the condition with Philip LeBoit of the University of California-San Francisco, said as many as 1 in 20 kidney patients could be at risk of contracting NSF after undergoing an MRI using gadolinium.
Gadolinium-based dyes latch into specific tissue types in the body, making them easy to contrast from other tissues on an MRI. The tests can be administered without a contrasting agent, but they are considered to be significantly less useful.
Complicating the problem is that gadolinium is the only contrasting agent approved for use in most MRIs. Two others, Feridex I.V. and Teslascan, are limited to use only in examinations of specific liver problems.
NSF has been confirmed in children and the elderly, but it tends to affect the middle-aged most commonly, according to the International Center for Nephrogenic Fibrosing Dermopathy Research. It affects men and women equally.
The FDA recommended that all patients with serious kidney problems ask their doctors not to use contrasting agents in MRI exams, unless there is no alternative.
‘Hardest thing I’ve ever had to deal with’
Numerous lawsuits have been filed against GE Healthcare, a division of General Electric Co., which manufactures gadodiamide, the type of gadolinium implicated in a large majority of the cases known to date. GE Healthcare said that the company does not comment on pending litigation but that in general, it believes it has “a number of meritorious defenses.”
For 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.
“It’s been the hardest thing I’ve ever had to deal with in my life,” she said.
Fracella’s mother, Susan, said her daughter’s condition was “terrifying.”
“It’s agonizing to watch your child suffer,” she said. “… I mean, knowing this now, would you want any of your children to have an MRI?”