MRI’s Are Not All Made The Same: FDA Alerts About Burn Risk

March 11th, 2009

Magnetic Resonance System may have sounded like the greatest medical invention sweeping the nation twenty years ago. Radio wave signals able to penetrate the body using a magnetic field to transform the images of the body’s soft tissue. Sounds impressive, right? It is. Yet, problems associated with MRI testing may be enough for one to question the procedure and the methodology.

Recently, there was the outbreak of Steven Johnson’s Syndrome. This outbreak was associated with Gadolinium Dye that was used during some MRI procedures. Some MRI patients are required to receive injectible contrast dye to identify changes in non-bony matter of the body. Some of these patients received   gadolinium dye. There are numerous types of contrast dyes to select from for MRI’S, none traditionally associated with life changing risks. However, the gadolinium dye produced long term debilitating effects for many, including: orange peel like skin that sloughs off the body over time, joint disabilities, and pain.

Transdermal drug patches used in some MRI procedures have been the latest safety risk identified by the FDA. Some patients are required to use transdermal patches for the delivery of medication during an MRI. Both brand and generic over-the-counter transdermal patches are identified risks, according to the FDA.
Transdermal patches from certain makers contain metal such as Aluminum. Metals typically do not affect the magnetic field of the MRI, but can conduct electricity. During the procedure, the transdermal patch can ignite and cause skin burns.

The brand and generic patches may not have a warning on the box to alert consumers of the risk. Product manufacturers must warn the public about risks that may be associated with their products. Product manufacturers must guard against risks in the design of their products. If they are not able to design out the risk, then they must warn fl the risk. Until warning labels are on transdermal patches, check with the manufacturer about their products risk of producing a burn.

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Gadolinium Contrast Dye and NSF

October 2nd, 2008

By Lesley Ranft

Gadolinium contrast dye may have been a typical component in an MRI since the early 1980’s. In fact, approximately 200 million people have received a gadolinium-based contrast agent for MRI testing since the 1980s. -1- Yet, no one knew then the risk of nephrogenic systemic fibrosis (NSF), an extremely debilitating disease that can be progressive and fatal over time. The disease is not fully understood, but is evident in people with pre-existing kidney dysfunction that receive MRI’s with gadolinium contrast dye and may be a risk for select members of the general public.

Gadolinium Contrast Dye Adverse Symptoms
Standard protocol prior to receiving an MRI with contrast dye is the patient instruction to report any symptoms following the MRI to the treating physician. As Kevin O’Brien, Attorney at Law of Chicago, Il explains, ” Based on personal experience, medical staff does not explain the risks associated with MRI’s. The information about risks is buried in the releases that are signed prior to the MRI.”  In fact, the symptoms that were initially and traditionally described to report appeared to be mere allergic reactions that would wane away in time. The adverse reactions associated with contrast dyes were hives, itchy skin, nausea, swollen eyes, throat tightness, and/or breathing difficulty. Yet, it has become apparent that people with kidney dysfunction and perhaps, select members of the general public may experience debilitating and life threatening conditions that may occur years after the injection of gadolinium contrast dye, including:
High blood pressure
Burning itching skin
Hardening of the skin, equivalent to an orange peel
Hyper-pigmentation, red or dark patchy skin areas
Yellowing around the eyes
Extreme pain in the bones, including hips and ribs
Muscle weakness       �
Joint rigidity
Inability to walk
Fibrosis and scarring of the diaphragm, muscles, esophagus, kidneys and lungs
Kidney or liver failure       �
Death

Furthermore, the FDA had stepped in during the beginning of second quarter in 2007 to request that there be additional warnings provided on the labeling of gadolinium contrast dye. The goal of this initiative is to better inform physicians so they can pass the information onto patients before they receive gadolinium.

Nephrogenic Systemic Fibrosis Diagnosis and Treatment

Nephrogenic Systemic Fibrosis may be diagnosed by viewing the skin and performing a punch skin biopsy which is viewed under a microscope to confirm the diagnosis of nephrogenic systemic fibrosis. It is suspected by some in the medical community that improved renal function may arrest the disease. As Ronald V. Miller, Jr., Attorney at Law, of Glen Burnie, Maryland adds, “NSF may be one of the most serious disabling medical conditions with slow deterioration. It is unfortunate that evidence has been presented that the manufacturers of gadolinium contrast dye were aware of accounts of complications associated with the dye, but did not further investigate the risks which could have prevented NSF for those who have been afflicted. On a positive note, there is closer attention being drawn to NSF and technology is progressing to improve the outcome for those who have or will have NSF as a result of gadolinium contrast dye complications.” Unfortunately, the disease is not fully understood and treatment options are considered investigative at this time, including:·       �
Oral Steriods
Topical Dovonex
Compression Garments
Extracorporeal photopheresis (ECP)       �
Plasmapheresis
Cytoxan
Thalidomide
Ultraviolet Therapy
Physical Therapy (PT)
Pentoxifylline (PXF)
High Dose Intravenous Ig Therapy
Renal Transplantation
It is important to note that the treatments above may have their own side effects and in some cases, are only considered clinical trial treatment plans for nephrogenic systemic fibrosis. It is also important to note that not all doctors are fully informed about nephrogenic systemic fibrosis. In addition, there are a select number of personal injury attorneys that have the knowledge of doctors who can diagnose and treat victims suffering from gadolinium contrast dye and nephrogenic systemic fibrosis. Nephrogenic systemic fibrosis due to gadolinium contrast dye is considered a personal injury and victims should seek out the advice of a personal injury attorney that focuses on gadolinium contrast dye as early after the symptoms and diagnosis as possible. -1-http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1705479

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