Gadolinium Nephrogenic Systemic Fibrosis
In December 2006, the US Food and Drug Administration released an advisory warning about the risks of using Gadolinium during an MRI procedure in certain situations. Researchers had discovered a link between using a solution containing Gadolinium for an MRI procedure and patients with renal failure or kidney problems developing a condition called Nephrogenic Systemic Fibrosis. Because of the strength of the link discovered, the American College of Radiology has released a revision of its guidelines for medical professionals for performing an MRI procedure.
A segment of the revised guidelines now focuses on the risks associated with using a Gadolinium based solution for performing an MRI on a patient with renal failure or acute kidney disease. Much of the segment focuses on the potential for the development of Nephrogenic Systemic Fibrosis in these patients, a debilitating and painful condition that could cause the death of the patient if not treated properly and promptly. The condition is considered to be progressive and there is no known cure for the condition to date.
Nephrogenic Systemic Fibrosis is characterized by the development of dark spots on the skin that itches and burns without relief. As the condition progresses, the affected skin will begin to harden and become stiff as calcium deposits begin to build up in the cells of the skin. The skin loses its elasticity and the tendons and muscles beneath the skin are restricted by the immovable nature of the skin above.
If the condition is not treated quickly, the joints of the body can become deformed and lose their ability to move at all. The person will eventually become completely immobile as their skin continues to calcify. The condition is considered to be extremely rare and less than 300 cases have been confirmed around the world since the condition was originally discovered in 1997. It has only been found in patients with renal failure and advanced or moderate kidney disease after they have undergone an MRI procedure with the use of a Gadolinium based contrast agent.
Until more is understood about this serious and debilitating condition, the revised guidelines for performing an MRI procedure detail the precautions that should be taken with all patients. Any patient that is suspected of having a kidney condition, diagnosed or not, should not be given any type of solution containing Gadolinium prior to their MRI procedure. If a person that is experiencing renal failure has been given a Gadolinium based contrast agent prior to an MRI procedure, then dialysis should be used directly after the procedure to remove the Gadolinium from the blood as quickly as possible.
Researchers are working diligently to learn why solutions containing Gadolinium are affecting patients in this manner. Of the 5 contrast agents that contain Gadolinium that are generally used for MRI procedures, 3 of them have been associated with the patient developing Nephrogenic Systemic Fibrosis at some point following the procedure. Some of the patients developed the condition over a period of a months and the condition progressed relatively slowly while some others developed the condition rapidly and were immobile within a matter of months. The key to understanding the condition and why it occurs lies in further research into the condition, including its causes and effects.
Do I Have a Gadolinium Induced Nephrogenic Systemic Fibrosis Lawsuit?
If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries.
Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.
Gadolinium, also known as Gadodiamide, is known throughout the world by a number of different trade names. One of the most common trade names for gadolinium is Omniscan, which was released for use in medical imaging in 1993. Gadolinium has also been branded as ProHance as a product from Bracco Diagnostics, which was released for use by the US Food and Drug Administration in 1992. The longest approved brand name for Gadolinium is Magnavist, approved in 1988 and released by Bayer Healthcare Pharmaceuticals.
The main use of Gadolinium is to improve the effectiveness of MRI imaging by acting as a contrast agent to improve the results obtained by the imaging scan. When introduced into the body of the patient, the solution tends to collect around areas that would be of great important to the attending doctor, such as tumors, abnormal fluid deposits, and abnormal tissue growth. These areas are highlighted on the imaging scan, allowing the doctor to focus on these problem areas for further testing.
Gadolinium is considered by many doctors to be a very important diagnostic tool because it allows them to see problem areas in the body in an easy and efficient manner. This colorless solution illuminates when exposed to the MRI imaging, causing bright areas on the scan for the doctor to review with more testing methods. A MRI imaging scan of the body is generally taken before the contrasting agent is introduced to provide an overall picture of the body of the patient and another scan is taken after the Gadolinium solution has been introduced to highlight any worrisome areas.
Using a gadolinium based contrasting agent can greatly enhance the results of the MRI imaging scan and illuminate tumors and abnormal growths that are too small to be detected with imaging alone. The increased clarity of the MRI imaging scan allows medical problems to be detected more quickly and ensures that areas where issues are present are not overlooked by the specialist. Any tumors that are present in the body will be highlighted so that the doctor can see the exact size and shape of the tumor and will provide an exact location for the tumor so that the doctor does not have to search for it when it is time for the tumor to be treated or removed.
There are a number of different side effects associated with the use of Gadolinium as a contrasting agent. Some people are allergic to the solution, which can cause irritation of the eyes, difficulty breathing, and the appearance of hives on the body. Other common side effects include nausea, a headache, and a burning or stinging sensation at the site of the injection of the solution.
Gadolinium based contrasting agents have been associated with some severe complications in people that have experienced renal failure or other medical conditions involving the kidneys. The solutions are eliminated from the body through the kidneys, generally in a fairly quick manner, but if the person’s kidneys are not functioning properly, then it is believed that the solution remains in the body where it can cause numerous problems. One of the most serious issues discovered is the development of a condition known as nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy.
Nephrogenic systemic fibrosis is a condition characterized by itching, darkened or reddened patches appearing on the skin and a burning sensation occurring beneath the skin. As the condition progresses, the skin begins to harden and the person begins to have trouble moving their arms and legs. Over time, the progression of the condition becomes debilitating and can result in the death of the person. There is no known cure for nephrogenic systemic fibrosis and the progression of the condition can only be reversed by improving the function of the kidneys or dialysis immediately after the MRI to remove the Gadolinium from the body manually.
Do I Have a Gadolinium Lawsuit?
If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries.
Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.
All of the contrast agents that have been approved by the US Food and Drug Administration for use in MRI imaging to date contain a metal ion that has magnetic properties called Gadolinium. Gadolinium has proven to be very helpful for doctors attempting to diagnose a health issue because of its ability to illuminate abnormal tissues, fluid deposits, and tumors in many areas of the body under the magnetism of an MRI imaging machine. This allows many conditions to be diagnosed more quickly and with greater accuracy than if a contrast agent containing Gadolinium had not been used.
For use during an MRI imaging procedure, the contrast agent containing Gadolinium is injected into the bloodstream to be carried throughout the body. The contrast agent tends to collect anywhere there is an abnormal fluid deposit in the body, which could be an indicator of a number of different conditions. The areas with the higher concentration of Gadolinium show up much brighter on the MRI image, showing the doctor which areas should be focused on for further testing. Contrast agents containing Gadolinium have been found to enhance the images obtained by an MRI machine enough so that the exact size, shape, and location of a tumor can be discerned from the images of the body.
There are some complications associated with the use of a contrast agent containing Gadolinium for MRI imaging. Most of the complications that have been documented have been mild and easily remedied, but a complication associated with injecting a person with renal failure or kidney disease prior to an MRI imaging procedure has proven to be dangerous and life threatening to the people that are affected by the condition. The condition has been named Nephrogenic Systemic Fibrosis and has been positively diagnosed in at least 300 people since the condition’s discovery in 1997.
Nephrogenic Systemic Fibrosis is a disfiguring condition that can cause excruciating pain in the people that it affects. The disorder is characterized by hardened, tight skin that has lost all elasticity and has the appearance and roughness of orange peel. The toughing of the skin is accompanied by an itching sensation on the surface of the skin and a burning sensation beneath as the muscles begin to calcify. Over time, the areas that are affected by the condition become deformed and the person loses the ability to move any of the areas of the body that becomes affected by the disorder.
There is no effective treatment method for Nephrogenic Systemic Fibrosis currently available, although some patients were able to halt the progression of the condition and even reverse the effects by improving the function of the kidneys. There is no cure for the condition and the condition can progress at various rates, but it is proving difficult for researchers to identify who will develop the condition and at which rate the condition will progress. For some people, Nephrogenic Systemic Fibrosis progresses over a period of months or years, with the condition becoming gradually worse over time. In some others, the condition progresses rapidly with the patient becoming immobile within a matter of weeks. It is now recommended that doctors not use a contrast solution containing Gadolinium prior to MRI imaging if they believe that the patient’s kidneys are not functioning properly.
Do I Have a Gadolinium Induced Nephrogenic Systemic Fibrosis Lawsuit?
If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries.
Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.
When Nephrogenic Systemic Fibrosis was first discovered in 1997, very little was known about the condition other than what it was doing to the exterior of the bodies of the patients affected. The initial appearance of the condition was focused on the slow fibrosis of the skin on the trunk and extremities of the people affected, turning healthy skin into a dull, hardened shell with the consistency of an orange peel. As the disorder progressed, the affected patients lost their ability to move unassisted and were eventually confined to wheelchairs or became bedridden when they lost most of their mobility.
As the condition was studied further, it was discovered that Nephrogenic Systemic Fibrosis affected the tissues and the organs of the people affected as well. The muscles beneath the affected skin were calcifying, turning stiff and immobile as the condition progressed. The organs of some of the patients were calcifying as well, causing numerous health issues and making the condition a life threatening disorder for which there was no cure or even an effective treatment method.
It was discovered that all of the patients that had developed Nephrogenic Systemic Fibrosis had a few things in common. All of the patients had impaired renal function, either from renal failure or advanced kidney disease. All of the patients affected had also undergone an MRI imaging procedure with the use of an injection of a contrast solution containing Gadolinium to enhance the images obtained by the scan. The link between the Gadolinium injections and the development of Nephrogenic Systemic Fibrosis became stronger the more the researchers reviewed the cases.
There are currently only 300 cases of Nephrogenic Systemic Fibrosis positively diagnosed worldwide, making the condition one of the rarest conditions discovered. None of the cases that had been positively diagnosed could be traced back farther than 1997, providing a date for the researchers to begin their focus on. The first accounts of the condition were written into medical literature in 2000, with many researchers still attempting to discover why some people are developing the condition while others are not.
There are currently five different contrast agents that contain Gadolinium that have been approved for use by the US Food and Drug Administration for use in MRI imaging procedures, but only three of the contrast agents have been positively linked to people that have developed Nephrogenic Systemic Fibrosis. There are no contrast agents approved for use that do not contain Gadolinium, but not all people that have impaired kidney function who received an injection of a contrast agent containing Gadolinium prior to an MRI procedure have developed Nephrogenic Systemic Fibrosis. It is currently impossible to predict which patients will develop the condition and which will not.
Because of the strength of the link between contrast agents that contain Gadolinium and the development of Nephrogenic Systemic Fibrosis, the US Food and Drug Administration and the American College of Radiology has both issued warnings to doctors and healthcare professionals about the dangers of giving a patient with impaired renal function an injection of a solution containing Gadolinium prior to an MRI imaging procedure. They recommend that giving the solution to these patients should be avoided and if an injection of the solution is given, then the patient will need to undergo immediate dialysis after the procedure to remove the Gadolinium from their body. Because the condition can prove to be fatal to the person affected and there is no cure or treatment available for the disorder, prevention is the only way to guarantee that the person will not die from the development of Nephrogenic Systemic Fibrosis.
Do I Have a Gadolinium Induced Nephrogenic Systemic Fibrosis Lawsuit?
If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries.
Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.
Nephrogenic Systemic Fibrosis is a serious disorder that can negatively affect many different areas of the body. The condition is typically characterized by the way that it affects the skin of the patient, but it also affects the tissues, muscles, and organs of the body as well. The condition is considered to be extremely painful and debilitating to the people that it affects, with a number of them becoming wheelchair bound or immobile within a few months of receiving a diagnosis of the condition.
The most visible effect of Nephrogenic Systemic Fibrosis for a patient is the appearance of their skin. The skin begins to break out in reddened or dark blotches on different areas of the body which is accompanied by an irritating itching sensation that cannot be easily relieved. As the condition progresses, the itching begins to be accompanied by a burning sensation under the skin and the areas that have become red begin to stiffen and tighten as the skin loses its elasticity. Eventually, the skin becomes so hardened that the joints are immobilized and the person begins to lose their ability to move, becoming wheelchair bound or bedridden within a short period of time.
Nephrogenic Systemic Fibrosis was first diagnosed in 1997, making it a relatively new condition that little is known about. Researchers have continued to study the condition for clues on possible methods to treat or cure the condition and have come up with a link that provides some information about the reason for the development of the disorder. All of the patients that have received a confirmed diagnosis of the condition have renal failure or advanced kidney disease and have undergone an MRI imaging procedure using a contrasting agent containing Gadolinium. The association between the two is so strong that the American College of Radiology has revised its guidelines for performing an MRI imaging procedure to include the risks associated with giving a patient with renal failure or limited kidney function an injection of a solution containing Gadolinium.
Since the discovery of the condition in 1997, more than 300 people around the world have been diagnosed with Nephrogenic Systemic Fibrosis, making it an extremely rare condition by any standards. Other than developing in patients with renal failure, it is impossible to predict who will develop the condition and how fast the condition will progress. In some cases, the development of the condition goes very slowly with months between new developments in the disorder. For other people, the time span between the onset of the condition and the total loss of their mobility can occur within a few months.
There is currently no cure or effective treatment method available to halt or reverse the progression of Nephrogenic Systemic Fibrosis. Some patients have shown limited improvement in their condition with the improvement of their renal function, but this is hard to accomplish and is not a guaranteed result. The US Food and Drug Administration has released an advisory warning medical professionals and patients about the risks of injecting a patient experiencing renal failure or impaired kidney function with a solution containing Gadolinium prior to an MRI procedure, advising that alternate treatment methods be used to prevent the occurrence of Nephrogenic Systemic Fibrosis.
Do I Have a Gadolinium Induced Nephrogenic Systemic Fibrosis Lawsuit?
If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries.
Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.
The debilitating condition Nephrogenic Systemic Fibrosis is considered a very rare condition, with only 300 cases confirmed worldwide since the condition was first discovered in 1997. Because the condition is relatively new by medical standards, not much is know about the condition, its progression, and its causes. The strongest link that has been discovered so far is the link between the development of Nephrogenic Systemic Fibrosis and an injection of a Gadolinium based solution prior to an MRI procedure.
There are five contrast solutions containing Gadolinium that have been approved for use in MRI imaging procedures by the US Food and Drug Administration and three of them have been positively linked to individuals that have developed Nephrogenic Systemic Fibrosis. There are not any solutions available that are approved for use as a contrast agent that do not contain Gadolinium and not all patients that have undergone an MRI imaging procedure have developed the condition. Researchers are still looking for the exact cause of how the development of Nephrogenic Systemic Fibrosis is triggered and how to halt the progression of the condition or prevent the development of the condition completely.
All of the patients that have developed a confirmed case of Nephrogenic Systemic Fibrosis have impaired renal function, such as advanced kidney disease or renal failure. This has led researchers to surmise that Nephrogenic Systemic Fibrosis may be caused by the body of a patient with impaired kidney function being unable to remove the Gadolinium that has been injected into the body. Gadolinium is removed from the body by the kidneys and if the Gadolinium remains in the body traveling through the blood stream, then it could cause numerous problems for the person.
Nephrogenic Systemic Fibrosis affects many different areas of the body and there is no treatment available that can halt or reverse the progression of the disorder. The most visible symptom of the condition is the hardening of the skin, which will begin to look like the peel of an orange as the condition gets worse. The muscles beneath the skin and some of the bodily organs will begin to calcify and lose their elasticity, slowly robbing the person of their mobility until they have become bedridden or wheelchair bound. The condition can be fatal to the patient and can develop very quickly in certain cases, with the time between the appearance of symptoms and immobility lasting only a few months.
Nephrogenic Systemic Fibrosis is typically diagnosed by a visual inspection of the skin of the patient, followed by a biopsy of the tissue beneath. Only 5% of the people that have impaired kidney function that have used a Gadolinium based solution prior to an MRI procedure have developed the condition, but the link between the Gadolinium based solutions and the development of Nephrogenic Systemic Fibrosis is strong enough that both the American College of Radiology and the US Food and Drug Administration have issued warnings to the healthcare community about the association between the two. It is now recommended that doctors avoid giving any patient that they suspect of having impaired kidney function an injection of a solution containing Gadolinium.
Do I Have a Gadolinium Induced Nephrogenic Systemic Fibrosis Lawsuit?
If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries.
Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.
There are very few side effects that have been found to be associated with the use of Gadolinium as a contrast agent for MRI procedures. Solutions containing Gadolinium have been approved for use in MRI procedures since 1988 and have been used for thousands of procedures since then. Until recently, the most serious side effect that was associated with the use of contrast agents containing Gadolinium was an allergic reaction to the solution.
An allergic reaction to a solution containing Gadolinium could become life threatening very quickly without proper medical intervention. Many of the patients that experienced an allergic reaction after receiving an injection of a Gadolinium based contrast agent broke out in hives all over their bodies, which was often accompanied by a rash and uncomfortable, itchy eyes. Some people experienced a mild allergic reaction with localized burning where the solution has been injected into the skin or an itchy sensation that is spread over a significant portion of the body.
Patients that experience a severe allergic reaction to a solution containing Gadolinium may experience difficulty breathing, swelling of the face and neck area, and sweating excessively. A person that is experiencing a severe allergic reaction can go into shock if the reaction is not treated appropriately in a quick manner. Other common side effects associated with the use of a Gadolinium based solution prior to an MRI procedure include nausea and a mild headache that fades within a few hours.
In 1997, a new condition was found to be a side effect associated with using a solution containing Gadolinium in a patient with kidney disease or renal failure prior to an MRI procedure. This condition was named Nephrogenic Systemic Fibrosis and there have been around 300 cases of the condition diagnosed worldwide since the condition has been discovered. The distinguishing characteristics of the condition include hardened rough skin, a burning or itching sensation beneath the skin that cannot be relieved, and the progressive deterioration of the body’s mobility as the condition ravages the body.
Researchers are still unsure about why some of these patients have developed this debilitation condition after undergoing an MRI procedure with the use of a solution containing Gadolinium as a contrast agent. Some researchers believe that since Gadolinium is eliminated from the body through the kidneys, people with renal failure or advanced kidney disease are unable to remove the Gadolinium from circulating in the blood. This continued presence in the body somehow affects the cells of the skin by causing excessive collagen production and affects the muscles, causing them to slowly calcify and lose their elasticity.
If Nephrogenic systemic fibrosis is not treated quickly, the patient could eventually lose their ability to move on their own completely. In some of the cases discovered since 1997, the disorder took months to develop and progressed slowly through the stages of the condition. In other cases, the condition developed within days and the patient was confined to a wheelchair within a matter of weeks. There is no known cure available for the condition and the only effective treatment method to date is improving the renal function of the patient to eliminate the Gadolinium from the body naturally.
Do I Have a Gadolinium Lawsuit?
If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries.
Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.
The mechanical equipment used during most imaging scans is only half of the equation, because, without a contrast agent being used, many of the images are almost worthless for diagnostic imaging. This is one of the reasons why the use of a contrast solution containing Gadolinium is so popular with diagnostic technicians when performing an MRI. There have been many advances in the production of Gadolinium based solutions in recent years, resulting in a contrast agent that is safer, less toxic, less uncomfortable for the patient, and are easier for radiologists to administer.
There are five solutions containing Gadolinium approved for use in the United States by the US Food and Drug Administration (FDA) for MRI imaging procedures. These include Magnevist, Omniscan, ProHance, OptiMARK, and MultiHance. Each of these contrast agents work by introducing Gadolinium into the body safely, and when used with MRI, the magnetic properties of the Gadolinium provides highly detailed images of the body, helping the radiologist identify any areas that seem abnormal or is host to a cancerous growth. Some of these solutions can be used for specific areas of the body and all provide greatly enhanced imaging.
Magnevist is manufactured by Berlex Inc., located in Wayne, New Jersey. Many doctors prefer to use Magnevist for their MRI images because the solution does not interfere with certain other types of diagnostic testing. The safety record for Magnevist is considered excellent and the manufacturer holds educational classes for doctors to make sure that they are using the contrast agent correctly and as intended. This solution was approved by the US Food and Drug Administration in 1988, and was the first Gadolinium based contrast agent to gain approval from the FDA.
MultiHance is manufactured by Bracco Diagnostics located in Princeton, New Jersey. This solution received approval from the FDA and was released for use in 2004. It was the last Gadolinium based solution approved by the FDA before issues began to arise with the usage of these types of contrast agents. MultiHance was extremely effective in initial clinical studies, enhancing images twice as well as some other contrast agents. The solution is typically used to enhance images of the central nervous system to discover any areas of abnormal growth or lesions in the brain, spine, or associated tissue.
ProHance is also manufactured by Bracco Diagnostics and was approved by the FDA in 1992. ProHance is commonly used to enhance the images of the central nervous system in adults and children over the age of 2. It is considered to have high stability and a low osmolality and it very good at visualizing lesions in the spine, brain, and other associated tissues. The solution can also be used to image any lesions in the head or neck of adult patients.
OptiMARK was created by Mallinckrodt, a division of Tyco Healthcare, located in Hazelwood, Missouri. This solution is administered by IV and is used for the imaging of the liver, brain, and spine. It is also the one of the few contrast agents approved for power injection. It is typically used with the OptiStar LE, an injection system created specifically for use with OptiMARK.
Omniscan was approved by the US Food and Drug Administration in 1993. Manufactured by GE Healthcare, Omniscan is used to enhance MRI images of the central nervous system, specifically the spine, brain, and other associated tissues. The contrast agent is approved for use in adults and in children.
Solutions containing Gadolinium have recently been linked to the development of a serious, debilitating disorder called Nephrogenic Systemic Fibrosis. This condition is considered very painful and in rare cases, can cause death due to organ failure. Although only three of the five approved Gadolinium based contrast agents have been positively linked to the development of Nephrogenic Systemic Fibrosis, researchers believe that all five agents present an increased risk for the disorder. As new information continues to be discovered, healthcare professionals and researchers gain a greater understanding of the condition and, hopefully, will one day find a cure.
Do I Have a Gadolinium Lawsuit?
If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries.
Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.
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