Brain stents are a type of medical device that is used to help reopen passageways in the brain of patients who have suffered a stroke and those who are at an elevated risk for suffering more strokes in the future. These medical devices have provided life saving benefits to a large number of people, however not all stents are created equal and not all stents have provided positive results for patients.
One major manufacturer of brain stents has come under fire as of late because of reports of patients suffering strokes following having the stent implanted in the brain. The reports are being investigated as the stents appear to place patients at a higher than average risk of death and strokes compared to those who are just treated with more conventional drug therapy. Defective medical devices should not be allowed to be used on patients, and when they enter the market place, prompt action needs to be taken.
If you or someone you know has been harmed because of a defective brain stent, you should not hesitate to contact a personal injury attorney specializing in defective medical devices as soon as possible. These legal professionals can review the details of your case and may be able to help you to gain compensation for past, present, and future medical bills, lost income, pain and suffering, along with other types of damages from the manufacturer.
The defective brain stent systems in question were first approved as humanitarian use devices in 2005 by the United States Food and Drug Administration. The point of the system is to implant a small wire mesh tube, known as a stent, in the arteries that have narrowed blood supply in the brains of those who have had a transient ischemia, a stroke, or for those who are at high risk of suffering a stroke. This particular stent system was designed for use in difficult cases, in areas of the brain that are hard to reach. This system is quite a bit smaller in size than other types of stents used in the heart or neck areas of the body.
Humanitarian use devices (HDE) are subject to less strict approval protocols as compared to other types of medical devices. Because of this, the manufacturer was not required to provide evidence that the device was actually effective before it could be approved. In reality, the stent system in question was approved for use based on just one, uncontrolled trial that involved only forty five patients. There was no proof or evidence provided that the device was better than or safe than commonly used drug therapies.
In a study funded by the National Institutes of Health (NIH) in 2011, researchers found that the brain stent system not only did not perform better than other commonly used therapies, it actually increased the risk of future strokes and deaths. The complete results of the study were published in the New England Journal of Medicine in September of 2011 and found a greater than two and a half times increase in the chances of a stroke or death when using the system.Â
The study tracked four hundred and fifty one patients, and found that of those who had intracranial stents implanted, just over fourteen percent had a higher than average risk of stroke or death within a thirty day time period, increasing to a twenty percent chance within twelve months. The study's control group that used just medication had just over five percent risk of the same complications within thirty days, and a just over twelve percent risk within twelve months. The trail had to be stopped before all seven hundred and sixty four patients could enroll due to the high risk to those who received the stent. The researchers concluded that there is no possibility of a potential benefit to health by using the device, and that its benefits do not outweigh the risks of injuries or illness when considering other, safer, types of treatments.
A patient advocacy group known as Public Citizen requested that the Food and Drug Administration pull the HDE approval for the stent system in December of 2011. The group also requested that the manufacturer issue a full recall.
If you or someone you know has been harmed because of a procedure that made use of a defective brain stent, you must take prompt action to protect your legal rights. Manufacturers owe the public a particular duty of care to provide products that are safe and effective, and those which have been thoroughly tested to ensure they do not cause more harm than good. When this duty of care is breached, for any reason, it is important that those who are responsible are held accountable or the damage that has been done.
Medical device manufacturers have teams of attorneys working hard on their side to protect their interests at all costs. Because these cases can be quite complex and often focus on many small details, along with the fact that it is extremely difficult to take on large legal teams without assistance, you should not attempt to file a lawsuit on your own. A personal injury attorney specializing in defective medical devices can help you throughout the entire process in order to ensure you have the best chance at a favorable outcome.
A personal injury attorney cannot undo the harm that has been done, but he or she can help you to move forward in a positive direction. Since most of these legal professionals work on a contingency basis, you have no worry about funding your claim upfront, and often pay nothing until the time your case is settled. This means you have very little to lose, and a great deal to gain.
Taking action now not only protects your interests, and the interests of your loved ones, it also works to protect other innocent patients from falling victim to the same consequences down the road. Stopping medical device manufacturers from putting profits before people is essential to keeping the medical world as safe as possible.
One major manufacturer of brain stents has come under fire as of late because of reports of patients suffering strokes following having the stent implanted in the brain. The reports are being investigated as the stents appear to place patients at a higher than average risk of death and strokes compared to those who are just treated with more conventional drug therapy. Defective medical devices should not be allowed to be used on patients, and when they enter the market place, prompt action needs to be taken.
If you or someone you know has been harmed because of a defective brain stent, you should not hesitate to contact a personal injury attorney specializing in defective medical devices as soon as possible. These legal professionals can review the details of your case and may be able to help you to gain compensation for past, present, and future medical bills, lost income, pain and suffering, along with other types of damages from the manufacturer.
The defective brain stent systems in question were first approved as humanitarian use devices in 2005 by the United States Food and Drug Administration. The point of the system is to implant a small wire mesh tube, known as a stent, in the arteries that have narrowed blood supply in the brains of those who have had a transient ischemia, a stroke, or for those who are at high risk of suffering a stroke. This particular stent system was designed for use in difficult cases, in areas of the brain that are hard to reach. This system is quite a bit smaller in size than other types of stents used in the heart or neck areas of the body.
Humanitarian use devices (HDE) are subject to less strict approval protocols as compared to other types of medical devices. Because of this, the manufacturer was not required to provide evidence that the device was actually effective before it could be approved. In reality, the stent system in question was approved for use based on just one, uncontrolled trial that involved only forty five patients. There was no proof or evidence provided that the device was better than or safe than commonly used drug therapies.
In a study funded by the National Institutes of Health (NIH) in 2011, researchers found that the brain stent system not only did not perform better than other commonly used therapies, it actually increased the risk of future strokes and deaths. The complete results of the study were published in the New England Journal of Medicine in September of 2011 and found a greater than two and a half times increase in the chances of a stroke or death when using the system.Â
The study tracked four hundred and fifty one patients, and found that of those who had intracranial stents implanted, just over fourteen percent had a higher than average risk of stroke or death within a thirty day time period, increasing to a twenty percent chance within twelve months. The study's control group that used just medication had just over five percent risk of the same complications within thirty days, and a just over twelve percent risk within twelve months. The trail had to be stopped before all seven hundred and sixty four patients could enroll due to the high risk to those who received the stent. The researchers concluded that there is no possibility of a potential benefit to health by using the device, and that its benefits do not outweigh the risks of injuries or illness when considering other, safer, types of treatments.
A patient advocacy group known as Public Citizen requested that the Food and Drug Administration pull the HDE approval for the stent system in December of 2011. The group also requested that the manufacturer issue a full recall.
If you or someone you know has been harmed because of a procedure that made use of a defective brain stent, you must take prompt action to protect your legal rights. Manufacturers owe the public a particular duty of care to provide products that are safe and effective, and those which have been thoroughly tested to ensure they do not cause more harm than good. When this duty of care is breached, for any reason, it is important that those who are responsible are held accountable or the damage that has been done.
Medical device manufacturers have teams of attorneys working hard on their side to protect their interests at all costs. Because these cases can be quite complex and often focus on many small details, along with the fact that it is extremely difficult to take on large legal teams without assistance, you should not attempt to file a lawsuit on your own. A personal injury attorney specializing in defective medical devices can help you throughout the entire process in order to ensure you have the best chance at a favorable outcome.
A personal injury attorney cannot undo the harm that has been done, but he or she can help you to move forward in a positive direction. Since most of these legal professionals work on a contingency basis, you have no worry about funding your claim upfront, and often pay nothing until the time your case is settled. This means you have very little to lose, and a great deal to gain.
Taking action now not only protects your interests, and the interests of your loved ones, it also works to protect other innocent patients from falling victim to the same consequences down the road. Stopping medical device manufacturers from putting profits before people is essential to keeping the medical world as safe as possible.