Defective Spinal Discs
Every year thousands of patients across the United States seek medical professional help for chronic back pain.
In some cases, this pain can be so debilitating that patients are unable to carry out normal daily tasks, and may even have to quit their jobs.
For some people, they may have a serious medical emergency when one of their discs in their spine actually ruptures, leading to the need for emergency surgery to repair the issue.
One advancement in this area of medicine is replacement spinal discs.
These discs come with the promise of great relief to pain and suffering, and a final end to back problems for patients who have suffered for years.
Doctors tout the many benefits of these replacement discs and often encourage their patients to undergo the surgery so that they can get some much needed relief.
While the promises made by the manufacturer of these discs sounds very good, in reality the benefits may not be all they are cracked up to be.
Many patients who have been diagnosed with the condition of degenerative disc disease have chosen to undergo a surgical procedure using one particular type of spinal disc implants that are made by one of the largest medical product manufacturers in the United States.
With such a great reputation, patients often feel quite confident that their surgery will go well and that their pain levels will be significantly diminished.
Unfortunately, many patients who have undergone surgeries using these particular spinal disc implants have found that their pain has not only diminished as promised, it has actually increased.
They also have noted that they have little to no improvement in their range of motion and activity ability.
In some cases, the complications from the surgery are so severe that patients have no choice but to undergo revision surgeries.
Sometimes the revision surgeries are far more complicated and involved than the original surgery, and can be life threatening.
The reason so many surgeries are done using this particular spinal disc implant by this particular manufacturer is because it is currently the only artificial spinal disc that is approved for use in the United States.
Prior to it gaining approval in 2004, the manufacturer's trials on the discs only aimed to prove that their product worked as well as the one disc and one cage that were currently being used in spinal fusions.
Both of these products have since been discontinued by the majority of surgeons because of their high rates of failure.
What's more, the manufacturer did not include the issue of pain relief in their clinical trials as a measure of success of their product.
Another issue that was not included in the study's success definition was the artificial disc's ability to improve or preserve the range of natural motion in the patient.
The trial only successfully showed that fifty seven percent of patients who had this particular disc surgery measured a modest level of success.
In spite of these somewhat lackluster results, the manufacturer went to, and continues to market their disc with catch phrases that state natural motion will return, and that the product is an effective alternative to spinal fusion surgeries.
A transcript from the FDA showed that a statistician for the agency found the pre approval study to be biased in favor of the artificial disc, and that it also left out important information from clinical trials that were randomized.
A major contributor to the University of California Irvine Spine Center expressed a great deal of concern regarding the artificial discs and has issued a request to the FDA that they pull the product from the market entirely.
He voiced his concerns in a May 2005 article published on thestreet.
com.
In this article he raised questions as to how the disc was allowed to be approved because of the poor results and the high potential for revision surgeries that are life threatening.
The author has also spoken out a great deal in public regarding the amount of scientific debate that has been discouraged regarding the artificial disc.
If you or someone you know has undergone spinal surgery that involved these artificial discs and you have continued to have pain or if you have been faced with the issue of having to undergo a secondary revision surgery, you should know that you have legal rights that can be protected.
You should not hesitate to contact a personal injury attorney who is skilled in the area of medical negligence, malpractice, and defective medical devices.
These legal professionals know the ins and outs of this area of the law better than anyone, and will help you with every aspect of your legal claim from start to finish.
Medical device manufacturers, as well as doctors and hospitals, have teams of attorneys working hard to protect their interests at all costs.
You should have someone in your corner who is going to work just as hard for you, and will get you a fair settlement without being intimidated by corporate attorneys.
In many cases, damages can be sought for a variety of issues including medical expenses (past, present, and future), loss of income, loss of quality of life, pain and suffering, and various other expenses.
In some cases, punitive damages can also be sought for the harm that has been done.
Punitive damages are a type of legal punishment handed down by the court in an effort to deter future similar acts from happening again.
For the most part, personal injury attorneys work on a contingency basis, which means that you do not pay anything until the time your case settles.
This can provide a great deal of relief during a time that is already quite stressful.
Removing this issue, and knowing you have an attorney working to secure your legal rights, can allow you to focus your attention on much more important issues, such as your personal health and recovery, as well as spending valuable time with your family.
Taking legal action is important for many reasons, so do not delay in seeking professional guidance.
In some cases, this pain can be so debilitating that patients are unable to carry out normal daily tasks, and may even have to quit their jobs.
For some people, they may have a serious medical emergency when one of their discs in their spine actually ruptures, leading to the need for emergency surgery to repair the issue.
One advancement in this area of medicine is replacement spinal discs.
These discs come with the promise of great relief to pain and suffering, and a final end to back problems for patients who have suffered for years.
Doctors tout the many benefits of these replacement discs and often encourage their patients to undergo the surgery so that they can get some much needed relief.
While the promises made by the manufacturer of these discs sounds very good, in reality the benefits may not be all they are cracked up to be.
Many patients who have been diagnosed with the condition of degenerative disc disease have chosen to undergo a surgical procedure using one particular type of spinal disc implants that are made by one of the largest medical product manufacturers in the United States.
With such a great reputation, patients often feel quite confident that their surgery will go well and that their pain levels will be significantly diminished.
Unfortunately, many patients who have undergone surgeries using these particular spinal disc implants have found that their pain has not only diminished as promised, it has actually increased.
They also have noted that they have little to no improvement in their range of motion and activity ability.
In some cases, the complications from the surgery are so severe that patients have no choice but to undergo revision surgeries.
Sometimes the revision surgeries are far more complicated and involved than the original surgery, and can be life threatening.
The reason so many surgeries are done using this particular spinal disc implant by this particular manufacturer is because it is currently the only artificial spinal disc that is approved for use in the United States.
Prior to it gaining approval in 2004, the manufacturer's trials on the discs only aimed to prove that their product worked as well as the one disc and one cage that were currently being used in spinal fusions.
Both of these products have since been discontinued by the majority of surgeons because of their high rates of failure.
What's more, the manufacturer did not include the issue of pain relief in their clinical trials as a measure of success of their product.
Another issue that was not included in the study's success definition was the artificial disc's ability to improve or preserve the range of natural motion in the patient.
The trial only successfully showed that fifty seven percent of patients who had this particular disc surgery measured a modest level of success.
In spite of these somewhat lackluster results, the manufacturer went to, and continues to market their disc with catch phrases that state natural motion will return, and that the product is an effective alternative to spinal fusion surgeries.
A transcript from the FDA showed that a statistician for the agency found the pre approval study to be biased in favor of the artificial disc, and that it also left out important information from clinical trials that were randomized.
A major contributor to the University of California Irvine Spine Center expressed a great deal of concern regarding the artificial discs and has issued a request to the FDA that they pull the product from the market entirely.
He voiced his concerns in a May 2005 article published on thestreet.
com.
In this article he raised questions as to how the disc was allowed to be approved because of the poor results and the high potential for revision surgeries that are life threatening.
The author has also spoken out a great deal in public regarding the amount of scientific debate that has been discouraged regarding the artificial disc.
If you or someone you know has undergone spinal surgery that involved these artificial discs and you have continued to have pain or if you have been faced with the issue of having to undergo a secondary revision surgery, you should know that you have legal rights that can be protected.
You should not hesitate to contact a personal injury attorney who is skilled in the area of medical negligence, malpractice, and defective medical devices.
These legal professionals know the ins and outs of this area of the law better than anyone, and will help you with every aspect of your legal claim from start to finish.
Medical device manufacturers, as well as doctors and hospitals, have teams of attorneys working hard to protect their interests at all costs.
You should have someone in your corner who is going to work just as hard for you, and will get you a fair settlement without being intimidated by corporate attorneys.
In many cases, damages can be sought for a variety of issues including medical expenses (past, present, and future), loss of income, loss of quality of life, pain and suffering, and various other expenses.
In some cases, punitive damages can also be sought for the harm that has been done.
Punitive damages are a type of legal punishment handed down by the court in an effort to deter future similar acts from happening again.
For the most part, personal injury attorneys work on a contingency basis, which means that you do not pay anything until the time your case settles.
This can provide a great deal of relief during a time that is already quite stressful.
Removing this issue, and knowing you have an attorney working to secure your legal rights, can allow you to focus your attention on much more important issues, such as your personal health and recovery, as well as spending valuable time with your family.
Taking legal action is important for many reasons, so do not delay in seeking professional guidance.
Source...