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The Food & Drug Administration has received at least 280 reports for Medtronic's Infuse bone graft side effects. About 75% of the reports involved off-label use, particularly in the cervical spine.
Off-label use of FDA-approved medical devices and drugs is unregulated. However, it's legal except in the case of some controlled substances. When doctors discover new uses for medical devices and drugs, this is known as off label.Contact Our Infuse Bone Graft Lawyers Today »
According to a 2006 study published in the Archives of Internal Medicine, 21% of all prescriptions, even without any scientific evidence, are prescribed off label.
Even though new uses have been found for the drugs and medical devices, drug makers and medical device makers rarely choose to put these already approved products through more lengthy approval processes. Both the drug maker and the medical device manufacturer cannot advertise the new off label usage unless the new information is submitted to the FDA for approval. Then, of course, it would no longer be considered off label, once approved. The FDA encourages drug makers to add new information, but doesn't require it.
This seems like a medical malpractice or wrongful death lawsuit waiting to happen. To use a drug or medical device like Medtronic's Infuse bone graft for which there are no clinical trials when implanted in other parts of the spine than the approved use.
Some grievous concerns about off label medical devices are that the insurance companies won't cover the cost. If doctors can prove through some reliable medical grapevine, that could help being reimbursed for insurance purposes. Another risk is when there is no evidence whatsoever in off label effectiveness; in some cases it's downright dangerous.
One has to wonder what the problem is if the FDA is receiving too many negative reports about the off-label usage of Medtronic's Infuse bone graft use? Why doesn't the FDA change the ruling and start to regulate off label medical devices like Infuse? Why do doctors and hospitals still use Medtronic Infuse bone graft for off label use? Is there no communication between hospital administrators and the FDA? Why is Medtronic permitted to keep promoting the off use label? If you're reading about it here, why is someone somewhere not making the dangerous off label practice be discontinued at the source?Do You Have A Medtronic Spinal Medical Device Case? »
Talk to a lawyer today to find out how we can support you during this difficult time. Start by contacting Monheit Law for your free, no-obligation, consultation.