The Medtronic Infused Bone Growth Stimulator, also known as the Bone Graft, is intended for patients with damaged spinal disks. Instead of harvesting bone grafts from other regions of the patient’s body, the stimulator utilizes rhBMP (recombinant human bone morphogenetic protein) to trigger natural bone growth in specific regions of the spinal column. In some cases, the stimulator has been used for patients who suffer from neck injuries. However, this is an off-label application of the product that can lead to a variety of complications and side effects.
Medtronic Infused Bone Growth Simulator Side Effects
The Medtronic Infused Bone Growth Stimulator has been widely tested for its approved use, which is for anterior lumbar fusion procedures. Off-label uses may pose risks to patients though. Examples of off-label uses may include cervical fusions, posterior lumbar fusions, and thoracic fusions. Multiple fusions have also not been tested and approved for this product. Here are some of the side effects that have been linked to off-label applications of the Medtronic Infused Bone Graft:
Breathing difficulties (including trouble swallowing and speaking)
Hypoventilation (respiratory depression)
In some cases, the product has even been linked to occurrences of death, or patients require further medical treatments to counteract the side effects. For example, certain patients may need feeding tubes, respiratory support, or tracheotomies.
FDA Warning and Conflict of Interest
The FDA issued an off-label use warning in July of 2008, after receiving over 38 reports of medical complications related to the Medtronic Infused Bone Growth Stimulator. They stated that “that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.” The Wall Street Journal also published an article that stated Medtronic paid around $800,000 over a three-year time period to a surgeon who was conducting a study regarding the bone stimulator. It was alleged that the surgeon was fabricating the findings of the study.
Patients who have received the Medtronic Infused Bone Growth Stimulator may be entitled to compensation, particularly if it has resulted in serious side effects of adverse reactions. Speaking with a qualified legal professional can help to determine if a patient or their loved ones may be eligible for lost wages, medical bills, or other expenses.