In the event of a broken bone or bone defect,1 it may not always be possible for the bone to heal without assistance. One solution is for patients to receive a bone graft. A bone graft is a surgical procedure in which a surgeon places new bone or substitute bone around a broken or defective bone. Companies such as Medtronic manufacture synthetic bone graft products. These products can be a good alternative to traditional bone graft methods. There are, however, risks from the use of Medtronic INFUSE® Bone Grafts.
How Medtronic INFUSE Bone Grafts work
Medtronic INFUSE Bone Grafts2 are comprised of a synthetic, liquid protein known as recombinant human Bone Morphogenetic Protein (rhBMP). This protein encourages new bone growth by stimulating a patient’s own cells to make new bone (osteoinduction). This is preferable to bone transplantation, particularly for patients needing a spinal fusion. The protein may be able to stimulate new growth more quickly and reliably than other methods. The U.S. Food and Drug Administration approved the Medtronic INFUSE for use in the lumbar spine in 2002.3 The FDA also approved the product in 20044 for tibial fractures and in 2007 for use in spinal augmentations.
Complications and risks of Medtronic INFUSE
A number of complications may arise in patients using Medtronic INFUSE:
- Inflammation and swelling around the treated area
- Back and leg pain
- Degeneration of bone tissue (osteolysis)
- Unwanted bone formation in the spinal canal (ectopic bone formation)
It is even possible to die as a result of Medtronic INFUSE. Studies of Medtronic INFUSE have led to some serious allegations.
Medtronic INFUSE trials and studies
In 2011, an editorial published in The Spine Journal revealed that Medtronic-sponsored clinical trials had not disclosed some of the potential life-threatening side effects arising from the use of rhBMP. The editorial in the medical journal also noted that Medtronic had paid some of the researchers running these studies millions of dollars per year in royalties and other fees. The editorial also disclosed the results of an independent study, which found that the risk of post-surgical complications with INFUSE was the same or greater than traditional bone graft methods. Medtronic markets the product as superior to traditional bone grafts.
Consulting an attorney
If you or a loved one suffers an injury from Medtronic INFUSE, you should consult an attorney as soon as possible. Patients suffering from Medtronic INFUSE injuries are filing lawsuits against the manufacturer. These patients are claiming compensation for their pain and suffering as a result of the product's advertising. A trained attorney can help you determine whether you may be able to file a lawsuit and guide you through all the appropriate steps that you will need to follow.