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While the bone morphogenetic protein-2 used in Infuse® Bone Graft and LT-Cage® Device is supposed to promote and increase bone formation in the vertebrae, it has also been linked to forming bone in unwanted areas of the body. This condition is known as ectopic bone growth.
The risk of ectopic bone growth can be high, especially in off-label procedures. The risks that weigh in with unwanted bone growth are extremely cumbersome and uncomfortable for the patient. In some cases, there are two to three surgeries that have to be performed if this condition occurs: the first surgery is the implantation of Infuse® Bone Graft (which can ultimately lead to the unwanted bone growth); the second is the removal of the device and the extra bone growth and possibly a third surgery to remove ectopic bone that has continued growing. There are cases where ectopic bone, even after being removed, can grow back at an increased rate in size and pace.
In studies performed in the beginning of clinical trials of the product showed that 70% of patients that had a procedure with Infuse® Bone Graft had ectopic bone growth that could be seen in their CT scans. Unwanted bone growth can cause complications in patients; however, there are times when no symptoms or discomfort arises from it at all. There is a high risk for severe nerve damage if the bone growth is an area near nerve receptors. The unwanted bone growth can also cause severe discomfort if it interferes with soft tissue. In rare cases, ectopic bone growth can result in permanent or paralysis disabilities.
The Food and Drug Administration label on Infuse® Bone Graft does warn of potential ectopic bone growth. Patients should discuss any concerns of unwanted bone growth prior to having surgery. If discomfort arises in the back post surgery, a patient should seek professional medical advice. Symptoms related to ectopic bone growth, especially in the neck area, are swelling and problems swallowing. If these symptoms are seen in a patient that has undergone a procedure involving Infuse® Bone Graft they should seek immediate medical attention.
If you or someone you know suffered painful injuries after being implanted with a Medtronic Infuse Bone Graft device, you may have valuable legal rights. We’re here to answer any questions you may have. For a free case review, please fill out our online form or call our office at 727-397-9198.