Infuse Bone Graft Complications
The Medtronic Infuse bone graft has been under intense scrutiny by the Food and Drug Administration (FDA) for several years. It can cause serious and permanent complications. This implant contains recombinant human bone morphogenetic protein 2, or rhBMP-2. This is a genetically modified version of the BMP-2 protein, altered to promote accelerated growth when combined with collagen and placed in an implant cage. The device was designed to provide extra osseous tissue for patients, eliminating the need to take it from elsewhere in the body during a procedure.
However, medical practitioners have used it in ways not approved by the FDA, and patients are often not notified that the implant is being used off-label prior to treatment. In fact, the FDA has approved the usage of rhBMP-2 in only one major patient population. Patients suffering from degenerative disc disease may be approved for rhBMP-2 treatment if they are skeletally mature, are suffering from open tibial shaft fractures that have been stabilized and are being treated within 14 days of injury. These procedures are only performed on the lumbar part of the spine, which consists of the five vertebrae located between the rib cage and pelvis. The Medtronic Infuse bone graft is also approved in a small number of oral procedures.
The device is not approved for use in other areas of the body, but the FDA has received dozens of reports of the Medtronic Infuse bone graft being used in cervical treatment. The cervical part of the spine consists of the vertebrae that form the neck. The FDA has not verified the device’s safety for use on this part of the spine, and many case reports suggest that it is not worth the risk. In fact, the FDA recommends patients find an alternative form of treatment when considering cervical fusion.
Serious Side Effects
There are several serious side effects noted in patients who receive the implant in areas other than the lumbar spine. When placed in the cervix, the device can cause swelling in the throat or neck, which may lead to constriction of the airway or nervous tissue. The FDA’s case reports found that patients that suffered from swelling had difficulty breathing, swallowing or talking. Though swelling was usually transient, it often required immediate medical attention, including intubation or tracheotomy. Some patients required additional surgeries to drain the area of excess fluid.
Other serious complications include radiculopathy, or pain emanating from the arms or legs. This pain manifests constantly, making it difficult for the sufferer to function. Some patients experience excessive overgrowth of osseous tissue in the spine, which will require secondary surgeries to manage. Nerve injuries have also been reported and can cause permanent disability or pain. Male patients may also be rendered sterile or suffer from other urogenital complications. These disorders are typically irreversible and require ongoing care to manage.
Consulting An Attorney
Doctors that use the implant off-label are acting negligently, especially if they do not inform the patient of this ahead of time. Complications associated with the device can leave a permanent, debilitating impact on a patient’s life, possibly resulting in expensive medical bills, loss of occupation or loss of quality of life. Anyone who has received this device and suffered from these side effects should consider speaking to a personal injury lawyer. With the help of a knowledgeable legal expert, a victim may be able to get the compensation they need to recover and reclaim their life.