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Infuse bone1/7/2023 Eugene Carragee, the editor of The Spine Journal. Some of this information was brought to light by Dr. It was also uncovered that several researchers involved in early studies of INFUSE, which did not disclose all the side effects, were given monetary kickbacks, in the form of millions of dollars in consulting fees and royalties. Nearly ten years after the INFUSE Bone Graft came on the market, information started to come to light that Medtronic may not have been completely transparent about the risks posed by rhBMP-2, the protein used in the graft. The graft is also contraindicated for children or anyone whose bones have not finished growing or in areas in which a patient has a tumor or had a tumor removed. The INFUSE Bone Graft is not indicated for use in pregnant women, and so women who could become pregnant are urged to have pregnancy tests and use contraception if having the surgery. The bone graft may also fail, break, bend or loosen, which may require additional surgery. These include allergic reactions, bone fractures, abnormal bone formation and growth, tissue damage, infections, pain, a bad reaction to anesthesia, paralysis or neurological problems, spinal cord damage, or nerve damage. ComplicationsĪlthough the idea is to reduce the risk of complications by eliminating one surgical procedure, there are still possible complications from using INFUSE Bone Graft to treat a degenerative disc. Performing one instead of two surgeries to treat lumbar degenerative disc disease reduces the risks of complications and reduces recovery time. The benefits of using INFUSE Bone Graft instead of a piece of bone harvested from the patient’s body is that it negates the need for this secondary surgery. This carrier releases the rhBMP-2 in small amounts to stimulate bone growth and is absorbed into the bone tissue. The scaffold for the bone graft is a sponge made from bovine collagen. This protein stimulates and regulates the growth and healing of bone tissue. The first is an engineered protein based on human bone protein, called rhBMP-2. The INFUSE Bone Graft includes two main components that make it work for re-growing bone and healing spinal discs. Using a bone graft is one way to repair the damage. Treatments that involve exercise, physical therapy, or medication can help, but for some patients, nothing but surgery will relieve the pain and increase flexibility and movement. When a disc becomes damaged it only gets worse over the years, causing pain and reducing mobility. The discs in the spine have minimal blood flowing to them so when they get damaged they can’t repair themselves very well. Discs exist between the vertebrae, the bones, of the spine and act like shock absorbers. Degenerative disc disease occurs when a disc in the spine is damaged and causes pain. Food and Drug Administration (FDA) approved INFUSE Bone Graft in 2002 for the treatment of degenerative disc disease in the lumbar region, or the spine in the lower area of the back. A bone graft can also be a synthetic material that is similar to real bone and that will be absorbed into the bone tissue. A bone graft can be a piece of bone harvested from somewhere else in the patient’s body or can come from a donor. A bone graft can act as that scaffold and allow the natural process of bone regrowth to occur. Bone tissue can regrow on its own, but it needs something to grow on, a scaffold. This may be needed after an injury, disease, or infection causes bone loss.Ī bone graft acts like a scaffold to support bone growth. Finally, a bone graft can be used to regenerate lost bone and promote the growth after regeneration begins. A bone graft may be used to heal a diseased joint. One reason is to help heal a bone fracture that is not healing well enough on its own. There are four main reasons that a patient may need a bone graft. What Are Bone Grafts?īone grafting is a surgical procedure used to repair, heal, and regenerate bone. Lawsuits have been filed against Medtronic for the grafts that have led to some of these issues accusing the company of deceptive marketing. The INFUSE product has caused some serious issues in some patients, including cancer, infections, and nerve pain. This synthetic material combines proteins and collagen from cows and is used in treating degenerative disc disease. INFUSE Bone Grafts are made by Medtronic and have been on the market since 2002. With a synthetic material, like the INFUSE Bone Graft, this extra surgical step can be avoided. Using real bone from within the patient requires additional surgical procedures, which increases the risk of complications. Bone grafts can be done with a piece of bone from the patient, donated bone, or synthetic material. A bone graft is a fragment of bone or material that mimics bone that is used to repair damaged or lost bone anywhere in the body.
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