![]() Serious conditions such as Medtronic Infuse cancer and Medtronic Infuse sterility were potentially much more likely than what was previously thought. However, more and more patients over the years began reporting infuse bone graft complications. The widespread use of Medtronic Infuse bone drafts was due to both the product’s effectiveness and the perceived lack of serious side effects. Infuse has proven effective at encouraging bone growth in patients, but many have experienced severe side effects, the dangers of which may have been covered up by Medtronic themselves. The product is a man-made protein that is soaked in a sponge and then implanted into the spine in a metal casing. Has any condition that in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study.Medtronic Infuse bone grafts are designed to encourage bone growth in spinal fusion operations.Has received treatment with an investigational therapy (drug, device, and/or biologic) within 30 days prior to bone graft implantation surgery or such treatment is planned during the 12-month period following the study surgery.Has a history of allergy to bovine collagen products.Has a known hypersensitivity or allergy to titanium.Has a known hypersensitivity or allergy to collagen or protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins).Has a known history of prior exposure to silicone or injectable collagen implants.Has any previous exposure to any recombinant BMPs of either human or animal extraction.Has a history of autoimmune disease (e.g., systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis, etc.). ![]() congenital connective tissue disease (e.g., Ehlers-Danlos syndrome, osteogenesis imperfecta).Has a disease that affects bone metabolism, such as: methotrexate within the past 12 months.estrogen replacement therapy within the past 2 months or.chronic tetracycline (e.g., ongoing within the past month) or tetracycline analogs within the past 12 months.any previous use of intravenous bisphosphonates.cumulative use of oral bisphosphonates for 5 years or more.cumulative use of oral bisphosphonates for less than 5 years within the past 6 months.fluorides for 30 days or more within the past 12 months.Is taking medications or having treatment known to have an effect on bone metabolism, such as, but not limited to: Is alcohol or drug dependent, as determined by the investigator.Is actively using any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc.Has presence of an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).Has a planned augmentation site in the area of a resected or extant tumor.Has an overt or active systemic infection, such as human immunodeficiency virus (HIV), bacteremia, or hepatitis C virus (HCV).Has a pathology finding that would either compromise a bone grafting procedure or interfere with obtaining quantitative measurements from postoperative CT scans.Has a history of a failed alveolar ridge augmentation procedure. ![]()
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