1/4/2024 0 Comments Infuse bone graft![]() ![]() With offices across the state, we help victims of product liability throughout Florida. For a free evaluation of your case involving defective medications or pharmaceuticals, contact the personal injury attorneys at Rubenstein Law at 1-800-FL-LEGAL, we are available for you 24/7, nights and weekends. If you or a loved one is experiencing complications after surgery from the use artificial bone graft during surgery, you may be eligible to file a lawsuit. Off-label surgeries using the INFUSE Bone Graft trigger serious and sometimes debilitating side effects including infection, bone and nerve injury, sterility, urinary problems and potentially an increased risk of cancer.įree Consultation with a Qualified INFUSE Bone Graft Attorney What INFUSE bone graft complications can occur? In 2012, the US Senate found that Medtronic influenced research studies and secretly paid surgeons to write positive articles about their devices. Due in large part to persistent and deceptive marketing, 85% of INFUSE sales were for off-label uses by 2011. Medtronic is accused of fraud, encouraging the use of the bone protein in off-label situations and failure to issue notifications of complications or a product recall. The FDA issued an INFUSE warning in July 2008 after receiving several reports of serious complications caused by the protein. Yet, with dangerous results doctors have been using Infuse in unapproved neck (cervical) and lower back fusions. They were not given approval for use in neck surgeries or surgeries originating through the side or back. In 2002, Medtronic received limited approval from the Food and Drug Administration (FDA) to use their synthetic bone protein in specific surgeries on the lower spine that approach from the front only, tibia fractures, sinus augmentation and some dental procedures. This allows doctors to implant a synthetic bone graft instead of using bone from a cadaver or harvesting a graft from a patient’s hip, which can be painful. Name of Infuse, implant, Manufacturer, Lot No., Reference No.Infuse contains recombinant human Bone Morphogenetic Protein, which triggers bone growth. Infuse Graft Details: Product Label Details – i.e.Contraindications for Infuse Graft Usage: rhBMPs are contraindicated for all uses in patients who are skeletally immature (Cervical Spine Infuse – whether patient informed of off-label use, informed decision/consent made.Whether patient right candidate for infuse use? – Skeletally mature i.e.Need and Indication for Spine Surgery, Use of Infuse graft.Medical issues directly or indirectly related to spine – particularly degenerative disc disease, spine surgeries, prior infuse graft use.Patients not allowed to make an informed decision whether or not to proceed with surgeryĮctopic Bone Growth, swelling of neck and throat tissue resulting in compression of airway and nerves – leading to respiratory depression and other complications.Patients not told about off-label nature of the surgery, and/or were not told of the potential risks of serious and permanent injuries related to such use of Infuse.It is made from a genetically engineered version of a protein the body makes naturally when bones are growing called recombinant human bone morphogenetic protein-2 (rhBMP-2). (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge. Complications Due to Off-Label Use of Bone Graft in Cervical Surgery Procedures The Infuse Bone Graft is an alternative to harvesting bone from patients with certain bone or joint problems. INFUSE Bone Graft consists of recombinant human Bone Morphogenetic Protein-2.FDA Safety Alert: Note that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse Bone Graft With Mastergraft Strip and Posterior Fixation for Posterolateral Fusion.rhBMP-2 is also approved for certain oral and maxillofacial uses. rhBMP-2 (contained in InFuse Bone Graft) has received FDA premarket approval for fusion of the lumbar spine in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L 2-S 1 and for healing of acute, open tibial shaft fractures stabilized with an IM nail and treated within 14 days of the initial injury.Recombinant Human Bone Morphogenetic Protein (rhBMP) – Bioengineered liquid bone protein housed in a small container or cage that is implanted into the spine (spinal fusion surgery) – encourages bone growth.Medtronic Bone Infuse Graft Complications – Case Review – Focus Blocks
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