Bone graft function structural support of articular fracture tibial plateau fracture prevent postop collapse. Medtronic infuse bonegrowth lawsuit parker waichman llp. Bone grafts and bone graft substitutes in orthopaedic trauma surgery. Infuse bone graft stimulates the recruitment and differentiation of bone forming cells inducing new bone formation or healing existing bone. Infuse bone graft should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy or patients undergoing treatment for a malignancy. The table below reflects the infuse bone graft kit components, including the labeling documents. Infuse bone graft consists of recombinant human bone morphogenetic protein 2. Medtronic infuse is a medical device that is supposed to help regrow bone in the spine, but it has become controversial because of safety concerns. Infuse bone graft has been on the market since 2002 and has been used in more than 1 million patients worldwide. Infuse contains a synthesized human hormone that causes bone to grow. Bone graft prior authorization request security health plan. The composition of allograft and synthetic bone graft substitutes and their mechanism of action can vary widely. Examples of bone graft applications bone recession restorative surgery implant surgery thoracic closure spine fusion supplement cages distal tibiafibula fractures. For all patients, a standard surgical procedure will be used, including.
Approval by the fda for the use of infuse bone grafts to treat open tibial fractures was granted on april 30, 2004 pdf. Currently, two rhbmps and four associated carrierdelivery systems one of which has been voluntarily withdrawn from the u. Bone grafting spine and trauma surgery infuse bone graft. Medtronic sofamor danek, memphis, tn is now widely used as an iliac crest bone graft icbg substitute for lumbar spine fusion. Medtronic infuse bone graft lawsuit filed over complications. I am a year post op from a l3 l4 l5 s1 spinal fusion using titanium scews, rods and cages with infuse bone graft material made by medtronics. These patients received either infuse bone graft or autogenous bone graft. Infuse bone graft is the premium product for autograft replacement due to its high osteoinductivity. Medtronic announces new clinical trial to study infuse bone. Bone morphogenetic protein2 bmp2 is an osteoinductive bone growth factor found in small amounts in the body that stimulates pluripotent cells to form bone. Infuse bone graft induces new bone tissue at the site of implantation. There are two main components to the infuse bone graft.
Sep 26, 2019 medtronic has initiated site recruitment for the tlif clinical trial with the potential to enroll up to 50 sites with over 1,000 patients. Some reports described difficulty swallowing, breathing, or speaking. Over the years, the range of reported complications have included infection, male sterility, bone and nerve injury, urinary problems, severe pain. The perioperative cost of infuse bone graft in posterolateral. Infuse bone graft should not be used in patients who are skeletally immature infuse bone graft medtronic interbody fusion device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease ddd at one level from l2s1. This is the second expanded indication in just over two years.
Infuse bone graft complications complications, fda warnings. The infuse system is designed for use in people with degenerative disc disease, including grade i spondylolisthesis, more commonly known as a slipped disc in the spine. There is a lack published material on the use of infuse bone graft for anterior lumbar interbody fusion, the indication for which the technology received the fda approval. Medtronic announces infuse settlements orthopedics this week. A sponge is manufactured from bovine collagen to act as a carrier, or a framework for the new bone growth. A study of infuse bone graft bmp2 in the treatment of. The infuse is used in spinal fusion surgeries to stimulate bone. Food and drug administration fda approved the medtronic infuse bone graft made from synthetic protein mixed with cow collagen for use in spinal fusion procedures.
Damaged or diseased bones are often held together by a synthetic, concentrated protein called a bone graft. Mar 24, 2016 a total of 54 patients will be randomized for treatment with or without infuse bone graft at the time of surgical repair. Infuse bone graft and mastergraft granules with cd horizon. Bone or soft tissue healing and fusion enhancement products community plan medical policy. Additional medtronic perspective rhbmp2 integrity and patient safety are medtronics highest priorities, and we strongly believe that the safety profile reported to the fda and summarized in the product label support the safe use of infuse bone graft rhbmp2 for the identified indications. Bone graft materials are often combined to extend graft. The infuse bone graft was generally viewed as a safe substitute to traditional bone grafts, but the discovery of unreported adverse events from patients and doctors put the product into question. Infuse bone graftltcage lumbar tapered fusion devices are implanted side by side 9. Infuse bone graft problems medtronic bone graft complications. Prior to implantation, rhbmp2 is reconstituted with sterile water for injection and the solution is then uniformly applied to the acs. Infuse bone graft kits are stored at room temperature. Jan 24, 2011 two studies have documented the costeffectiveness of infuse in spinal surgery.
Infuse bone graft medtronic has gained fda approval in new spine surgery indications. Glassman and colleagues trial 2008 had the advantage of comparing rhbmp2 to iliac crest bone graft in a randomized controlled trial. Bone or soft tissue healing and fusion enhancement products page 1 of 14. Bone graft substitutes need for bone graft alternatives has lead to development of numerous bone graft substitutes avoid morbidity of autogenous bone graft harvest mechanical properties vary most offer osteoconductive properties some provide osteoinductive properties. Infuse bone graftltcage lumbar tapered fusion device extension of device use from l2 to s1 may be used with retrolisthesis 0704 p000058s002 infuse bone graftltcage lumbar tapered fusion device indicated for acute, open tibial shaft fractures stabilized with nail fixation 1009 p000058s033. For many patients who received the product, the story will never end. Mdt said today it launched a longterm clinical study of its infuse bone graft for use during posterolateral fusion and transforaminal lumbar interbody fusion spine procedures. The first is an engineered protein based on human bone protein, called rhbmp2. The infuse bone graft medtronic interbody fusion device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease ddd at one level from l2s1. Mar 06, 20 the complaint pdf was filed by clinton thorn in the u. Infuse bone graft is contraindicated for patients with a known hypersensitivity to recombinant human bone morphogenetic protein2, bovine type i collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with an active malignancy or patients undergoing treatment for a. A total of 54 patients will be randomized for treatment with or without infuse bone graft at the time of surgical repair. An independent licensee of the blue cross and blue shield association bone morphogenetic protein.
Recombinant human bone morphogenetic protein2 rhbmp2 is a potent biologic agent that carries both osteoinductive and osteoconductive properties. Doctors have done a full battery of tests, blood work. Infuse bone graft consists of recombinant human bone morphogenetic protein2 rhbmp2, known as dibotermin alfa p laced on an absorbable collagen sponge acs. Bone grafts can be harvested from the patient autograft, a cadaver allograft, or they can be synthetic.
One of the functions of the protein is to stimulate natural bone formation. The infuse bone graft is made from synthetic material and it was proposed as a safer method of boosting bone structure. This protein stimulates and regulates the growth and healing of bone tissue. Status of infuse bone graft lawsuits financial documents filed with the federal government in june 2017 reported medtronic planned to settle substantially all of the remaining 6,000 or so lawsuits over its infuse device. The perioperative cost of infuse bone graft in posterolateral lumbar spine fusion. Its potential as an autologous bone graft substitute in spine surgery led to its approval by the united states food and drug administration fda in 2002 following a series of industrysponsored.
Faqs about medtronics infuse bone graft national injury help. District court for the western district of michigan on march 1, alleging that medtronic illegally promoted use of the infuse bmp bone. Ddd is defined as discogenic back pain with degeneration of the disc. The infuse bone graft component induces new bone tissue at the site of implantation. Medtronic incs infuse bone graft, a bioengineered bonegrowth product used in spinal surgery, has been linked to a greater cancer risk than previously thought in patients treated with high doses of medtronics controversial protein. Bone or soft tissue healing and fusion enhancement. These patient lawsuits are just the latest news in the decadelong infuse controversy. Infuse bone graft important medical information these.
Medtronics infuse bone graft is also at the center of thousands of injury lawsuits, scathing medical reports, and federal investigations. Bone grafts can be done with a piece of bone from the patient, donated bone, or synthetic material. The only spinal surgical technique that is fda approved for use with the infuse bone graft is the anterior lumbar interbody fusion alif. The infuse bone graftmedtronic interbody fusion device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease ddd at one level from l2s1, who may also have up to grade i spondylolisthesis or grade 1 retrolisthesis at the involved level. Fda approval for infuse bone graft in expanded spinal.
Infuse bone graft systems received initial fda pma approval p000054 in april 2004 for treatment of fractures. In the first, a prospective randomized trial assessed the relative costeffectiveness and efficacy of infuse bone graft rhbmp2acs. Nov 11, 2016 medtronic infuse bone graft side effects. Ddd is defined as discogenic back pain with degeneration of the. For patients who need more bone to place dental implants. Now, the product is being linked to serious injuries, including nerve damage and a possible increased risk in developing cancer.
Infuse bone graft is recombinant human bone morphogenetic protein2 rhbmp2 applied to an absorbable collagen sponge carrier acs. Bone or soft tissue healing and fusion enhancement products. Based on data from nonclinical studies, the bone formation process. The infuse bone graft includes two main components that make it work for regrowing bone and healing spinal discs.
Bone grafting and bone graft substitutes original author. Your doctor has recommended that you consider surgery. Infuse bone graft overview 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. Infuse contains a bioengineered bone protein, bmp, and it is used as an alternative to bone grafting, which involves the transplantation of a piece of bone. There is extensive level i clinical data supporting the efficacy of rhbmp2acs for anterior interbody fusion. Infuse bone graft for the treatment of open tibial fractures. Infuse has been linked to side effects such as cancer, male sterility and, excess bone. Medtronic infuse was introduced in 2002 as an alternative to traditional bone grafting procedures, where bone is harvested from another part of the body or from cadavers to encourage bone. Based on data from nonclinical studies, the bone formation process develops from the outside of the implant towards the center until the entire device is replaced by. Defendants manufactured, designed, marketed, promoted, and sold infuse for use in lumbar spine fusion surgeries. Bone morphogenetic protein infuse bone graftmedtronic interbody fusion device approval 1215, marketing name change expanded indication for 2 additional interbody fusion devices perimeter interbody fusion device implanted via retroperitoneal alif l2 to s1 or olif l5 to s1.
The infuse bone graftmedtronic interbody fusion device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease ddd at one level from l2s1. Medtronic launches longterm plf, tlif infuse bone protein. It contains a recombinant version of bone morphogenetic protein2 rhbmp2, which is known to be upregulated in the bone healing process assisting in bone regeneration. Multiple studies were conducted on approximately 312 patients who did not have enough bone in their upper jaw to place implants. Medtronic has initiated site recruitment for the tlif clinical trial with the potential to enroll up to 50 sites with over 1,000 patients. The popular infuse bone graft, used in spinal fusion surgery and other procedures, has been linked to serious complications and deceptive. The infuse bone graft is an alternative to harvesting bone from patients with certain bone or joint problems. Glassman sd, carreon ly, djurasovic m, campbell mj, puno rm, johnson jr. The infuse bone graftltcage lumbar tapered fusion device is indicated for spinal fusion procedures in skeletally mature patients with.
It is used as an alternative bone graft fill to iliac crest bone harvesting. Modeling bone morphogenetic protein diffusion of infuse. Rhbmp2 versus iliac crest bone graft for lumbar spine fusion. It is made from a genetically engineered version of a protein the body makes naturally when bones are growing called recombinant human bone morphogenetic protein2 rhbmp2. Infusebone graft is now approved for use with additional spinal implants made of peek in olif 25, olif 51, and alif procedures at a single level. In 2017, medtronic announced the fda approval of a separate clinical trial to study infuse bone graft in posterolateral fusion plf procedures. The medtronic infuse bone graft has a colorful history from beginning to wherever it ends. A randomized, controlled trial in patients over sixty years of age. Dec 14, 2011 infuse bone graft and mastergraft granules with cd horizon for posterolateral lumbar fusion in patients with degenerative disc disease pilot study the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Infuse bone graft grew bone without the need of a bone harvest procedure that is necessary for autogenous bone grafting. Medtronic launches longterm plf, tlif infuse bone protein study. Infuse bone graft is a combination product consisting of a recombinant version of a naturally occurring protein for bone healing and regeneration and an absorbable carrier matrix. I have done reasonably well as far as pain levels, but have been seriously ill with general poor health,fatigue,loss of sleep and appetite. Infuse bone graft for open tibial fractures instructions for preparation the instructions for preparation must be followed and the rhbmp2 must be reconstituted to a solution concentration of 1. Jul 17, 2007 the identification and development of recombinant human bone morphogenetic protein2 rhbmp2 has lead to the commercial availability for the first time of an osteoinductive autograft replacement infuse bone graft, medtronic spinal and biologics, memphis, tn. Modeling bone morphogenetic protein diffusion of infuse bone.
Infuse bone graft should not be used in patients who are skeletally immature bone graft is a revolutionary bone graft that helps stimulate natural bone formation and remodeling and avoids the need for harvesting bone from other parts of a patients body. Medtronic announces new clinical trial to study infuse. Infuse has been on the market since 2002 and has been used in more than 1 million patients worldwide. Malpractice lawsuit filed over medtronic infuse bmp.