WHAT IS INFUSE BONE GRAFT?
Infuse™ Bone Graft is a growth factor enhanced bone graft option from Medtronic. Growth factors are a manufactured (genetically engineered) version of a natural protein normally found in small quantities in the body, which regulates bone healing and growth. The natural carrier is made of a material found in bovine tendons. It releases the protein over time where it is placed, provides a scaffold (framework) for new bone to grow into, and is absorbed and replaced by bone over time.
HOW DOES INFUSE BONE GRAFT WORK?
Infuse Bone Graft stimulates the growth of bone-forming cells, manufacturing new bone to replace or heal existing bone. Infuse Bone Graft consists of two parts: a protein that is found in everyone’s body, plus a natural carrier for delivery. RhBMP-2 is the active ingredient in Infuse Bone Graft.
Infuse Bone Graft tells your body to make its own bone:
- Infuse Bone Graft is surgically placed where you need bone to grow.
- A protein signal is sent out to the body to recruit cells to that area.
- Those cells are changed into bone building cells.
- Bone building cells begin making your own bone in that area.
AVOID THE PAIN ASSOCIATED WITH REMOVING BONE FROM YOUR BODY
Using Infuse Bone Graft eliminates the need for a second surgery to “harvest,” or remove surgically, bone from your body (”autogenous” bone) for placement at the oral surgery site. Autogenous bone harvest has the risk of pain, complications, longer surgical time and more anesthesia. For procedures where autogenous bone is not typically used, Infuse Bone Graft can also be used.
BENEFITS OF USING INFUSE BONE GRAFT IN DENTAL SURGERY
Infuse Bone Graft has been proven clinically safe and effective for bone formation. It offers several benefits:
- You don’t need a second surgery to harvest bone from another place in your body.
- Bone grows where Infuse Bone Graft is placed.
- Bone growth results are proven and predictable.
- Infuse Bone Graft directs your body to grow your own bone. There is no residual graft material after bone is formed.
DRAWBACKS OF INFUSE BONE GRAFT
- You may experience short term mild to severe facial swelling (edema) after the surgery.
- It has not been studied for use in patients under 18 years of age.
- It cannot be used in patients with an active infection at the defect site.
- It should not be used in pregnant women, women who plan to become pregnant in the next 12 months, or women who are nursing.
- It should not be used in people with immune deficiencies due to other treatments, such as radiation therapy, chemotherapy, or steroid therapy.
CLINICAL DATA SUPPORTS INFUSE BONE GRAFT FOR DENTAL SURGERIES1,2
Multiple studies were conducted on approximately 312 patients who did not have enough bone in their upper jaw to place implants. These patients received either Infuse Bone Graft or autogenous bone graft. Infuse Bone Graft grew bone without the need of a bone harvest procedure that is necessary for autogenous bone grafting.
Both the Infuse Bone Graft and autogenous bone graft formed new bone that allowed for the placement of dental implants into patients who otherwise would not have been able to have implants placed. These implants were retained by the majority of patients for two years.
In the sinus lift clinical studies, most patients grew enough bone to place a dental implant regardless of whether they had autogenous bone or Infuse Bone Graft. However, the patients who received autogenous bone graft had a higher success rate of dental implant placement without additional augmentation and a higher rate of significant adverse events, such as limping, pain, and infection.
Complications were reported for both Infuse Bone Graft and autogenous bone graft patients. Patients who received Infuse Bone Graft had fewer complications than those patients who had autogenous bone graft. However, one adverse event, face swelling, was reported more often in the Infuse Bone Graft group.
Please speak with your doctor concerning potential complications associated with your procedure, as well as for more information on these clinical studies.
▪In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Reduced ossification of the frontal and parietal bones of the skull was noted infrequently (<3%) in fetuses of rabbit dams immunized to rhBMP-2; however, there was no effect noted in limb bud development. There are no adequate and well-controlled studies in human pregnant women. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments.
▪Women of childbearing potential should be advised that antibody formation to rhBMP-2 or its influence on fetal development has not been completely assessed. In the clinical trial supporting the safety and effectiveness of the Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device, 2/277 (0.7%) patients treated with Infuse™ Bone Graft component and 1/127 (0.8%) patients treated with autograft bone developed antibodies to rhBMP-2. The effect of maternal antibodies to rhBMP-2, as might be present for several months following device implantation, on the unborn fetus is unknown. Additionally, it is unknown whether fetal expression of BMP-2 could re-expose mothers who were previously antibody positive. Theoretically, re-exposure may elicit a more powerful immune response to BMP-2 with possible adverse consequences for the fetus. However, pregnancy did not lead to an increase in antibodies in the rabbit study. Studies in genetically altered mice indicate that BMP-2 is critical to fetal development and that a lack of BMP-2 activity may cause neonatal death or birth defects. It is not known if anti-BMP-2 antibodies may affect fetal development or the extent to which these antibodies may reduce BMP-2 activity.
▪Infuse™ Bone Graft should not be used immediately prior to or during pregnancy. Women of childbearing potential should be advised not to become pregnant for one year following treatment with the Infuse™ Bone Graft/Medtronic Interbody Fusion Device.
▪The safety and effectiveness of the Infuse™ Bone Graft/Medtronic Interbody Fusion Device in nursing mothers has not been established. It is not known if BMP-2 is excreted in human milk.
▪Women of childbearing potential should be advised that antibody formation to rhBMP-2 or its influence on fetal development has not been completely assessed. In the clinical trial supporting the safety and effectiveness of the Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device, 2/277 (0.7%) patients treated with Infuse™ Bone Graft component and 1/127 (0.8%) patients treated with autograft bone developed antibodies to rhBMP-2. The effect of maternal antibodies to rhBMP-2, as might be present for several months following device implantation, on the unborn fetus is unknown. Additionally, it is unknown whether fetal expression of BMP-2 could re-expose mothers who were previously antibody positive. Theoretically, re-exposure may elicit a more powerful immune response to BMP-2 with possible adverse consequences for the fetus. However, pregnancy did not lead to an increase in antibodies in the rabbit study. Studies in genetically altered mice indicate that BMP-2 is critical to fetal development and that a lack of BMP-2 activity may cause neonatal death or birth defects. It is not known if anti-BMP-2 antibodies may affect fetal development or the extent to which these antibodies may reduce BMP-2 activity.
▪Infuse™ Bone Graft should not be used immediately prior to or during pregnancy. Women of childbearing potential should be advised not to become pregnant for one year following treatment with the Infuse™ Bone Graft/Medtronic Interbody Fusion Device.
▪The safety and effectiveness of the Infuse™ Bone Graft/Medtronic Interbody Fusion Device in nursing mothers has not been established. It is not known if BMP-2 is excreted in human milk.
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTION FOR INFUSE BONE GRAFT FOR CERTAIN ORAL MAXILLOFACIAL AND DENTAL REGENERATIVE USES
INFUSE® Bone Graft is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.
The INFUSE® Bone Graft consists of two components-recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an absorbable collagen sponge (ACS). These components must be used as a system for the prescribed indication. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in the package insert.
INFUSE® Bone Graft is contraindicated for consumers with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, 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 consumers with any active malignancy or consumers undergoing treatment for a malignancy, in pregnant women, or consumers with an active infection at the operative site.
There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of childbearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible dental treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of childbearing potential should be advised to not become pregnant for one year following treatment with this device.
INFUSE® Bone Graft has not been studied in consumers who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure).
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
1
Fiorellini, JP, et al. Randomized Study Evaluating Recombinant Human Bone Morphogenetic Protein-2 for Extraction Socket Augmentation. J Periodontol. 2005 Apr;76(4):605-13.
2
Triplett RG, et al. Pivotal, Randomized, Parallel Evaluation of Recombinant Human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge and Autogenous Bone Graft for Maxillary Sinus Floor Augmentation. J Oral Maxillofac Surg. 2009 Sep;67(9):1947-60. doi: 10.1016/j.joms.2009.04.085.