A PERSONAL EXPERIENCE WITH INFUSE BONE GRAFT
Years after a car accident in her teenage years, severe jaw bone resorption left Edna with receding gums and tooth loss. Infuse™ Bone Graft helped rebuild Edna's jaw bone density in preparation for dental implants, restoring her confidence and "great big smile."
Temporary Treatment Before Dental Bone Grafting Surgery
In 1995, Edna was in a serious car accident that badly injured the right side of her face. Her jaw was shattered, she lost several teeth, and other teeth were damaged. At the time, the primary focus of her treatment was to repair her jaw and restore her mouth's normal appearance and function.
"I was 18 and just about to start college, so the main goal was to give me a mouth that looked good and worked properly," she says. Her treatment included multiple root canals and veneers, which are wafer-thin porcelain shells that are bonded to the front side of the teeth. "But this was basically just a Band-Aid, and I was told I'd need more work done down the road." Her doctor felt that in about 10 years new technology might be available to better help her. Fortunately for Edna, her doctor was right.
Effects of Dental Bone Loss
Ten years after the accident, Edna noticed that her gums were receding, leaving the roots of some of her teeth exposed. She went to her dentist, who found that in addition to losing her gums, she had also lost a significant amount of bone in her jaw.
Jaw bone loss commonly occurs in people whose teeth have been extracted or, as in Edna's case, knocked out. Activities such as biting and chewing stimulate the root structure in the jaw. When teeth are missing, the bone no longer receives this physical stimulation and starts to resorb, or break down.
Dental prostheses, such as Edna's veneers, also may cause the bone to break down. "My doctor explained to me that when you have veneers rubbing on natural teeth, this exerts too much pressure on the bone and it begins to resorb away." Veneers had replaced a back molar she lost as a result of the accident. "Over time, I 'chewed' away the area of bone above these veneers," she says.
Bone resorption in the jaw can cause pain. Edna couldn't bear to chew on that side of her mouth because her gums were sore and irritated and her teeth were very sensitive to hot and cold. Headaches woke her up in the middle of the night. "I was in a whole lot of pain," she says.
Because her receding gums emphasized the gap where her molar used to be, Edna also became very unhappy with her appearance. "I'm a big smiler, and I used to have this big, toothy grin," she says. "But I became really self-conscious about not smiling too wide."
Infuse Bone Graft
Realizing the dental "Band-Aid" she'd been living with for more than a decade was now just making her miserable, Edna met with periodontist Dr. James L. Madigan, DDS, of Knoxville, TN. He recommended dental implants: tiny metal posts implanted into the bony tissue beneath the gum line, with a natural-looking, artificial tooth fastened on top. However, the first step in Edna's treatment plan would be to increase the bone mass in the portion of Edna's upper jaw that anchors her teeth — the alveolar bone— with bone grafts, which not only fill the void of bone, but also promote bone growth.
When Edna and Dr. Madigan discussed which type of bone graft to use, she was reminded of just how accurate her previous doctor's predictions had been regarding the potential for new technology in the future. Dr. Madigan recommended Infuse Bone Graft, an alternative to autograft (bone from the patient's own body) or allograft (bone from a donor). Infuse Bone Graft offers the same bone-regenerating properties as autograft while eliminating the additional surgical procedure that's required to harvest bone from the patient's own body.
Peace of Mind
"Knowing this was a product that would use my own cells to grow bone really gave me peace of mind," says Edna. "I think the technology is amazing. It stimulates your body's own bone-producing mechanism, and it eliminates the risk that comes with that second procedure."
Dr. Madigan performed a ridge augmentation, which involved placing Infuse Bone Graft directly into the bone of the localized alveolar ridge. This was performed in Dr. Madigan's office, with Edna under both a local anesthetic and oral sedation. She says the aftermath was surprisingly pain-free, except for a little spot in the roof of her mouth where a small skin graft was taken to cover an incision. "My surgery was done on a Friday. The following Monday I was in Memphis for a training class," Edna says. "There was hardly any swelling, and my soft tissues seemed to heal really fast."
Within six months — the typical waiting period for graft healing and new bone growth — Edna was ready for the installation of her dental implant post. During the procedure, Dr. Madigan discovered Edna also was lacking sufficient bone in the floor of her sinus cavity. He performed a sinus augmentation, which involved placing the Infuse Bone Graft above the localized alveolar ridge of Edna's upper jaw to promote bone growth and thicken the sinus floor.
Life After Dental Bone Grafting Surgery
Two months later, Edna was ready for her new, artificial molar. "It was so easy. When the tooth was ready they just screwed it on the post and I was done!"
Although the process took more than eight months to complete, Edna is thrilled with her results. "This has given me back my confidence," she says. "If I had not had these procedures done, I would have left myself open to a lot of distortion in my appearance. The shape of my mouth was already starting to change, and it was affecting the way I smiled and related to those around me. Now I don't have that problem anymore.
"I'm smiling my big smile again, and I'm so much happier. I've got all my teeth!"
▪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.