VIVIAN'S STORY DENTAL BONE GRAFTING

JAW BONE SURGERY WITH INFUSE BONE GRAFT

Vivian, who received Infuse Bone Graft for a dental procedure

Vivian's progressive bone loss in her jaw, which began in her 30s, affected daily life in her 60s when her dentures no longer fit. Desperate for a solution, she discovered how a bone graft and oral-maxillofacial surgery could give her new hope.

Bone Loss Made Social Situations Difficult

At the age of 72, Vivian enjoys "the good life." She likes eating a perfectly char-grilled steak at her favorite restaurant, or spending a few minutes laughing and talking with the friends and neighbors she runs into each day.

Several years ago, however, life for Vivian wasn't so good. Rather than steak, she found herself settling for "soup of the day." Instead of calling out to the friend she spotted across the parking lot, she'd quickly duck into her car to avoid a conversation. A long-time denture wearer, Vivian's plates no longer fit due to extensive bone loss in her jaw. This made eating and talking extremely difficult, and caused her quite a bit of social anxiety.

"The condition of my mouth had deteriorated to the point that my gums were just like Jell-O," Vivian says. "I was limited as to who I felt comfortable being around, in the event my dentures came out."

Although Vivian was in her 60s when these difficulties began to interfere with her daily life, the root of her oral problems started much earlier. In her 30s, she noticed a couple of her teeth were coming loose. Dental radiographs revealed a lot of bone loss. This was the result of advanced gum disease that, over time, can cause the bone and gum tissues that support the teeth to break down, a process called resorption.

Despite conservative treatments, eventually most of her teeth loosened and an oral-maxillofacial surgeon recommended she have them all removed and replaced with a full set of dentures.

For a long time, Vivian managed very well with her plates. About the time she turned 60, however, she noticed they didn't fit as well as they used to. Even after she replaced her natural teeth with dentures, her jaw bone loss in had continued. She tried every kind of denture adhesive, but they didn’t work for long. "I tried everything but Superglue before I realized I just couldn't go on. I needed to try something different—something that really worked."


A Solution to Jaw Bone Loss with Infuse Bone Graft

Vivian met with Dr. Daniel Spagnoli with University Oral and Maxillofacial Surgery in Charlotte, NC. He recommended she have her dentures replaced with dental implants—a system of tiny metal posts implanted into the bony tissue beneath the gum line, with a natural-looking, artificial tooth fastened on top once the post has successfully bonded with the bone. Implants, however, required a sufficient amount of healthy bone with which the post can bond. Bone grafts would restore the portion of the jaw that anchors the teeth— the alveolar bone—by not only filling the void, but promoting bone growth.

Vivian jumped at the chance to participate in a clinical study investigating Infuse™ Bone Graft for oral use. After Dr. Spagnoli explained the product to her, "I was so excited my first thought was, 'Just do it!'" Vivian says. "He seemed confident this treatment could help me. I was ready to go. I had no reservations at all."

Dr. Spagnoli performed a sinus augmentation to place the graft material above the localized alveolar ridge of the upper jaw. Vivian's procedure, which took about two hours, was performed in Dr. Spagnoli's office, with Vivian under both local and intravenous sedation. "When I was done, I was bandaged just a little and prescribed pain medication," she says. "I went home, took my meds, put ice on my face and went to sleep. I had to eat soup for a couple of weeks because of the sutures, but that was OK. Soup was something I was used to."


Life after Dental Bone Grafting Surgery

Post-surgery, pain was not the issue, Vivian says. The challenge was waiting for the graft to heal and the new bone to grow. After a couple of monthly radiographs, "We could finally see the bone growing! At six months, I was ready for my implants."

Today, Vivian says she doesn't know where she'd be if she hadn't had her procedure with Infuse Bone Graft. "I'd probably still be sucking soup in the backyard," she says. "I know I wouldn't be going out. I can't tell you how embarrassing it was to say 'Hi' to someone and then have your teeth pop out. That's not the kind of life I wanted.

"But that doesn't happen today. They're in there secure and solid, and that makes a huge difference in my life. I've always liked to cook and go out to eat, and I enjoy being able to do those things again. And I can laugh and cough and sneeze and not worry about it. I'm having a really good time!"


▪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.

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.