BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR: INFUSE® BONE GRAFT
The INFUSE® Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. INFUSE® Bone Graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.
The INFUSE® Bone Graft is contraindicated for patients 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 patients with an active malignancy or patients undergoing treatment for a malignancy. The INFUSE® Bone Graft should also not be used in patients who are skeletally immature, in patients with an inadequate neurovascular status, in patients with compartment syndrome of the affected limb, in pregnant women, or in patients 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 child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.
This device has not been tested in pregnant women to determine if there is any effect on a developing fetus. This device has also not been studied in nursing mothers.
When tested in female rabbits that received the rhBMP-2, a component of the device, developed an immune response and later became pregnant, the following was seen:
- The antibodies developed by the mother were able to reach the developing rabbit fetus. The effect of these antibodies on the developing rabbit fetus is not currently known.
- Some bone formation abnormalities were observed in a small number of the rabbit fetuses tested. It is not known if these changes would disappear as the rabbit fetus continued to develop or at some time after birth.
This device should not be used immediately prior to or during pregnancy. Women of child-bearing potential should be advised not to get pregnant for one year following treatment with the device. Women of child bearing potential should be warned of potential risk to a fetus and should discuss other possible orthopedic treatments with their surgeon.
BMP-2 plays a critical role during fetal development in humans and other animals. It is not known whether a pregnant woman, previously exposed to BMP-2 by implantation with the device, might develop a second immune response to BMP-2 from the developing fetus with adverse effects for the woman or baby. In a rabbit pregnancy study to investigate this issue, no increase in anti-BMP-2 antibodies was observed.
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.
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