Is Infuse Bone Graft With the LT-Cage Device Right for You?
Infuse® Bone Graft and the LT-Cage® Device are indicated for spinal fusion surgery in skeletally mature patients for the treatment of degenerative disc disease (DDD) at one level from L2-S1 (the lower part of the back).
DDD is defined as a disc that has deteriorated and causes low back pain. The disc deterioration is confirmed by history and x-ray studies. In addition to the disc degeneration, there may also be a small amount of slippage of one disc relative to the next at the diseased spinal level (known as Grade I spondylolisthesis or Grade I retrolisthesis). Prior to this surgery, you should have been non-responsive to at least 6 months of non-operative therapy.
Detail - Spinal Infuse Bone Graft
Infuse Bone Graft and the LT-Cage Device should not be used if:
- You are pregnant or suspect that you might be pregnant
- You are sensitive to titanium, titanium alloy, bovine (cow) Type I collagen, or recombinant human Bone Morphogenetic Protein-2
- You have an infection near the area of the surgical incision
- You had a tumor removed from the area of the implantation site or currently have a tumor in that area
- Your bones have not stopped growing
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.
In addition, this device has not been tested:
- To see if there are side effects by using it more than once in the same person
- In people with liver or kidney problems (this might be important because these organs are involved in removing any by-products of the device)
- In people with metabolic bone diseases, such as osteoporosis
- In people with autoimmune or immunosuppressive disease, such as lupus or HIV/AIDS
- In people with immune deficiency due to other treatments, such as radiation therapy, chemotherapy or steroid therapy
Sufficient numbers of patients 65 years and older have not been studied to determine whether they respond differently from younger people.
After this device is implanted using the anterior laparoscopic surgical approach, some males may experience retrograde ejaculation (a form of sexual dysfunction).
Although not seen in these studies performed by the manufacturer, there is a possibility that too much bone may form at the implantation site (exuberant bone formation), bone may form at a location away from the implantation site (ectopic bone formation), or the bone that is formed may be abnormal.
Some patients may have an allergic reaction to the Infuse Bone Graft component.
Please talk to your doctor about the above warnings and precautions.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
Last updated: 19 Aug 2008
