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Benefits and Risks – Infuse Bone Graft and LT-Cage Device

Benefits

Spinal fusion surgery for degenerative disc disease (DDD) involves removing the damaged disc and replacing it with bone graft that will fuse, or join, the two vertebrae together to stabilize the spine. The bone graft placed in the spine is often taken from the patient’s own hip.

Today there is a clinically studied, proven alternative to taking bone graft from the patient. A potential advantage to having spinal fusion surgery using the Infuse® Bone Graft and LT-Cage® Device is that it removes the need to collect bone from your hip to fill the inside of the LT-Cage Lumbar Tapered Fusion Device.

Risks of Surgery

As with any surgery, spinal surgery is not without risk. A variety of complications related to the use of Infuse Bone Graft and the LT-Cage Device can occur. These may occur singly or in combination. Some of these may be severe, affecting your outcome. You may also need to have additional surgery to correct these complications.

Some of the possible complications include:

  • Allergic reaction to the implant materials
  • Bending, breakage, loosening, and/or migration of the implants
  • Bleeding, which may require a blood transfusion
  • Bone fracture or failure to fuse
  • Bone formation that is abnormal, excessive, or in an unintended location
  • Bowel, bladder, or gastrointestinal problems
  • Damage to nearby tissues
  • Death
  • Fetal development complications
  • Infection
  • Pain or discomfort
  • Paralysis or other neurological problems
  • Postoperative changes in spinal curvature, loss of correction, or disc height
  • Respiratory (breathing) problems
  • Scar formation or other problems with the surgical incision
  • Sexual dysfunction
  • Side effects from anesthesia or the surgical approach
  • Spinal cord or nerve damage
  • Tears of the dura (a layer of tissue covering the spinal cord)
  • Vascular problems other than bleeding

Risks of the Infuse Bone Graft/LT-Cage Device

Contraindications

The Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion 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

Warnings and Precautions

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: 22 Sep 2010

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