Infuse Bone Graft Side Effects
Significant side effects are associated with spinal fusion using Infuse Bone Graft. These risks may occur independent from each other or in combination, and some may be severe enough to affect the outcome of the surgery. It is also possible that a patient will require additional surgery to correct the complications. Some of the potential side effects are listed below, grouped together according to the organ systems that they can affect:
Bones and muscles
- Abnormal or excessive bone formation at the site of implantation
- Bone fracture
- Failure of the bones to fuse
- Bone formation in an unintended location
- Postoperative changes in spinal curvature, loss of correction, or disc height
Heart, lungs and blood vessels
- Bleeding (possibly severe enough to require a blood transfusion)
- Vascular problems other than bleeding
- Difficulty breathing
Implant-associated side effects
- Bending, breaking, loosening, and/or migration of the implants
- Damage to nearby tissues
- Allergic reaction to the implant materials
Brain and spine
- General pain and discomfort
- Damage to the spinal cord or other nerves
- Tears of the dura (the layer of tissue that surrounds the spinal cord)
- Complications with fetal development
- Sexual dysfunction (retrograde ejaculation in males)
- Scar formation or other problems surrounding the surgical incision
Other possible side effects associated with Infuse Bone Graft include infection, gastrointestinal and urinary problems, side effects from anesthesia or the surgical approach, and death.
The Infuse Bone Graft / LT-Cage Device should not be used under any of the following circumstances:
- Women who are pregnant or suspect that they might be pregnant
- Individuals with allergies or sensitivity to titanium, titanium alloy, bovine (cow) Type I collagen or recombinant human Bone Morphogenetic Protein-2
- Individuals who have an infection near the area of the surgical incision
- Individuals who have had a tumor removed from the area of the implantation site or who currently have a tumor in that area
- Individuals whose bones have not stopped growing.
Warnings and Precautions
It is important to note that Infuse Bone Graft has not been tested in pregnant women nor has it been studied in nursing mothers. Furthermore, the device has also not been tested in the following groups:
- Individuals with liver or kidney problems
- Individuals with metabolic bone diseases, such as osteoporosis
- Individuals with autoimmune or immunosuppressive disease, such as lupus or HIV/AIDS
- Individuals with immune deficiency due to other treatments, such as radiation therapy, chemotherapy or steroid therapy.
In addition, Infuse Bone Graft has not been tested to see if there are any side effects by using it more than once in the same person, nor have sufficient numbers of patients age 65 and over been studied to determine if they respond differently than younger people.
Sterility in Males
Adding to the controversial history of Infuse Bone Graft, a study published in the May 2011 issue of The Spine Journal reported the findings of a retrospective analysis of 240 patients previously treated with either Infuse Bone Graft or another form of bone graft. Of the 69 treated with Infuse Bone Graft, five developed complications related to sterility versus only one out of the 174 who received a different bone graft procedure. The complication of interest is a condition known as retrograde ejaculation, a condition where semen is misdirected into the bladder. Retrograde ejaculation can result in permanent or temporary sterility in men. For three of the six patients who experienced retrograde ejaculation, the condition resolved itself.
The results of this study are in contrast to earlier findings from doctors (all of whom received compensation from Medtronic) who found no connection between Infuse Bone Graft and sterility in males. While retrograde ejaculation is noted on the Infuse Bone Graft package label, Medtronic-sponsored researchers declare in published reports that the complication is attributable to the surgical technique that is used rather than the product itself. Regardless, the new study estimates that as many as 1,000 men may be faced with Infuse Bone Graft-related sterility each year.