The medical device was approved in 2002. Infuse was approved for a lumbar fusion performed through the stomach. However, Infuse has been used off label for other spinal related issues without ever being tested for efficacy or safety.
In a recent article by the Spinal Journal, it was noted that surgeons, who were paid tens of millions of dollars by Infuse bone graft maker Medtronic failed to report serious complications such as cancer, male sterility, infections, bone dissolution, and worsened back and leg pain. Shockingly, the article said complications occurred in 10 to 50 percent of patients who were implanted with the product in 13 Medtronic-funded clinical trials between 2000 and 2010.
Infuse contains a chemical called rhBMP or BMP. During surgery, rhBMP-2 is soaked onto and binds with an absorbable collagen sponge designed to disappear, over time. As the sponge dissolves, the rhBMP-2 stimulates the cells to produce new bone. BMP also is used in oral dental surgery and implant dentistry.
Potential adverse side effects include:
- Some of these side effects may be severe, affecting patient outcome:
- Additional surgery/surgeries to correct problems
- Bone fracture
- Bowel, bladder or gastrointestinal problems
- Change in mental status
- Damage to blood vessels, bleeding (which may require a blood transfusion) or cardiovascular system compromise
- Damage to nearby tissues
- Development of respiratory problems
- Disassembly, bending, breakage, loosening, and/or migration of IM nail components
- Ectopic and/or exuberant bone formation
- Fetal development complications
- Foreign body (allergic) reaction
- Incision complications
- Neurological system compromise
- No fusion present
- Scar formation
- Side effects from anesthesia or the surgical approach
- Tissue or nerve damage
For patients who are 65 years and older, there has not been enough studies done to determine whether they respond differently to this medical device than younger patients.
Why do the medical device makers allegedly use their bone graft products off label risking the health of trusting patients?