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The Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device is designed to aid in the treatment of degenerative disc disease (DDD).
How It Works The Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device is designed to aid in the treatment of degenerative disc disease (DDD) in skeletally mature patients at one level from L2-S1. It consists of two parts - the LT-Cage Lumbar Tapered Fusion Device and a bone graft alternative* (Infuse Bone Graft). The LT-Cage Lumbar Tapered Fusion Device component is intended to restore the degenerated disc space to its original height. Two implants are placed side by side.
The Infuse Bone Graft component is used to fill the LT-Cage Lumbar Tapered Fusion Device. The Infuse Bone Graft consists of two parts - a solution containing recombinant human bone morphogenetic protein-2 (rhBMP-2) and an absorbable collagen sponge (ACS). The protein is a manufactured (genetically engineered) version of a natural protein normally found in small quantities in the body.
The purpose of the protein is to stimulate bone formation. During surgery, the protein solution is soaked into the ACS. The ACS acts as a scaffold for the formation of new bone that the protein stimulates. The ACS is a sponge manufactured from Type I collagen, and is designed to resorb over time.
Potential Benefit A potential advantage of spinal fusion surgery with the Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device is that it removes the need to collect iliac crest autograft for use with the LT-Cage Lumbar Tapered Fusion Device, which involves a second or larger incision that may be painful and/or take longer to heal.
Risks Along with the benefits of this technology, there also may be some potential risks involved with the use of Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device.
There are no adequate and well-controlled studies in human pregnant women.
Ectopic Bone Growth
In an experimental rabbit study, the active ingredient in Infuse® Bone Graft, recombinant human bone morphogenetic protein-2 (rhBMP-2), was shown to elicit antibodies capable of crossing the placenta.
Women of childbearing potential should ask their physician about the potential risk to a fetus, as well as about other treatment options.
The safety and effectiveness of this device has not been established in nursing mothers.
Women of childbearing potential should be advised to not become pregnant for 1 year following treatment with this device.
The most common and serious adverse events associated with use of the LT-Cage® Device include intraoperative vascular injuries, neurological injuries, and retrograde ejaculation in men.
Contact Us Its important to hold Medtronic accountable for concealing the dangers of their product. Off-label use of the Infuse bone graft led to complications when surgeons used it in methods that were not approved by the FDA. An investigation into the off-label use of Infuse bone graft was launched when nearly 300 complaints were filed with FDA citing side effects of the device. Previous to this surgeons received lucrative financial deals for writing favorably about off-label use of Infuse bone graft in medical literature.
Even if you are unsure of what kind of bone graft you may have received, it is imperative that you get your claim legally evaluated if you suffered complications following surgery. Contact or call us today at 727-397-9198 to receive a free evaluation of your claim. You may be entitled to compensation for:
• Lost Income • Bills (Medical) • Treatments • Emotional and Physical Pain • Future Financial Burdens
After Spinal Fusion Surgery did You or a Loved one Have Serious Complications?
According to U.S. Senators - Medtronic, the Manufacturer of the Infuse Bone Graft System, has been charged with unethically influencing medical studies in order to cover up the dangers with their product. This led to people like yourself having surgery without knowing all of the risks.
After a thorough investigation, these alarming injuries have been reported:
If you had spinal surgery and now have any of the injuries listed above contact us today for a free, no-hassle, no-obligation consultation. Our experienced lawyers can fight for your rights to get you the compensation you deserve by holding Medtronic accountable for its negligence.