Medtronic Infuse Bone Graft Side Effects
Potential Adverse Effects of The Medtronic Infuse Bone GraftThere have been
reported side effects from undergoing the Medtronic Infuse Bone Graft Procedure:
- 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
Warnings & Recalls for Medtronic Infuse Bone Graft
Precautions Before Taking The Medtronic Infuse Bone Graft ProcedureThere are a set of circumstances that might hinder a patient’s ability to undergo the Medtronic Infuse Bone Graft:
- If you’re pregnant or suspect that you might be pregnant.
- If you’re sensitive to titanium, titanium alloy, the Type I collagen from the sponge in the Infuse Bone Graft, or the protein that is used in the Infuse Bone Graft.
- If you’ve got an infection close to the area of the surgical incision.
- If you’ve got a tumor removed from the spinal area or if you currently have a tumor in that area.
- If you’re bones haven’t stopped growing.
This device shouldn’t be used immediately prior to or when pregnant. Women who are of child-bearing potential are advised not to get pregnant for one year after treatment with this device. As the protein rhBMP – 2
plays a critical role in the development during fetal development in humans, it is currently unknown what effects the Medtronic Infusion Bone Graft procedure might have on the fetus.It is strongly urged to routinely follow up with your doctor for these contraindications.
Medtronic Infuse Bone Graft Treatment and Use
The Infuse® Bone Graft is a technology that has been developed by the company Medtronic to assist in a surgery called an Anterior Lumbar Interbody Fusion (ALIF).
It is used concurrently with a device called the LT-Cage® Device, which has also been developed by Medtronic to reduce pain and complications associated with degenerative disc disease (DDD) in the spine. It is primarily used for eliminating a second surgery for avoiding the harvesting of the bone from the patient’s hip that is the standard and traditional procedure for transplantation to the spine.
The Infuse Bone Graft consists of two parts – a solution which contains rhBMP – 2 (recombinant human Bone Morphogenetic Protein-2), which is a protein found in the human body and an absorbable collagen sponge which is biologically manufactured from bovine (cow) Type I collagen.
Working in synchronization, the protein’s purpose is to stimulate bone formation and during surgery, the protein solution is soaked into the sponge.
The purpose of the sponge is to act as a scaffold for the formation of new bone that is stimulated by the protein solution. The sponge is specially designed to resorb, or disappear, over time.
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