Pros, cons, and costs of INFUSE in spinal surgery

Abstract

Background:INFUSE (recombinant human bone morphogenetic protein-2 [rh-BMP-2]; Medtronic, Memphis, TN, USA) is approved by the Federal Drug Administration (FDA) only for use with the lumbar tapered fusion device (LT Cage; Medtronic) to perform single-level anterior lumbar interbody fusions (ALIF: L2-S1 levels). INFUSE, however, is widely utilized in an “off-label” capacity for anterior and/or posterior cervical, thoracic, and lumbar surgery. Nevertheless, Medicare and other insurance companies, are now increasingly denying reimbursement (average cost of a “large” INFUSE to the hospital without overhead $5000-6000) to hospitals for INFUSE when utilized “off-label”.Methods:This commentary looks at several representative studies citing the cons associated with utilizing INFUSE in spinal surgery, contraindications, complications, and cost factors.Results:There are multiple cons of utilizing INFUSE in an “off-label” capacity for spinal surgery. Direct contraindications include pregnancy, allergy to titanium, allergy to bovine type I collagen or rhBMP-2, infection, tumor, liver or kidney disease, immunosuppression (e.g., lupus, HIV/AIDS); contraindications are also seen in those receiving radiation, chemotherapy, or steroids. Reported complications include exuberant/ectopic bone formation, paralysis (cord, nerve damage), dural tears, bowel–bladder and sexual dysfunction, respiratory failure, inflammation of adjacent tissues, fetal developmental complications, scar, excessive bleeding, and even death. Complications are so prevalent in the anterior cervical spine, that many surgeons no longer use it in this region. Similarly, INFUSE complications and indications for posterior lumbar interbody fusions (PLIFs) and transforaminal interbody lumbar fusions (TLIFs) should also be reexamined.Conclusions:More surgeons need to question the safety, efficacy, and appropriate “off-label” use of INFUSE in all spine surgeries.

Delivery of Phenamil Enhances BMP-2-Induced Osteogenic Differentiation of Adipose-Derived Stem Cells and Bone Formation in Calvarial Defects

“…4,27 Among the various osteoinductive factors available, BMPs have received solid attention for exerting strong effects on osteogenic differentiation of progenitor cells and are currently approved for spinal fusion, fracture healing, and maxillofacial regeneration. 28 While BMPs have successfully induced bone formation in vivo, high dose requirements and paradoxical activities of BMPs on progenitor cells may lead to unexpected side effects such as ectopic bone formation while also rendering high treatment costs to patients.…”

Imaging symptomatic bone morphogenetic protein-2–induced heterotopic bone formation within the spinal canal: case report

“…While attempts to identify optimal formulations and methods of delivery are ongoing, the use of BMP-2 in spine surgery remains controversial due to reports of safety issues. 1,3,7,9,11,12,14,16,17,19 Although the basic mechanisms underlying BMP-2-induced vertebral fusion and heterotopic ossification are largely understood, [4][5][6]13,15 the parameters for optimal imaging of these complications are still being identified.…”

Targeting the hypoxic response in bone tissue engineering: A balance between supply and consumption to improve bone regeneration

“…However, when these factors are used as monotherapy for bone repair, they often have to be applied in high doses and frequently result in adverse side effects such as soft tissue inflammation and swelling, haematoma formation, heterotopic ossification and induction of osteolysis. These complications seriously limit their clinical applicability (Epstein, 2011;Shields et al, 2006). Nevertheless, these growth factors may potentially be used at much lower doses when they are combined with cell-based constructs.…”