The complication rate with Kyphon® Balloon Kyphoplasty has been demonstrated to be low (< 1% procedure- and cement-related1). As with all surgical procedures, there are risks associated with the procedure, including serious complications, and though rare, some of which can be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.
Adverse events potentially associated with use of the Inflatable Bone Tamps (IBT)
Serious adverse events, some with fatal outcome, associated with the use of acrylic bone cements (Kyphon® HV-R® Bone Cement)
Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include:
Inflatable Bone Tamps (IBT) – Indications for Use
Kyphon® Xpander™ and Kyphon® Express™ Inflatable Bone Tamps (IBT) are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with Kyphon® HV-R® Bone Cement), hand, tibia, radius, and calcaneus.
Kyphon® HV-R® Bone Cement – Indications for Use
The Kyphon® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.
Quantitative analysis of perioperative complication rates in balloon kyphoplasty and vertebroplasty (meta-analysis). Medtronic Spine LLC; 2006 December 11, 2006.