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.
The complication rate with Kyphon™ Balloon Kyphoplasty has been demonstrated to be low (< 1% procedure- and cement-related1).
Adverse events potentially associated with use of the Inflatable Bone Tamps (IBT)
Risks of acrylic bone cements include cement leakage which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as:
Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include:
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), hand, tibia, radius, and calcaneus.
Kyphon Xpede™ Bone Cement and Kyphon HV-R™ Bone Cement are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. They are also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. 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. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
Kyphon ActivOs™ 10 Bone Cement with Hydroxyapatite is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Quantitative analysis of perioperative complication rates in balloon kyphoplasty and vertebroplasty (meta-analysis). Medtronic Spine LLC; 2006 December 11, 2006.