Safety Information on Bone Cements Used in Vertebroplasty and Kyphoplasty Procedures - Notice to Hospitals

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POSTED BUT NOT FAXED

This notice supersedes the Notice to Hospitals issued by Health Canada on February 9, 2007, as Health Canada has revised information

May 30, 2007

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Radiology, Orthopaedic Surgery, Neurosurgery, and other involved professional staff and post this NOTICE in your institution.

Subject: Complications Associated with the Use of Bone Cements in Vertebroplasty and Kyphoplasty Procedures

Health Canada has been made aware of reports relating to serious complications, including deaths, associated with the use of bone cement in Vertebroplasty and Kyphoplasty procedures and wishes to alert healthcare professionals to this safety information.

Vertebroplasty and Kyphoplasty are relatively new procedures that are being increasingly used in the treatment of patients with vertebral compression fractures. Advocates of both procedures claim to offer advantages over the conservative therapy in immediate pain relief and mechanical stabilization of the vertebral body. Vertebroplasty is performed by percutaneously injecting bone cement into the vertebral bodies under fluoroscopic and/or computed tomography guidance. Kyphoplasty includes an attempt to expand the vertebra with an inflatable balloon prior to the injection of bone cement. Currently, only certain polymethylmethacrylate (PMMA) bone cements are licensed by Health Canada for use in these procedures.

Serious complications associated with the use of the bone cements in these procedures have been reported. They include:

• Death due to sudden blood pressure drop that may be related to the release of the PMMA monomer into the vascular system;
• Bone cement extravasation into the spinal canal leading to neurologic deficit, with compression of the spinal cord and/or nerve roots;
• New fractures, usually of adjacent non-augmented vertebrae;
• Pulmonary embolism of the PMMA.

These adverse events can result in neurologic complications ranging from minor motor and sensory loss to paraplegia. Further intervention (surgical correction, rehabilitation therapy) is required in many cases. Deaths due to sudden blood pressure drop, PMMA embolism and other factors related to pre-existing cardiovascular disease, have been reported internationally.

Though the available data does not allow for a direct comparison of the rates of new fracture after vertebroplasty, kyphoplasty and conservative treatment, there is evidence to suggest that the occurrence of new vertebral fractures after vertebroplasty and kyphoplasty may be nonlinear, with the majority of cases diagnosed within the first few months after augmentation. Augmentation of the vertebral body with PMMA cement increases the strength and stiffness of the vertebrae and may dispose the adjacent vertebral bodies to new fractures.

In order to minimize the risk of these and other complications associated with the use of bone cements in Vertebroplasty and Kyphoplasty procedure, Health Canada recommends the following:

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients treated with Vertebroplasty and Kyphoplasty procedures should be reported to the marketing authorization holder or to Health Canada at the following address:

References:

1) Guglielmi G, Andreula C, Muto M, Gilula LA. Percutaneous vertebroplasty: indications, contraindications, technique, and complications. Acta Radiol 2005 May;46(3):256-68.

2) Pflugmacher R, Kandziora F, Schroeder RJ, Melcher I, Hass NP, Klostermann CK. Percutaneous balloon kyphoplasty in the treatment of pathological vertebral body fracture and deformity in multiple myeloma: a one-year follow-up. Acta Radiol. 2006 May;47(4):369-76.

3) Galibert P, Deramond H, Rosat P, Le Gars D. Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty. Neurochirurgie 1987;33(2):166-8.

4) Yeom JS, Kim WJ, Choy WS, Lee CK, Chang BS, Kang JW. Leakage of cement in percutaneous transpedicular vertebroplasty for painful osteoporotic compression fracture. J Bone J Surg Br 2003 Jan;85(1):83-9.

5) Peh WC, Gilula LA. Percutaneous Vertebroplasty for severe osteoporotic vertebral body compression fractures. Radiology 2002 April;223(1):121-6.

6) Lin EP, Ekholm S, Hiwatashi A, Westesson PL. Vertebroplasty: Cement leakage into the disc increases the risk of new fracture of adjacent vertebral body. AJNR Am J Neuroradiol 2004 Feb;25(2):175-80.

7) Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and Kyphoplasty: a systematic review of 69 clinical studies. Spine 2006 Aug;31(17):1983-2001.

8) Hadjipavlou AG, Tzermiadianos MN, Katonis PG, Szpalski M. Percutaneous vertebroplasty and balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures and osteolytic tumours. J Bone Joint Surg 2005 Dec;87(12):1595-604.