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FDA Public Health Web Notification: Complications Related to the Use of Bone Cement in Vertebroplasty and Kyphoplasty Procedures

This notification is to inform you about reports related to the use of polymethylmethacrylate bone cement to treat osteoporotic compression fractures of the spine using surgical procedures known as vertebroplasty and kyphoplasty. Complications related to these procedures have been reported in the literature and to FDA. Reported complications, such as soft tissue damage and nerve root pain and compression, are related specifically to the leakage of bone cement. Other reported complications include pulmonary embolism, respiratory and cardiac failure, and death.1-9

Current Status

FDA is currently working with appropriate professional organizations and manufacturers of orthopedic devices to consider the regulatory options available to evaluate the long-term safety and effectiveness of bone cement in vertebroplasty and kyphoplasty procedures. We encourage you to be aware of considerations and recommendations regarding patient selection, vertebroplasty and kyphoplasty techniques, complications, and patient monitoring described in the literature when considering these procedures to treat osteoporotic compression fractures of the spine.3,10-12

Background

Vertebroplasty involves the percutaneous injection of a mixture of polymethylmethacrylate bone cement and a contrast agent, typically barium sulfate, into the vertebral bodies using fluoroscopic and/or computed tomography guidance. Early vertebroplasty procedures were primarily performed to alleviate pain and to stabilize fractured bone in patients with hemangiomas, malignant metastases, or other types of tumors of the spine. The use of vertebroplasty to treat osteoporotic compression fractures in patients where conservative treatment has failed is relatively recent with no prospective, randomized, controlled trials to characterize its long-term safety or effectiveness.

In kyphoplasty procedures, a surgical instrument is introduced, with the intent to expand the vertebra. Once this instrument is withdrawn, the space created is then filled with the bone cement mixture. By creating space in this way, kyphoplasty procedures may correct deformity or restore body height. Like vertebroplasty, the use of kyphoplasty to treat osteoporotic compression fractures in patients where conservative treatment has failed is relatively recent with no prospective, randomized, controlled trials to characterize its long-term safety or effectiveness.

Although acrylic bone cement has been used for many years for the fixation of metal and plastic prostheses in joint replacement and less frequently in the fixation of pathological fractures, it has not been specifically evaluated for the treatment of spinal compression fractures. Acrylic bone cement is modified for vertebroplasty and kyphoplasty procedures by increasing the amount of contrast agent and changing the handling properties. The effects of these modifications are not well known in the spine. To date, there are no standardized formulations, biomechanical standards or safety guidelines for the types or amounts of opacifying additives used.

Reporting Adverse Events to FDA

The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices, including bone cement. We request that you follow the procedures established by your facility for such mandatory reporting.

We also encourage you to report bone cement malfunctions. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch one of four ways: online athttp://www.accessdata.fda.gov/scripts/medwatch/ by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.

FDA Contact

a SimenauerOffice of Surveillance and Biometrics (HFZ-510)1350 Piccard Drive, Rockville, land, 20850Fax at 301-594-2968, or by e-mail at phann@....

Additionally, a voice mail message may be left at 301-594-0650 and your call will be returned as soon as possible.

References

Garfin SR, Yuan HA, Reiley MA. New technologies in spine: kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 2001; 26(14):1511-5. Heini PF, Walchli B, Berlemann U. Percutaneous transpedicular vertebroplasty with PMMA: operative technique and early results. A prospective study for the treatment of osteoporotic compression fractures. Eur Spine J. 2000 Oct;9(5):445-50. Levine SA, Perin LA, D, et al. An evidenced-based evaluation of percutaneous vertebroplasty. Managed Care 2000 Mar; 9(3):56-60, 63. JB, B, Sugiu K, et al. Vertebroplasty: clinical experience and follow-up results. Bone 1999 Aug;25(2 suppl):11S-15S. Ratliff J, Nguyen T, Heiss J. Root and spinal cord compression from methylmethacrylate vertebroplasty. Spine 2001; 26(13):E300-2. Watts NB, ST, Genant HK. Treatment of painful osteoporotic vertebral fractures with percutaneous vertebroplasty or kyphoplasty. Osteoporos Int. 2001;12(6):429-37. Padovani B, Kasriel O, Brunner P, et al. Pulmonary Embolism caused by acrylic cement: a rare complication of percutaneous vertebroplasty. AJNR 1999;20(3):375-7. Cortet B, Cotton A, Boutry N, et al. Percutaneous Vertebroplasty in the Treatment of Osteoporotic Vertebral Compression Fractures: An Open Prospective Study. J Rheumatol. 1999 Oct;26(1):2222-8. Cyteval C, Sarrabere MP, Roux JO, et al. Acute osteoporotic vertebral collapse: open study on percutaneous injection of acrylic cement in 20 patients. AJR 1999;173(6):1685-90. Do HM. Resonance imaging in the evaluation of patients for percutaneous vertebroplasty. Top Magn Reson Imaging 2000 Aug;11(4)235-44. Hardouin P, Grados F, Cotton A, et al. Should percutaneous vertebroplasty be used to treat osteoporotic fractures? An update. Joint Bone Spine 2001 May;68(3)216-21. Mathis JM, Barr JD, Belkoff SM, et al. Percutaneous vertebroplasty: a developing standard of care for vertebral compression fractures. AJNR 2001;22(2):373-81.

Updated 10/31/2002

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