The US Food and Drug Administration (FDA) has issued a caution concerning the use of a type of bone cement to treat osteoporosis-related fractures of the spine during procedures known as vertebroplasty and kyphoplasty.

The agency said in a statement that there have been reports both to the FDA and in the published literature linking complications to leakage of polymethylmethacrylate cement. Complications include soft-tissue damage and nerve-root pain and compression.

Other reported problems include blood clots in the lungs, respiratory and cardiac failure, and death, according to the FDA.

In vertebroplasty, the bone cement is injected into fractured vertebrae to stabilize it and prevent further collapse. In kyphoplasty, a surgical instrument is used to expand the space between the vertebra. The space is then filled with bone cement.

The long-term safety and efficacy of the use of polymethylmethacrylate bone cement in these specific procedures has not been tested in prospective, randomized, controlled trials, the FDA said.

The agency also noted that the procedures involve modifications to the cement that have not been well studied and for which standardized formulations and safety guidelines do not exist.

"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," the agency said.

In the meantime, the FDA's statement advises surgeons "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."