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The U.S. Food and Drug Administration (FDA) has issued a warning which states that
severe complications can result from the cement substance used in procedures to treat
spinal fractures. According to the FDA, polymethylmethacrylate bone cement, used during vertebroplasty and kyphoplasty surgical procedures, could
leak, and this leakage could result in soft tissue damage and nerve root pain and
compression. While the FDA works with other agencies to evaluate the long-term risks of
the surgical procedures, it urges physicians to consider the warning before recommending
vertebroplasty or kyphoplasty to patients.
Percutaneous vertebroplasty (PV) is an experimental treatment that involves injecting a
special liquid cement into fractured vertebral sections. The procedure is used to fill
holes in the spinal column left from osteoporosis, a bone-thinning
disease that significantly increases the risk of bone fractures. Kyphoplasty is similar to
vertebroplasty but involves the use of a surgical instrument to expand the vertebra prior
to the insertion of the cement into the newly created space. These procedures are usually
reserved for patients who have been unsuccessfully treated with standard osteoporosis
therapies. However, there are no large studies that have followed patients who have
received vertebroplasty and kyphoplasty to evaluate long-term safety and effectiveness.
In October 2002, the FDA issued a warning about the cement used 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."
The FDA statement explains that it is working with manufacturers and professional
organizations to "consider the regulatory options available to evaluate the long-term
safety and effectiveness of bone cement in vertebroplasty and kyphoplasty
procedures." In the meantime, the FDA urges physicians to be aware of the possible
complications when considering the procedures for their patients.
The FDA noted that acrylic bone cement has been used for years in other procedures,
such as the creation of metal and plastic prostheses in joint replacement. However, the
cement is altered in vertebroplasty and kyphoplasty procedures by increasing the amount of
contrast agent and changes the handling properties.
Osteoporosis is a degenerative bone disease that primarily affects post-menopausal
women. A loss of bone density causes bones to become brittle, and in turn, can lead to
frequent fractures and other serious effects. According to researchers, when a spine
fracture occurs from osteoporosis, 20% to 30% of the damaged vertebral section is
typically lost. Within weeks, more fractures may occur which can lead to a loss of height.
Older women who are affected by osteoporosis-induced spinal fractures generally lose
weight and develop a hunched back.
Traditional treatments of osteoporosis include:
- Calcium and vitamin D supplements
- Hormone replacement therapy
- Other drug therapies such as Evista (generic name,
raloxifene), Fosamax (alendronate), Miacalcin (calcitonin), or Actonel (risedronate
sodium).
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