FDA Warns About Possible Complications of Cement Used to Treat Spinal Fractures
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).
- The FDA statement referenced in this article is available on the FDA website, http://www.fda.gov/cdrh/safety/bonecement.html
- Imaginis provides information on percutaneous vertebroplasty at http://www.imaginis.com/osteoporosis/news/news4.06.2000.asp
- To learn more about treatments of osteoporosis, please visit http://www.imaginis.com/osteoporosis/osteo_treatment.asp