FDA warning raises interventional radiologists' ire
Interventional radiologists are crying foul about an FDA warning regarding the use of bone cement for spinal fracture procedures.
The blanket warning could send the wrong message about a procedure that is basically safe when performed by qualified interventional radiologists, said Dr. Kieran Murphy, director of interventional neuroradiology at Johns Hopkins University.
The warning states that polymethylmethacrylate bone cement used to treat spinal fractures in both vertebroplasty and kyphoplasty could leak and produce soft-tissue damage, nerve root pain, and compression. The FDA also cites other complications including pulmonary embolism, respiratory and cardiac failure, abdominal intrusions, and death.
The warning does state, however, that current information is insufficient to establish overall complication rates for either procedure.
Both vertebroplasty and kyphoplasty are safe when performed by well-trained physicians using optimal equipment, according to Murphy. Response to a Freedom of Information Act request he sent to the FDA revealed that the highest complication rate was associated with kyphoplasty performed by nonradiologists.
Vertebroplasty uses a mixture of polymethylmethacrylate bone cement and a contrast agent injected into the vertebra using fluoro or CT guidance. Kyphoplasty resembles vertebroplasty but involves the use of a balloonlike device to expand the vertebra before cement injection. While both procedures were developed to alleviate pain and restore deformed or fractured vertebra, some practitioners have been offering kyphoplasty for purely aesthetic reasons, Murphy said.
"Personally, I don't care who does it, as long as they do it right," he said.
