FDA cautions use of metallic tracheal stents
Ambulatory Safety Monitor, October 13, 2005
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The Food and Drug Administration (FDA) is cautioning healthcare professionals against the use of metallic tracheal stents in patients with benign airway disorders.
If used, metallic stents may cause several complications including obstructive granulation tissue, stenosis, stent migration, and infection. Removal after insertion of the stent can cause mucosal tears, severe bleeding, re-obstruction, and respiratory failure.
The FDA says metallic stents should be used only as a last resort after other options, such as silicone stents or surgical procedures, are explored.
If a metallic stent must be used, it should be inserted and, if necessary, removed by a physician trained or experienced in the use of the stent.
For additional information, click here.
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