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Healthcare professionals were alerted of serious complications associated with the use of metallic tracheal stents in patients with benign airway disorders. The public health advisory, issued July 29, 2005, advised avoiding the use of the medical devices because of complications including obstructive granulation tissue, stenosis at the ends of the stent, migration of the stent, mucous plugging, infection and stent fracture.
Metal stents are used to prop open the airway, but the FDA said it received at least 60 reported problems with the devices and was working with makers to change product labels. Boston Scientific and C.R. Bard Inc. manufacture the device, and privately held firms including Cook, W.L. Gore and Alveolus produce it. The agency said it wanted to make sure potential metallic tracheal stent complications are adequately conveyed in product labels.
The FDA alert included all covered and uncovered metallic tracheal stents and was based on its reviews of recently published literature, medical device reports it received and information from physicians. The FDA recommended metallic tracheal stents only be used in patients with benign disorders after thoroughly exploring all other treatment options first.
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