Metallic Tracheal Stents

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Metallic Tracheal Stents

The FDA issued a public heath advisory on July 29, 2005 recommending the use of all covered and uncovered metallic tracheal stents is avoided. Warning of serious tracheal stent complications associated with the use of the devices in patients with benign airway disorders, the agency made the decision after reviewing recent literature, medical device reports and information from physicians suggesting complications.

According to Daniel Schultz, MD, FDA director of the Center for Devices and Radiological Health, use of the stents among the particular patient population might prevent them from receiving future alternative therapies after a metallic stent is removed. As a result, the patient population has a greater risk of serious tracheal stent complications than those with malignant disorders since the device is left in place longer.

Evidence indicated tracheal stent complications could include obstructive granulation tissue, stenosis at the ends of the stent, stent migration or fracture, mucus plugging and infection. The FDA said the tracheal stent complications reports mainly focused on stent fracture, but the agency believed other complications noted in the literature carry potential risks with the covered and uncovered metallic tracheal stents.

Removing metallic stents also carry serious complications including mucosal tears, severe bleeding, reobstruction, respiratory failure necessitating postoperative mechanical ventilation and tension pneumothorax. Should tracheal stent complications include failure or fracture during removal causing the stent to be removed in pieces, retained stent fragments may be permanently incorporated into tissue.

The FDA recommended, because of potential metallic tracheal stent complications, that the devices be used in patients with benign airway disorders only after thorough exploration of all other treatment options occur, including tracheal surgical procedures or placement of silicone stents. In addition, the agency recommended the devices be avoided as a bridge to other therapies because of potential tracheal stent complications associated to the removal of the stents.

If metallic tracheal stents are the only option, a physician that is expertly trained and experienced in metallic tracheal stent procedures should perform the insertion and removal because of the potential for serious complications. Professional organizations have recommended guidelines regarding specific providers skills and competency for the procedures, which highlight, among other things, potential tracheal stent complications.

Metallic tracheal stents are used to help prop open the airway. The FDA received at least 60 reported tracheal stent complications and said product label changes will be made to “adequately convey the risks.” Both Boston Scientific and C.R. Bard Inc. manufacture the device, and privately held firms including Cook, W.L. Gore and Alveolus produce it as well.

Doctors have been encouraged to immediately report tracheal stent complications, should they arise.

Contact an expert product liability lawyer for more information on metallic tracheal stent complications.

Product Liability Breaking News

"FDA notifies public of metallic tracheal stents complications"

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 devi...

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