August 3 , 2005

FDA ALERT

FDA MedWatch-Metallic Tracheal Stents in Patients with Benign Airway Disorders associated with serious complications

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA issued a Public Health Notification to alert healthcare professionals to serious complications associated with the use of metallic tracheal stents in patients with benign airway disorders, and to recommend specific actions to prevent or minimize the problem. This notification includes all covered and uncovered metallic tracheal stents. These complications include obstructive granulation tissue, stenosis at the ends of the stent, migration of the stent, mucous plugging, infection, and stent fracture. This notification focuses on patients with benign airway disorders because use of metallic stents in this patient population may preclude them from receiving future alternative therapies (such as tracheal surgical procedures or placement of silicone stents) after a metallic stent is removed.

Read the complete MedWatch 2005 Safety summary, including a link to the Public Health Notification, at:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#Metallic