Public Health Warning – Complications of Implanting Metal Tracheal Stents for Benign Airway Lesions The purpose of this article is to alert you to the serious complications of the use of metal tracheal stents for benign airway lesions and to recommend measures to avoid or reduce the occurrence of such problems. This warning is for all covered and non-covered metal tracheal stents. Problem This warning is for patients with benign disease, primarily because the application of metal stents in such patients may result in the loss of future opportunities for other treatments (such as surgical tracheal surgery or implantation of silicone stents) after removal of the metal stent. Because metal stents remain in the body for a longer period of time, the risk of serious complications is higher in patients with benign airway lesions than in those with malignant airway lesions. Concerns about complications associated with metal therapy for benign airway lesions stem from a recent review of published literature, medical device reports received by the FDA, and information provided by physicians. These complications include obstructive granulation tissue formation, stent end stenosis, stent migration, mucus plugging, infection, and stent fracture. Although many of the medical device reports received by the FDA relate to stent fracture, we believe that other complications mentioned in the literature are also potential risks associated with the use of overmolded and non-overmolded metal stents. Removal of metal stents can also lead to serious complications such as mucosal tears, hemorrhage, reocclusion, respiratory failure requiring postoperative mechanical ventilation, and tension pneumothorax. The FDA has no data to evaluate the safety and efficacy of removing metal stents embedded in tissue from the airway. We know that patients can benefit from the proper use of metal tracheal stents in carefully selected cases. We currently work with manufacturers to ensure that stent instructions adequately inform patients with benign airway disease of the risks associated with the use of metal stents. Recommendations: l In patients with benign airway disease, metal tracheal stents should be considered only after other treatment options have been exhausted (e.g., tracheal surgery or implantation of silicone stents). The use of metal tracheal stents is not recommended as a transitional measure to the application of other treatments, as their removal can lead to serious complications. If a metal tracheal stent is the only option for the patient, the placement procedure should be performed by a surgeon trained or experienced in stenting procedures. If removal of the metal stent is necessary, the removal procedure should be performed by a surgeon who is trained or experienced in stent removal. Always read the instructions before using a stent, especially the indications, warnings and precautions for use, and select patients carefully. We urge you to be aware of guidelines developed by professional groups regarding the skills and qualifications of providers for these procedures (e.g., training requirements and clinical experience). These guidelines include information about surgical equipment, medical personnel, anesthesia and monitoring, surgical techniques, indications, contraindications, and risks of surgery. Reporting Adverse Reactions to FDA Timely reporting of adverse reactions improves the FDA’s ability to recognize and coordinate device risks and helps identify potential future problems. the FDA requires hospitals and other using facilities to report deaths and serious injuries associated with the use of medical devices. If a reported adverse event is suspected to be related to the use of a metal tracheal stent, it should be reported in accordance with the reporting procedures established by the hospital in which it is used. When reporting adverse events, you should indicate whether the initial placement of the metal tracheal stent placement was due to a benign or malignant lesion. We also encourage you to report adverse events related to metal tracheal stents that are not mandated to be reported. You may report directly to the manufacturer or to MedWatch, the FDA’s autonomous reporting system, by telephone, fax, e-mail, and the Internet.