Description of Event or Problem · 1
THERE IS AN INCREASING NUMBER OF SEVERE AND LIFE THERATENING PROBLEMS ASSOCIATED WITH THE USE OF METAL STENTS IN BENIGN AIR WAY OBSTRUCTION. STENTS HAVE BEEN IN USE FOR THE TREATMENT OF AIRWAY OBSTRUCTIONS AND IN RECENT YEARS, METAL STENTS HAVE BEEN INCREASINGLY POPULAR FOR THEIR RELATIVE EASE OF PLACEMENT. REPORTER RECEIVED TRANSFERS AND REFERRALS OF PTS FROM THROUGHOUT WHO EXPERIENCED PROBLEMS WITH THEIR AIRWAY PROSTHESIS. THE MOST COMMON COMPLICATIONS ARE BREAKAGE (OFTEN IN MULTIPLE LOCATIONS), SEVERE GRANULATION FORMATION AND EVEN RESPIRATORY FAILURE. FREQUENTLY PTS ARE LEFT WITH WORSE PROBLEMS AFTER STENTING THAT THEY HAD EXPERIENCED PRIOR TO THE INTERVENTION. REMOVAL OF THESE STENTS CAN BE HAZARDOUS AND IS ASSOCIATED WITH SEVERE COMPLICATIONS, SUCH AS RESPIRATORY FAILURE, MASSIVE BLEEDING, AIRWAY TEARS, TENSION PNEUMOTHORACES AND SO ON. REPORTER IS LOOKING AT MORE THAN 150 AFFECTED PTS TREATED AT THEIR INSTITUTIONS ALONE AND A NUMBER OF THEM HAVE ALREADY BEEN PUBLISHED. THIS NUMBER WOULD OBVIOUSLY BE SIGNIFICANTLY HIGHER, IF OTHER INSTITUTIONS WOULD BE INCLUDED. EVEN THOUGH THESE STENTS CAN BE QUITE BENEFICIAL FOR THE USE IN PTS WITH LIMITED LIFE EXPECTANCY, REPORTER HAS SEEN TERRIBLE COMPLICATIONS IN BENIGN AIRWAY DISORDERS AND CONTRARY TO EXPECTATION OCCASIONALLY IN PTS WITH CANCER. REPORTER HAS CONCERNED ABOUT PT'S WELFARE. IT SEEMS ESPECIALLY TROUBLESOME THAT SOME STENT MAKERS ARE NOW APPLYING FOR APPLICATIONS FOR BENIGN DISEASES FOR THEIR METAL STENTS. AS THIS MATERIAL IS ALWAYS PRONE TO BREAKAGE DUE TO METAL FATIGUE, SAFE REMOVAL CAN NEVER BE GUARANTEED IN PTS WHO MAY LIVE FOR YEARS TO COME. RPTR FEELS THE FDA SHOULD INVESTIGATE THE USE OF METAL STENTS IN AIRWAY DISORDERS AND EVEN CONSIDER A MORATORIUM FOR BENIGN APPLICATIONS. AT THE VERY LEAST SHOULD REQUIRE ONLY FOR WELL-TRAINED ENDOSCOPISTS WHO ARE ABLE TO PLACE DIFFERENT STENT TYPES (INCLUDING SILICONE) TO USE THESE DEVICES, SO THE BEST POSSIBLE DECISION FOR THE PTS ARE MADE.