Description of Event or Problem · 1
ONE OF MY SCIENTIFIC INTERESTS IS THE FOREIGN BODY REACTION. RECENTLY I HAVE REC'D E-MAILS FROM TWO WOMEN IN THE US WHO HAVE HAD DEVASTATING ALLERGIC REACTIONS TO VICRYL (POLYGLACTIN 910) SUTURES MANUFACTURED BY EHTICON. IN BOTH CASES THE SUTURES WERE USED IN A PEVIOUS OPERATION AND CAUSED LESS VIOLENT REACTIONS. BOTH WOMEN MENTIONED TO THE SURGEONS THAT THEY WERE ALLERGIC TO VICRYL AND AT LEAST ONE OF THEM WORE AN ARM BAND SAYING "DO NOT USE VICRYL SUTURES." UNBELIEVABLY, THESE WARNINGS WERE IGNORED, APPARENTLY BECAUSE THE SURGEONS HAD NEVER HEARD OF REACTIONS TO VICRYL AND SIMPLY DID NOT BELIEVE THAT THE SUTURES COULD BE ALLERGENIC. OF COURSE, I AM TAKING THESE STORIES AT FACE VALUE AND I HAVE NOT CONFIRMED ANY OF THE FACTS. I HAVE DISCUSSED THIS PROBLEM WITH A SURGEON COLLEAGUE WHO IS CHIEF OF SURGERY AT A LARGE HOSPITAL AND HE HAD ALSO NEVER HEARD OF PROBLEMS WITH VICRYL, SO THESE ALLERGIES MUST BE RARE. HOWEVER THERE ARE TWO REPORTS IN THE LITERATURE DESCRIBING THE PROBLEM: EUR J MED RES. 2005 DEC 7; 10(12):52-6. SAYEGH ET AL. J. BONE AND JOINT SURG. 85:2006-2009, 2003. I ALSO CAME ACROSS A WEB SITE, HTTP://BRAIN.HASTYPASTRY.NET/FORUMS/SHOWTHREAD.PHP?T=3184, IN WHICH THE PROBLEM IS DISCUSSED. MY PURPOSE IN WRITING IS TO ASK WHETHER THE FDA MIGHT BE INTERESTED IN LOOKING INTO AND PERHAPS PUBLICIZING THIS APPARENT PROBLEM. I DO NOT KNOW WHETHER ETHICON CURRENTLY ATTACHES A WARNING TO THEIR SALES OF THESE SUTURES.