NOTE: BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE REPORTED EVENT THROUGH VARIOUS LEGAL DOCUMENTS; THE EVENTS HAD NOT BEEN PREVIOUSLY REPORTED TO BSC. BSC RECEIVED A LETTER FROM THE PATIENT'S ATTORNEY WHICH REPORTED THAT IN 1998, A PATIENT (AGE AND WEIGHT UNKNOWN) UNDERWENT A BLADDER NECK SUSPENSION SURGERY USING THE VESICA SLING SYSTEM. ACCORDING TO THE COMPLAINANT, IN 2006, THE PATIENT WENT TO THE EMERGENCY ROOM COMPLAINING OF "KNOTS IN HER ABDOMEN" (TREATMENT UNKNOWN). IT WAS REPORTED THAT APPROXIMATELY IN APPROX TWO AND A HALF MONTHS LATER, A PIECE OF METAL WAS PROTRUDING FROM WHERE SHE PREVIOUSLY HAD A LUMP. ONE OF THE METAL ANCHORS FROM THE VESICA SLING SYSTEM HAD BROKEN LOOSE AND HAD MADE ITS WAY TO THE SURFACE OF HER SKIN. THE NATURE OF THE PATIENT OUTCOME IS UNKNOWN AT THIS TIME. WE ARE UNABLE TO OBTAIN ANY FURTHER INFORMATION REGARDING THIS EVENT OR THE PATIENT'S CONDITION. IT IS UNKNOWN AT THIS TIME IF MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.
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Patient 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS IMPLANTED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. IT WAS NOT POSSIBLE TO IDENTIFY ANY POTENTIAL LOTS FOR THIS PRODUCT THROUGH A SHIP HISTORY RECORD REVIEW DUE TO THE AGE OF THE PRODUCT. THE OCTOBER 2007 15-MONTH SLING FIXATION COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED.