Description of Event or Problem · 1
DURING THE PERIOD FROM 8/2003 TO 8/2004, 22 PATIENTS HAD UFE, UTERINE FIBROID EMBOLIZATION, TREATMENTS. FIVE WERE LOST TO FOLLOW-UP BUT OF THE 17 REMAINING, 12 HAD FAILURES FOR FIBROID REDUCTION REQUIRING REPEAT TREATMENT OR HYSTERECTOMY. ADDITIONAL FOLLOW-UP REVEALS: THE SPHERES WERE DESCRIBED AS "CLUMPING." THEY WERE ATTRACTED TO EACH OTHER AND NOT BEING DISPERSED TO ALL THE BLOOD VESSESLS. THROUGHOUT WE WERE TOLD BY THE MANUFACTURER THAT WE WERE THE ONLY ONE HAVING PROBLEMS WITH THE PRODUCT. RECENTLY, WE WERE INFORMED THAT THERE HAD BEEN ISSUES AND A DOCTOR IN FRANCE HAD WORKED ON IMPROVING THE PERFORMANCE OF THE PRODUCT AND THAT NOW BOSTON SCIENTIFIC SUGGESTS TO USE LARGER PARTICLES OF THE PRODUCT. THEY HAD CHOSEN NOT TO INFORM US ABOUT ISSUES WITH THE PRODUCT, WHEN WE ASKED BEFORE, SINCE THEY FIRST WANTED TO KNOW WHAT TO RECOMMEND INSTEAD. ACCORDING TO OUR RESULTS, WE HYPOTHESIZE THAT THE PRODUCT WE USED (500-700 MICRON) TENDS TO CLUMP AND LEAD TO PROXIMAL OCCLUSION (THERE WAS A VERY POOR CORRELATION BETWEEN FIBROID SIZE AND AMOUNT OF PARTICLES USED), THUS USING LARGER PARTICLES WOULD SEEM COUNTERINTUITIVE. WE HAVE SHARED THIS OPINION WITH THE MANUFACTURER. TECHNIQUE WAS RULED OUT AS A POSSIBLE CAUSE. STORAGE OF THE SPHERES IS CONSISTENT WITH THE MANUFACTURERS RECOMMENDATIONS - IN A DRY PLACE AND ONLY FRESH PRODUCT WAS USED.