Just ran across this MAUDE database entry on 2/1/22 submitted by Boston Scientific regarding fistulas in salvage HDR and thought it would be a good addition to this thread. I searched for the publication as mentioned below but was unable to locate it. Perhaps it isn't published yet? Who knows...
"BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT THROUGH THE ARTICLE "REVIEW OF RECTO-URETHRAL FISTULAE FOLLOWING FOCAL SALVAGE HIGH DOSE RATE BRACHYTHERAPY" WRITTEN BY DOCTOR ROBERTO ALONZI . IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR DEVICE WAS USED IN 7 SPACEOAR PLACEMENT PROCEDURES PERFORMED ON UNKNOWN DATES. THE SPACEOAR DEVICE WAS INSERTED PRIOR TO SALVAGE BRACHYTHERAPY IN ALL SEVEN PATIENTS. THE PATIENTS EACH DEVELOPED A FISTULA 4-7 MONTHS AFTER SALVAGE HIGH DOSE RATE (HDR) BRACHYTHERAPY. IN 2 OF THE PATIENT'S THERE WAS EVIDENCE OF RECTAL WALL COMPROMISE. IN 3 OF THE PATIENT'S THE SPACEOAR GEL WAS DIFFICULT TO VISUALIZE AND DISPERSED THROUGHOUT THE PERI PROSTATIC, PERI RECTAL TISSUE. THE PLACEMENT OF THE SPACEOAR GEL WAS DEEMED THE CAUSE OF THE FISTULAE. THE PATIENT RECEIVED A COLOSTOMY AND BILATERAL NEPHROSTOMY AS TREATMENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION TO DATE, DESPITE GOOD FAITH EFFORTS. Manufacturer Narrative: AGE AT TIME OF EVENT: PATIENT 1: (B)(6) YEARS, PATIENT 2: (B)(6) YEARS, PATIENT 3: (B)(6) YEARS, PATIENT 4: (B)(6) YEARS, PATIENT 5: (B)(6) YEARS, PATIENT 6: (B)(6) YEARS, PATIENT 7: (B)(6) YEARS. THE EXACT DATE OF THE EVENT IS UNKNOWN."