Description of Event or Problem · 0
IN (B)(6) 2023, I UNDERWENT LEFT HEMI-ABLATION OF THE PROSTATE USING THE FOCAL ONE HIFU SYSTEM (EDAP TMS) FOR LOCALIZED PROSTATE CANCER. I WAS VERBALLY INFORMED DURING THE CONSENT PROCESS THAT HIFU WOULD PRESERVE ALL FUTURE TREATMENT OPTIONS SHOULD RECURRENCE OCCUR. APPROXIMATELY SIX MONTHS LATER, BIOPSY DEMONSTRATED RECURRENT PROSTATE CANCER, INCLUDING INVOLVEMENT OF THE PREVIOUSLY ABLATED LEFT ZONE. I ELECTED TO UNDERGO SALVAGE STEREOTACTIC BODY RADIATION THERAPY (SBRT). FOR CYBERKNIFE SBRT PLANNING, FOUR GOLD FIDUCIAL MARKERS WERE PLACED TRANSPERINEALLY INTO THE PROSTATE AND CONFIRMED IN CORRECT POSITION ON CT IMAGING. AT THE FIRST CYBERKNIFE TREATMENT SESSION, THE TWO FIDUCIAL MARKERS THAT HAD BEEN PLACED WITHIN THE PREVIOUSLY HIFU-ABLATED LEFT ZONE WERE NO LONGER VISIBLE. THEY WERE NOT IDENTIFIABLE WITHIN THE PROSTATE OR ELSEWHERE IN THE PELVIS ON IMAGING. BECAUSE CYBERKNIFE REQUIRES STABLE FIDUCIALS FOR REAL-TIME TRACKING, TREATMENT ON THAT PLATFORM COULD NOT PROCEED. I WAS THEREFORE REQUIRED TO SWITCH TO A TRUEBEAM LINEAR ACCELERATOR PLATFORM USING CONE-BEAM CT GUIDANCE INSTEAD OF CONTINUOUS FIDUCIAL TRACKING. FOLLOWING SALVAGE SBRT, I EXPERIENCED MULTIPLE SIGNIFICANT COMPLICATIONS, INCLUDING: RADIATION CYSTITIS WITH EPISODES OF GROSS HEMATURIA DEVELOPMENT OF A 2 CM FIBROUS STRICTURE IN THE MEMBRANOUS URETHRA REQUIRING SURGICAL MANAGEMENT MILD URINARY INCONTINENCE REQUIRING PAD USE SEVERE ERECTILE DYSFUNCTION REQUIRING INTRACAVERNOSAL INJECTION THERAPY MY PSA RESPONSE HAS BEEN FAVORABLE (0.08 NG/ML AT 26 MONTHS POST-SBRT), AND I AM CURRENTLY ALIVE; HOWEVER, I CONTINUE TO MANAGE THE ABOVE COMPLICATIONS. I AM SUBMITTING THIS REPORT BECAUSE THE HIFU-TREATED TISSUE DID NOT APPEAR TO RELIABLY RETAIN FIDUCIAL MARKERS, WHICH DIRECTLY LIMITED ACCESS TO A FIDUCIAL-DEPENDENT RADIATION PLATFORM (CYBERKNIFE). THIS REPRESENTS A POTENTIAL DEVICE-RELATED LIMITATION AFFECTING DOWNSTREAM COMPATIBILITY WITH SUBSEQUENT STANDARD-OF-CARE CANCER THERAPIES. ADDITIONALLY, SALVAGE RADIATION THERAPY AFTER HIFU MAY CARRY HIGHER RATES OF URINARY AND SEXUAL COMPLICATIONS COMPARED TO PRIMARY SBRT. THESE POTENTIAL DOWNSTREAM LIMITATIONS AND RISKS WERE NOT DISCLOSED TO ME DURING THE INFORMED CONSENT PROCESS FOR FOCAL ONE HIFU. HAD I BEEN AWARE THAT HIFU-TREATED TISSUE MIGHT COMPROMISE FIDUCIAL STABILITY OR ALTER THE RISK PROFILE OF SUBSEQUENT RADIATION THERAPY, MY TREATMENT DECISION MAY HAVE BEEN DIFFERENT. I RESPECTFULLY SUBMIT THIS REPORT SO THAT THE FDA MAY EVALUATE WHETHER LABELING, PATIENT EDUCATION MATERIALS, OR INFORMED CONSENT GUIDANCE FOR THE FOCAL ONE HIFU SYSTEM SHOULD INCLUDE CLEARER DISCLOSURE REGARDING: POTENTIAL INSTABILITY OR LOSS OF FIDUCIAL MARKERS IN ABLATED PROSTATE TISSUE. POSSIBLE LIMITATIONS IN COMPATIBILITY WITH FIDUCIAL-DEPENDENT RADIATION PLATFORMS. THE POTENTIAL FOR INCREASED MORBIDITY ASSOCIATED WITH SALVAGE RADIATION AFTER HIFU. THIS REPORT IS INTENDED TO DOCUMENT A DEVICE-RELATED ISSUE AFFECTING SUBSEQUENT TREATMENT OPTIONS AND PATIENT OUTCOMES. THIS WAS A MEDICAL DEVICE NOT A LABORATORY TEST.