SONABLATE

Additional Manufacturer Narrative

THERE IS NOT ENOUGH ADDITIONAL INFORMATION ABOUT THE PATIENT'S TREATMENT TO INVESTIGATE THIS INCIDENT WITHOUT KNOWING MORE ABOUT THE DEVICE SERIAL NUMBER, LOCATION, OR PHYSICIAN. REOCCURRENCE CAN HAPPEN WITH ANY PROSTATE CANCER TREATMENT OPTION; THEREFORE, IT IS RECOMMENDED THAT PATIENTS FOLLOW UP WITH THE PHYSICIAN THAT PROVIDED THE PRIMARY TREATMENT TO DISCUSS FUTURE CLINICAL DECISIONS. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE, POTENTIAL PROBLEMS AND COMPLICATIONS AFTER A HIFU PROCEDURE ARE SIMILAR TO THOSE SEEN WITH OTHER PROCEDURES FOR PROSTATE TISSUE ABLATION PROCEDURES OR OTHER UROLOGICAL PROCEDURES. HOWEVER, THE ETIOLOGY AND MANAGEMENT OF SUCH POTENTIAL COMPLICATIONS ARE SLIGHTLY DIFFERENT THAN IF THEY OCCURRED INDEPENDENTLY OF HIFU. THE MANUFACTURER'S RISK MANAGEMENT PROCESS HAS EVALUATED RISKS SPECIFICALLY TO THE USE OF HIFU FOR PRIMARY AND SALVAGE ABLATION OF PROSTATE. AS FOR PROSTATECTOMY, AND PROSTATECTOMY FOR POST-OPERATIVE CARE, THERE IS INHERENTLY A GREATER RISK OF ADVERSE EFFECTS. FINALLY, THE SONABLATE DEVICE IS ESTABLISHED IN THE MARKET, AND THE RISKS ASSOCIATED WITH THE USE OF THE DEVICE ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT.

Description of Event or Problem

A REPORT WAS SUBMITTED TO MHRA BY A PATIENT DETAILING THAT THE PATIENT RECEIVED HIFU AS A PRIMARY TREATMENT FOR PROSTATE CANCER AND LATER HAD A PROSTATECTOMY AS A SALVAGE TREATMENT AFTER A REOCCURRENCE. FOLLOWING THE PROSTATECTOMY, PATIENT NOW SUFFERS POOR INCONTINENCE. THE PATIENT REPORT ALLEGES THAT THE ABLATION TREATMENT CAUSED LOSS OF APICAL SUPPORT BECAUSE OF FIBROSIS OF THE END-PELVIC FASCIA, PARTICULARLY THE LATERAL PELVIC FASCIA, AND TRACTION INJURY TO THE NERVES.