BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 18808729 · Received February 29, 2024

    Report

    Report Number
    2125050-2024-00339
    Event Type
    Injury
    Date Received
    February 29, 2024
    Report Date
    February 29, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: THE NATURAL HISTORY OF BENIGN PROSTATIC HYPERPLASIA-RELATED VOIDING SYMPTOMS FOLLOWING PENILE PROSTHESIS IMPLANTATION. AUTHOR(S): RAEVTI BOLE, PRAJIT KHOOBLALL AND PETAR BAJIC.

    Description of Event or Problem · 0

    METHODS: FOLLOWING INSTITUTIONAL REVIEW BOARD APPROVAL, WE PERFORMED A RETROSPECTIVE REVIEW OF ALL ADULT MALES WITH A PREOPERATIVE DIAGNOSIS OF LUTS UNDERGOING PENILE PROSTHESIS SURGERY AT OUR INSTITUTION FROM (B)(6) 2017 TO (B)(6) 2022. THE PRIMARY OUTCOME WAS PROGRESSION TO TRANSURETHRAL SURGERY. RESULTS: FROM 2017 TO 2022, 211 PATIENTS WITH PREEXISTING LUTS UNDERWENT PENILE PROSTHESIS SURGERY AND MET ALL CRITERIA FOR INCLUSION INCLUDING NO HISTORY OF TRANSURETHRAL SURGERY. THE MEDIAN (INTERQUARTILE RANGE, IQR) AUA SYMPTOM SCORE (AUA-SS) WAS 12 (12). POST-VOID RESIDUAL WAS BELOW 200 CC IN 96.2% OF PATIENTS PREOPERATIVELY AND 99.1% OF PATIENTS AFTER SURGERY. AT A MEDIAN (IQR) FOLLOW-UP DURATION OF 9 (23) MONTHS AFTER SURGERY, 5.7% (12/211) OF PATIENTS HAD PROGRESSED TO BLADDER OUTLET SURGERY AND 35.5% OF PATIENTS ENDORSED LUTS BOTHER WITH A MEDIAN (IQR) AUA-SS OF 14.5 (11.8). CONCLUSION: THE MAJORITY OF PATIENTS WITH UNCOMPLICATED LUTS DID NOT REQUIRE BLADDER OUTLET SURGERY FOLLOWING PENILE PROSTHESIS IMPLANTATION AND COULD BE MANAGED WITH CONSERVATIVE OR PHARMACOLOGIC MEASURES ALONE. PROSTATE GLAND SIZE WAS SIGNIFICANTLY LARGER IN PATIENTS WHO PROGRESSED TO BLADDER OUTLET SURGERY. WHILE THE RESULTS ARE OVERALL REASSURING, FURTHER STUDY IS NEEDED TO IDENTIFY SPECIFIC FACTORS ASSOCIATED WITH PURSUING BLADDER OUTLET SURGERY IN THIS SMALL SUBSET OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895881 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention