BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 18602668 · Received January 29, 2024

    Report

    Report Number
    2125050-2024-00147
    Event Type
    Injury
    Date Received
    January 29, 2024
    Report Date
    February 27, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: TO DRAIN OR NOT TO DRAIN AN INFLATABLE PENILE PROSTHESIS IMPLANTATION? A MULTIINSTITUTIONAL EXPERIENCE TRACKING SCROTAL HEMATOMA AND INFECTION OCCURRENCE. EUR UROL VOL 79 S687-S688 AUTHOR(S): OSMONOV, D.; RAGHEB, A.; OTERO, J.; BETTOCCHI, C.; VAN RENTERGHEM, K.; JÜNEMANN, K.; WILSON, S.

    Additional Manufacturer Narrative · 0

    AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AUTHOR(S): D. OSMONOV, A. M. RAGHEB, T. PETRY, A. ERAKY, C. BETTOCCHI, K. G. LAMERS, K. VAN RENTERGHEM, M. TROPMANN-FRICK, E. CHUNG, K. P. JÜNEMANN, G. GARAFFA, H. PORST, A. G. MOHAMED AND S. K. WILSON. FULL DETAILS CAN BE FOUND IN THE ATTACHED ARTICLE TITLED: VALUE OF PROLONGED SCROTAL DRAINAGE AFTER PENILE PROSTHESIS IMPLANTATION: A MULTICENTER PROSPECTIVE NONRANDOMIZED PILOT STUDY.

    Description of Event or Problem · 0

    METHOD: OUR SUBJECTS UNDERWENT IPP IMPLANTATION BY THREE EUROPEAN HIGH-VOLUME SURGEONS. ALL IMPLANTATIONS WERE PERFORMED VIA THE PENOSCROTAL ACCESS USING THE COLOPLAST TITAN TOUCH DEVICE. ONLY PATIENTS WITHOUT A PREVIOUS PENILE IMPLANTATION WERE INCLUDED. WE DIVIDED OUR PATIENTS INTO 3 GROUPS: GROUP 1: NO-DRAIN (N=60), GROUP 2: 24-HOUR DRAIN (N=60) AND GROUP 3: 72-HOUR DRAIN (N=60). ALL PATIENTS RECEIVED SIMILAR PERIOPERATIVE ANTIBIOTICS ACCORDING TO CLINICAL GUIDELINES. SURGICAL OUTCOMES SUCH AS PRESENCE OR ABSENCE OF PO SCROTAL HEMATOMA AND INFECTION WERE EVALUATED AND COMPARED BETWEEN THE 3 GROUPS. WE DEFINED HEMATOMA AS A SCROTAL SWELLING CORRELATED WITH EVIDENCE OF SCROTAL FREE FLOATING FLUID ON ULTRASOUND EXAMINATION. THE ULTRASOUND WAS DONE AFTER 24 HOURS AND ON THE 3RD AND 10TH PO DAYS. OVERALL PO FOLLOW UP WAS FOR 80 DAYS. RESULTS: THERE WERE NO SIGNIFICANT DIFFERENCES IN AGE, BMI, OPERATIVE TIME, MEDICAL COMORBIDITIES AMONG OUR STUDY GROUPS. THE PATIENTS FROM GROUP 3 DEVELOPED SIGNIFICANTLY LESS HEMATOMA COMPARED TO GROUPS 1 AND 2. THE EXACT DISTRIBUTION OF HEMATOMA INCIDENCE WAS GREATEST IN GROUP 1: N=12 (20%, P=0.005) FOLLOWED BY GROUP 2: N=8 (13.3%, P=0.05) AND LEAST IN GROUP 3: N=1 (1.7%, P=0.002). FOUR PATIENTS IN THE NO-DRAIN GROUP (6.7% P=0.005) DEVELOPED IPP ASSOCIATED INFECTION REQUIRING DEVICE REMOVAL. ALL FOUR HAD A HEMATOMA PRIOR TO THE INFECTION. GROUPS 2 AND 3 WERE INFECTION-FREE. CONCLUSION: PROLONGED DRAINAGE UP TO 72 HOURS AFTER VIRGIN IPP IMPLANTATION SIGNIFICANTLY REDUCES HEMATOMA RATES WITHOUT THE INCREASED RISK OF DRAIN-ASSOCIATED INFECTIONS. MOREOVER, WE BELIEVE THAT THE DEVELOPMENT OF A SCROTAL HEMATOMA, BY ITSELF, MAY BE A POTENTIAL CAUSE FOR SURGICAL SITE INFECTION.

    Description of Event or Problem · 0

    METHODS: WE CONDUCTED A MULTICENTER PROSPECTIVE NONRANDOMIZED PILOT STUDY. SURGERY WAS CARRIED OUT BY FOUR EUROPEAN AND ONE AUSTRALIAN HIGH-VOLUME SURGEONS AT FIVE DIFFERENT CENTERS OF EXCELLENCE. ONLY VIRGIN IPP CASES WERE INCLUDED IN THE SERIES. PATIENTS WITH PEYRONIE¿S DISEASE OR SEVERE FIBROSIS AFTER PRIAPISM WERE NOT INCLUDED. PATIENTS ON PROPHYLACTIC ANTICOAGULATION WERE BRIDGED PRIOR TO SURGERY. THE PATIENTS THAT COULD NOT BE BRIDGED WERE EXCLUDED. ALL PROCEDURES WERE PERFORMED THROUGH THE PENOSCROTAL ACCESS AND FOLLOWING THE SAME SURGICAL STEPS ACCORDING TO THE KIEL PROTOCOL FOR IPP IMPLANTATION. FOR STAY SUTURES, OVERLAPPING STAY STITCHES WERE UTILIZED TO ACHIEVE WATER TIGHT CLOSURE OF THE CORPOROTOMIES AFTER IMPLANT PLACEMENT. OUR DRAIN OF CHOICE WAS A 12 FRENCH CLOSED SUCTION DRAIN ROUTING BELOW THE CORPOROTOMIES AND BEHIND THE PUMP IN ALL THE PATIENTS. FOR CLOSURE, DARTOS AND SKIN LAYERS WERE CLOSED BY INTERRUPTED SUTURES IN A LOCKING FASHION FOR WOUND SEALING. ALL PATIENTS RECEIVED THE SAME PERIOPERATIVE ANTIBIOTIC PROPHYLAXIS. DEVICES WERE LEFT PARTIALLY INFLATED (75%) AND A MUMMY WRAP WAS APPLIED FOR ALL THE PATIENTS FOR 24 H. THE URETHRAL CATHETER WAS REMOVED AFTER 48 H AND ALL PATIENTS WERE DISCHARGED AFTER THE 3RD POSTOPERATIVE DAY. PATIENTS WERE DIVIDED INTO 3 GROUPS. NO DRAIN WAS INSERTED IN GROUP 1 PATIENTS (N=114); A DRAIN WAS INSERTED FOR 24 H IN GROUP 2 (N=114) AND FOR 72 H IN GROUP 3 (N=117). OUT OF THE SURGICAL OUTCOMES THE PRESENCE OR ABSENCE OF POSTOPERATIVE SCROTAL HEMATOMA AND INFECTION WERE THE FOCUS OF OUR STUDY. THEY WERE EVALUATED AND COMPARED BETWEEN THE THREE GROUPS. WE DEFINED HEMATOMA AS A SCROTAL SWELLING CORRELATED WITH ULTRASONOGRAPHIC EVIDENCE OF SCROTAL FREE-FLOATING FLUID. AN US SCAN WAS CARRIED OUT ON DAY 1, 3 AND 10 POSTOPERATIVELY. PATIENTS WERE FOLLOWED UP FOR 80 DAYS POSTOPERATIVELY. THIS STUDY WAS APPROVED BY THE ETHICAL COMMITTEE OF THE CHRISTIAN ALBRECHT¿S UNIVERSITY OF KIEL, GERMANY (D 444/19). RESULTS: TABLE 1 DEMONSTRATES THAT THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE AMONG THE 3 GROUPS WITH REGARDS TO AGE, BMI, COMORBIDITIES, TYPE OF IMPLANT UTILIZED AND OPERATIVE TIME. (TABLE 1) AFTER THE FIRST DAY OF SURGERY, THE NO-DRAIN GROUP RANKED HIGHEST IN HEMATOMA INCIDENCE [8.8%], FOLLOWED BY THE 24 H GROUP [5.3%] AND THE 72 H GROUP [1.7%] (P = 0.05). ON THE 3RD POSTOPERATIVE DAY, BOTH DRAINED GROUPS (24 AND 72 H DRAIN) DEMONSTRATED A STATISTICALLY SIGNIFICANT LOWER INCIDENCE OF HEMATOMA IN [6.1% AND 0.9%, RESPECTIVELY] VS. THE NO-DRAIN GROUP [11.4%] (P = 0.004). NEVERTHELESS, WHEN WE SEPARATELY COMPARED THE NO-DRAIN GROUP TO THE 24 H DRAIN GROUP (P = 0.157) AND THE 24 H TO THE 72 H DRAIN GROUP (P = 0.031), THIS DIFFERENCE, ALTHOUGH MAY BE CLINICALLY SIGNIFICANT, WASN¿T STATISTICALLY SIGNIFICANT. IT WAS STATISTICALLY SIGNIFICANT ONLY WHEN WE COMPARED THE 72 H GROUP WITH THE NO DRAIN GROUP (P = 0.001). ON THE 10TH DAY AFTER SURGERY, WE IDENTIFIED A STATISTICALLY SIGNIFICANT LOWER INCIDENCE OF HEMATOMA IN PATIENTS WHO HAD A DRAIN FOR 72 H [0.9%] COMPARED TO THE 24 H GROUP [9.6%] AND THE NO-DRAIN GROUP [7%], (P = 0.013). THERE WAS ALSO A STATISTICALLY SIGNIFICANT LOWER INCIDENCE OF HEMATOMA WHEN WE SEPARATELY COMPARED PATIENTS IN THE NO-DRAIN GROUP WITH THE 24-GROUP (P = 0.017) AND PATIENTS IN THE 24 H GROUP WITH 72 H GROUP (P = 0.003). HOWEVER, THE DIFFERENCE WASN¿T STATISTICALLY SIGNIFICANT WHEN WE COMPARED THE NO-DRAIN GROUP WITH THE 24 H GROUP (P = 0.477). (TABLE 2 AND FIG. 1). THE STRATIFICATION OF THE GROUPS BY SURGICAL TIME (UNDER OR ABOVE 60 MIN) DID NOT AFFECT OUR RESULTS REGARDING THE INCIDENCE OF HEMATOMA WITH SUPERIORITY REMAINING FOR THE 72 H DRAIN GROUP. EARLY POSTOPERATIVE INFECTION RATES WERE HIGHEST IN THE NO DRAIN GROUP [4.4%] FOLLOWED BY THE 24-DRAIN GROUP [3.5%] AND LOWEST IN THE 72 H GROUP [0.9%]. DESPITE THE CLINICAL SIGNIFICANCE OF SUCH DIFFERENCES, THERE WERE NO SIGNIFICANT STATISTICAL DIFFERENCES (P = 0.210). INTERESTINGLY, THE ONLY SIGNIFICANT FACTOR ASSOCIATED WITH THE INCREASED INCIDENCE OF POSTOPERATIVE INFECTION WAS THE OCCURRENCE OF A HEMATOMA AT 24 H AFTER SURGERY (P = 0.01). THE PRESENCE OF A DRAIN WAS NOT FOUND TO BE A RISK FOR INFECTION. THIS WAS DEMONSTRATED AFTER ADJUSTING FOR AGE, PRESENCE OF DIABETES AND INTRAOPERATIVE TIME, IN THE PRESENCE OF A DRAIN FOR 24 AND 72 H, AND THE PRESENCE OF HEMATOMA AT 24 H (TABLE 3). CONCLUSION: PROLONGED DRAINAGE FOR UP TO 72 H AFTER VIRGIN IPP IMPLANTATION SIGNIFICANTLY REDUCES HEMATOMA FORMATION AND THE RISK OF INFECTIONS REGARDLESS OF SURGICAL TIME. DUE TO THE NATURE OF THIS SERIES, ITS RESULTS NEED TO BE CONFIRMED BY LARGER RANDOMIZED TRIALS, WHICH CAN BE POSSIBLE ONLY AFTER THE ESTABLISHMENT OF THE EUROPEAN REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143292 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention