BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8941223 · Received August 28, 2019

    Report

    Report Number
    2210968-2019-86387
    Event Type
    Injury
    Date Received
    August 28, 2019
    Report Date
    August 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: 31ST CONGRESS OF THE SOCIETE INTERNATIONALE D'UROLOGIE, SIU. 2011; 78 (SUPPL.1): S403. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SUBURETHRAL BONE-SCREWED SLING IN MALE INCONTINENCE: TECHNIQUE AND EXPERIENCE" AUTHOR(S): LEYTON R., ANDRUSCO A., OLIVARES R. CITATION: 31ST CONGRESS OF THE SOCIETE INTERNATIONALE D'UROLOGIE, SIU. 2011; 78 (SUPPL.1): S403. MALE URINARY INCONTINENCE IS A CONDITION THAT SERIOUSLY COMPROMISES THE MAN'S QUALITY OF LIFE AND SOCIAL PERFORMANCE. IT IS PRODUCED MAINLY SECONDARY TO SURGICAL OR IRRADIATING PROSTATE CANCER TREATMENT. THIS PATHOLOGY HAS HAD A DIFFICULT MANAGEMENT THROUGHOUT HISTORY, WITH DIFFERENT TECHNIQUES, SOME OF WHICH ARE HIGH COST, SHOWING POOR RESULTS AND A SIGNIFICANT PERCENTAGE OF COMPLICATIONS. THE AUTHORS REPORTED THE EXPERIENCE IN IMPLEMENTING A NOVEL TECHNIQUE FOR THE MANAGEMENT OF THIS CONDITION. THE AUTHORS DESCRIBED THE TECHNIQUE AND A PROSPECTIVE ANALYSIS IS PERFORMED ON 24 PATIENTS, WHO HAD URINARY INCONTINENCE WITH INTRINSIC SPHINCTER FAILURE, CONFIRMED BY URODYNAMICS. DURING THE SURGICAL PROCEDURE, A SUBURETHRAL SCREWED SLING WAS INSTALLED BY A SINGLE SURGEON. THE AUTHORS INSTALLED A PROLENE MESH (ETHICON) BY PERINEAL APPROACH ANCHORED WITH FOUR TITANIUM SCREWS LATERALLY INTO BOTH BRANCHES OF THE ISCHIAL BONE, CREATING A CONTROLLED COMPRESSION ON THE BULBAR URETHRA. REPORTED EVENTS INCLUDED COMPLICATIONS (N-7); ONLY 1 SERIOUS WHICH REQUIRED SLING REMOVAL AND 3 PATIENTS REQUIRED REOPERATION. THE SCREWED SUBURETHRAL SLING IS A SIMPLE, REPRODUCIBLE AND CHEAP TECHNIQUE, WITH A HIGH SUCCESS RATE AND SATISFACTION OF THE PATIENT. ALTHOUGH IT REQUIRES A GREATER NUMBER OF PROCEDURES AND COMPARATIVE STUDIES TO ESTABLISH CONCLUSIVE ANALYSIS, THIS TECHNIQUE COULD BE AN OPTION, SECURE AND EASY TO LEARN, TO TREAT A DISEASE UNTIL NOW DIFFICULT TO DEAL WITH, THAT SERIOUSLY IMPAIR THE QUALITY OF LIFE OF MEN WHO HAVE OVERCOME CANCER, BUT WITH A VERY HIGH FUNCTIONAL, PSYCHOLOGICAL AND SOCIAL COST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733080 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention