BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8966746 · Received September 5, 2019

    Report

    Report Number
    2210968-2019-86617
    Event Type
    Injury
    Date Received
    September 5, 2019
    Report Date
    August 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: GYNECOLOGY OBSTETRICS & FERTILITY (2005); 33:970¿974. DOI: 10.1016/J.GYOBFE.2005.10.023. (B)(4).

    Description of Event or Problem · 1

    TITLE : RISK FACTORS FOR PROSTHESIS EXPOSURE IN TREATMENT OF GENITAL PROLAPSE VIA THE VAGINAL APPROACH THE PURPOSE OF THIS STUDY IS TO DEFINE THE RISK FACTORS FOR EXPOSURE OF THE PROSTHETIC MATERIAL. THIS RETROSPECTIVE STUDY CARRIED OUT FROM JANUARY 2002 TO DECEMBER 2003 INVOLVES 277 FEMALE PATIENTS (AVERAGE AGE: 64 YEARS; AGE RANGE: 37-81 YEARS) WHO UNDERWENT SURGERY DUE TO PELVIC PROLAPSE. TENSION-FREE VAGINAL MESH (TVM) WAS PERFORMED CONSISTING OF THE PLACEMENT OF A SYNTHETIC PROSTHESIS IN THE AREAS OF VESICOVAGINAL AND RECTOVAGINAL DETACHMENT. THE CORRECTION OF THE CYSTOCELE REQUIRES A BILATERAL TRANSOBTURATOR PASSAGE OF THE PROSTHESIS TO SUPPORT THE BLADDER (IN THE MANNER OF A TVT). ON EACH SIDE, THE ANTERIOR PROSTHESIS HAS TWO ARMS (ONE ANTERIOR AND ONE POSTERIOR) THAT ARE PASSED USING A MODIFIED EMMET NEEDLE INTO THE PARAVESICAL SPACE FROM INSIDE TO OUTSIDE. THE ANTERIOR ARM IS PLACED THROUGH THE PUBIC END OF THE TENDINOUS ARCH OF THE PELVIC FASCIA AND THE POSTERIOR ARM THROUGH THE ARCH TO WITHIN ONE CENTIMETER OF THE ISCHIAL SPINE. THE CORRECTION OF THE RECTOCELE REQUIRES A BILATERAL TRANSGLUTEAL PASSAGE OF THE PROSTHESIS. THE POSTERIOR COLPOTOMY SHOULD BE LONGITUDINAL AND AT A DISTANCE FROM THE ANTERIOR COLPOTOMY AND THE HYSTERECTOMY SCAR, IF THERE HAS BEEN ONE. THEN, ON EACH SIDE, THE POSTERIOR PROSTHESIS WITH TWO ARMS (ONE LEFT AND ONE RIGHT) IS PASSED FROM INSIDE TO OUTSIDE IN THE PARARECTAL SPACE AND THEN THROUGH THE SACROSCIATIC LIGAMENT (IN THE MANNER OF A RICHTER). THE TWO ARMS WILL FINALLY BE EXTERNALIZED IN TWO ORIFICES LOCATED TWO CENTIMETERS BELOW AND OUTSIDE THE ANUS. GYNECARE MESH (ETHICON) WAS USED IN ALL PATIENTS, PROLENE MESH (ETHICON) USED IN 108 CASES AND PROLENE SOFT MESH (ETHICON) USED IN 169 CASES. THE CLOSURE OF THE COLPOTOMY IS DONE BY A VICRYL 0 CONTINUOUS SUTURE (ETHICON) WITHOUT ADDITIONAL COLPECTOMY. THE CUTANEOUS SUTURE REQUIRES A SINGLE VICRYL 2/0 SUTURE (ETHICON) WITH RAPID ABSORPTION ON THE SIX SKIN INCISIONS. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE HEMATOMA (N-1), PROSTHESIS EXPOSURE (N-?), HEAVY AND DIRTY LEUCORRHEA (N-?), AND DYSPAREUNIA (N-?). IN THIS STUDY, THE AUTHORS ONLY FOUND RISK FACTORS OF OPERATIVE PROTOCOL. OTHER INFORMATION AS AGE, MENOPAUSE STATUS OR MEDICAL HISTORY OF THE PATIENT WERE FOUND TO BE NOT SIGNIFICANT. THE UTERUS MUST BE PRESERVED AND THE NUMBER AND EXTENT OF COLPOTOMIES NEEDED TO INSERT THE PROSTHESIS MUST BE LIMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760732 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention