BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7969763 · Received October 16, 2018

    Report

    Report Number
    2210968-2018-76563
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    September 24, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: INT UROGYNECOL J. 2008; 19: 1415-1422. DOI: 10.1007/S00192-008-0657-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "LAPAROSCOPIC SACROCOLPOPEXY FOR UTERINE AND POST-HYSTERECTOMY PROLAPSE: ANATOMICAL RESULTS, QUALITY OF LIFE AND PERIOPERATIVE OUTCOME¿A PROSPECTIVE STUDY WITH 101 CASES." AUTHORS: DIMITRI SARLOS, SONJA BRANDNER, LAVONNE KOTS, NICOLLE GYGAX, GABRIEL SCHAER. CITATION: INT UROGYNECOL J. 2008; 19: 1415-1422. DOI: 10.1007/S00192-008-0657-0. THE AUTHORS PROSPECTIVE STUDY EVALUATES LAPAROSCOPIC SACROCOLPOPEXY FOR VAGINAL VAULT PROLAPSE FOCUSING ON PERIOPERATIVE DATA, OBJECTIVE ANATOMICAL RESULTS USING THE PELVIC ORGAN PROLAPSE QUANTIFICATION (POP-Q) SYSTEM AND POSTOPERATIVE QUALITY OF LIFE USING THE KINGS HEALTH QUESTIONNAIRE. A TOTAL OF 101 PATIENTS (AGE: 36 TO 81 YEARS OLD; BMI: 19 TO 38) COMPLETED THE STUDY. FIFTY FIVE PATIENTS HAD LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND SACROCOLPOPEXY FOR UTERINE PROLAPSE, 46 PATIENTS HAD LAPAROSCOPIC SACROCOLPOPEXY FOR POST-HYSTERECTOMY PROLAPSE; IT WAS ALSO REPORTED THAT 30 PATIENTS IN THE STUDY GROUPS HAD CONCURRENT SUBURETHRAL SLING (TVT-O [ETHICON]) PROCEDURE BECAUSE OF URINARY STRESS INCONTINENCE. DURING THE PROCEDURE, ANTERIORLY, THE VESICO-VAGINAL FASCIA WAS DISSECTED UP TO THE LOWER THIRD OF THE VAGINA JUST BELOW THE TRIGONUM OF THE BLADDER. TWO SEPARATE GYNEMESH MESH (ETHICON) A MACRO POROUS MULTIFILAMENT POLYPROPYLENE MESH, WERE USED FOR THE ANTERIOR AND POSTERIOR COMPARTMENT. ALL FIXATIONS WERE PERFORMED BY LAPAROSCOPIC SUTURING USING ETHIBOND 2-0 SUTURES (ETHICON) WITH EXTRA CORPORAL KNOTTING TECHNIQUE. AT THE END OF THE PROCEDURE, A TVT-O SUBURETHRAL SLING (ETHICON), WAS PLACED UNDER THE MID-URETHRA WHEN URODYNAMICALLY PROVEN CONCOMITANT STRESS URINARY INCONTINENCE WAS PRESENT. REPORTED COMPLICATIONS INCLUDED SEVERE ADHESIONS (N-1) WHICH REQUIRED CONVERSION TO LAPAROTOMY, SEPTICAL PERITONITIS (N-1) WHICH REQUIRED LAPAROTOMY WITH FLUSHING AND DRAINAGE AND A SIGMOIDOSTOMY. THE MESH WAS EXCISED DURING THE REVISION LAPAROTOMY. POST-OPERATIVELY, THE PATIENT DID WELL, BLADDER LESION (N-4) WHICH REQUIRED LAPAROSCOPIC REPAIR AND FOLEY CATHETER INSERTION FOR 7 DAYS AFTER SURGERY, DYSURIA AND HEMATURIA DUE TO MESH EROSION (N-1) WHICH REQUIRED LAPAROSCOPIC CYSTOTOMY WITH PARTIAL RESECTION OF THE ANTERIOR MESH AND BLADDER REPAIR, POST-OPERATIVE VOIDING DYSFUNCTION (N-8) WHICH REQUIRED SUPRAPUBIC DRAINAGE AND 2 PATIENTS NEEDED TRANSECTION OF THE SUBURETHRAL SLINGS, MECHANICAL ILEUS (N-1) WHICH REQUIRED LAPAROTOMY, ADHESIOLYSIS, AND BOWEL SEGMENT RESECTION , URINARY TRACT INFECTION (N-17), WOUND INFECTION AT TROCAR SITE INSERTION (N-1), DE NOVO STRESS INCONTINENCE (N-24) WHICH REQUIRED A SECONDARY TVT OR TVT-O PROCEDURE IN 15 PATIENTS AND MANAGED CONSERVATIVELY WITH PHYSIOTHERAPY, DE NOVO URGE INCONTINENCE (N-2) WHICH WERE TREATED MEDICALLY AND DISAPPEARED AT 6 MONTHS FOLLOW-UP VISIT, DE NOVO DYSPAREUNIA (N-1), RECURRENCE IN THE POSTERIOR COMPARTMENT (N-2), AND RECURRENCE IN THE ANTERIOR VAGINAL WALL (N-6) WHICH REQUIRED VAGINAL PROLAPSE SURGERY WITH AN ISOLATED PROLIFT VAGINAL MESH AUGMENTATION OF THE ANTERIOR WALL. IT WAS CONCLUDED THAT THE LAPAROSCOPIC SACROCOLPOPEXY WITH OR WITHOUT SUPRACERVICAL HYSTERECTOMY IS A FEASIBLE AND REPRODUCIBLE PROCEDURE WITH HIGH SUBJECTIVE AND OBJECTIVE CURE RATES, WITH VERY LOW RATES OF VAGINAL MESH EROSIONS AND DE-NOVO DYSPAREUNIA IN THE SHORT TIME FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809561 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention