BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8906290 · Received August 19, 2019

    Report

    Report Number
    2210968-2019-85725
    Event Type
    Injury
    Date Received
    August 19, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: COLORECTAL DISEASE (2007); 10:138¿143. DOI:10.1111/J.1463-1318.2007.01259.X. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: LAPAROSCOPIC VENTRAL RECTOPEXY, POSTERIOR COLPORRHAPHY AND VAGINAL SACROCOLPOPEXY FOR THE TREATMENT OF RECTO-GENITAL PROLAPSE AND MECHANICAL OUTLET OBSTRUCTION. WHILST TRANS-ABDOMINAL FIXATION RESECTION OFFERS BETTER FUNCTIONAL RESULTS AND LOWER RECURRENCE THAN PERINEAL PROCEDURES, MESH RECTOPEXY IS COMPLICATED BY CONSTIPATION. LAPAROSCOPIC AUTONOMIC NERVE-SPARING, VENTRAL RECTOPEXY ALLOWS CORRECTION OF THE UNDERLYING ABNORMALITIES OF THE RECTUM, VAGINA, BLADDER AND PELVIC FLOOR. BETWEEN JANUARY 1997 AND DECEMBER 2005, 80 PATIENTS (6 MALE AND 74 FEMALE; MEDIAN AGE: 59 YEARS; AGE RANGE: 31¿90 YEARS; BMI: 19¿36) UNDERWENT NOVEL LAPAROSCOPIC PROLAPSE SURGERY FOR FULL THICKNESS PROLAPSE AND/OR MECHANICAL OUTLET OBSTRUCTION. A HARMONIC SCALPEL (ETHICON) IS USED FOR THE DISSECTION. A 15X15 CM PROLENE POLYPROPYLENE MESH (ETHICON) IS TRIMMED IN THE HYPOTENUSE AXIS TO 3X17 CM, THE LAST 7 CM TAPERING TO 1 CM. THE MESH IS SUTURED TO THE VENTRAL ASPECT OF THE SEROMUSCULAR WALL OF THE RECTUM USING THREE, INTERRUPTED, NON-ABSORBABLE SUTURES ETHIBOND 0 (ETHICON). THE POSTERIOR WALL OF THE VAGINA IS THEN SUTURED TO THE VENTRAL ASPECT OF THE MESH WITH THREE SUTURES AS BEFORE. THE MOST CRANIAL IS SUTURED TO THE POSTERIOR VAGINAL FORNIX. THE TAPERED END OF MESH IS FIXED TO THE SACRAL PROMONTORY WITHOUT PLACING ANY PARTICULAR TRACTION ON THE RECTUM. DURING THE RESECTION RECTOPEXY, THE UPPER 1/3 OF THE RECTUM IS DIVIDED USING A LINEAR CUTTER (ETHICON). THE UMBILICAL PORT IS EXTENDED EITHER SIDE OF THE UMBILICUS IN THE MIDLINE TO ALLOW DELIVERY OF THE BOWEL. THE PROXIMAL BOWEL AND HEAD OF A CIRCULAR STAPLING DEVICE (ETHICON) IS RETURNED TO THE ABDOMINAL CAVITY AND THE INCISION IS CLOSED AROUND THE RE-INTRODUCED UMBILICAL PORT. REPORTED COMPLICATIONS INCLUDED FECAL IMPACTION (N-3), EXTRACTION PORT SITE INFECTION (N-1), WOUND INFECTION (N-2%), BLEEDING (N-1), RESECTION RECTOPEXY ANASTOMOSIS LEAKED (N-1) WHICH REQUIRED A TEMPORARY LOOP ILEOSTOMY, URINARY RETENTION (N-1), MINOR EVACUATORY DIFFICULTIES (N-3) WHICH WERE MANAGED WITH A COMBINATION OF SENNA AND ENEMAS. AND TWO, URINARY STRESS INCONTINENCE (N-2) WHICH RESPONDED TO A TVT SLING. IN CONCLUSION, LAPAROSCOPIC VENTRAL RECTOPEXY IS SAFE WITH RELATIVELY LOW MORBIDITY. IN THE MEDIUM-TERM, IT PROVIDES GOOD RESULTS FOR PROLAPSE AND ASSOCIATED SYMPTOMS OF INCONTINENCE AND OBSTRUCTED DEFECATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701518 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention