BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7769851 · Received August 9, 2018

    Report

    Report Number
    2210968-2018-75050
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    July 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: INT UROGYNECOL J. 2008; 19: 473¿479. DOI: 10.1007/S00192-007-0476-8. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RISK EVALUATION OF SMOKING AND AGE ON THE OCCURRENCE OF POSTOPERATIVE EROSIONS AFTER TRANSVAGINAL MESH REPAIR FOR PELVIC ORGAN PROLAPSES". AUTHOR: FRANCESCO ARACO & GIANPIERO GRAVANTE & ROBERTO SORGE & DAVIDE DE VITA & EMILIO PICCIONE. CITATION: INT UROGYNECOL J. 2008; 19: 473¿479. DOI: 10.1007/S00192-007-0476-8. THIS STUDY EVALUATED THE INFLUENCE OF AGE AND SMOKING ON THE OCCURRENCE OF VAGINAL EROSIONS AFTER TRANSVAGINAL MESH REPAIR OF PELVIC ORGAN PROLAPSES (POP). THE STUDY BEGAN IN JANUARY 2002 AND ENDED IN DECEMBER 2006 WITH THE RECRUITMENT OF THE LAST PATIENT. THE AUTHORS EVALUATED A TOTAL OF 325 PATIENTS (AGE RANGE: 45 TO 75 YEARS OLD; BMI: 29 ± 4) WHO UNDERWENT MESH CORRECTION OF POP. DURING THE PROCEDURE, THE PROSTHESES WERE INTRODUCED VIA THE ANTERIOR OR POSTERIOR APPROACH. FOR THE ANTERIOR REPAIR, 2 TINY SKIN INCISIONS WERE MADE ON THE GENITORFEMORALIS FOLD, NEAR THE HYMEN, AND 2 OTHER INCISIONS MORE CAUDALLY AND LATERALLY. A TUNNELLER, WITH THE GYNECARE GYNEMESH-SOFT PS MESH PROSTHESIS (ETHICON) INCLUDED, WAS INTRODUCED IN THE OBTURATOR FORAMEN AND PASSED THROUGH THE OBTURATOR MEMBRANE AND OBTURATOR INTERNAL MUSCLE UNTIL IT REACHED THE VAGINA. AT THIS POINT, THE PROSTHESIS WAS ANCHORED AND THE ARMS DISTENDED. FOR THE POSTERIOR REPAIR, A TUNNELLER WAS INTRODUCED, WITH THE GYNECARE GYNEMESH-SOFT PS MESH PROSTHESIS, AND PASSED THROUGH THE ISCHIATIC FOSSA AND EXITED ON THE PARA-RECTAL SPACE. THE POSTERIOR COLPOTOMY WAS CLOSED WITH ABSORBABLE SUTURE. REPORTED COMPLICATIONS INCLUDED SUPERFICIAL VAGINAL EROSION (N-13) WHICH WERE TREATED BY RESUTURING THE VAGINAL MUCOSA IN LOCAL ANESTHESIA AND, WHEN MESH WAS EXPOSED, THE AUTHORS RESECTED A SMALL PIECE OF IT, DEEP VAGINAL EROSION WITH EVIDENT SIGNS OF INFECTION (N-6) IN WHICH THE PATIENTS WERE READMITTED TO THE HOSPITAL AND THE MESH WAS REMOVED IN GENERAL ANESTHESIA, DYSPAREUNIA (N-18), VAGINAL PERFORATION (N-4), RECURRENCE (N-9), AND BACTERIAL COLONIZATION OF (B)(6). THE RESULTS OF THIS STUDY SUGGESTS THAT PATIENTS PRONE TO DEVELOP EROSIONS COULD BE EASILY IDENTIFIED PREOPERATIVELY BY THE CLASS OF AGE AND THE SMOKING STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608570 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention