BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 7481543 · Received May 2, 2018

    Report

    Report Number
    2210968-2018-72557
    Event Type
    Injury
    Date Received
    May 2, 2018
    Report Date
    April 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTM
    PMA / PMN Number
    UNKNOWN
    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. CITATION: INT UROGYNECOL J (2010) 21:1455¿1462; DOI 10.1007/S00192-010-1223-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: TOTAL TRANSVAGINAL MESH (TVM) TECHNIQUE FOR TREATMENT OF PELVIC ORGAN PROLAPSE: A 3-YEAR PROSPECTIVE FOLLOW-UP STUDY¿ AUTHOR(S): BERNARD JACQUETIN & BRIGITTE FATTON & CLAUDE ROSENTHAL & HENRI CLAVÉ & PHILIPPE DEBODINANCE & PIET HINOUL & JUDI GAULD & OLIVIER GARBIN & JUAN BERROCAL & RICHARD VILLET & DELPHINE SALET LIZÉE & MICHEL COSSON CITATION: INT UROGYNECOL J (2010) 21:1455¿1462; DOI 10.1007/S00192-010-1223-0 THE OBJECTIVE OF THE STUDY WAS TO ASSESS THE EFFECTIVENESS, BOTH ANATOMIC AND SUBJECTIVE, AND COMPLICATIONS FOR THE TRANSVAGINAL MESH TECHNIQUE FOR PELVIC ORGAN PROLAPSE REPAIR. BETWEEN JAN2004 AND DEC2004, 90 PATIENTS (MEAN AGE SD OF 65.2±10.4 YEARS) WITH PELVIC ORGAN PROLAPSE UNDERWENT TOTAL TRANSVAGINAL MESH REPAIR, BUT ONLY 85 PATIENTS WERE AVAILABLE FOR 3-YEAR FOLLOW-UP. THE TOTAL TRANSVAGINAL MESH TECHNIQUE COMPRISED PLACEMENT OF THE GYNEMESH OF A SPECIFIC SIZE AND SHAPE. THE ANTERIOR COMPONENT WAS INSERTED BETWEEN THE BLADDER AND THE VAGINA AND SECURED BILATERALLY BY TWO ARMS THROUGH EACH OBTURATOR FORAMEN, USING AN EMMET-LIKE NEEDLE. THE POSTERIOR COMPONENT WAS PLACED BETWEEN THE RECTUM AND THE VAGINA, AND SECURED BY ONE ARM PASSING THROUGH EACH ISCHIORECTAL FOSSA AND SACROSPINOUS LIGAMENT. THE INTERMEDIATE SECTION CORRESPONDING TO THE VAGINAL APEX SEPARATED THE ANTERIOR AND POSTERIOR PARTS. POSTOPERATIVELY, ONE PATIENT HAD EXTRUSION OF THE MESH WHICH REQUIRED RESECTION. FIFTEEN PATIENTS DEVELOPED URINARY INFECTION. THERE WERE 13 PATIENTS WHO HAD MESH EXPOSURE DURING THE 3-YEAR FOLLOW-UP WHERE 8 PATIENTS REQUIRED SURGERY, 1 PATIENT REQUIRED MEDICAL TREATMENT AND 4 PATIENT WITH NO TREATMENT REQUIRED. AT 3 YEAR FOLLOW UP, 14 CASES OF ANATOMICAL FAILURE WAS REPORTED WHERE 10 PATIENTS REQUIRED NO FURTHER INTERVENTION. THREE OF THESE PATIENTS REQUIRED REINTERVENTION: LAPAROSCOPIC SACROCOLPOPEXY (N=1), ENTEROCELE REPAIR AND A RIGHT SIDED SACROSPINOUS LIGAMENT FIXATION WITH TWO VAGINAL FLAPS (N=1), AND MESH EXCISION WITH SURGICAL TREATMENT (N=1). ANATOMICAL FAILURES MAY ALSO BE CAUSED BY A DISTAL RETRACTION OF THE MESH. THE AUTHORS STATED THAT THE EARLY POSITIVE ANATOMICAL FINDINGS AND POSITIVE IMPACT ON PATIENTS¿ QUALITY OF LIFE SCORES ARE SUSTAINED AFTER 3 YEARS. THE TVM PROCEDURE IS ASSOCIATED WITH A HIGH TOTAL REINTERVENTION RATE (13.3%) BUT THE LOW RE-INTERVENTION RATE FOR PROLAPSE (3.3%) SUGGESTS THAT A TOTAL VAGINAL MESH SEEMS TO LEAD TO A STABLE REPAIR OF THE PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324456 GYNECARE MESH UNKNOWN MESH, SURGICAL FTM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention