BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7748866 · Received August 3, 2018

    Report

    Report Number
    2210968-2018-74897
    Event Type
    Injury
    Date Received
    August 3, 2018
    Report Date
    July 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: INT UROGYNECOL J (2009) 20:523¿531; DOI 10.1007/S00192-009-0818-9. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : COMPLICATIONS FROM VAGINALLY PLACED MESH IN PELVIC RECONSTRUCTIVE SURGERY". AUTHOR: ROBERTA E. BLANDON & JOHN B. GEBHART & EMANUEL C. TRABUCO & CHRISTOPHER J. KLINGELE. CITATION: INT UROGYNECOL J (2009) 20:523¿531; DOI 10.1007/S00192-009-0818-9. THIS RETROSPECTIVE STUDY AIMED TO DESCRIBE COMPLICATIONS ASSOCIATED WITH THE USE OF TRANSVAGINAL MESH FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE. FROM JAN 2003 TO SEP 2007, 21 FEMALE PATIENTS (MEAN AGE OF 61 [SD OF 11]) PRESENTED COMPLICATIONS AFTER PELVIC RECONSTRUCTION SURGICAL PROCEDURES FOR THE TREATMENT OF SYMPTOMATIC PELVIC ORGAN PROLAPSE WERE INCLUDED. OF THESE PATIENTS, MESHES USED WERE GYNEMESH, PROLENE MESH AND PROLIFT MESH. IN SOME PATIENTS, PROLENE SUTURES WERE USED TO FIX THE MESH. PRESENTING SYMPTOMS INCLUDED DYSPAREUNIA (N=10) FOR WHICH ONE PATIENT OPTED TO TRY VAGINAL DILATORS, CHRONIC VAGINAL DRAINAGE (N=9), PAIN NOT RELATED TO INTERCOURSE (N=7) FOR WHICH ONE WHO HAD PERSISTENT PELVIC PAIN UNDERWENT REOPERATION, PELVIC ORGAN PROLAPSE SYMPTOMS (N=7), STRESS URINARY INCONTINENCE (N=6) OF WHICH 3 HAD REPEAT SURGERIES, URINARY URGENCY (N=6), URGE INCONTINENCE (N=4), CONSTIPATION (N=4), VAGINAL BLEEDING/SPOTTING (N=3), URINARY RETENTION (N=3) AND FECAL URGENCY (N=2). MESH EROSION WAS OBSERVED IN 12 PATIENTS OF WHICH FOUR HAD EROSIONS AT MORE THAN ONE SITE TREATED WITH COMPLETE VAGINAL MESH EXCISION AND ADDITIONAL EXCISION OF ERODED MESH FROM BLADDER/URETHRA (N=2). OTHER SURGICAL INTERVENTIONS (N=16) INCLUDED ANTERIOR COLPORRHAPHY (N=5), POSTERIOR COLPORRHAPHY (N=7), VAGINAL VAULT PROLAPSE REPAIR (N=5), ABDOMINAL SACROCOLPOPEXY WITH MESH (N=3), AUTOLOGOUS RECTUS FASCIA SLING (N=4), AND SYNTHETIC MIDURETHRAL SLING (N=1). FIVE PATIENTS OPTED FOR A CONSERVATIVE NON-SURGICAL APPROACH. IN THIS STUDY, THE SURGICAL TECHNIQUE MAY CONTRIBUTE TO THE DEVELOPMENT OF THESE COMPLICATIONS AND EMPHASIZES THE NEED FOR SPECIALIZED TRAINING. USE OF VAGINAL MESH FOR PELVIC RECONSTRUCTION CAN PRODUCE COMPLICATIONS. MULTIPLE INTERVENTIONS MAY BE NECESSARY, AND BOTHERSOME SYMPTOMS MAY PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590779 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention