BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8255214 · Received January 16, 2019

    Report

    Report Number
    2210968-2019-78451
    Event Type
    Injury
    Date Received
    January 16, 2019
    Report Date
    January 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 (2005) 16: 165¿167; DOI 10.1007/S00192-004-1229-6. ADVERSE EVENT 6 MONTHS POST OP FOR ETHIBOND SUTURE REPORTED IN MEDWATCH # 2210968-2019-78450. ADVERSE EVENT 2 MONTHS AFTER THE LAST TREATMENT FOR PROLENE MESH REPORTED IN MEDWATCH # 2210968-2019-78451. ADVERSE EVENT 2 MONTHS AFTER THE LAST TREATMENT FOR ETHIBOND SUTURE REPORTED IN MEDWATCH # 2210968-2019-78452. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: COMPLICATIONS OF SYNTHETIC GRAFT MATERIALS USED IN SUBURETHRAL SLING PROCEDURES". AUTHORS: KWONG-PANG TSUI, SOO-CHEEN NG, YI-TORNG TEE, GUANG-PERNG YEH, GIN-DEN CHEN CITATION: INT UROGYNECOL J (2005) 16: 165¿167; DOI 10.1007/S00192-004-1229-6. THIS STUDY AIMED TO PRESENT FOUR UNUSUAL CASES OF WOMEN USING DIFFERENT SYNTHETIC MATERIALS AND THE COMPLICATIONS OCCURRED. IN THE FIRST CASE, A (B)(6)-YEAR-OLD FEMALE PATIENT WITH URODYNAMIMC STRESS INCONTINENCE AND UTEROVAGINAL PROLAPSE STAGE II WHO UNDERWENT A PUBOVAGINAL SLINGPLASTY USING A PATCH OF PROLENE MESH WITH 1-0 ETHIBOND AS SUSPENSION MATERIAL. SHE PRESENTED WITH CHRONIC URINARY TRACT INFECTIONS 6 MONTHS POSTOPERATIVELY. CYSTOSCOPY REVEALED ETHIBOND THREAD IN THE RIGHT SIDE OF THE BLADDER IN WHICH IT WAS CUT USING AN ENDOSCOPIC SCISSOR. TWO MONTHS AFTER THE LAST TREATMENT, SYMPTOMS OF URINARY TRACT INFECTION RELAPSED AND DURING SECOND CYSTOSCOPY, ETHIBOND THREAD WAS FOUND TO BE MIGRATED INTO THE BLADDER AND THE RIGHT END OF THE PROLENE MESH ERODED. SHE UNDERWENT RECONSTRUCTION OF THE ANTERIOR VAGINAL WALL IN WHICH THE LOWER END OF THE ETHIBOND WAS PULLED OUT OF THE PARAVAGINAL FASCIA AND THE PROLENE MESH WAS REMOVED SIMULTANEOUSLY. THE PATIENT WAS FOLLOWED UP REGULARLY AND SHE REMAINED CONTINENT. THE TRANSABDOMINAL PROCEDURES FOR THE REMOVAL OF THE SYNTHETIC MATERIALS WERE DIFFICULT BECAUSE THE MESHES CAUSED A SEVERE FIBROSIS TO THE SURROUNDING TISSUES OR THE POSTERIOR RAMI OF THE PUBIC RAMIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46346 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention