BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7902836 · Received September 24, 2018

    Report

    Report Number
    2210968-2018-75955
    Event Type
    Injury
    Date Received
    September 24, 2018
    Report Date
    August 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J. 2015; 26: 1147¿1154. DOI: 10.1007/S00192-015-2659-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: "TRANSVAGINAL REPAIR OF STAGE III¿IV CYSTOCELE USING A LIGHTWEIGHT MESH: SAFETY AND 36-MONTH OUTCOME." AUTHORS: RENAUD DE TAYRAC & MAJID BROUZIYNE & GÉRARD PRIOU & GUY DEVOLDÈRE & GÉRARD MARIE & JOËL RENAUDIE. CITATION: INT UROGYNECOL J. 2015; 26: 1147¿1154. DOI: 10.1007/S00192-015-2659-Z. THE AIM OF THIS STUDY WAS TO ASSESS THE 36-MONTH SAFETY AND EFFICACY OF A LIGHTWEIGHT POLYPROPYLENE MESH USED FOR THE TRANSVAGINAL REPAIR OF STAGE III¿IV CYSTOCELE. THIS PROSPECTIVE COHORT MULTICENTER STUDY INCLUDED A TOTAL OF 111 PATIENTS (AGE RANGE: 47 TO 89 YEARS OLD; BMI: 26.2 ± 5). DURING THE SURGICAL PROCEDURE, THE POSTERIOR PART OF THE MESH WAS ANCHORED TO THE ANTERIOR SIDE OF THE CERVIX USING TWO PROLENE 2-0 SUTURES (ETHICON) OR TO THE UTEROSACRAL LIGAMENTS IN PATIENTS WITH ASSOCIATED OR PREVIOUS HYSTERECTOMY. THE MESH WAS THEN SPREAD BY SECURING ITS ANTERIOR PARTS BENEATH THE BLADDER NECK USING TWO OR THREE MONOCRYL 2-0 SUTURES (ETHICON). THE MESH WAS THEN ADJUSTED IN A TENSION-FREE MANNER BENEATH THE BLADDER AND THE ANTERIOR VAGINAL WALL WAS CLOSED USING MONOCRYL 3-0 ABSORBABLE SUTURES (ETHICON), WITHOUT COLPECTOMY. REPORTED COMPLICATIONS INCLUDED BLADDER INJURY (N-1), BLEEDING (N-1) WHICH REQUIRED VAGINAL SUTURE REPLACEMENT WITHOUT EXPLANTATION OF THE MESH, DE NOVO DYSPAREUNIA (N-1), MESH SHRINKAGE (N-4), MESH EXPOSURE (N-1) WHICH REQUIRED REPEAT SURGERY, AND RELAPSED CYSTOCELE (N-2) WHICH REQUIRED TRANSVAGINAL SURGERY (N-1) AND SACROCOLPOPEXY (N-1). THE AUTHORS OBSERVED THAT TRANSVAGINAL REPAIR OF SEVERE CYSTOCELE USING A LIGHTWEIGHT TRANSOBTURATOR POLYPROPYLENE MESH WAS ASSOCIATED WITH GOOD CLINICAL TOLERANCE REGARDING ALL PARAMETERS STUDIED. THE ANATOMIC AND FUNCTIONAL RESULTS OBTAINED WERE ENCOURAGING DESPITE THE LIGHTNESS OF THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743695 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SURGIMESH