BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 7906931 · Received September 25, 2018

    Report

    Report Number
    2210968-2018-75993
    Event Type
    Injury
    Date Received
    September 25, 2018
    Report Date
    August 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT 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 PRODUCT USED IN THIS PROCEDURE? CITATION: HERNIA. 2013; 17: 141¿144. DOI: 10.1007/S10029-011-0821-1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RECURRENT PERINEAL HERNIA REPAIR: A NOVEL APPROACH". AUTHORS: J. BERENDZEN · P. COPAS JR. CITATION: HERNIA. 2013; 17: 141¿144. DOI: 10.1007/S10029-011-0821-1. POSTOPERATIVE PERINEAL HERNIAS ARE RARE COMPLICATIONS FROM PROCEDURES, WHICH COMPROMISE THE PELVIC FLOOR, MAINLY ABDOMINOPERINEAL RESECTION, PROCTOCOLECTOMY, AND PARTIAL OR TOTAL PELVIC EXENTERATION. SURGICAL REPAIR CAN BE ACCOMPLISHED THROUGH ABDOMINAL, LAPAROSCOPIC, OR TRANSPERINEAL APPROACHES. IN 2003, A (B)(6) WHITE MALE WITH A LONG HISTORY OF COLON POLYPS PRESENTED FOR REPEAT COLONOSCOPY AND FOUND TO HAVE A 5-CM ADENOCARCINOMA IN THE POSTERIOR CURVATURE OF THE RECTUM, IMPINGING ON THE PUBORECTALIS IN THE POSTERIOR RIGHT QUADRANT. BIOPSIES RETURNED AS MODERATELY DIFFERENTIATED ADENOCARCINOMA. AFTER SEVERAL PROCEDURES, THE PATIENT WAS PRESENTED WITH RECURRENT PERINEAL HERNIA. THE PATIENT UNDERWENT AN OPEN PERINEAL REPAIR USING PROCEED SURGICAL MESH (ETHICON). THE MESH WAS USED TO COVER THE DEFECT. THE MESH WAS SECURED WITH POLYPROPYLENE SUTURES WITH CAREFUL ATTENTION TO ENSURE THAT THE MESH WAS FLAT AND THAT THERE WAS NO ENTRAPMENT OF THE HERNIA CONTENTS. SEVEN MONTHS AFTER THE PROCEDURE, THE PATIENT WAS PRESENTED BACK WITH RECURRENT PERINEAL HERNIA AND WAS TREATED WITH RE-OPERATION WITH INSERTION OF THE GYNECARE PROLIFT MESH (ETHICON). THE PATIENT DID WELL POSTOPERATIVELY AND REMAINS IN GOOD HEALTH WITH NO EVIDENCE OF RECURRENCE OF THE PERINEAL HERNIA. THERE MAY HAVE BEEN MULTIPLE FACTORS THAT CONTRIBUTED TO THE FAILURE OF THE PRIOR OPERATIONS. THESE FACTORS INCLUDED POOR TISSUE AND ATTENUATED MUSCULATURE, POSSIBLE INAPPROPRIATE GRAFT SIZE, INNATE PROPERTIES OF THE PRIOR MESH WHICH IS DESIGNED FOR DECREASED TISSUE ADHERENCE, AND POSSIBLE IMPAIRED WOUND HEALING DUE TO MULTIPLE SURGICAL PROCEDURES. HOWEVER, IT WAS CONCLUDED THAT THE GYNECARE PROLIFT MESH (ETHICON) WAS ULTIMATELY SUCCESSFUL, LIKELY DUE TO IMPROVED DISSECTION OF PERINEAL ANATOMY ALLOWING BETTER VISUALIZATION, IMPROVED FIXATION OF THE MESH IN SECURE PELVIC LIGAMENTS, AND THE LARGE GRAFT SIZE AND VERSATILITY OF THE MESH SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748984 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention