BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8039513 · Received November 5, 2018

    Report

    Report Number
    2210968-2018-76945
    Event Type
    Injury
    Date Received
    November 5, 2018
    Report Date
    October 23, 2018
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. 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 PRODUCT (PROLENE MESH) 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 (PROLENE MESH) INVOLVED? CITATION: HERNIA; DOI: HTTPS://DOI.ORG/10.1007/S10029-018-1790-4. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, TITLE: "ELECTRIC CAUTERIZATION OF THE HERNIA SAC IN LAPAROSCOPIC VENTRAL HERNIA REPAIR REDUCES THE INCIDENCE OF POSTOPERATIVE SEROMA: A PROPENSITY SCORE-MATCHED ANALYSIS THIS RETROSPECTIVE ANALYSIS AIMED TO INVESTIGATE THE EFFECTIVENESS OF CAUTERIZATION OF THE HERNIA SAC IN TERMS OF REDUCING THE INCIDENCE OF POSTOPERATIVE SEROMA FORMATION. BETWEEN JUN2011 AND DEC2014, 40 CASES OF PRIMARY REDUCIBLE INCISIONAL OR VENTRAL HERNIAS, UNDERWENT ELECTIVE INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) AND WERE CLASSIFIED INTO TWO GROUPS: STANDARD IPOM (SIPOM) GROUP (N=20; N=14 MALE AND N=6 FEMALE; AGE±SD OF 58.7±14.1 YEARS) AND THE ELECTRIC "CAUSTERIZATION" IPOM (CSIPOM) GROUP (N=20; N=11 MALE AND N=9 FEMALE; AGE±SD OF 58.2±13.7 YEARS). ON BOTH GROUPS, A PROLENE MESH WAS USED ON THE HERNIA DEFECT. ALL PATIENTS (N=40) HAD MILD PAIN 48 HOURS POSTOPERATIVELY WHICH WAS TREATED WITH POSTOPERATIVE ANALGESIC MEDICATIONS. EARLY POSTOPERATIVE COMPLICATIONS INCLUDED SEROMA (N=5) WHICH RESOLVED SPONTANEOUSLY IN FOUR PATIENTS AND PERSISTED IN ONE PATIENT BUT WAS TREATED WITH REPEATED NEEDLE ASPIRATION. AT A MEDIAN FOLLOW-UP OF 18 MONTHS, MEAN CHRONIC PAIN WAS RECORDED AS 0.53±1.35 IN CSIPOM GROUP (N=15) AND 0.69±1.25 IN SIPOM GROUP (N=16). THERE WERE A TOTAL OF TWO RECURRENCES ON SIPOM GROUP. POSTOPERATIVE SEROMA FORMATION IS BELIEVED TO BE A DIRECT CONSEQUENCE OF THE FOREIGN BODY REACTION TRIGGERED BY THE PROSTHETIC MESH. THIS RESULTS IN THE ACCUMULATION OF ASEPTIC INFLAMMATORY EXUDATE, MAINLY CONSISTING OF MONOCYTES AND MACROPHAGES. THE PRESENT STUDY CONFIRMS OUR HYPOTHESIS THAT LAPAROSCOPIC SIPOM COMBINED WITH ELECTRIC CAUTERIZATION OF THE HERNIA SAC (CSIPOM) SIGNIFICANTLY REDUCES THE RATE OF POSTOPERATIVE SEROMA COMPARED TO THE SIPOM TECHNIQUE IN PATIENTS WITH VENTRAL AND INCISIONAL HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878729 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention