BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8918669 · Received August 21, 2019

    Report

    Report Number
    2210968-2019-85960
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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: HERNIA (2007) 11:163¿167; DOI 10.1007/S10029-007-0189-4; PUBLISHED ONLINE: 2 FEBRUARY 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: COMPARISON OF PROSTHETIC MESH REPAIR AND TISSUE REPAIR IN THE EMERGENCY MANAGEMENT OF INCARCERATED PARA-UMBILICAL HERNIA: A PROSPECTIVE RANDOMIZED STUDY" AUTHORS: N. A. ABDEL-BAKI · S. S. BESSA · A. H. ABDEL-RAZEK CITATION: HERNIA (2007) 11:163¿167; DOI 10.1007/S10029-007-0189-4; PUBLISHED ONLINE: 2 FEBRUARY 2007. THE OBJECTIVE OF THIS PROSPECTIVE RANDOMIZED STUDY WAS TO COMPARE RESULTS FROM PROSTHETIC REPAIR AND TISSUE REPAIR IN THE MANAGEMENT OF THE ACUTELY INCARCERATED PUH. FROM MAY 1, 2004 UNTIL DECEMBER 1, 2005, 42 PATIENTS WITH ACUTELY INCARCERATED PUH WERE PROSPECTIVELY RANDOMIZED TO EITHER THE PROSTHETIC-REPAIR GROUP (N=21) (MEAN AGE 49.6±15.8 YEARS, MALE N=1, FEMALE N=20) OR THE TISSUE-REPAIR GROUP (N=21) (MEAN AGE 48.1±15.5 YEARS, FEMALE N=21). A TRANSVERSE ELLIPTICAL INCISION OVERLYING THE HERNIA WAS USED. AFTER EXCISION OF THE SAC AND DEALING WITH ITS CONTENTS, THE DEFECT WAS VERTICALLY CLOSED BY USE OF SIMPLE INTERRUPTED NON-ABSORBABLE SUTURES (PROLENE 1, ETHICON). IN THE TISSUE-REPAIR GROUP, HERNIORRHAPHY WAS PERFORMED BY INVERTING THE MEDIAL 1.5¿2 CM OF THE RECTUS SHEATH ON EITHER SIDE OVER THE CLOSED DEFECT AND SUTURING BOTH SIDES TOGETHER USING SIMPLE INTERRUPTED NON-ABSORBABLE SUTURES (PROLENE 1, ETHICON), THUS CREATING A SECOND LAYER OF REPAIR AND SIMULATING THE SO-CALLED KEEL METHOD. THESE SUTURES EXTENDED FOR AT LEAST 2¿4 CM BEYOND THE DEFECT. IN THE PROSTHETIC-REPAIR GROUP, SKIN AND SUBCUTANEOUS FLAPS WERE ELEVATED TO FIT A 15 CM X 15 CM MONOFILAMENT POLYPROPYLENE MESH (PROLENE, ETHICON). THE MESH WAS THEN FIXED TO THE ABDOMINAL WALL MUSCLES AS AN ONLAY PATCH USING INTERRUPTED NON-ABSORBABLE SUTURES (PROLENE 2/0, ETHICON). RESECTION ANASTOMOSIS OF NON-VIABLE BOWEL WAS PERFORMED IN A SINGLE LAYER, SERO-MUSCULAR EXTRA-MUCOSAL MANNER USING INTERRUPTED ABSORBABLE SUTURES (VICRYL 3/0, ETHICON). COMPLICATIONS IN THE PROSTHETIC REPAIR GROUP INCLUDED WOUND INFECTION (N=2), SEROMA (N=2) WHICH NECESSITATED RE-INSERTION OF A CATHETER TUBE DRAIN UNDER LOCAL ANESTHESIA AND PROLONGED REDIVACK EFFLUENT (N=1). COMPLICATIONS IN THE TISSUE-REPAIR GROUP INCLUDED WOUND INFECTION (N=3) AND RECURRENCE (N=4). ONLY ONE OF THE PATIENTS WHO HAD A MESH IMPLANTED AFTER BOWEL RESECTION DEVELOPED WOUND INFECTION. ALL WOUND INFECTIONS ENCOUNTERED IN THIS STUDY WERE SUCCESSFULLY TREATED BY LOCAL MEASURES AND APPROPRIATE ANTIBIOTICS GUIDED BY CULTURE AND SENSITIVITY STUDIES. IN CONCLUSION, USE OF PROSTHETIC REPAIR FOR EMERGENCY MANAGEMENT OF INCARCERATED PUH IS SAFE AND LEADS TO SUPERIOR RESULTS, IN TERMS OF RECURRENCE, COMPARED WITH CONVENTIONAL TISSUE REPAIR. THE PRESENCE OF NON-VIABLE INTESTINE CANNOT, FURTHERMORE, BE REGARDED AS A CONTRAINDICATION FOR PROSTHETIC REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709356 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention