BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8889505 · Received August 13, 2019

    Report

    Report Number
    2210968-2019-85502
    Event Type
    Injury
    Date Received
    August 13, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : THE USE OF MITEK BONE ANCHORS FOR SYNTHETIC MESH FIXATION TO REPAIR RECALCITRANT ABDOMINAL HERNIAS" AUTHOR : ALI A. ALI, BA (CANTAB), AND CHARLES M. MALATA CITATION: ANN PLAST SURG.2012; 69: 59-63. REPAIR OF RECURRENT ABDOMINAL HERNIAS IS A SURGICAL CHALLENGE. THESE PATIENTS USUALLY PRESENT TO THE PLASTIC SURGEON AS A LAST RESORT FOR TREATMENT. SUCH RECALCITRANT HERNIAS CAUSE ENORMOUS MORBIDITY AND CONSTITUTE A FINANCIAL BURDEN TO ANY HEALTH SERVICE. THE AUTHORS REPORTED ON A TECHNIQUE USING OVERLAY PROLENE MESH (ETHICON) FIXED TO BONE BY MITEK ANCHORS. A TOTAL OF 7 PATIENTS (6 FEMALE AND 1 MALE PATIENT; AGE RANGE: 35 TO 60 YEARS OLD) WHO HAD MITEK BONE ANCHOR FIXATION OF SYNTHETIC MESH, TO REPAIR RECURRENT IATROGENIC ABDOMINAL HERNIAS BETWEEN 2003 AND 2010 WERE RETROSPECTIVELY REVIEWED. DURING THE SURGICAL PROCEDURE, TWO LAYERS OF PROLENE MESH (ETHICON) MEASURING 30 × 30 CM WERE USED IN THE OVERLAY POSITION IN ALL 7 PATIENTS. THE SUPERIOR FREE BORDER OF THE MESH WAS ADDITIONALLY SECURED TO THE ANTERIOR ABDOMINAL FASCIA WITH PROLENE 3-0 SUTURES (ETHICON) ROUTINELY. REPORTED COMPLICATIONS INCLUDED PATIENT 1, A (B)(6) YEAR OLD FEMALE PATIENT WITH LATERAL CUTANEOUS NERVE OF THIGH PARESTHESIA AND RECURRENT BULGE WHICH REQUIRED REMOVAL OF MESH AFTER 2 YEARS; PATIENT 4, A (B)(6) YEAR OLD MALE PATIENT WITH LOCALIZED PAIN AND TENDERNESS WHICH REQUIRED REMOVAL OF 2 ANCHORS; PATIENT 5, A (B)(6) YEAR OLD FEMALE PATIENT WITH SEROMA WHICH REQUIRED REPEATED ASPIRATION. REPAIR OF RECURRENT ABDOMINAL WALL HERNIAS CAN BE CHALLENGING BECAUSE THEY TEND TO BE RESISTANT TO TREATMENT AND RECUR FREQUENTLY. IN CONCLUSION, MITEK BONE ANCHOR FIXATION OF PROSTHETIC MESH REINFORCEMENT OF HERNIA REPAIRS MAY BE A USEFUL ADDITION TO THE ARMAMENTARIUM AVAILABLE TO THE PLASTIC SURGEON. NONETHELESS, MORE STUDIES ARE REQUIRED TO ESTABLISH THE DEFINITIVE ROLE OF THIS TECHNIQUE IN CLINICAL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681341 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention