BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH UNKNOWN PRODUCT

    MDR report key: 8488512 · Received April 5, 2019

    Report

    Report Number
    2210968-2019-80063
    Event Type
    Injury
    Date Received
    April 5, 2019
    Report Date
    March 12, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. CITATION: ANNALS OF SURGERY 2016; 264: 923¿928; DOI: 10.1097/SLA.0000000000001684. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: "PREVENTING PARASTOMAL HERNIA USING A MODIFIED SUGARBAKER TECHNIQUE WITH COMPOSITE MESH DURING LAPAROSCOPIC ABDOMINOPERINEAL RESECTION." THIS RANDOMIZED, PROSPECTIVE, DOUBLE-BLIND, AND CONTROLLED STUDY AIMED TO ASSESS THE REDUCTION IN THE INCIDENCE OF PARASTOMAL HERNIA (PH) AFTER PLACEMENT OF PROPHYLACTIC SYNTHETIC MESH USING A MODIFIED SUGARBAKER TECHNIQUE WHEN A PERMANENT END-COLOSTOMY IS NEEDED. BETWEEN JANUARY 2012 AND JANUARY 2014, 52 PATIENTS WERE SCHEDULED FOR AN ELECTIVE LAPAROSCOPIC APR WITH PERMANENT END SIGMOID COLOSTOMY TO TREAT CANCER OF THE LOWER THIRD OF THE RECTUM. THE CONTROL GROUP (WITHOUT MESH) (N=28) WITH MEAN AGE OF 67.3 YEARS CONSISTED OF PATIENTS RECEIVING CONVENTIONAL SIGMOID END COLOSTOMY. THE STUDY GROUP (WITH MESH) (N=24) (MALE N=21 AND FEMALE N=3) WITH MEAN AGE OF 70.5 YEARS CONSISTED OF PATIENTS RECEIVING CONVENTIONAL SIGMOID END COLOSTOMY ALONG WITH A PROSTHETIC MESH ACCORDING TO THE MODIFIED SUGARBAKER TECHNIQUE. A 15X20 CM OVAL, LARGE-PORE LIGHTWEIGHT COMPOSITE MESH (ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH; ETHICON, JOHNSON & JOHNSON COMPANY) WAS USED, COMPOSED ON A NONABSORBABLE MACROPOROUS POLYPROPYLENE MESH LAMINATED BETWEEN 2 POLYGLECAPRONE-25 FILMS, WITH AN UNDYED POLYDIOXANONE FILM THAT PROVIDES THE BOND BETWEEN THE POLYGLECAPRONE-25 FILM AND THE POLYPROPYLENE MESH, AND AN ADDITIONAL CENTRAL DYED POLYDIOXANONE FILM MARKER FOR ORIENTATION PURPOSES. THE MESH WAS FIXED TO THE ABDOMINAL WALL WITH A DOUBLE CROWN OF REABSORBABLE STRAPS (ETHICON SECURESTRAP; ETHICON, JOHNSON&JOHNSON COMPANY). COMPLICATIONS INCLUDED PARTIAL COLOSTOMY DEHISCENCE (N=2), PERINEAL WOUND INFECTION (N=3), POSTOPERATIVE ILEUS (N=5) AND PARASTOMAL HERNIA (TYPE IB N=1, TYPE II N=1 AND TYPE III N=4). SURGERY WAS NECESSARY IN 1 PATIENT FROM THE MESH GROUP DUE TO SYMPTOMATIC PARASTOMAL HERNIA. IN CONCLUSION, THE PLACEMENT OF A PROSTHETIC MESH BY THE LAPAROSCOPIC APPROACH FOLLOWING THE MODIFIED SUGARBAKER TECHNIQUE IS SAFE AND EFFECTIVE IN THE PREVENTION OF PH, REDUCING SIGNIFICANTLY THE INCIDENCE OF PH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280744 PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention