BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 11738805 · Received April 28, 2021

    Report

    Report Number
    2210968-2021-03922
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    August 25, 2018
    Report Date
    March 29, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: HERNIA (2018); 22:1045¿1050. DOI: HTTPS://DOI.ORG/10.1007/S10029-018-1811-3. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE 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 INVOLVED?

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: USE OF POLYPROPYLENE MESH IN CONTAMINATED AND DIRTY STRANGULATED HERNIAS: SHORT-TERM RESULTS. THE AIM OF THIS PROSPECTIVE OBSERVATIONAL COHORT STUDY IS TO EVALUATE THE OUTCOME OF POLYPROPYLENE MESH IN THE SETTINGS OF BOWEL RESECTION PERFORMED FOR STRANGULATED HERNIAS OF THE ABDOMINAL WALL. BETWEEN 1ST MARCH 2015 AND 31ST AUGUST 2017, A TOTAL OF 68 HERNIAS REQUIRED EMERGENCY SURGERY FOR INCARCERATION; OUT OF THESE 38 HERNIAS COULD BE REDUCED WITHOUT RESECTION OF CONTENTS. THE REMAINING 30 PATIENTS (22 MALE AND 8 FEMALE; AGE RANGE = 25 TO 82 YEARS; MEAN AGE = 49.9 YEARS) WHO REQUIRED RESECTION OF GANGRENOUS BOWEL AND ANASTOMOSIS CONSTITUTED THE STUDY COHORT. SURGERY WAS PERFORMED USING POLYPROPYLENE MESH (PROLENE, ETHICON). REPORTED COMPLICATIONS INCLUDED IN THE GROUP WHERE BOWEL RESECTION AND ANASTOMOSIS WAS REQUIRED WERE WOUND INFECTION (N=8) WHICH WAS MANAGED CONSERVATIVELY WITH ANTIBIOTICS AND WOUND DRESSING BY OPENING A FEW SUTURES, DRAINING THE COLLECTION, AND IRRIGATING WITH HYDROGEN PEROXIDE AND POVIDONE IODINE, AND ALL OF THESE WOUNDS HEALED BY SECONDARY INTENTION; SEROMA (N=10); RECURRENCES (N=2) WERE OBSERVED AND BOTH PATIENTS HAD COMORBID ILLNESS (DIABETES AND HYPERTENSION) AND WERE ELDERLY (> 60 YEARS OLD). BOTH PATIENTS ARE ON FOLLOW-UP AND HAVE NOT YET OPTED FOR REOPERATION. IN THE GROUP WHERE HERNIAS COULD BE REDUCED, WOUND INFECTION (N=2) WAS SIGNIFICANTLY LESS NOT REQUIRING BOWEL RESECTION; AND SEROMA FORMATION (N=11). IN CONCLUSION, THE USE OF POLYPROPYLENE MESH FOR CONTAMINATED AND DIRTY STRANGULATED HERNIAS IS EFFECTIVE AND SAFE, WITH ACCEPTABLE MORBIDITY AND GOOD SHORT-TERM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635236 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention