BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 11751255 · Received April 30, 2021

    Report

    Report Number
    2210968-2021-04093
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    March 10, 2020
    Report Date
    March 31, 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
    MX
    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 (2020) 24:781¿786 HTTPS://DOI.ORG/10.1007/S10029-020-02155-0. 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 POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (PROLENE® MESH) USED IN THIS PROCEDURE? WAS THE DEATH OF ONE PATIENT 3 YEARS AFTER HIS INITIAL SURGERY FROM BLADDER CANCER METASTASIS TO THE LUNGS A DIRECT RESULT OF THE USE OF THE PROLENE® MESH AND WHICH AMONG THE 7 PATIENTS DIED? PATIENT DEMOGRAPHICS? WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? EVENT RELATED TO (B)(6) YEAR-OLD PATIENT WITH MILD DYSPNEA DURING PPP REPORTED VIA MW # 2210968-2021-04091. EVENT RELATED TO (B)(6) YEAR-OLD PATIENT WITH MILD DYSPNEA DURING PPP REPORTED VIA MW # 2210968-2021-04092. EVENT RELATED TO (B)(6) YEAR-OLD PATIENT WITH RIGHT SCROTAL ABSCESS PPP REPORTED VIA MW # 2210968-2021-04094.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PREOPERATIVE PROGRESSIVE PNEUMOPERITONEUM: THE ANSWER FOR TREATING GIANT INGUINAL HERNIAS WHILE AVOIDING MORBIDITIES? THE MAIN OBJECTIVE OF THIS STUDY WAS TO DESCRIBE OUR TECHNIQUE IN THE USE OF PREOPERATIVE PROGRESSIVE PNEUMOPERITONEUM (PPP) IN THE TREATMENT OF GIANT INGUINAL HERNIAS (GIH) IN A SERIES OF PATIENTS WHO PRESENTED WITH THIS CHALLENGING CONDITION, ALONG WITH THEIR SURGICAL OUTCOMES. DURING A 6-YEAR PERIOD (2012¿2018), A SERIES OF PATIENTS WERE TREATED WITH PPP USING A PROLENE® MESH (ETHICON, USA) FOR GIH. ALL PATIENTS WERE MALE, WITH A MEDIAN AGE OF 64 (RANGE 30¿89) YEARS. FOUR (57.2%) PATIENTS HAD SYSTEMIC HYPER-TENSION, AND THREE (42.8%) PATIENTS DID NOT HAVE ANY COMORBIDITY. THE MEDIAN HISTORY TIME WITH THE INGUINAL HERNIA WAS 8 (RANGE 2¿20) YEARS. A 46 YEAR OLD MALE PATIENT HAD MILD DYSPNEA DURING PPP. A 64 YEAR OLD MALE PATIENT HAD MILD DYSPNEA DURING PPP. A 64 YEAR OLD MALE PATIENT HAD BILATERAL GRADE III HYDROCELE 4 YEARS AFTER HIS INITIAL PROCEDURE, WHICH WAS TREATED WITH AN ULTRASOUND-GUIDED PUNCTURE WITH EXCELLENT OUTCOMES. A 50 YEAR OLD MALE PATIENT HAD × 4-CM RIGHT SCROTAL ABSCESS 2 MONTHS AFTER THE BILATERAL PLASTY. THE ABSCESS WAS DRAINED AND TREATED SUCCESSFULLY WITH ANTIBIOTICS. ALL SIX PATIENTS ARE WELL AND ALIVE, WITHOUT THE RECURRENCE OF THEIR HERNIAS, AND ARE CURRENTLY BEING FOLLOWED UP. WITH OUR LIMITED EXPERIENCE, IT IS TOO EARLY TO TELL IF THIS SHOULD BE THE GOLD STANDARD FOR THE TREATMENT OF GIH. TO SEE IF THERE IS SUPERIORITY AMONG DIFFERENT PROCEDURES, MORE STUDIES THAT COMPARE THE MORBIDITY OF PPP WITH THAT OF OTHER TRANS OPERATIVE TECHNIQUES ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652831 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention