BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 13556939 · Received February 18, 2022

    Report

    Report Number
    2210968-2022-01171
    Event Type
    Death
    Date Received
    February 18, 2022
    Date of Event
    March 17, 2021
    Report Date
    February 17, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (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 CITE: LANGENBECK'S ARCHIVES OF SURGERY (2021) 406:1651¿1657 HTTPS://DOI.ORG/10.1007/S00423-021-02145-5. 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 PRODUCTS (PROLENE SUTURE, PROLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WERE THE DEATH EVENTS ATTRIBUTED TO THE ETHICON PRODUCTS (PROLENE SUTURE, PROLENE MESH) USED IN THE PROCEDURES? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE, PROLENE MESH) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS? EVENTS ASSOCIATED WITH PROLENE MESH DEVICE REPORTED VIA 2210968-2022-01172. EVENT ASSOCIATED WITH PROLENE SUTURE DEVICE REPORTED VIA 2210968-2022-01173.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PROSTHETIC MESH HERNIOPLASTY VERSUS PRIMARY REPAIR IN INCARCERATED AND STRANGULATED GROIN AND ABDOMINAL WALL HERNIAS WITH OR WITHOUT ORGAN RESECTION. RETROSPECTIVE STUDY. BETWEEN MARCH 2012 AND JANUARY 2020, MEDICAL RECORDS OF 301 PATIENTS WHO UNDERWENT EMERGENCY SURGERY FOR INCARCERATED AND STRANGULATED ABDOMINAL WALL HERNIAS WERE RETROSPECTIVELY EVALUATED. THE INTERVENTIONS WERE EXCLUSIVELY REALIZED BY TWO SURGICAL TEAMS, ONE OF WHICH USED POLYPROPYLENE MESH PROSTHESES (GROUP I), WHEREAS THE SECOND TEAM PERFORMED PRIMARY HERNIA REPAIR (GROUP II). THE OUTCOME OF PATIENTS WAS OBSERVED FOR A MEAN FOLLOW-UP PERIOD OF 18.2 MONTHS. INGUINAL HERNIAS WERE EITHER REPAIRED BY TENSION-FREE REPAIR USING A POLYPROPYLENE MESH (PROLENE, ETHICON) AND A 2/0 POLYPROPYLENE INTERRUPTED SUTURE TO FIX THE MESH OR HERNIORRHAPHY WAS PERFORMED USING SHOULDICE OR BASSINI METHODS. FEMORAL HERNIAS WERE TREATED BY A MESH PLUG REPAIR OF THE FEMORAL RING OR HERNIORRHAPHY WAS PERFORMED USING THE MCVAY METHOD. UMBILICAL AND INCISIONAL HERNIAS WERE REPAIRED USING AN ONLAY POLYPROPYLENE MESH AFTER CLOSING THE FASCIA UNDERNEATH THE MESH. IN INCISIONAL HERNIAS, THE DEFECT WAS VERTICALLY CLOSED BY SIMPLE INTERRUPTED NON-ABSORBABLE SUTURES (PROLENE NO.1- ETHICON). REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION (N=26), SEROMA (N=19), HEMATOMA (N=9), SKIN WOUND DETACHMENT (N=2), HERNIA RECURRENCE (N=6), CHRONIC PAIN (N=2). THERE WERE TWO ANASTOMOTIC LEAKAGES. THESE PATIENTS UNDERWENT PRIMARY REPAIR OF UMBILICAL AND FEMORAL HERNIAS WITH SMALL INTESTINAL RESECTION-ANASTOMOSIS. ONE PATIENT DIED IN ICU. (N=1)PATIENT WHO WAS INITIALLY OPERATED UPON FOR AN INCARCERATED UMBILICAL HERNIA PRESENTED WITH SMALL INTESTINE STRANGULATION 1 YEAR AFTER THE INITIAL OPERATION. (N=1) PATIENT INITIALLY OPERATED UPON FOR INCARCERATED INGUINAL HERNIA PRESENTED WITH SMALL INTESTINE STRANGULATION 2 MONTHS AFTER THE INITIAL OPERATION. (N=1) PATIENT INITIALLY TREATED FOR STRANGULATED UMBILICAL HERNIA WITH SMALL INTESTINE RESECTION UNDERWENT TWO ADDITIONAL OPERATIONS FOR INCARCERATION 1 YEAR AND 2 YEARS AFTER THE INITIAL OPERATION. IN CONCLUSION SYNTHETIC MATERIALS MAY SAFELY BE USED IN THE EMERGENCY MANAGEMENT OF INCARCERATED AND STRANGULATED GROIN AND ABDOMINAL WALL HERNIAS IN PATIENTS WITH OR WITHOUT ORGAN RESECTION, ALTHOUGH THEY CANNOT FORMALLY BE RECOMMENDED DUE TO THE LIMITED NUMBER OF CASES OF THE PRESENT STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472960 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death