BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 11711863 · Received April 22, 2021

    Report

    Report Number
    2210968-2021-03641
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    January 17, 2019
    Report Date
    March 24, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO CLARIFY 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF SO, PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? (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. EVENTS RELATED TO ULTRAPRO MESH CAPTURED VIA 2210968-2021-03640. CITATION: HERNIA (2019) 23:1053¿1059, HTTPS://DOI.ORG/10.1007/S10029-019-01882-3.

    Description of Event or Problem · 1

    TITLE: IS YOUNG AGE A RISK FACTOR FOR CHRONIC POSTOPERATIVE INGUINAL PAIN AFTER ENDOSCOPIC TOTALLY EXTRAPERITONEAL (TEP) REPAIR? THE AIM OF THIS STUDY WAS TO DETERMINE IF YOUNG ADULTS (18¿30 YEARS) ARE MORE PRONE TO EXPERIENCE CHRONIC POSTOPERATIVE INGUINAL PAIN (CPIP) AFTER TOTALLY EXTRAPERITONEAL(TEP) REPAIR COMPARED TO ADULTS OF = 31 YEARS OF AGE. BETWEEN MARCH 2010 AND OCTOBER 2012, 919 MALE PATIENTS WHO UNDERWENT INGUINAL HERNIA REPAIR WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 55 YEARS (RANGE, 44-64) AND THE MEAN BMI WAS 24.9. THERE WERE 64 PATIENTS WHO WERE AGED 18-30 YEARS OLD AND 855 PATIENTS WHO WERE AGED =31 YEARS OLD. ALL PATIENTS UNDERWENT ENDOSCOPIC TEP REPAIR WITH TENSION FREE PLACEMENT OF EITHER A LIGHTWEIGHT MESH (ULTRAPRO, ETHICON) OR A HEAVYWEIGHT MESH (PROLENE, ETHICON). A TOTAL OF 464 PATIENTS WERE IMPLANTED WITH THE ULTRAPRO MESH (ETHICON), 31 OF THESE PATIENTS WERE AGED 18-30 YEARS AND 433 WERE AGED = 31 YEARS. MEANWHILE, A TOTAL OF 455 PATIENTS WERE IMPLANTED WITH PROLENE MESH (ETHICON), 33 OF THESE PATIENTS WERE AGED 18-30 YEARS AND 422 WERE AGED = 31 YEARS. FIXATION OF THE MESH WAS NOT PERFORMED. PATIENTS WERE ROUTINELY DISCHARGED ON THE DAY OF SURGERY, UNLESS COMPLICATIONS PROHIBITED EARLY DISCHARGE. PATIENTS WERE ADVISED TO TAKE ANALGESICS WHEN IN PAIN, AND STRENUOUS PHYSICAL ACTIVITY WAS DISCOURAGED DURING THE FIRST WEEK POSTOPERATIVELY. NO RESTRICTIONS WERE GIVEN FOR ACTIVITIES OF DAILY LIVING. COMPLICATIONS IN THE = 31 YEARS AGE GROUP INCLUDE HERNIA RECURRENCE AT 3 MONTHS FOLLOW-UP (N=3), HERNIA RECURRENCE AT 1 YEAR FOLLOW-UP (N=4), CLINICALLY RELEVANT PAIN AT 3 MONTHS FOLLOW-UP (N=32), CLINICALLY RELEVANT PAIN AT 1 YEAR FOLLOW-UP (N=23), AND CLINICALLY RELEVANT PAIN AT 2 YEARS FOLLOW-UP (N=29), WORST PAIN IN THE PAST WEEK (N=?), EXPERIENCE OF FOREIGN BODY FEELING (MESH) (N=?), AND PAIN IN THE TESTICLE ON THE OPERATED SIDE (N=?). COMPLICATIONS IN THE 18-30 YEARS AGE GROUP INCLUDE CLINICALLY RELEVANT PAIN AT 3 MONTHS FOLLOW-UP (N=1), CLINICALLY RELEVANT PAIN AT 1 YEAR FOLLOW-UP (N=1), AND CLINICALLY RELEVANT PAIN AT 2 YEARS FOLLOW-UP (N=29), WORST PAIN IN THE PAST WEEK (N=?), EXPERIENCE OF FOREIGN BODY FEELING (MESH) (N=?), AND PAIN IN THE TESTICLE ON THE OPERATED SIDE (N=?). IN CONCLUSION, AGE DID NOT PROVE TO BE A RISK FACTOR FOR THE DEVELOPMENT OF CPIP AFTER TEP MESH REPAIR, WHICH JUSTIFIES THIS TECHNIQUE IN PATIENTS 18¿30 YEARS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607847 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention