BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 20835826 · Received December 3, 2024

    Report

    Report Number
    2210968-2024-12774
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: INT J UROLOGY.

    Description of Event or Problem · 0

    TITLE: LONG-TERM OUTCOMES OF TRANSVAGINAL MESH SURGERY FOR PELVIC ORGAN PROLAPSE AT A SINGLE CENTER IN JAPAN. THIS STUDY AIMED TO INVESTIGATE THE LONG-TERM EFFECTIVENESS AND SAFETY OF TRANSVAGINAL MESH SURGERY FOR PELVIC ORGAN PROLAPSE AT A HIGH-VOLUME CENTER IN JAPAN. A TOTAL OF 711 PATIENTS WHO UNDERWENT TRANSVAGINAL MESH SURGERY BETWEEN MARCH 2010 AND AUGUST 2015 WERE INCLUDED AND FOLLOWED UP FOR 5¿YEARS. AS NO MESH KITS WERE AVAILABLE IN JAPAN, WE USED A TEMPLATE BASED ON THE PROLIFT¿ (GYNECARE, SOMERVILLE, NJ, USA) MODEL, A SELF-CUT POLYPROPYLENE MESH DEVELOPED AND VALIDATED USING PELVIC MEASUREMENTS OF FRENCH WOMEN. THIS APPROACH WAS CALLED JAPANESE-STYLE TVM, WHICH WE EXAMINED IN THIS STUDY. THE CASES IN WHICH THE MESH WAS INSERTED IN THE ANTERIOR WALL WERE DESIGNATED ANTERIOR TVM (TVM-A). IN CONTRAST, THE CASES IN WHICH THE MESH WAS INSERTED IN THE ANTERIOR¿POSTERIOR WERE DESIGNATED ANTERIOR¿POSTERIOR TVM (TVM-AP) AND COMBINED TVM (TVM-C), WHEREAS THOSE FOR WHICH THE MESH WAS INSERTED IN THE POSTERIOR WALL WERE DESIGNATED POSTERIOR TVM (TVM-P). THE MESH TYPE USED IN 611 CASES BEFORE MAY 28, 2014, WAS GYNEMESH¿ PS (ETHICON INC., SOMERVILLE, NJ, USA), AND THAT USED IN 100 CASES AFTER MAY 28, 2014, WAS POLYFORM¿ (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA). REPORTED COMPLICATIONS INCLUDE PROLAPSE RECURRENCE (N=?), MESH EXPOSURE (N=?), AND UNKNOWN EVENT (N=?) REQUIRING URINARY INCONTINENCE SURGERY. IN CONCLUSION, THE FREQUENCIES OF RECURRENCE REQUIRING REOPERATION AND MESH-RELATED COMPLICATIONS WERE LOW, AND VAGINAL MESH EXPOSURE WAS MOSTLY ASYMPTOMATIC. THEREFORE, THE JAPANESE-STYLE TRANSVAGINAL MESH IS SAFE AND EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544380 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention