BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7830288 · Received August 29, 2018

    Report

    Report Number
    2210968-2018-75538
    Event Type
    Injury
    Date Received
    August 29, 2018
    Report Date
    August 15, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS 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 PRODUCTS INVOLVED? CITATION: INT UROGYNECOL J (2014) 25:847¿849; DOI 10.1007/S00192-013-2251-3. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : TRANSVAGINAL REMOVAL OF MESH EXPOSURE INVOLVING THE BLADDER" AUTHOR: TONG-XIN YANG AND YI DAI & HONG SHEN. AUTHOR(S): TONG-XIN YANG AND YI DAI & HONG SHEN. CITATION: INT UROGYNECOL J (2014) 25:847¿849; DOI 10.1007/S00192-013-2251-3. THE STUDY AIMED TO PRESENT THREE CASES OF TRANSVAGINAL REMOVAL OF MESH EXPOSURE INVOLVING THE BLADDER, INCLUDING PATIENT FOLLOW-UP. THE FIRST CASE WAS A (B)(6) FEMALE PATIENT WITH 6-MONTH HISTORY OF INTERMITTENT DYSURIA AND FREQUENT URINATION WHO UNDERWENT TRANSVAGINAL MESH (TVM) PROCEDURE USING PROLIFT-T KIT (ETHICON) 2 YEARS EARLIER. THE SECOND CASE WAS A (B)(6) FEMALE PATIENT WITH 2-YEAR HISTORY OF PAINFUL URINATION AND URGENCY WHO UNDERWENT TVM USING PROLIFT-T KIT 4 YEARS EARLIER. THE THIRD CASE WAS A (B)(6) FEMALE PATIENT WITH 14-MONTH HISTORY OF PAIN DURING URINATION WHO UNDERWENT TVM PROCEDURE USING PROSIMA-C KIT (ETHICON). THESE THREE PATIENTS PRESENTED MESH EXPOSURE WHERE THEY WERE TREATED WITH TRANSVAGINAL REMOVAL OF MESH OF MESH EXPOSURE. ANY CALCULI OR FOREIGN BODIES WERE REMOVED, ALONG WITH A SUFFICIENT PORTION OF ERODED MESH WITH DEFECTIVE BLADDER WALL. TENSION-FREE CLOSURE OF THE MUCOSAL LAYER OF THE BLADDER WALL WAS PERFORMED USING 3¿0 VICRYL SUTURES. SURGICAL SCARRING WAS OBSERVED ON CYSTOSCOPY IN ALL CASES. RECURRENCE OF MESH EXPOSURE WAS CONFIRMED 12 MONTHS AFTER SURGERY IN THE FIRST CASE, ON THE FAR SIDE OF THE RIGHT ANTERIOR ARM OF THE MESH REMAINING IN THE TISSUE WHICH WAS MANAGED EASILY WITH ENDOSCOPIC APPROACH. THE RESULTS SHOWED THAT THE PURE TRANSVAGINAL APPROACH CANNOT GUARANTEE THAT RESIDUAL FIBERS WILL NOT BE EXPOSED THROUGH THE BLADDER WALL AGAIN. THE FAR SIDE OF THE MESH ARM REMAINS IN THE AREA OF WEAKENED BLADDER WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670193 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention