BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH UNKNOWN PRODUCT

    MDR report key: 7726016 · Received July 27, 2018

    Report

    Report Number
    2210968-2018-74665
    Event Type
    Injury
    Date Received
    July 27, 2018
    Report Date
    July 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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? PLEASE CONFIRM IF THE EVENTS VAGINAL LESION, GRANULOMA, HEMATOMA, DEEP VEIN THROMBOSIS, AND URINARY TRACT INFECTION WERE ASSOCIATED WITH THE USE OF ANY ETHICON PRODUCTS. IF YES, PLEASE SPECIFY THE TYPE OF MESH OR SUTURE. CITATION: INT UROGYNECOL J (2016) 27:1347¿1355; DOI 10.1007/S00192-016-2974-Z . PLEASE SEE REFERENCED ARTICLE ATTACHED. [(B)(4)].

    Description of Event or Problem · 1

    JOURNAL ARTICLE TITLE : INCIDENCE AND RISK FACTORS FOR MESH EROSION AFTER LAPAROSCOPIC REPAIR OF PELVIC ORGAN PROLAPSE BY LATERAL SUSPENSION WITH MESH THE OBJECTIVE OF THIS CASE-CONTROL STUDY NESTED WITHIN A COHORT WAS TO ESTIMATE THE INCIDENCE AND IDENTIFY THE RISK FACTORS FOR MESH EROSION AFTER LAPAROSCOPIC REPAIR OF PELVIC ORGAN PROLAPSE (POP) BY LATERAL SUSPENSION WITH MESH. BETWEEN JAN 2004 AND OCT 2012, 480 FEMALE PATIENTS WITH POP UNDERWENT LAPAROSCOPIC POP RECONSTRUCTIVE PROCEDURES WITH MESH USING LATERAL SUSPENSION. IN THIS NESTED CASE-CONTROL STUDY, 18 PATIENTS (CASE GROUP) (AGE OF 58.4 [9.9] YEARS) SHOWED MESH EROSION FOLLOWING THE FIRST INTERVENTION THROUGH DEC 2014, AND 133 PATIENTS (CONTROL GROUP) (AGE OF 59.7 [11.8] YEARS) WHICH WERE RANDOMLY SELECTED FROM THE SAME COHORT WHO DID NOT HAVE ANY EROSION. DURING THE STUDY PERIOD, THERE WERE FIVE TYPES OF MESHES USED: MERSILENE (N=16 CASE GROUP; N=80 CONTROL GROUP), GYNEMESH (N=2 CASE GROUP; N=34 CONTROL GROUP), PROLENE SOFT/BIOMESH (N=2 CONTROL GROUP), AND TILOOP (N=17 CONTROL GROUP). THE MESHES WERE FIXED TO VAGINA USING VICRYL/ABSORBATACK (N=1 CASE GROUP; N=20 CONTROL GROUP), ETHIBOND (N=10 CASE GROUP; N=99 CONTROL GROUP), AND GLUBRAN (N=7 CASE GROUP; N=14 CONTROL GROUP). IN THE 18 PATIENTS WITH MESH EROSION, 16 PATIENTS REQUIRED REOPERATION AND 4 OF THEM DEVELOPED INFECTION OF THE MESH REQUIRING TOTAL LAPAROSCOPIC REMOVAL. ALL OF THEM HAD MERSILENE MESH AND HAD PREVIOUS TREATMENT FOR EROSION. THE OTHER TWO PATIENTS HAD SMALL EROSION WHICH WERE TREATED IN AN AMBULATORY SETTING WITH REMOVAL OF VISIBLE MESH. SEVEN OF THESE WOMEN REQUIRED MORE THAN ONE OPERATION TO TREAT EROSION. OVERALL, OTHER COMPLICATIONS INCLUDED VAGINAL LESION REQUIRING TREATMENT (N=35), EXTRUSION OF UNRESORBABLE SUTURE (N=20) TREATED IN AMBULATORY SETTING, GRANULOMA (N=11) ALSO TREATED IN AN AMBULATORY SETTING, HEMATOMA (N=2 CASE GROUP; N=3 CONTROL GROUP), DEEP VEIN THROMBOSIS (N=1 CONTROL GROUP) AND URINARY TRACT INFECTION (N=2 CASE GROUP; N=17 CONTROL GROUP). IN ONLY ONE WOMAN IN OUR COHORT, IN THE CONTROL GROUP, WAS TOTAL HYSTERECTOMY ASSOCIATED WITH EROSION. THE USE OF MERSILENE MESH WAS ASSOCIATED WITH A SIGNIFICANTLY INCREASED RISK OF EROSION COMPARED WITH MACROPOROUS POLYPROPYLENE MESH. BASED ON THE DATA, THE AUTHORS BELIEVE THE RISK OF REOPERATION FOR MESH EROSION AFTER LAPAROSCOPIC POP REPAIR WITH MESH MAY BE REDUCED BY USING APPROPRIATE MESH MATERIAL AND BY SELECTING PATIENTS WITH A LOW RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567215 MERSILENE POLYESTER FIBER MESH UNKNOWN PRODUCT MESH, SURGICAL FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GYNEMESH,PROLENE MESH,ETHIBOND, VICRYL