BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISYN Y-SHAPED MESH UNKNOWN PRODUCT

    MDR report key: 11095708 · Received December 30, 2020

    Report

    Report Number
    2210968-2020-10411
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    January 9, 2019
    Report Date
    December 14, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K113205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. 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. WHAT GROUP DID THE PATIENT BELONG TO, AS PER ARTICLE, "IN ONE PATIENT, THE MESH REMOVED BY LOCAL EXCISION, AND A SACROSPINOUS FIXATION PROCEDURE WAS APPLIED¿? DOES THE SURGEON BELIEVE THAT ANY OF THE 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 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? CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL (2019) 30:623¿632; DOI: HTTPS://DOI.ORG/10.1007/S00192-018-03858-W. 2210968-2020-10410 WILL CAPTURE THE EVENTS RELATED TO UNKNOWN GYNEMESH MESH. 2210968-2020-10411 WILL CAPTURE THE EVENTS RELATED TO UNKNOWN ARTISYN MESH.

    Description of Event or Problem · 1

    TITLE: LONG-TERM FOLLOW-UP OF LAPAROSCOPIC SACROCOLPOPEXY: COMPARISON OF TWO DIFFERENT TECHNIQUES USED IN UROLOGY AND GYNECOLOGY THE AIM OF THIS PROSPECTIVE STUDY IS TO INVESTIGATE THE LONG-TERM OUTCOMES OF LAPAROSCOPIC SACROCOLPOPEXY PERFORMED BY TWO DIFFERENT SURGICAL DISCIPLINES, UROLOGY AND GYNECOLOGY. BETWEEN 2011 AN 2014, 190 PATIENTS UNDERWENT LAPAROSCOPIC SACROCOLPOPEXY PROCEDURE. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: UROLOGY PATIENTS (N=94; AGE RANGE=45 ¿ 59 YEARS, MEAN AGE 52.5 ± 1.8 YEARS; BODY MASS INDEX (BMI) RANGE= 21.0 ¿ 30.6 KG/M^2, MEAN BMI= 27.4 ± 1.7 KG/M^2) AND GYNECOLOGY PATIENTS (N=90; AGE RANGE=45 ¿ 60 YEARS, MEAN AGE 52.1 ± 1.6 YEARS; BMI RANGE= 21.0 ¿ 30.0 KG/M^2, MEAN BMI= 27.6 ± 1.3 KG/M^2). DURING THE PROCEDURE IN UROLOGY GROUP, INSERTION OF THE TWO MANUALLY TAILORED MESHES (GYNEMESH, ETHICON) INTO THE ABDOMEN, POSTERIOR MESH FIXATION WHICH WAS MINIMUM FIVE INTRACORPOREAL SIMPLE INTERRUPTED SUTURES WITH 2.0 POLYPROPYLENE SUTURES AND ANTERIOR MESH FIXATION WHICH WAS MINIMUM FIVE INTERCORPOREAL SIMPLE INTERRUPTED SUTURES WITH 2.0 POLYPROPYLENE SUTURES. FIXATION OF THE MESHES TO THE PROMONTORY WITH MINIMUM TWO INTRACORPOREAL SIMPLE INTERRUPTED SUTURES WITH 2.0 POLYPROPYLENE SUTURES. FOR GYNECOLOGY GROUP, INSERTION OF THE Y-SHAPED MESH (ARTISYN, ETHICON) INTO THE ABDOMEN. POSTERIOR FIXATION OF THE Y-SHAPED MESH WHICH WAS MINIMUM FIVE INTERCORPOREAL SIMPLE INTERRUPTED SUTURES WITH 2.0 POLYPROPYLENE SUTURES. FIXATION OF THE Y-SHAPED MESH TO THE PROMONTORY WHICH WAS MINIMUM SIMPLE INTERCORPOREAL SIMPLE INTERRUPTED SUTURES WITH 2.0 POLYPROPYLENE SUTURES. REPORTED COMPLICATIONS IN UROLOGY GROUP INCLUDED DE NOVO STRESS URINARY INCONTINENCE (N=7) WHICH A TRANSOBTURATOR TAPE PROCEDURE (OUTSIDE-IN) WAS APPLIED TO THE 5 PATIENTS. OTHER PATIENTS WERE TREATED SYMPTOMATICALLY. ALL THE PATIENTS WHO UNDERWENT SURGERY WERE CONTINENT WITHIN A YEAR; POSTOP CONSTIPATION (N=1); POSTOP VOIDING DISORDERS (N=9); DE NOVO URGE URINARY INCONTINENCE (N=3) WHICH WERE TREATED WITH ANTICHOLINERGIC PHARMACOTHERAPY; DYSPARONIA (N=3); ANTERIOR WALL PROLAPSE (N=6), POSTERIOR WALL PROLAPSE (N=5), RECURRENCE OF APICAL COMPARTMENT (N=2), BOTH ANTERIOR AND APICAL COMPARTMENT PROLAPSE (N=1). FIVE OF THESE PATIENTS UNDERWENT A SECOND OPERATION, SUCH AS COLPORRHAPHY AND/OR SACROSPINOUS FIXATION; MESH EROSION (N=2) WHICH THE PATIENTS RESPONDED TO LOCAL ESTROGEN THERAPY BECAUSE THE EXPOSED MESH AREA WAS <1 CM^2. IN ONE PATIENT, THE MESH WAS REMOVED BY LOCAL EXCISION, AND A SACROSPINOUS FIXATION PROCEDURE WAS APPLIED. REPORTED COMPLICATIONS IN GYNECOLOGY GROUP INCLUDED DE NOVO STRESS URINARY INCONTINENCE (N=8) WHICH A TRANSOBTURATOR TAPE PROCEDURE (OUTSIDE-IN) WAS APPLIED TO THE 5 PATIENTS. OTHER PATIENTS WERE TREATED SYMPTOMATICALLY. ALL THE PATIENTS WHO UNDERWENT SURGERY WERE CONTINENT WITHIN A YEAR. POSTOP CONSTIPATION (N=1); POSTOP VOIDING DISORDERS (N=10); DE NOVO URGE URINARY INCONTINENCE (N=3) WHICH WERE TREATED WITH ANTICHOLINERGIC PHARMACOTHERAPY; DYSPARONIA (N=3); ANTERIOR WALL PROLAPSE (N=7), POSTERIOR WALL PROLAPSE (N=5), RECURRENCE OF APICAL COMPARTMENT (N=2), BOTH ANTERIOR AND APICAL COMPARTMENT PROLAPSE (N=1). SIX OF THESE PATIENTS UNDERWENT A SECOND OPERATION, SUCH AS COLPORRHAPHY AND/OR SACROSPINOUS FIXATION; MESH EROSION (N=2) WHICH THE PATIENTS RESPONDED TO LOCAL ESTROGEN THERAPY BECAUSE THE EXPOSED MESH AREA WAS <1 CM^2. IN ONE PATIENT, THE MESH WAS REMOVED BY LOCAL EXCISION, AND A SACROSPINOUS FIXATION PROCEDURE WAS APPLIED. IN CONCLUSION, ALTHOUGH DIFFERENT SURGICAL BRANCHES PERFORM LAPAROSCOPIC SACROCOLPOPEXY WITH THEIR OWN TECHNIQUES, LONG-TERM ANATOMICAL AND FUNCTIONAL RESULTS ARE SIMILAR BETWEEN THE BRANCHES. FROM A UROGYNECOLOGICAL POINT OF VIEW, LAPAROSCOPIC SACROCOLPOPEXY IS A GOLD STANDARD SURGICAL PROCEDURE THAT CAN BE PERFORMED BY BOTH UROLOGISTS AND GYNECOLOGISTS WITH SIMILAR LONG-TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563393 ARTISYN Y-SHAPED MESH UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention