BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7757847 · Received August 7, 2018

    Report

    Report Number
    2210968-2018-74978
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    July 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2007) 14, 577¿583; DOI:10.1016/J.JMIG.2007.03.005. - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : LAPAROSCOPIC SACRAL COLPOPEXY WITH GYNEMESH AS GRAFT MATERIAL¿EXPERIENCE AND RESULTS" AUTHOR: NEENA AGARWALA, MD, NANCYE HASIAK, APRN, AND MARCIA SHADE, RN CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2007) 14, 577¿583; DOI:10.1016/J.JMIG.2007.03.005. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF PROLENE (ETHICON, INC., JOHNSON AND JOHNSON, (B)(4)) GRAFT FOR SACRAL COLPOPEXY AND EASE OF USE LAPAROSCOPICALLY. FROM MARCH 2003 TO MARCH 2006, 74 PATIENTS, MEDIAN AGE WAS 63 YEARS (RANGE 48¿76 YEARS), AND MEDIAN BODY MASS INDEX WAS 35 (RANGE 24¿41), WITH RECURRENT PROLAPSE OF THE APEX OR SEVERE UTERINE PROLAPSE (STAGE II¿IV) UNDERWENT LAPAROSCOPIC SACRAL COLPOPEXY OR CERVICOPEXY WITH GYNEMESH (ETHICON, INC.) USED AS THE GRAFT MATERIAL WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE TECHNIQUE OF LAPAROSCOPIC SACROCOLPOPEXY AND SACROCERVICOPEXY INVOLVES PLACEMENT OF A Y-SHAPED POLYPROPYLENE MESH (GYNEMESH, GYNECARE; ETHICON, INC.) AND ATTACHING T TO THE VAGINAL APEX AND THE ANTERIOR SACRAL LIGAMENT. THE ARMS OF THE Y-SHAPED GRAFT WERE THEN SECURED TO THE FIBROMUSCULAR PUBOCERVICAL FASCIA ANTERIORLY AND THE RECTOVAGINAL SEPTUM POSTERIORLY WITH A SERIES OF 4¿6 PERMANENT 2-O ETHIBOND SUTURES (ETHIBOND; ETHICON, INC.) THEREBY SPREADING OUT THE TENSION ON THE GRAFT OVER THE ENTIRE VAGINAL APEX. THE Y ARM WAS THEN SECURED TO THE ANTERIOR SACRAL LIGAMENT WITH 2 ETHIBOND STITCHES WITHOUT ANY TENSION ON THE GRAFT. ANOTHER PROCEDURE WAS COMPLETED AS A PROLIFT (JOHNSON AND JOHNSON) PROCEDURE BECAUSE OF FINDING OF A PRIOR MERSILENE (PHILLIPS SUMIKA POLYPROPYLENE CO., (B)(4)) MESH THAT WAS DENSELY ADHERENT TO THE PELVIC CONTENTS. INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS INCLUDED 1 MIDDLE SACRAL BLEED MANAGED BY SUTURING IN THE MIDDLE SACRAL REGION AND 1 POSTOPERATIVE CERVICAL ABSCESS REQUIRING REOPERATION AND REMOVAL OF THE GRAFT AT 10 DAYS. OTHER POSTOPERATIVE COMPLICATIONS INCLUDED URINARY TRACT INFECTION IN 8 PATIENTS AND VOIDING DIFFICULTIES IN 2 PATIENTS. ONE PATIENT WITH SACRO-UTEROPEXY STILL HAS STAGE I PROLAPSE OF HER CERVIX, BUT IT FEELS WELL SUPPORTED. THERE HAVE BEEN NO CASES OF COLPOPEXY GRAFT EXPOSURE/ EROSION OR RECURRENCE OF PROLAPSE. ONE PATIENT HAD A GRAFT INFECTION AND GRAFT REMOVAL. ONE PATIENT WITH A VERY LARGE POSTERIOR DEFECT UNDERWENT A SEPARATE GRAFT PLACEMENT IN THE POSTERIOR WALL AND HAS A SMALL AREA OF GRAFT EXPOSURE THAT HAS BEEN TREATED 2 TIMES WITH EXCISION OF THE GRAFT AND VAGINAL MUCOSAL REPAIR. THE PATIENT WITH CERVICAL ABSCESS AND GRAFT REMOVAL HAS ALSO HEALED WITH NO RECURRENCE OF HER PROLAPSE. DYSPAREUNIA WAS THE COMPLAINT OF ONLY 1 PATIENT WHO HAD THE POSTERIOR VAGINAL GRAFT EXPOSURE AND A SLIGHT BUNCHING OF THE GRAFT IN THE MIDLINE. POSTOPERATIVE RECOVERY HAS BEEN LARGELY UNEVENTFUL, AND OBJECTIVE CURE IS 100% AS MEASURED BY ABSENCE OF STAGE 2 OR GREATER PROLAPSE AT POSTOPERATIVE VISITS. IN CONCLUSION, LAPAROSCOPIC SACRAL COLPOPEXY OR CERVICOPEXY IS A SAFE AND EFFECTIVE PROCEDURE WITH EXCELLENT RESULTS. GYNEMESH (ETHICON, INC.), A WIDE-PORE POLYPROPYLENE MESH SEEMS TO BE AN EXCELLENT GRAFT MATERIAL WITH LOW RISK FOR GRAFT INFECTION (1.4%) OR EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601074 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention