BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7746476 · Received August 3, 2018

    Report

    Report Number
    2210968-2018-74873
    Event Type
    Injury
    Date Received
    August 3, 2018
    Report Date
    July 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 08/03/2018. (B)(4). CITATION: ARCH GYNECOL OBSTET (2013) 287:1159¿1165; DOI 10.1007/S00404-012-2685-8 -[(B)(4)].

    Additional Manufacturer Narrative · 1

    PC-000234470 DATE SENT TO THE FDA: 08/03/2018 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. DOES THE SURGEON BELIEVE THE CASES OF SUB-URETHRAL TAPES FOR THE DE NOVO STRESS URINARY INCONTINENCE WERE RELATED TO ANY ETHICON PRODUCTS? 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 (GYNEMESH, PDS SUTURE OR VICRYL SUTURE) USED IN THIS PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : RISK FACTORS OF SURGICAL FAILURE FOLLOWING SACROSPINOUS COLPOPEXY FOR THE TREATMENT OF UTEROVAGINAL PROLAPSE." AUTHOR: AYMAN QATAWNEH, FIDA THEKRALLAH, MAJED BATA, FAWAZ AL-KAZALEH, MAHMOUD ALMUSTAFA, ILHAM ABU-KADER. CITATION: ARCH GYNECOL OBSTET (2013) 287:1159¿1165; DOI 10.1007/S00404-012-2685-8. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO ANALYSE THE POTENTIAL RISK FACTORS OF SURGICAL FAILURE FOLLOWING SACROSPINOUS COLPOPEXY. FROM JAN2005 TO JAN2008, 114 FEMALE PATIENTS (MEAN AGE OF 56±8.9 YEARS) WITH VARYING DEGREES OF VAGINAL VAULT AND UTEROVAGINAL PROLAPSE UNDERWENT UNILATERAL SACROSPINOUS COLPOPEXY. IN THE PROCEDURE, THE ANTERIOR VAGINAL WALL WAS SHARPLY DISSECTED FROM THE UNDERLYING PUBOCERVICAL FASCIA, WHICH WAS PLICATED IN THE MIDLINE WITH A DELAYED ABSORBABLE 2-0 POLYDIOXANONE SUTURE (ETHICON). IN SOME WOMEN, THE RETROPUBIC SPACE WAS WIDENED USING SHARP AND BLUNT DISSECTION, AND GYNEMESH PS WAS DESIGNED AND TAILORED, LEAVING TWO TABS ON EACH SIDE, WHICH WERE PLACED INTO THE RETROPUBIC SPACE IN A TENSION-FREE FASHION WITHOUT SUTURES. THE MESH WAS LOOSELY FIXED AT FOUR POINT USING 3-0 VICRYL SUTURES. VAGINAL INCISION WAS CLOSED WITH 0 VICRYL SUTURE. A TRIPLE N0. 0 DELAYED ABSORBABLE POLYDIOXANONE SUTURE (ETHICON) WAS INSERTED INTO THE RIGHT SACROSPINOUS LIGAMENT 2 CM MEDIAL TO THE ISCHIAL SPINE. FIFTY THREE OF THESE PATIENTS HAD MESH AUGMENTATION OF THE ANTERIOR VAGINAL WALL. TWO PATIENTS HAD MESH EROSION WHICH FAILED TO RESPOND TO CONSERVATIVE MANAGEMENT. THUS, THE PATIENT HAD REOPERATION DURING THE FOLLOW-UP PERIOD. THREE PATIENTS HAD DE NOVO STRESS URINARY INCONTINENCE TREATED WITH SUB-URETHRAL TAPES ON REOPERATION. IN CONCLUSION, THE PRESENCE OF ADVANCED ANTERIOR VAGINAL WALL PROLAPSE, PRIOR VAGINAL REPAIR AND A LACK OF MESH AUGMENTATION OF THE ANTERIOR COMPARTMENT ARE SIGNIFICANT RISK FACTORS FOR THE SURGICAL FAILURE OF SACROSPINOUS SUSPENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590425 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention