BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7856911 · Received September 7, 2018

    Report

    Report Number
    2210968-2018-75720
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    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. 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 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 OR ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J (2014) 25:1207¿1212; DOI 10.1007/S00192-014-2369-Y. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LONG-TERM FOLLOW-UP OF LAPAROSCOPIC SACROCOLPOPEXY". AUTHORS: DIMITRI SARLOS & LAVONNE KOTS & GLORIA RYU & GABRIEL SCHAER. CITATION: INT UROGYNECOL J (2014) 25:1207¿1212; DOI 10.1007/S00192-014-2369-Y. THE AIM OF THIS PROSPECTIVE STUDY WAS TO REPORT THE LONG-TERM FOLLOW-UP OF LAPAROSCOPIC SACROCOLPOPEXY REGARDING ANATOMICAL RESULTS, RECURRENCE RATES, AND POSTOPERATIVE QUALITY OF LIFE AFTER 60 MONTHS (MEAN FOLLOW-UP). FROM 2003 TO 2007, 99 FEMALE PATIENTS HAD LAPAROSCOPIC SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE AND WERE INCLUDED IN THE ANALYSIS. IN THE PROCEDURE TWO SEPARATE GYNEMESH WERE USED FOR ANTERIOR AND POSTERIOR COMPARTMENTS. THE MOST DISTAL PART OF THE POSTERIOR MESH WAS SUTURED TO THE LEVATOR ANI MUSCLE AND THE PROXIMAL MESH TO THE APEX OF THE VAGINA OR TO THE CERVIX. THE ANTERIOR MESH WAS PLACED UNDERNEATH THE BLADDER AND ATTACHED TO THE CAUDAL PART OF THE VAGINA AND THE APEX WITH A FOUR-POINT FIXATION BY LAPAROSCOPIC SUTURING USING ETHIBOND 2¿0 WITH THE EXTRACORPOREAL KNOTTING TECHNIQUE. THE ANTERIOR AND POSTERIOR MESHES WERE SUTURED TOGETHER AT THE LEVEL OF THE VAGINAL APEX AND THEN ATTACHED WITHOUT TENSION TO THE LONGITUDINAL SACRAL LIGAMENT AT THE LEVEL OF THE PROMONTORY. IN MEAN FOLLOW-UP OF 60 MONTHS COMPLICATIONS INCLUDED DE NOVO STRESS INCONTINENCE (N=32) TREATED WITH SLING PROCEDURE (N=16); POSTOPERATIVE CONSTIPATION (N=4); POSTOPERATIVE VOIDING DISORDERS (N=11) FOR WHICH 2 PATIENTS UNDERGO SLING TRANSECTION AND THE OTHER 9 PATIENTS WERE MANAGED CONSERVATIVELY; DE NOVO URGE INCONTINENCE (N=7) TREATED WITH MEDICAL TREATMENT WITH ANTICHOLINERGICS; SEVERE DE NOVO DYSPAREUNIA (N=10) FOR WHICH 3 PATIENTS WERE TREATED WITH LOCAL ESTROGEN THERAPY BECAUSE OF ATROPHIC COLPITIS; RECURRENCE OF ANTERIOR WALL (N=6) FOR WHICH TWO PATIENTS WERE RE-OPERATED AND TREATED WITH AN ANTERIOR VAGINAL MESH PROCEDURE USING PROLIFT DUE TO SEVERE PROLAPSE SYMPTOMS AND THE OTHER FOUR WERE TREATED CONSERVATIVELY; RECURRENCE OF POSTERIOR WALL (N=4) FOR WHICH ONE PATIENT WAS TREATED SUCCESSFULLY WITH POSTERIOR REPAIR AND THE OTHER THREE PATIENTS DID NOT REQUIRE FURTHER TREATMENT AS THERE WERE ASYMPTOMATIC; AND APICAL RECURRENCE (N=1) TREATED WITH A PESSARY DUE TO MINOR SYMPTOMS OF VAGINAL BULGE. THE AUTHORS STATED THAT A SUBOPTIMAL ANTERIOR MESH PLACEMENT PROBABLY WAS NOT CLOSE ENOUGH TO THE TRIGONE OF THE BLADDER TO BE A RISK FACTOR FOR ANTERIOR RECURRENCE. MOST OF THE PATIENTS REPORTING DYSPAREUNIA AT 60 MONTHS FOLLOW-UP WAS PROBABLY NOT RELATED TO THE SURGERY BUT TO OTHER CAUSES SUCH AS ATROPHY. IN BOTH CASES OF MESH EROSION, THE BLADDER WAS ACCIDENTALLY OPENED DURING THE INITIAL SURGERY, SHOWING THAT A BLADDER LESION, EVEN IF IT IS RECOGNIZED AND REPAIRED IMMEDIATELY, SEEMS TO BE A RISK FACTOR FOR LATE MESH EROSIONS INTO THE BLADDER. IT CAN BE MENTIONED THAT MESH EROSION INTO THE BLADDER IS PROBABLY RELATED TO SURGERY AND NOT A MESH-ASSOCIATED PROBLEM. LAPAROSCOPIC SACROCOLPOPEXY HAS DEMONSTRATED EXCELLENT ANATOMICAL AND FUNCTIONAL LONG-TERM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695263 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention