BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9831911 · Received March 13, 2020

    Report

    Report Number
    2210968-2020-02058
    Event Type
    Injury
    Date Received
    March 13, 2020
    Report Date
    February 21, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: D3, G1, G2. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? 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?

    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. CITATION: BJOG 2019;126:1065¿1073; DOI: 10.1111/1471-0528.15696. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ROBOT-ASSISTED SURGERY FOR THE MANAGEMENT OF APICAL PROLAPSE: A BI-CENTRE PROSPECTIVE COHORT STUDY. THIS PROSPECTIVE OBSERVATIONAL COHORT STUDY AIMED TO PRESENT THE ROBOT-ASSISTED SURGERY IN THE MANAGEMENT OF PELVIC ORGAN PROLAPSE (APICAL). BETWEEN 2008 AND 2016, A TOTAL OF 305 FEMALE PATIENTS WITH PELVIC ORGAN PROLAPSE UNDERWENT EITHER ROBOT-ASSISTED SACROCOLPOPEXY (RASC) OR ROBOT-ASSISTED LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY WITH SACROCERVICOPEXY (RSHS). IN RASC GROUP (N=188; MEAN AGE OF 63.1±8.7 YEARS; MEDIAN BMI OF 26.6 KG/M^2 [24.2-29.7 KG/M^2), SUSPENSION WAS PERFORMED WITH TYPE-1 POLYPROPYLENE MESH (PROLENE, ETHICON) OR RESTORELLE (COLOPLAST) WHICH WAS ATTACHED DISTALLY USING ETHIBOND SUTURES (ETHICON) OR GORE-TEX (GORE MEDICAL). PROXIMAL ANCHORING OF THE MESH TO THE SACRAL PROMONTORY WAS PERFORMED WITH TITANIUM TACKS. IN RSHS GROUP (N=117; MEAN AGE OF 59.9±11.2 YEARS; MEDIAN BMI OF 25.2 KG/M^2 [23.2-27.7 KG/M^2), PATIENTS UNDERWENT SUPRACERVICAL HYSTERECTOMY PERFORMED PRIOR TO ATTACHING THE MESH TO THE ANTERIOR AND POSTERIOR ASPECT OF THE CERVIX USING THE MESH AND SUTURES AS DESCRIBED FOR THE RASC GROUP. AT 6 WEEKS AFTER SURGERY, STAGE 2 APICAL RECURRENCE (N=2) OCCURRED IN RASC GROUP WHICH UNDERWENT RETREATMENT. AT 12-MONTH FOLLOW-UP, RECURRENCES OCCURRED IN ANTERIOR COMPARTMENT (N=22 RASC GROUP AND N=24 RSHS GROUP) TREATED WITH ANTERIOR VAGINAL REPAIR (N=12 RASC GROUP (ONE WITH COMBINED PERINEORRHAPHY) AND N=2 RSHS GROUP); POSTERIOR COMPARTMENT (N=6 RASC GROUP AND N=8 RSHS GROUP) TREATED WITH POSTERIOR VAGINAL REPAIR (N=6 RASC GROUP); AND APICAL COMPARTMENT (N=1 RASC GROUP). RECURRENCE OF MULTIPLE COMPARTMENTS INCLUDING APICAL COMPARTMENT INCLUDED 11 PATIENTS IN RASC GROUP AND 1 PATIENT IN RSHS GROUP; AND RECURRENCE MULTIPLE COMPARTMENTS EXCLUDING APICAL COMPARTMENT INCLUDED 6 PATIENTS IN RASC GROUP AND 4 PATIENTS IN RSHS GROUP. ADDITIONAL 12 PATIENTS WERE TREATED WITH BOTH ANTERIOR AND POSTERIOR VAGINAL REPAIR (WITH ONE PATIENT COMBINED PERINEORRHAPHY, ONE CERVICAL AMPUTATION), 1 PATIENT WITH COLPOCLEISIS AND 2 PATIENTS WITH UNKNOWN RETREATMENT FOR PROLAPSE. ONE VAGINAL PESSARY WAS PERFORMED IN RSHS GROUP. ANOTHER PATIENT IN RSHS GROUP UNDERWENT REDO-CERVICOPEXY WHICH REVEALED LAXITY OF THE MESH; IT WAS SHORTENED WITH NO RECURRENCE AFTERWARDS. MESH-RELATED COMPLICATIONS AFTER RASC INCLUDED VAGINAL MESH EXPOSURE (N=4) IN WHICH TWO PATIENTS NEEDED COMPLETE SURGICAL MESH REMOVAL. LATE COMPLICATION IN RSHS GROUP INCLUDED VAGINAL MESH EXPOSURE (N=1). THIS LARGE PROSPECTIVE COHORT STUDY SHOWS THAT ROBOT-ASSISTED APICAL REPAIR SURGERY GIVES DURABLE ANATOMICAL RESULTS. APICAL SUCCESS RATES WERE 91 AND 99% FOR RASC AND RSHS, RESPECTIVELY. POSTOPERATIVE ANTERIOR WALL RECURRENCES CAN OCCUR AND PATIENTS SHOULD BE COUNSELLED ACCORDINGLY. BOTH PROCEDURES ARE SAFE AND, WHEN PERFORMED REGULARLY, ARE PERFORMED WITHIN ACCESSIBLE TIME RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294038 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention