BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7416238 · Received April 10, 2018

    Report

    Report Number
    2210968-2018-72062
    Event Type
    Injury
    Date Received
    April 10, 2018
    Report Date
    March 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 USED IN THIS PROCEDURE? CITATION: FEMALE PELVIC MED RECONSTR SURG. 2016; 22: 146 150. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: DOES PELVIC ORGAN PROLAPSE QUANTIFICATION EXAMINATION D POINT PREDICT UTEROSACRAL LIGAMENT SUSPENSION OUTCOMES?" AUTHORS: LEE A. RICHTER, MD AMY J. PARK, MD JENINE E. BOILEAU, MD MEGAN JANNI, MD SAMEER DESALE, MS CHERYL B. IGLESIA, MD CITATION: FEMALE PELVIC MED RECONSTR SURG. 2016; 22: 146 150. DOI: 10.1097/SPV.0000000000000245, THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO DETERMINE IF THERE IS A CORRELATION BETWEEN THE PREOPERATIVE D POINT AND ANATOMIC OUTCOMES FOR APICAL PROLAPSE AFTER 1 YEAR. A TOTAL OF 125 WOMEN UNDERWENT TRANSVAGINAL UTEROSACRAL LIGAMENT SUSPENSION (USLS) AND WERE INCLUDED IN THE STUDY. ALL USLS PROCEDURES INVOLVED PLACEMENT OF 2 TO 3 SUTURES INTO EACH UTEROSACRAL LIGAMENT (USL) AT THE LEVEL OF THE ISCHIAL SPINE. SUTURES PLACED IN THE USL WERE THEN ANCHORED INTO THE ANTERIOR AND POSTERIOR VAGINAL CUFF. SUTURES WERE PDS 0 SUTURES AND CV-2-0 POLYTETRAFLUOROETHYLENE. THE DECISION OF SUTURE QUANTITY AND MATERIAL WAS BASED ON ATTENDING PREFERENCE, BUT ALL CASES USED A COMBINATION OF BOTH PDS AND POLYTETRAFLUOROETHYLENE MATERIAL ON EACH SIDE. THE MONOFILAMENT POLYDIOXANONE SUTURE WAS ANCHORED THROUGH THE FULL THICKNESS OF THE VAGINAL WALL IN THE MOST LATERAL POSITION AT THE ANTERIOR AND POSTERIOR VAGINAL CUFF (AS THIS SUTURE WAS LOCATED IN THE MOST DISTAL POSITION ON THE USL). IT WAS REPORTED THAT ALL OF THE PATIENTS HAD PRIMARY PROLAPSE EXCEPT FOR 1 PATIENT WITH RECURRENCE AFTER GYNECARE PROLIFT USE. OTHER REPORTED COMPLICATIONS INCLUDED APICAL FAILURE (N-5), ANTERIOR WALL FAILURE (N-20) WHICH REQUIRED CONCOMITANT ANTERIOR WALL REPAIR, POSTERIOR WALL FAILURE (N-8) WHICH REQUIRED CONCOMITANT POSTERIOR WALL REPAIR (N-5) AND MANAGEMENT WITH PESSARY INSERTION (N-1), SYMPTOMATIC PROLAPSE (N-10) WHICH REQUIRED LAPAROSCOPIC SACRAL COLPOPEXY (N-2). IT WAS CONCLUDED THAT THE PREOPERATIVE D POINT CORRELATES WITH POST-OPERATIVE APICAL SUPPORT AND A CLINICALLY MEANINGFUL RELATIONSHIP EXISTS BETWEEN THE PREOPERATIVE D POINT AND ANATOMIC APICAL SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253211 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention