BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 11799537 · Received May 10, 2021

    Report

    Report Number
    2210968-2021-04400
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    January 1, 2014
    Report Date
    May 5, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: FEMALE PELVIC MED RECONSTR SURG 2014;20: 208Y211; DOI 10.1097/SPV.0000000000000091. EVENTS RELATED TO GYNECARE TVTABBREVO CAPTURED VIA 2210968-2021-04401. EVENTS RELATED TO GYNECARE TVT RETROPUBIC SYSTEM CAPTURED VIA 2210968-2021-04402. EVENTS RELATED TO 0 PDS SUTURE CAPTURED VIA 2210968-2021-04403. EVENTS RELATED TO 0 PROLENE SUTURE CAPTURED VIA 2210968-2021-04404.

    Description of Event or Problem · 1

    TITLE: GLUTEAL AND POSTERIOR THIGH PAIN IN THE POSTOPERATIVE PERIOD AND THE NEED FOR INTERVENTION AFTER SACROSPINOUS LIGAMENT COLPOPEXY THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE THE RATE OF GLUTEAL OR POSTERIOR THIGH PAIN AFTER SSL COLPOPEXY USING THE CAPIO DEVICE IN THE IMMEDIATE POSTOPERATIVE PERIOD, TO COMPARE IT TO THE RATE AT THE 6-WEEK POSTOPERATIVE VISIT, AND TO DETERMINE THE RISK OF NEEDING INTERVENTION FOR THIS TYPE OF PAIN IN OUR PATIENT POPULATION. BETWEEN 2007 AND 2012, 242 WOMEN WHO UNDERWENT SACROSPINOUS LIGAMENT (SSL) COLPOPEXY WITH THE COMPETITORS CAPIO DEVICE FOR VAGINAL APEX PROLAPSE WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 66 (10 YEARS) AND THE MEAN BODY MASS INDEX (BMI) WAS 28.7 (5.4) KG/M2. PATIENTS INCLUDED IN THIS STUDY UNDERWENT CONCOMITANT PROCEDURES AT THE TIME OF SSL COLPOPEXY, IF NEEDED. PROCEDURES INCLUDED VAGINAL HYSTERECTOMY, CYSTOCELE REPAIR, RECTOCELE REPAIR, AND MIDURETHRAL SLING PLACEMENT. MIDURETHRAL SLINGS USED INCLUDE THE GYNECARE TVT OBTURATOR SYSTEM (ETHICON), GYNECARE TVTABBREVO (ETHICON), GYNECARE TVT RETROPUBIC SYSTEM (ETHICON), AND A COMPETITORS TOT DEVICE. COMPLICATIONS INCLUDED IMMEDIATE GLUTEAL OR POSTERIOR THIGH PAIN (N=134) AND GLUTEAL OR POSTERIOR THIGH PAIN AT 6 WEEKS (N=36) WITH PATIENTS NEEDING INTERVENTION FOR THIS PAIN (N=5). IN CONCLUSION, THE RATE OF IMMEDIATE POSTOPERATIVE GLUTEAL AND POSTERIOR THIGH PAIN IS HIGH IN PATIENTS UNDERGOING SSL COLPOPEXY FOR VAGINAL APEX PROLAPSE; HOWEVER, THE RATE OF PAIN AT 6 WEEKS IS MUCH LOWER, AND THE NEED FOR INTERVENTION IS EVEN LOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696693 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention