BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7939213 · Received October 5, 2018

    Report

    Report Number
    2210968-2018-76342
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    September 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT ( TENSION FREE VAGINAL TAPE - OBTURATOR ) 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 PRODUCT INVOLVED? CITATION: INT UROGYNECOL J (2018) 29: 859¿864; DOI 10.1007/S00192-017-3413-5. (B)(4).

    Description of Event or Problem · 1

    TITLE: "IS PAIN RELIEF AFTER VAGINAL MESH AND/OR SLING REMOVAL DURABLE LONG TERM?" AUTHOR: KAREN JONG & SHREEYA POPAT & ALANA CHRISTIE & PHILIPPE E. ZIMMERN. CITATION: INT UROGYNECOL J (2018) 29: 859¿864; DOI 10.1007/S00192-017-3413-5. THIS STUDY AIMED TO EXPLORE WHETHER PAIN RELIEF AFTER VAGINAL MESH AND/OR SLING REMOVAL (VMSR) WAS LASTING. BETWEEN 2006 AND 2015, 125 FEMALE PATIENTS WHO UNDERWENT VMSR FOR PAIN WERE INCLUDED IN THE ANALYSIS AND WERE FOLLOW-UP FOR 6 MONTHS. OF THE 125 PATIENTS, 25 REPORTED LONG-TERM PAIN DURING LONG-TERM FOLLOW-UP AND ONLY FOUR WOMEN EXPERIENCED DELAYED PAIN RETURN POSSIBLY RELATED TO THEIR ORIGINAL SYNTHETIC DEVICE. A (B)(6) FEMALE PATIENT WHO HAD GYNECARE TVT-O WHO EXPERIENCED PELVIC PERINEAL PAIN RECURRENCE WHICH WAS TREATED BY VAGINAL EXPLORATION WITH ADDITIONAL MESH REMOVAL. THE OTHER THREE PATIENTS USED MINIARC, SPARC AND TVT-O. THE OTHER PATIENTS WHO HAD PAIN RECURRENCE WERE DETERMINED TO BE UNRELATED TO THE WOMEN¿S ORIGINAL SYNTHETIC DEVICE PLACEMENT. THIS OBSERVATION EMPHASIZES THE IMPORTANCE OF A THOROUGH EVALUATION OF PAIN WHEN IT RETURNS AFTER VMSR, AS WOMEN OFTEN ATTRIBUTE THIS RETURN OF PAIN SYMPTOMS TO THE PRIOR SYNTHETIC IMPLANT. THE EXPLANTED MESH SPECIMENS HAD HIGH RATES OF COLONIZATION AND SUGGESTED THAT DELAYED-ONSET COMPLICATIONS SUCH AS PAIN COULD BE SECONDARY TO LOW-GRADE INFECTIONS, WHICH MAY OR MAY NOT RESOLVE AFTER MESH REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780811 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention