BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

    MDR report key: 9152846 · Received October 3, 2019

    Report

    Report Number
    2210968-2019-88339
    Event Type
    Injury
    Date Received
    October 3, 2019
    Report Date
    September 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    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. CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL; 19 JULY 2019/ACCEPTED 19 AUGUST 2019; DOI.ORG/10.1007/S00192-019-04096-4.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: 3-YEAR FOLLOW-UP OF TENSION-FREE VAGINAL TAPE ¿ ABBREVO PROCEDURE FOR THE TREATMENT OF PURE URODYNAMIC STRESS URINARY INCONTINENCE: EFFICACY AND ADVERSE EFFECTS" ANDREA BRAGA; GIORGIO CACCIA; GIOVANNI RUGGERI; LUCA REGUSCI; ANDREA PAPADIA; MAURIZIO SERATI CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL; 19 JULY 2019/ACCEPTED 19 AUGUST 2019; DOI.ORG/10.1007/S00192-019-04096-4. THE TENSION-FREE VAGINAL TAPE ABBREVO (TVT-A) IS A NEW SURGICAL PROCEDURE FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI). HOWEVER, DATA REPORTING MEDIUM- AND LONG-TERM OUTCOMES ARE LACKING. THE AIM OF THE STUDY WAS TO ASSESS THE EFFICACY AND SAFETY OF TVT-A IN PATIENTS WITH AT LEAST A 3-YEAR FOLLOW-UP. ALL CONSECUTIVE WOMEN WHO COMPLAINED OF PURE SUI SYMPTOMS WITH URODYNAMICALLY PROVEN SUI UNDERGOING A TVT-A PROCEDURE WERE PROSPECTIVELY ENROLLED. THIS IS A (B)(6) STUDY PERFORMED AT THE UROGYNECOLOGIC UNIT OF THE (B)(6) HOSPITAL, JUNE BETWEEN JUNE 2016. WE ENROLLED ALL CONSECUTIVE WOMEN WHO COMPLAINED OF PURE SUI SYMPTOMS WITH URODYNAMICALLY PROVEN SUI. ALL PATIENTS DEEMED ELIGIBLE FOR SURGICAL TREATMENT WERE SCHEDULED FOR A TVT ABBREVO PROCEDURE (GYNECARE TVT ABBREVO® CONTINENCE SYSTEM; ETHICON INC., SOMERVILLE, NJ, USA). EXCLUSION CRITERIA WERE AS FOLLOWS: WOMEN WITH A PREVIOUS HISTORY OF RADICAL PELVIC SURGERY, PSYCHIATRIC AND NEUROLOGIC DISORDERS, CONCOMITANT VAGINAL PROLAPSE GREATER THAN STAGE 1 ACCORDING TO THE PELVIC ORGAN PROLAPSE QUANTIFICATION (POP-Q) SYSTEM [13], OAB SYMPTOMS, URODYNAMICALLY PROVEN DETRUSOR OVERACTIVITY (DO) AND POSTVOID RESIDUAL > 100 ML. DATA REGARDING SUBJECTIVE OUTCOMES (INTERNATIONAL CONSULTATION ON INCONTINENCE QUESTIONNAIRE-SHORT FORM, PATIENT GLOBAL IMPRESSION OF IMPROVEMENT AND PATIENT SATISFACTION SCORES), OBJECTIVE CURE (STRESS TEST) RATES AND ADVERSE EVENTS WERE COLLECTED DURING FOLLOW-UP. A TOTAL OF 41 WOMEN UNDERWENT TVT-A IMPLANTATION. AT 3-YEAR FOLLOW-UP, 40 WOMEN (97.5%) WERE AVAILABLE FOR THE EVALUATION. WE DID NOT FIND ANY SIGNIFICANT CHANGE IN SURGICAL OUTCOMES DURING THIS TIME. AT 3 YEARS AFTER SURGERY, 36 OF 40 (90%) PATIENTS WERE SUBJECTIVELY CURED (P FOR TREND 0.18) AND 37 OUT OF 40 (92.5%) PATIENTS WERE OBJECTIVELY CURED (P FOR TREND 0.22). THE UNIVARIATE ANALYSIS DID NOT FIND ANY RISK FACTOR STATISTICALLY ASSOCIATED WITH THE RECURRENCE OF SUI. NO SERIOUS LATE COMPLICATIONS OR GROIN-THIGH PAIN WERE REPORTED. THE ONSET OF DE NOVO OAB SYMPTOMS WAS REPORTED AS 4.9% (2/41) AND 15% (6/40) AT THE 1- AND 3-YEAR FOLLOW-UP, RESPECTIVELY. A SIGNIFICANT TREND OF DE NOVO OAB OCCURRENCE WAS REGISTERED AT THE 3-YEAR FOLLOW-UP (P = 0.03). THE CLAVIEN-DINDO CLASSIFICATION OF LONG-TERM COMPLICATIONS IS SHOWN IN TABLE 4. POST-OPERATIVE COMPLICATIONS WERE REPORTED TO BE (CLAVIEN GRADE I) PERSISTENCE OF VOIDING DYSFUNCTION IN 1 PATIENT (2.4%) AND PATIENT WAS UNDER OBSERVATION; (CLAVIEN GRADE II ) RECURRENT UTIS IN 2 PATIENTS (2.4%) TREATED WITH ANTIMICROBIAL PROPHYLAXIS OR THERAPY; DE NOVO OAB IN 6 PATIENTS (15%) TREATED WITH ANTIMUSCARINICS/B-AGONISTS; (CLAVIEN GRADE IIIA) VAGINAL MESH EXPOSURE OCCURRED IN 2 PATIENTS (1 ASYMPTOMATIC) AND WAS TREATED WITH LOCAL ESTROGEN AND SUBSEQUENT SURGICAL INTERVENTION WITHOUT MESH EXCISION. NO PATIENT REQUIRED TAPE RELEASE OR RESECTION DURING THESE 3 YEARS. NO SIGNIFICANT PELVIC ORGAN PROLAPSE, BLADDER OR URETHRAL EROSION, OR DE NOVO DYSPAREUNIA WAS RECORDED IN THE STUDY POPULATION. THE UNIVARIATE ANALYSIS DID NOT FIND ANY RISK FACTOR STATISTICALLY ASSOCIATED WITH THE RECURRENCE OF SUI. THE RATE OF GROIN-THIGH PAIN IS SUMMARIZED IN TABLE 5. IN OUR STUDY, POSTOPERATIVE SIGNIFICANT GROIN OR THIGH PAIN (VAS = 5) WAS VERY LOW: 7.3%, 4.9% AND 0% AT DAY 0, DAY 1 AND 1 MONTH, RESPECTIVELY. CONCLUSION: THE 3-YEAR RESULTS OF THIS STUDY SHOWED THAT TVT-A IS A HIGHLY EFFECTIVE AND SAFE OPTION FOR THE TREATMENT OF FEMALE SUI. INDEED, WE RECORDED BOTH VERY HIGH OBJECTIVE AND SUBJECTIVE CURE RATES WITH A LOW RATE OF COMPLICATIONS AND GROIN-THIGH PAIN. FURTHERMORE, WE RECORDED A TREND TOWARD THE OCCURRENCE OF DE NOVO OAB, WHICH SHOULD BE TAKEN INTO ACCOUNT FOR PREOPERATIVE COUNSELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947002 TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention