BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7759147 · Received August 7, 2018

    Report

    Report Number
    2210968-2018-74985
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    July 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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: ULTRASOUND OBSTET GYNECOL 2017; 49: 404¿408, DOI: 10.1002/UOG.15882, PUBLISHED ONLINE 7 FEBRUARY 2017. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : LAPAROSCOPIC SACROCOLPOPEXY: HOW LOW DOES THE MESH GO?" AUTHOR: V. WONG*, R. GUZMAN ROJAS, K. L. SHEK, D. CHOU, K. H. MOORE§ AND H. P. DIETZ CITATION: ULTRASOUND OBSTET GYNECOL 2017; 49: 404¿408, DOI: 10.1002/UOG.15882, PUBLISHED ONLINE 7 FEBRUARY 2017. THE AIM OF THIS STUDY WAS TO DOCUMENT THE POSTOPERATIVE ANTERIOR MESH POSITION AFTER LAPAROSCOPIC SACROCOLPOPEXY AND TO INVESTIGATE THE RELATIONSHIP BETWEEN MESH LOCATION AND ANTERIOR COMPARTMENT SUPPORT. BETWEEN JANUARY 2005 AND JUNE 2012, LAPAROSCOPIC SACROCOLPOPEXY WAS PERFORMED IN ALL PATIENTS WHO HAD APICAL PROLAPSE = STAGE 2 OR ADVANCED PROLAPSE =STAGE 3 IN THE ANTERIOR COMPARTMENT. DURING THE PROCEDURE, ONCE THE DISSECTION WAS CONSIDERED SATISFACTORY, ANTERIOR AND POSTERIOR POLYPROPYLENE MESHES (GYNECARE GYNEMESH, ETHICON US, LLC, (B)(4)) WERE INTRODUCED INTO THE ABDOMEN. THE ANTERIOR MESH WAS SECURED ONTO THE ANTERIOR VAGINAL WALL USING SIX 2.0 DISSOLVABLE POLYDIOXANONE SUTURES AND POSTERIORLY THE MESH WAS PLACED ONTO THE LEVATOR MUSCLE USING TWO 5-MM TACKERS BILATERALLY. THE MESHES WERE THEN SUTURED TOGETHER, AWAY FROM THE VAULT. IF DEEMED NECESSARY, UPON COMPLETION OF THE SACROCOLPOPEXY, A CONCOMITANT PARAVAGINAL REPAIR, A MODIFIED TANAGHO TECHNIQUE FOR COLPOSUSPENSION, OR ANTERIOR/POSTERIOR COLPORRHAPHY WAS PERFORMED. RECURRENT PROLAPSE SYMPTOMS WERE REPORTED IN 30 (32%) WOMEN. CLINICAL PROLAPSE RECURRENCE (ICS POP-Q=STAGE 2) WAS DIAGNOSED IN 80 PATIENTS, INCLUDING 60 CASES AFFECTING THE ANTERIOR COMPARTMENT AND 43 AFFECTING THE POSTERIOR COMPARTMENT; HOWEVER, RECURRENCE IN THE APICAL COMPARTMENT WAS NOT DIAGNOSED IN ANY PATIENT. NINE PATIENTS HAD DE-NOVO DEVELOPMENT OF ANTERIOR COMPARTMENT PROLAPSE AND 17 OF POSTERIOR COMPARTMENT PROLAPSE. NO PATIENT HAD UNDERGONE A REOPERATION FOR PROLAPSE IN THE FOLLOW-UP INTERVAL. THE TACKS IN THE LEVATOR MUSCLE WERE PALPABLE IN 20 PATIENTS, 16 (17%) OF WHOM COMPLAINED OF TENDERNESS UPON PALPATION AND 12 (12%) HAD SYMPTOMATIC DYSPAREUNIA. ULTRASOUND VOLUME ANALYSIS WAS PERFORMED APPROXIMATELY 6 MONTHS AFTER DATA ACQUISITION. EIGHTY-ONE PATIENTS HAD SONOGRAPHIC PROLAPSE RECURRENCE: 52 IN THE ANTERIOR COMPARTMENT, 64 IN THE POSTERIOR COMPARTMENT AND 11 IN THE APICAL COMPARTMENT. IN PATIENTS WHO HAD CONCOMITANT PARAVAGINAL REPAIRS, 49 HAD SIGNIFICANT PREOPERATIVE CYSTOCELE ON CLINICAL EXAMINATION WITH 45 BEING =STAGE 3, AND 24 HAD A SIGNIFICANT RECTOCELE WITH 15 BEING =STAGE 3. AT FOLLOW-UP, 35 PATIENTS HAD RECURRENCE IN THE ANTERIOR COMPARTMENT WITH THREE PATIENTS HAVING CYSTOCELE RECURRENCE =STAGE 3, AND 24 HAD RECURRENCE IN THE POSTERIOR COMPARTMENT WITH FOUR CASES OF DE-NOVO PROLAPSE. IN 37 PATIENTS, THE MESH WAS NOT VISIBLE ON ULTRASOUND. THIS WAS LIKELY BECAUSE THE MESH WAS LOCATED TOO CRANIAL FOR VISUALIZATION. ANALYSIS OF THESE PATIENTS SHOWED THAT 30% (11/37) WERE SYMPTOMATIC OF PROLAPSE AND 84% (31/37) HAD SIGNIFICANT PROLAPSE ON POP-Q ASSESSMENT: 21 IN THE ANTERIOR COMPARTMENT, 17 IN THE POSTERIOR COMPARTMENT AND NONE IN THE APICAL COMPARTMENT. ON ULTRASOUND, 76% (28/37) OF THESE PATIENTS HAD SIGNIFICANT PROLAPSE, 21 IN THE ANTERIOR COMPARTMENT, 16 IN THE POSTERIOR COMPARTMENT AND THREE IN THE APICAL COMPARTMENT. OF THOSE PATIENTS IN WHOM MESH COULD BE VISUALIZED ON ULTRASOUND, 33% (20/60) WERE SYMPTOMATIC OF PROLAPSE AT FOLLOW-UP AND 88% (53/60) HAD RECURRENT PROLAPSE ON POP-Q ASSESSMENT: 39 IN THE ANTERIOR COMPARTMENT, 30 IN THE POSTERIOR COMPARTMENT AND NONE IN THE APICAL COMPARTMENT. ON ULTRASOUND, 75% (45/60) OF THESE WOMEN HAD RECURRENT PROLAPSE, WITH 29 IN THE ANTERIOR, 33 IN THE POSTERIOR AND SEVEN IN THE APICAL COMPARTMENT. IN CONCLUSION, USING 4D ULTRASOUND FOR EVALUATION OF MESH MOBILITY AND LOCATION FOLLOWING LAPAROSCOPIC SACROCOLPOPEXY HAS GIVEN US A PERSPECTIVE ON WHERE PLACEMENT OF MESH MAY RESULT IN FAILURE. THE AUTHORS FOUND A CORRELATION BETWEEN MESH LOCATION AND PROLAPSE RECURRENCE, PARTICULARLY FOR THE ANTERIOR COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601560 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention