BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 12368809 · Received August 25, 2021

    Report

    Report Number
    2210968-2021-07706
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    March 9, 2020
    Report Date
    July 28, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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: JOURNAL OF OBSTETRICS AND GYNAECOLOGY (2021); 41 (1): 128-132. DOI: 10.1080/01443615.2020.1724914. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (GYNEMESH PS AND MONOCRYL SUTURE) 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 INVOLVED? PATIENT DEMOGRAPHICS? ADVERSE EVENTS ASSOCIATED WITH MONOCRYL SUTURE REPORTED VIA MW # 2210968-2021-07707.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: COMPLICATIONS AND CLINICAL OUTCOMES OF LAPAROSCOPIC SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE. THE AIM OF THIS SINGLE-CENTRE, RETROSPECTIVE COHORT STUDY IS TO DETERMINE THE PERIOPERATIVE COMPLICATIONS, SERIOUS EARLY POSTOPERATIVE COMPLICATIONS, AND SHORT-TERM OUTCOMES OF LSC SURGERY PERFORMED BY SURGEONS INEXPERIENCED WITH LSC. BETWEEN AUGUST 2015 AND JULY 2017, A TOTAL OF 46 FEMALE PATIENTS (MEAN AGE OF 70.0 ± 7.4 (54¿82) YEARS; MEAN BMI OF 23.6 ± 3.0 (17.7¿30.1) KG/M2) WITH PELVIC ORGAN PROLAPSE (POP) WHO UNDERWENT LAPAROSCOPIC SACROCOLPOPEXY (LSC) WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING TWO SEPARATE LONG-TAILED POLYPROPYLENE MESHES (GYNEMESH PS; ETHICON), 2¿0 ABSORBABLE SUTURE (MONOCRYL; ETHICON), AND A COMPETITOR DEVICE. THE MEDIAN FOLLOW-UP PERIOD WAS 12.0 ± 5.0 (RANGE: 11¿26) MONTHS. REPORTED COMPLICATIONS INCLUDED STRESS URINARY INCONTINENCE (N=21); URGENCY URINARY INCONTINENCE (N=7); MIXED URINARY INCONTINENCE (N=2); OVERACTIVE BLADDER (N=11); PERSISTENT CONSTIPATION (N=3) WHICH NECESSITATES CONTINUED LAXATIVE USE; DIARRHEA (N=1); UTI (N=1); SIGNIFICANT BLOOD LOSS (N=1) BUT NO BLOOD TRANSFUSION WAS REQUIRED; ANATOMICAL FAILURE (POP-Q STAGE = 2) (N=3), 2 WERE ASYMPTOMATIC AND WERE PLACED UNDER OBSERVATION WHILE 1 WAS SYMPTOMATIC AND WAS TREATED WITH PESSARY; PERSISTENT SUI (N=1) AT 6-MONTH AFTER INITIAL SURGERY REQUIRED REOPERATION USING A COMPETITOR DEVICE; FEVER AND MALAISE (N=1), PELVIC ABSCESS WITH EXTENSIVE INFLAMMATION (N=1) WHICH REQUIRED EXPLORATORY LAPAROTOMY ON POSTOPERATIVE DAY 12 WHERE URETER INJURY (N=1) WAS IDENTIFIED AND REQUIRED INTERVAL URETERAL REIMPLANTATION. THE MESH WAS SIMULTANEOUSLY COMPLETELY REMOVED ABDOMINALLY; SUSPENSION OF THE URETER SHOWED NO FAILURE. IN CONCLUSION, LSC IS AN EFFECTIVE PROCEDURE FOR CORRECTING POP, WITH SATISFACTORY SUBJECTIVE AND OBJECTIVE OUTCOMES AT 12 MONTHS¿ POSTOPERATIVELY. HOWEVER, OUR STUDY FOUND AN INCREASE IN THE NUMBER OF POSTOPERATIVE COMPLICATIONS AND UNIFORM RECURRENCE OF CYSTOCELE. FURTHER RIGOROUS EVALUATION OF LSC IS REQUIRED TO BETTER VALIDATE OUR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265247 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention