BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18773894 · Received February 23, 2024

    Report

    Report Number
    2210968-2024-01861
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    June 15, 2021
    Report Date
    February 23, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: AKBABA AND SEZGIN BMC WOMEN¿S HEALTH (2021) 21:244; HTTPS://DOI.ORG/10.1186/S12905-021-01388-0. RELATED EVENTS CAPTURED VIA 2210968-2024-01862.

    Description of Event or Problem · 0

    TITLE: MODIFIED LAPAROSCOPIC LATERAL SUSPENSION WITH A FIVE-ARM MESH IN PELVIC ORGAN PROLAPSE SURGERY THE OBJECTIVE OF THIS STUDY IS TO EVALUATE THE CLINICAL RESULTS OF LAPAROSCOPIC LATERAL SUSPENSION (LLS) FOR PELVIC ORGAN PROLAPSE (POP) USING A FIVE-ARM MESH INSTEAD OF A T-SHAPED MESH GRAFT TO REPAIR THE DEFECT OF THE POSTERIOR (B)(6) 2020, A TOTAL OF 49 PATIENTS WHO HAD STAGE 3 UTEROVAGINAL PROLAPSE AND UNDERWENT LAPAROSCOPIC LATERAL SUSPENSION (LLS) USING A FIVE-ARM MESH. THE MOST COMMON SYMPTOM WAS PALPABLE SWELLING IN THE GENITAL REGION AND A CONSEQUENT WALKING DIFFICULTY. A SIGNIFICANT IMPROVEMENT IN VAGINAL BULGE, URINARY URGENCY, INCOMPLETE VOIDING, AND URINARY FREQUENCY WAS OBSERVED AFTER SURGERY. AN IMPROVEMENT IN CONSTIPATION SYMPTOM WAS ALSO NOTED. FURTHERMORE, THE NUMBER OF SEXUALLY ACTIVE PATIENTS INCREASED FROM 13 PREOPERATIVELY TO 22 POST- OPERATIVELY. THREE (13.6%) OF THESE 22 PATIENTS HAD DYSPAREUNIA. OCCULT STRESS URINARY INCONTINENCE (SUI) WAS NOTED IN TWO PATIENTS PREOPERATIVELY, AND DE NOVO SUI DEVELOPED IN SEVEN PATIENTS POST-OPERATIVELY. CYSTOCELE OCCURRED IN THREE PATIENTS (BA + 1, + 2 AND + 2), AND RECTOCELE DEVELOPED IN TWO PATIENTS (BP + 1, + 3). ANTERIOR COLPORRHAPHY WAS PERFORMED IN THE TWO PATIENTS WITH CYSTOCELE RECURRENCE, AS THEY WERE SYMPTOMATIC. THE PATIENT WITH RECTOCELE (STAGE = 3) RECURRENCE DID NOT UNDERGO SURGERY DUE TO BEING ASYMPTOMATIC. ANTERIOR VAGINAL WALL MESH EXPOSURE GRADE 2 (> 1 CM) WAS OBSERVED IN ONE PATIENT. THE PART OF THE VAGINAL WALL WITH MESH EXPOSURE WAS DETERMINED AT THE FIFTH POSTOPERATIVE MONTH AND CLASSIFIED AS 3BT3S ACCORDING TO THE IUGA/ ICS PROSTHESIS/GRAFT COMPLICATION CLASSIFICATION SYSTEM. THE EXPOSED PART WAS RESECTED, AND THE VAGINAL MUCOSA WAS PRIMARILY REPAIRED. FOUR OF THE SEVEN PATIENTS WITH DE NOVO SUI UNDERWENT RETROPUBIC TENSION-FREE VAGINAL TAPE PROCEDURES, WHEREAS THE OTHER THREE OPTED FOR CONSERVATIVE TREATMENT METHODS. THE ANTERIOR PART OF THE MESH WAS PLACED IN THE VESICOVAGINAL SPACE AND SUTURED SEPARATELY TO THE ANTERIOR VAGINAL WALL AND THE CERVICAL AND ISTHMUS PARTS OF THE UTERUS WITH NO. 2¿0 PROLENE® (MONOFILAMENT POLYPROPYLENE SUTURE; ETHICON, SOMERVILLE, NJ, USA) TO PREVENT SHRINKAGE OF THE MESH. TWO LATERAL ARMS OF THE MESH WERE PASSED THROUGH THE WINDOWS OPENED ON THE LIGAMENTUM LATUM LEAVES AND BEHIND THE UTERUS BILATERALLY AND SUTURED SEPARATELY TO THE RECTOVAGINAL FASCIA, SACROUTERINE LIGAMENT, AND POSTERIOR VAGINAL WALL WITH A NO. 2¿0 PROLENE SUTURE. THE PARTS OF THE MESH THAT WERE PLACED IN THE VESICOVAGINAL AND RECTOVAGINAL SPACES WERE CLOSED BY PERITONIZATION USING A NO. 0 ABSORBABLE VICRYL RAPIDE¿ (POLYGLACTIN 910; ETHICON) SUTURE. REPORTED COMPLICATIONS INCLUDED PALPABLE SWELLING (N=?), WALKING DIFFICULTY (N=?), VAGINAL BULGING (N=2), URINARY URGENCY (N=3), INCOMPLETE VOIDING (N=3), URINARY FREQUENCY (N=8), STRESS URINARY INCONTINENCE (N=7), CYSTOCELE (N=3), RECTOCELE (N2), CONSTIPATION (N=3), FAECAL INCONTINENCE (N=2), SEXUAL ACTIVITY (N=22), DSYSPAREUNIA (N=3), PELVIC PAIN (N=8), ANTERIOR VAGINAL WALL MESH EXPOSURE GRADE 2 (N=1), RECURRENCE OF ANTERIOR COMPARTMENT (N=2), VAGINAL MESH EROSION (N=1), AND REOPERATION FOR SUI (N=4). IN CONCLUSION, IN ADVANCED-STAGE POP PATIENTS, THE POSTERIOR COMPARTMENT DAMAGE CAN ALSO BE REPAIRED IN LLS WITH THE USE OF A SINGLE FIVE-ARM MESH WITHOUT THE NEED FOR AN ADDITIONAL PROCEDURE, AND THE RECURRENCE RATE CAN BE REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129321 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention