BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7903962 · Received September 24, 2018

    Report

    Report Number
    2210968-2018-75967
    Event Type
    Injury
    Date Received
    September 24, 2018
    Report Date
    August 30, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 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: INT UROGYNECOL J (2014) 25:1597¿1599; DOI 10.1007/S00192-014-2427-5 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: COLLAGEN SCAFFOLD: A TREATMENT FOR LARGE MESH EXPOSURE FOLLOWING VAGINAL PROLAPSE REPAIR" AUTHOR(S): MARIANNA ALPERIN. CITATION: INT UROGYNECOL J (2014) 25:1597¿1599; DOI 10.1007/S00192-014-2427-5. THIS CASE REPORT AIMED TO DESCRIBE THE USE OF SURGISIS TO TREAT A LARGE MESH EXPOSURE AFTER NECROSIS OF THE FULL THICKNESS OF THE ANTERIOR VAGINA WITH MINIMAL MESH RESECTION. A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT VAGINAL HYSTERECTOMY, RECONSTRUCTION WITH TOTAL PROLIFT AND A MIDURETHRAL SLING FOR SYMPTOMATIC STAGE III UTEROVAGINAL PROLAPSE AND STRESS URINARY INCONTINENCE (SUI). TWO WEEKS LATER ON PELVIC EXAM, NECROSIS OF APPROXIMATELY 70 % OF THE ANTERIOR VAGINA WHICH WAS ATTACHED BY A 4-MM DISTAL STALK WAS OBSERVED. THE NECROSED PORTION OF THE VAGINA WAS SEPARATED FROM ITS STALK WITHOUT CAUSING ANY PAIN. TWO WEEKS LATER, NO FURTHER NECROSIS WAS OBSERVED. UPON THE RETURN OF THE PATIENT AFTER 6 MONTHS FROM OUT OF THE COUNTRY, SHE PRESENTED WITH MINIMAL TISSUE REGROWTH WITH A PERSISTENT, LARGE MESH EXPOSURE. MESH FIBERS THAT WERE NOT FLUSH WITH THE UNDERLYING BLADDER MUSCULARIS WERE TRIMMED, WITH THE MAJORITY OF MESH LEFT IN PLACE, AS IT CONTINUED TO PROVIDE PARAVAGINAL ATTACHMENTS FOR THE ANTERIOR VAGINA AND BLADDER SUPPORT. A 4×7-CM PIECE OF FOUR-LAYER SURGISIS® WAS PLACED OVER THE EXPOSED MESH AND SECURED WITH INTERRUPTED 3¿0 POLYGLACTIN SUTURES. THE PATIENT WAS SEEN 2 AND 4 WEEKS AFTER PLACEMENT OF THE SIS GRAFT. EXPOSED MESH WAS COMPLETELY COVERED WITH VAGINAL EPITHELIUM. TWENTY-FOUR MONTHS LATER, THE PATIENT HAD NO RECURRENT MESH EXPOSURE AND NO RECURRENT PROLAPSE. THIS REPORT ESTABLISHES THE FOUNDATION FOR THE ROLE OF COLLAGEN SCAFFOLDS IN MANAGING MESH EXPOSURES WITHOUT COMPROMISING PROLAPSE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744992 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention