BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2864556 · Received December 10, 2012

    Report

    Report Number
    2210968-2012-08022
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED CONCURRENTLY WITH BILATERAL SACROSPINOUS LIGAMENT FIXATIONS/IVS SLING, AND PARAVAGINAL DEFECT REPAIR DUE TO RECURRENT PROLAPSE, URINARY RETENTION WITH INCOMPLETE BLADDER EMPTYING, CYSTOCELE AND RECTOCELE. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2006 DUE TO MESH EROSION. IT WAS REPORTED THAT THAT THE PATIENT UNDERWENT ABDOMINAL SACROCOLPOPEXY, LEFT SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS, CYSTOTOMY WITH REPAIR TWO TIMES AND CYSTOSCOPY ON (B)(6) 2007. THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY FOR A RIGHT ADNEXAL/PELVIC MASS ON (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CYSTECTOMY, PERINEORRHAPHY, AND SUSPENSION ON (B)(6) 2006 DUE TO VAGINAL SCARRING, CYSTS, CYSTOCELE, RECTOCELE, ENTEROCELE, AND PAIN/DISCOMFORT. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CYSTECTOMY AND MESH REMOVAL ON (B)(6) 2012 DUE TO EXTREME PAIN AND MESH FAILURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT PROLAPSE, URINARY RETENTION WITH INCOMPLETE BLADDER EMPTYING, CYSTOCELE AND RECTOCELE. IT WAS REPORTED THAT THE PATIENT ALSO UNDERWENT INTEPRO LPP-Y SLING IMPLANT ON (B)(6) 2007, DUE TO RECURRENT VAGINAL VAULT PROLAPSE. IT WAS REPORTED THAT THE PATIENT ALSO UNDERWENT VENTRAL HERNIA REPAIR, IMPLANTATION OF LARGE (BARD) VENTRIO 11.4-CM CIRCULAR MESH IMPLANT ON (B)(6) 2009, DUE TO LEFT LOWER QUADRANT VENTRAL HERNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-08023. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA 1348692

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IVS SLING