BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3132696 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-06029
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-02138 AND 2210968-2012-06236 . THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY ON (B)(6) 2009 DUE TO PERSISTENT PELVIC PAIN, MESH EROSION AND URINARY INCONTINENCE. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL EXTENSION LEADS, INSERTION OF INTERNAL PULSE GENERATOR & AMP; PROGRAMMING OF PULSE GENERATOR DUE TO MESH COMPLICATIONS ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. THE PATIENT CONCOMITTANTLY UNDERWENT A MESH REMOVAL, CYCTOYSIS AND EXCISION OF VAGINAL SCARRING. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED MESH EROSION, DYSPAREUNIA, URINARY RETENTION AND URINARY PROBLEMS, LEAKING, SEVERE INCONTINENCE, BLADDER SPASMS, INCONTINENCE INTERSTITIAL CYSTITIS, PELVIC PAIN, PELVIC AND LOWER ABDOMINAL SHARP PAIN, ABDOMINAL PAIN, PAIN, CHRONIC PAIN, VAGINAL SCARING, MULTIPLE EXPLANT SURGERIES, LOSS OF SEXUAL RELATIONS, EMOTIONAL DISTRESS, CHANGE IN LIFESTYLE, CONSTANT PAIN, CHANGE IN MARITAL RELATIONSHIP, LOSS OF ENJOYMENT OF LIFE AND ACTIVITIES, HUMILIATION AND LOSS OF SELF ESTEEM. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2010 DUE TO PAIN, MESH EROSION, DYSPAREUNIA, LOWER ABDOMINAL SHARP PAIN, PULLING, URINARY PROBLEMS AND LACK OF SEXUAL RELATIONS. AS OF (B)(6) 2012, THE PATIENT REPORTED THAT ALL OR PART OF THE MESH REMAINS IMPLANTED AND REMOVAL WAS RECOMMENDED. THE PATIENT ALSO UNDERWENT THE FOLLOWING PROCEDURES: (B)(6) 2011: PHASE ONE INTERSTIM, PERMANENT PLACEMENT OF SACRAL NERVE NEUROSTIMULATOR IN UPPER LEFT BUTTOCKS. (B)(6) 2012: REMOVAL OF PREVIOUS NEUROSTIMULATOR AND PLACEMENT OF BILATERAL INTERSTIM II. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236729 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention