BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2801683 · Received October 23, 2012

    Report

    Report Number
    2210968-2012-06778
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXCISION OF MESH ON (B)(6) 2008, DUE TO EROSION S/P ABDOMINAL SACRAL COLPOPEXY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, VAULT PROLAPSE, CYSTOCELE AND RECTOCELE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE WHERE BOTH OVARIES WERE REMOVED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH, THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, FISTULAE, ORGAN PERFORATION, BLEEDING, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH EROSION INTO THE VAGINAL CUFF AND UNDERWENT PARTIAL EXCISION OF MESH ON (B)(6) 2010. THE PATIENT UNDERWENT REVISION OF PROSTHETIC VAGINAL GRAFT AND PARTIAL VAGINECTOMY DUE TO MESH EROSION ON (B)(6) 2010. THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND A LARGE VESSEL WAS CUT AND LARGE AMOUNTS OF BLEEDING ENSUED. IN ATTEMPTS TO STOP THE BLEEDING AND SAVE THE PATIENT¿S LIFE, THE SURGEONS TIED OFF THE RIGHT DISTAL URETER. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION OF MESH, THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. THE PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY IN 2008. THE PATIENT UNDERWENT MULTIPLE MESH REVISIONS WHICH WERE UNSUCCESSFUL AND AS A RESULT, UNDERWENT MESH REMOVAL ON (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL VAGINECTOMY AND REVISION OF MESH ON (B)(6) 2010 DUE TO MESH EXPOSURE AND EROSION.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 06/06/2016.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF MESH AND FIXING OF VAGINAL DEFECT ON (B)(6) 2008 DUE TO MESH EROSION AND S/P ABDOMINAL SACRAL COLPOPEXY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF PROSTHETIC VAGINAL GRAFT AND PARTIAL VAGINECTOMY ON (B)(6) 2013 DUE TO MECHANICAL COMPLICATION OF IMPLANTED DEVICE-MESH EXPOSURE, VAGINAL VAULT AND VAGINAL BLEEDING. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOURETHROSCOPY ON (B)(6) 2013 DUE TO RECURRENT MESH INFECTIONS, S/P ABDOMINAL SACROLPOPEXY WITH MESH AND TOT. (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT VAULT PROLAPSE, CYSTOCELE, RECTOCELE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF ABDOMINAL SACRAL COLPOPEXY, TOT AND CYSTOSCOPY AND OOPHORECTOMY SALPINGECTOMY. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2008. NO ADDITIONAL INFORMATION WAS PROVIDED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH & MONARC HAMMOCK WERE USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA ZGP956

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention MONARC HAMMOCK