BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 4570238 · Received March 4, 2015

    Report

    Report Number
    2210968-2015-02491
    Event Type
    Injury
    Date Received
    March 4, 2015
    Report Date
    February 10, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 TO TREAT BLADDER AND BOWEL PROLAPSE AND MESH WAS IMPLANTED AND A UTERINE ABLATION PROCEDURE WAS PERFORMED. ON (B)(6) 2009 THE PATIENT EXPERIENCED HEAVY VAGINAL BLEEDING. THE PATIENT RETURNED TO HER PHYSICIAN ON (B)(6) 2009 FOR PERSISTENT BLEEDING AND MINOR URINARY INCONTINENCE AND A VAGINAL MESH EROSION WAS OBSERVED AND REMOVED. IN (B)(6) 2010 THE PATIENT DISCOVERED ADDITIONAL VAGINAL EROSION UPON EXPERIENCING DYSPAREUNIA. VAGINAL BLEEDING CONTINUED AND THE PATIENT RETURNED TO HER PHYSICIAN ON (B)(6) 2010 AND A 2 CM LINEAR VAGINAL MESH EROSION WAS OBSERVED. ON (B)(6) 2010 THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE INCLUDING A VAGINAL HYSTERECTOMY TO TREAT SECOND DEGREE UTERINE PROLAPSE. THE PATIENT REPORTS AROUND (B)(6) 2010 INCREASING BOWEL PROBLEMS INCLUDING URGENCY AND PAIN AND RECURRENT DYSPAREUNIA. THE PATIENT RETURNED TO HER PHYSICIAN ON (B)(6) 2011 AND ADDITIONAL MESH EROSION WAS OBSERVED BEHIND THE INTROITUS AND IN THE MIDLINE OF THE VAGINA AND ANOTHER MESH REMOVAL PROCEDURE WAS DONE ON (B)(6) 2011. THE PATIENT REPORTS USING DIET MODIFICATION, PAIN KILLERS AND ENEMAS TO MANAGE PERSISTENT BOWEL PROBLEMS. THE PATIENT BEGAN EXPERIENCING SEVERE LEG AND BUTTOCK PAIN IN APPROXIMATELY (B)(6) 2014 AND SAW A PHYSICIAN IN (B)(6) 2014 WHO OPINED THAT THE MESH IS PULLING ON HER NERVES AND RECOMMENDED REMOVAL. THE PATIENT CONTINUES TO EXPERIENCE PROLAPSE, PAIN DOWN BOTH LEGS WHICH CAUSES MOBILITY PROBLEMS, BOWEL AND PELVIC PAIN AND BOUTS OF INCONTINENCE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149572 GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention