BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2884221 · Received December 21, 2012

    Report

    Report Number
    3005099803-2012-06333
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    September 30, 2011
    Report Date
    November 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN UPHOLD VAGINAL SUPPORT SYSTEM ON (B)(6) 2011. DURING THIS PROCEDURE, AN ANTERIOR COLPORRHAPHY AND SLING PLACEMENT WERE ALSO PERFORMED. THE PATIENT PRESENTED WITH URINARY RETENTION TWO DAYS POST-PROCEDURE. THE PHYSICIAN HAD HER CONTINUE THE FOLEY CATHETER OVER THE WEEKEND, AND PRESCRIBED AN ANTIBIOTIC PROPHYLACTICALLY. THE PHYSICIAN BELIEVED THAT HER URINARY RETENTION MAY RESOLVE ON ITS OWN. ON (B)(6) 2011, THE PATIENT RETURNED AND PRESENTED WITH URINARY DYSFUNCTION, BUT IT WAS NOTED THAT PAIN AND PRESSURE WERE SLOWLY IMPROVING. THERE WAS NO EVIDENCE OF MESH EROSION; HOWEVER, THERE WAS SIGNIFICANT VAGINAL ATROPHY AND THE PATIENT WAS PRESCRIBED ESTRACE CREAM. ON (B)(6) 2011, THE PATIENT RETURNED, AND THE PHYSICIAN NOTED THAT THERE WAS NO EVIDENCE OF VAGINAL INFECTION OR VAGINAL MESH EXPOSURE. HOWEVER, HE NOTED THAT THERE WAS A SMALL, DARK AREA NEAR THE LEFT VAGINAL FORNIX THAT APPEARED TO BE BRUISING. THE PHYSICIAN RECOMMENDED THAT THE PATIENT SHOULD CONTINUE USING THE ESTRACE CREAM. ON (B)(6) 2011, THE PATIENT RETURNED, AND APPEARED TO BE DOING VERY WELL, PER THE PHYSICIAN. THE PHYSICIAN NOTED THAT THERE WAS NO EVIDENCE OF MESH EXPOSURE, AND HER URINARY DYSFUNCTION (SPECIFICS UNKNOWN) WAS MINIMAL. ON (B)(6) 2012, THE PATIENT RETURNED TO THE PHYSICIAN AND PRESENTED WITH A SMALL EROSION OF MESH AT THE LEFT VAGINAL APEX. REPORTEDLY, THE PATIENT INITIALLY TRIED ESTROGEN CREAM FOR THE EROSION, BUT STOPPED USING IT. THE PHYSICIAN RECOMMENDED THE PATIENT TO CONTINUE USING THE ESTRACE CREAM FOR ANOTHER FOUR WEEKS, AND NOTED THAT IT MAY BE NECESSARY TO EXCISE A SMALL CORNER OF THE MESH. THIS MESH EXCISION WAS LATER PERFORMED IN THE PHYSICIAN'S OFFICE ON AN UNKNOWN DATE. WHEN THE PATIENT RETURNED FOUR WEEKS LATER ON (B)(6) 2012, HER MESH EXPOSURE HAD APPARENTLY RESOLVED. HOWEVER, THE PHYSICIAN NOTED A SMALL AMOUNT OF BLEEDING DURING SPECULUM EXAMINATION. THE PHYSICIAN RECOMMENDED THAT THE PATIENT CONTINUE USING THE ESTRACE CREAM FOR ONE TO TWO MONTHS, AND BELIEVED THAT IT WOULD ALLOW FURTHER HEALING AT HER VAGINAL MUCOSA AT THE LEFT APEX. SHE WAS ADVISED TO RESUME INTERCOURSE WHEN SHE WAS COMFORTABLE. THE PATIENT RETURNED ON (B)(6) 2012, AND PRESENTED WITH ACUTE-ONSET LEFT LOWER QUADRANT PAIN, WHICH THE PHYSICIAN OPINED WAS MUSCULOSKELETAL IN ORIGIN, AND UNRELATED TO THE UPHOLD MESH PROCEDURE. REPORTEDLY, THE PATIENT MAY HAVE ALSO HAD SOME LEVATOR PAIN AS WELL. THE PHYSICIAN PERFORMED AN ILIOINGUINAL BLOCK, WHICH PROVIDED SOME RELIEF FOR THE PATIENT'S PAIN. IN ADDITION, HE NOTED THAT THE MESH EXPOSURE SEEMED TO BE RESOLVING WITH THE ESTRACE CREAM. THE PHYSICIAN REQUESTED FOR THE PATIENT TO RETURN IN TWO WEEKS IN ORDER TO EVALUATE HER PAIN AND MESH EXPOSURE. ON (B)(6) 2012, THE PATIENT RETURNED AGAIN, AND HER MESH EXPOSURE APPEARED TO HAVE BEEN COMPLETELY RESOLVED. THE PHYSICIAN RECOMMENDED THAT THE PATIENT CONTINUE USING ESTRACE CREAM ONCE PER WEEK FOR ANOTHER THREE TO FOUR MONTHS. ADDITIONALLY, THE PHYSICIAN NOTED THAT IT WAS SAFE FOR THE PATIENT TO RESUME INTERCOURSE. THE PATIENT RETURNED AGAIN ON (B)(6) 2012, REPORTING SOME VAGINAL SPOTTING ON THE PREVIOUS NIGHT, WHICH THE PHYSICIAN BELIEVED TO BE POSSIBLY RELATED TO THE BLADDER OR UTERUS. IN ORDER TO INVESTIGATE THESE POSSIBILITIES, THE PHYSICIAN RECOMMENDED THAT A URINALYSIS AND PELVIC ULTRASOUND BE PERFORMED TO EXAMINE THE ENDOMETRIAL STRIPE, AND TO RULE OUT THE ADNEXAL MASS. THE PHYSICIAN DID NOT THINK THAT THE VAGINAL SPOTTING WAS DUE TO VAGINAL MESH EXPOSURE, AND NOTED THAT THE MESH APPEARED TO BE WELL ESTROGENIZED AND COVERED. ON (B)(6) 2012, THE PATIENT RETURNED, REPORTING CONTINUING SYMPTOMS OF DYSPAREUNIA, WHICH THE PHYSICIAN BELIEVES WAS RELATED TO THE ARCH OF THE MESH TISSUE PALPABLE IN THE ANTERIOR VAGINAL COMPARTMENT. THE PHYSICIAN THINKS HE PLACED THE MESH TOO TIGHTLY AND MAY NEED TO RELEASE IT. HE DISCUSSED THERAPY OPTIONS FOR THE PATIENT, AND OPINED THAT THE BEST APPROACH WAS TO CREATE AN INCISION IN THE VAGINAL MESH IN THE MIDLINE VERTICALLY, VERSUS PARTIAL EXCISION OF MESH AND THE ANTERIOR COMPARTMENT. IN ADDITION, THE PHYSICIAN NOTED THAT ANY REPEAT PROCEDURE MIGHT BE COMPLICATED BY VAGINAL MESH EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SOLYX SINGLE INCISION SLING SYSTEM