BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD

    MDR report key: 7939310 · Received October 5, 2018

    Report

    Report Number
    2210968-2018-76344
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    September 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT ( TENSION FREE VAGINAL TAPE- RETROPUBIC) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: CASE REPORTS IN UROLOGY VOLUME 2016, ARTICLE ID 6180756, 5 PAGES HTTP://DX.DOI.ORG/10.1155/2016/6180756 PLEASE SEE REFERENCED ARTICLE ATTACHED. (B)(4).

    Description of Event or Problem · 1

    TITLE : CONCOMITANT LAPAROSCOPIC BURCH URETHROPEXY AND COMBINED VAGINAL-LAPAROSCOPIC MESH SLING REMOVAL (X2) FOR PAIN AND PERSISTENT STRESS URINARY INCONTINENCE IN THE PRESENT CASE WE DESCRIBE THE SUCCESSFUL TREATMENT OF RECURRENT SUI IN A PATIENT REQUIRING VAGINAL/LAPAROSCOPIC REMOVAL OF TWO MIDURETERAL SLINGS WITH CONCOMITANT LAPAROSCOPIC BURCH URETHROPEXY. A (B)(6) POSTMENOPAUSAL PARA 3 WOMAN WITH A PRIOR SINGLE-INCISION MINISLING (AMS, (B)(4)) AND SUBSEQUENT RETROPUBIC (TVT, GYNECARE, (B)(4)) SLING PRESENTED WITH COMPLAINTS OF SEVERE DYSPAREUNIA AND CHRONIC PAIN. ON INITIAL INTERVIEW, SHE ALSO REPORTED PERSISTENT REFRACTORY STRESS URINARY INCONTINENCE (SUI). HER OTHER PRIOR SURGERIES INCLUDED A CHOLECYSTECTOMY AND TONSILLECTOMY. SHE ADMITTED TO A 32-PACK-YEAR SMOKING HISTORY AND HAD A BMI OF 34. SHE HAD NEVER BEEN ON HORMONEREPLACEMENT THERAPY AND WAS NOT CURRENTLY SEXUALLY ACTIVE SECONDARY TO PAIN. SIX YEARS BEFORE, SHE HAD A TOTAL ABDOMINAL HYSTERECTOMY, POSTERIOR COLPORRHAPHY, AND SINGLE-INCISION MINISLING FOR SUI USING THE STANDARD TECHNIQUE. HOWEVER, SHE CONTINUED TO REPORT PERSISTENT SUI AND FIVE YEARS AFTER HER INITIAL SLING PLACEMENT SHE RECEIVED A RETROPUBIC (RP) TVT SLING PLACED VIA THE STANDARD TECHNIQUE. POSTOPERATIVELY, SHE COMPLAINED OF URINARY RETENTION AND OBSTRUCTIVE VOIDING, AND THE RP SLING WAS TRANSECTED IN THE MIDLINE WITH RELIEF OF SOME OF HER OBSTRUCTIVE SYMPTOMS ONE MONTH AFTER PLACEMENT. APPROXIMATELY 4MONTHS FOLLOWING HER RP SLING INSERTION, SHE BEGAN TO EXPERIENCE NOTABLE DIFFUSE PELVIC/PERINEAL PAIN LOCALIZED TO THE PERIURETHRA, GROIN, RIGHT AND LEFT LOWER ABDOMINAL QUADRANTS, AND SUPRAPUBIC AREA. SHE ALSO EXPERIENCED DYSPAREUNIA AS WELL AS PERSISTENT MIXED URINARY COMPLAINTS. HER SPECIFIC URINARY SYMPTOMS INCLUDED URINARY URGENCY/FREQUENCY, NOCTURIA, DIFFICULTY EMPTYING HER BLADDER, AND STRESS URINARY INCONTINENCE. SHE ALSO REPORTED ANAL INCONTINENCE WITH NEED FOR SPLINTING FOR DEFECATION. PHYSICAL EXAMINATION REVEALED CONTRACTION AND BANDING OF THE MESH TAPE SLING(S) BILATERALLY IN THE PERIURETHRAL AREA. PALPATION OF THE MESH REPRODUCED HER PAIN, WITH RADIATION TO HER GROIN AND UP INTO HER LOWER ABDOMEN, RIGHT GREATER THAN LEFT. THERE WAS NO EVIDENCE OF MESH EXTRUSION. HER EXAM ALSO DIAGNOSED A STAGE II ANTERIOR AND POSTERIOR WALL PROLAPSE WITHOUT SIGNIFICANT TISSUE ATROPHY. SHE HAD PRONOUNCED URETHRAL HYPERMOBILITY AND A POSITIVE STANDING COUGH STRESS TEST. URINALYSIS WAS NEGATIVE WITH PRIOR URODYNAMIC TESTING SHOWING URODYNAMIC SUI WITHOUT SIGNIFICANT DETRUSOR OVERACTIVITY OR IMPAIRED VOIDING AND A NORMAL BLADDER CAPACITY. HER ICSIUGA MESH COMPLICATION SCORE WAS 1BE/T4/S2, S4. BASED ON THE PATIENT¿S HISTORY AND PHYSICAL EXAMINATION IT WAS RECOMMENDED THAT SHE UNDERGO VAGINAL REMOVAL OF THE SINGLE-INCISION SLING AND VAGINAL AND LAPAROSCOPIC REMOVAL OF THE RP MESH TAPE SLING WITH CONCOMITANT LAPAROSCOPIC PARAVAGINAL REPAIR, POSTERIOR REPAIR, AND BURCH URETHROPEXY. A TOTAL OF 18 CM OF TVT MESH SLING WAS REMOVED. THE DEFECTS IN THE PUBOCERVICAL FASCIA WERE REPAIRED WITH 2-0 ABSORBABLE POLYGLYCOLIC ACID SUTURE LAPAROSCOPICALLY. HER ANTERIOR WALL PROLAPSE AND PARAVAGINAL DEFECTS WERE THEN ADDRESSED USING INTERRUPTED PLACEMENT OF 2-0 NON-ABSORBABLE MULTIFILAMENT SUTURES FOR A BILATERAL PARAVAGINAL DEFECT REPAIR, WHICH SECURED THE PUBOCERVICAL FASCIA BACK TO THE ARCUS TENDINEUS FASCIA PELVIS BILATERALLY WITH THE INTENT TO RESTORE HER ANTERIOR ANATOMY PRIOR TO THE BURCH URETHROPEXY. THE PATIENT IS NOW MORE THAN 6 MONTHS OUT FROM SURGERY, CONTINUES TO DO WELL, AND IS SATISFIED WITH THE RESULTS. SHE DENIES ANY BOTHERSOME STRESS LEAKAGE AND REPORTS GOOD BLADDER EMPTYING. SHE IS STILL NOT SEXUALLY ACTIVE, BUT THIS IS UNRELATED TO PAIN WHICH SHE SAYS HAS FULLY RESOLVED. FOLLOWING HER SURGERY, SHE WAS RETROSPECTIVELY ENROLLED IN A LARGER STUDY EVALUATING VAGINAL MESH COMPLICATIONS WITH WAIVER OF PATIENT AUTHORIZATION AS PER INSTITUTIONAL REVIEW BOARD RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778943 TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention