BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7857001 · Received September 7, 2018

    Report

    Report Number
    2210968-2018-75721
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS 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 PRODUCTS (PROLIFT OR PROLENE SUTURE) USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J (2018) 29:847¿858; DOI: HTTPS://DOI.ORG/10.1007/S00192-017-3512-3. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LONG-TERM OUTCOME OF VAGINAL MESH OR NATIVE TISSUE IN RECURRENT PROLAPSE: A RANDOMIZED CONTROLLED TRIAL" AUTHORS: ALFREDO L. MILANI1 & ANNE DAMOISEAUX2 & JOANNA INTHOUT3 & KIRSTEN B. KLUIVERS4 & MARIELLA I. J. WITHAGEN5. CITATION: INT UROGYNECOL J (2018) 29:847¿858; DOI: HTTPS://DOI.ORG/10.1007/S00192-017-3512-3. THIS LONG-TERM FOLLOW-UP OF RANDOMIZED CLINICAL TRIAL (RCT) AIMED TO COMPARE THE LONG-TERM COMPOSITE SUCCESS (A COMBINATION OF ANATOMY, FUNCTIONAL SUCCESS, AND ABSENCE OF RETREATMENT) 7 YEARS AFTER SURGERY, AND TO DESCRIBE LONG TERM ADVERSE EVENTS, WITH PARTICULAR FOCUS ON PAIN AND DYSPAREUNIA. BETWEEN AUG2006 AND JUL2008, 127 FEMALE PATIENTS WITH RECURRENT PELVIC ORGAN PROLAPSE (POP) WHO UNDERWENT REPAIR WERE INCLUDED IN THE ANALYSIS FOR COMPOSITE OUTCOME IN THE 7-YEAR FOLLOW-UP. THESE PATIENTS WERE RANDOMIZED BETWEEN TROCAR-GUIDED NON-ABSORBABLE TENSION-FREE VAGINAL MESH (TVM) USING PROLIFT (N=58; AGE AT TIME OF SURGERY 60.9 ± 9.0 YEARS; AGE AT FOLLOW-UP 67.1 ± 8.9 YEARS) AND CONVENTIONAL VAGINAL NATIVE TISSUE REPAIR (N=69; AGE AT TIME OF SURGERY 62.4 ± 10.2 YEARS; AGE AT FOLLOW-UP 68.8 ± 9.9 YEARS). IN THE 7-YEAR FOLLOW-UP, COMPOSITE FAILURES FOR MESH GROUP INCLUDED FAILURE IN TREATED COMPARTMENT (N=3) TREATED WITH REOPERATION IN ONE PATIENT, FAILURE IN UNTREATED COMPARTMENT (N=17) TREATED WITH REOPERATION IN THIRTEEN PATIENTS, FAILURE DUE TO BULGE BUT NO POP >HYMEN (N=5) AND FAILURE DUE TO BULGE (QUESTIONNAIRE ONLY) (N=2). IN THE SAME GROUP, PAIN COMPLAINTS DURING GYNECOLOGICAL EXAMINATION INCLUDED PROVOKED PAIN (N=24) AND DYSPAREUNIA DURING SEXUAL INTERCOURSE (N=13). PAIN COMPLAINTS AT THE OUTPATIENT VISIT INCLUDED PAIN (N=8) AND DYSPAREUNIA (N=14) FOR WHICH 17 PATIENTS EXPERIENCED PAIN AND/OR DYSPAREUNIA. MOREOVER, GRAFT-RELATED COMPLICATIONS INCLUDED EXPOSURE (N=22) AND RETRACTION OF MESH (N=17), FOR WHICH 7 PATIENTS HAD REOPERATION FOR EXPOSURE AND 8 PATIENTS HAD REOPERATION FOR GRAFT-RELATED COMPLICATION. FURTHERMORE, DE NOVO STRESS URINARY INCONTINENCE (N=12) AND SUBJECTIVE SENSATION OF BULGE (N=14) WERE NOTED. IN THE NATIVE TISSUE GROUP, ONE PATIENT EXPERIENCED EXPOSURE DUE TO A PROLENE SUTURE USED FOR SACROSPINOUS LIGAMENT FIXATION. THE MESH KIT USED CONSISTED OF RELATIVELY LARGE PIECES OF NONABSORBABLE MESH (ANTERIOR 10 × 13 CM, POSTERIOR 7 × 16 CM) WITH RELATIVELY HIGH WEIGHT OF 45 G/M2. THE TOTAL AMOUNT AND WEIGHT OF IMPLANTED MESH ARE CORRELATED WITH THE RISK OF EXPOSURE. MESH DID NOT REDUCE LONG-TERM REPEAT SURGERY RATES DUE TO DE NOVO POP IN NON-MESH-TREATED VAGINAL COMPARTMENTS. MESH EXPOSURE RATES WERE HIGH, THOUGH SIGNIFICANT DIFFERENCES IN PAIN AND DYSPAREUNIA WERE NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695137 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention