BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 11892324 · Received May 27, 2021

    Report

    Report Number
    2210968-2021-05025
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    October 22, 2018
    Report Date
    April 28, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.1016/J.UROLOGY.2018.10.040. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (PROLIFT PELVIC FLOOR REPAIR) 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? PATIENT DEMOGRAPHICS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PELVIC FLOOR DISTRESS INVENTORY SCORES IMPROVE AFTER PROLAPSE SURGERY REGARDLESS OF SURGICAL APPROACH BUT NOT AFTER OBSERVATION ALONE. THIS STUDY AIMED TO EVALUATE THE EFFECT OF DIFFERENT SURGICAL PROCEDURES ON PELVIC FLOOR DISTRESS INVENTORY (PFDI) SCORES IN WOMEN WITH PELVIC ORGAN PROLAPSE. ALL WOMEN PRESENTING WITH A CHIEF COMPLAINT OF POP BETWEEN 2008 AND 2014 WERE INVITED TO ENROLL IN AN INSTITUTIONAL REVIEW BOARD-APPROVED PROSPECTIVE, LONGITUDINAL, AND OBSERVATIONAL DATABASE BY AN INDEPENDENT RESEARCH NURSE. A TOTAL OF 233/239 PATIENTS UNDERWENT SURGERY IN THE FIRST YEAR. FOR SGY VS N-SGY, SGY HAD SIGNIFICANT IMPROVEMENTS IN PFDI AND ALL SUBSCALE SCORES AT 1 YEAR WHILE N-SGY DID NOT. WHEN COMPARING VAGINAL TO ABDOMINAL APPROACH, MESH TO N-MESH AND HYST TO N-HYST, THERE WERE NO DIFFERENCES BETWEEN ANY SCORES AT BASELINE OR 1 YEAR BETWEEN THE GROUPS. ABDOMINAL PROLAPSE REPAIR WAS PERFORMED BY OPEN OR ROBOTIC ABDOMINAL SACROCOLPOPEXY (ASC) USING AMID TYPE 1 MESH, MOST COMMONLY WITH RESTORELLE Y-MESH (COLOPLAST). VAGINAL-APPROACH PROLAPSE REPAIR WAS PERFORMED EITHER WITH OR WITHOUT MESH AUGMENTATION. IF MESH WAS PLACED, AMS ELEVATE SYSTEM OR ETHICON GYNECARE PROLIFT SYSTEMS WERE USED; BOTH ARE AMID TYPE 1 MESH AND HAVE PREVIOUSLY BEEN SHOWN TO HAVE SIMILAR PERIOPERATIVE EXPERIENCES. IF PERFORMED, CONCOMITANT POSTERIOR REPAIR WAS CARRIED OUT VIA A MIDLINE PLICATION, OR RARELY WITH MESH USING AMS ELEVATE SYSTEM OR ETHICON GYNECARE PROLIFT SYSTEMS. IN BOTH ANTERIOR AND POSTERIOR COMPARTMENTS, USE OF MESH WAS BASED ON SURGEON PREFERENCE. SEVENTY-FIVE PATIENTS UNDERWENT ABDOMINAL SURGERY AND 142 VAGINAL SURGERY. ALL PATIENTS UNDERGOING ABDOMINAL SURGERY HAD MESH PLACED (75/75, 100%), WHILE 96/142 (68%) OF PATIENTS UNDERGOING VAGINAL SURGERY HAD MESH PLACED. PATIENTS UNDERGOING VAGINAL SURGERY WERE OLDER (MEDIAN 64 VS 60 YEARS; P = .006), BUT THERE WERE NO DIFFERENCES IN RACE (P = .28) OR MARITAL STATUS (P = .08; DATA NOT SHOWN). RATE OF HYSTERECTOMY DID NOT DIFFER WITH SURGICAL APPROACH (ABDOMINAL 25/75, 33% VS VAGINAL 39/142, 28%; P = .37). THERE WERE NO DIFFERENCES BETWEEN PFDI SCORES OR ANY SUBSCALE SCORES AT BASELINE OR 1 YEAR BETWEEN THE GROUPS. HOWEVER, ALL WITHIN-GROUP SYMPTOM SCORES IMPROVED FROM BASELINE TO 1 YEAR (P <.0001 FOR ALL), AND THE PFDI AND UDI IMPROVEMENTS IN BOTH GROUPS MET THE MID. THE CRADI SCORE IMPROVEMENT WAS SIGNIFICANT IN THE VAGINAL BUT NOT THE ABDOMINAL GROUP. THERE WERE NO DIFFERENCES IN PREVALENCE OF PAIN AT BASELINE OR 1 YEAR (BASELINE P = .93, 1 YEAR P = .68) OR BOTHER FROM PAIN (BASELINE P = 1.00, 1 YEAR P = .99) BETWEEN PATIENTS UNDERGOING ABDOMINAL AND VAGINAL SURGERY. PAIN DECREASED IN BOTH ABDOMINAL AND VAGINAL SURGERY PATIENTS (P <.0001 FOR BOTH). THE MAJORITY OF PATIENTS IN BOTH GROUPS WERE MODERATELY OR MARKEDLY IMPROVED ON GRA (VAGINAL 74/104, 71% VS ABDOMINAL 50/60, 83%), AND THERE WAS NO DIFFERENCE IN CHANGE OF OVERALL PROLAPSE SYMPTOMS BETWEEN GROUPS (P = .17). REPORTED COMPLICATION IN THE ABDOMINAL APPROACH GROUP INCLUDED PAIN (N=7) AT 1 YEAR POST-OP. REPORTED COMPLICATION IN THE VAGINAL APPROACH GROUP INCLUDED PAIN (N=14) AT 1 YEAR POST OP. IN CONCLUSION, WOMEN WHO HAD SURGICAL REPAIR OF PROLAPSE REGARDLESS OF APPROACH, MESH USE, OR CONCURRENT PROCEDURES HAD SIGNIFICANT IMPROVEMENT IN PFDI AND SUBSCALE SCORES. THESE PATIENTS ALSO HAD SIGNIFICANTLY IMPROVED PATIENT REPORTED LOWER ABDOMINAL AND GENITAL PAIN AT 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793260 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1