BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 24162144 · Received January 23, 2026

    Report

    Report Number
    2210968-2026-00927
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    July 16, 2007
    Manufacturer
    ETHICON INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AN ATTEMPT HAS BEEN 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. CITATION: NEUROUROL URODYN. 2007;26(7):990-4. DOI: 10.1002/NAU.20440. PMID: 17638307. HTTPS://PUBMED.NCBI.NLM.NIH.GOV/17638307/.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: A MULTICENTER, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL COMPARING TENSION-FREE VAGINAL TAPE SURGERY AND NO TREATMENT FOR THE MANAGEMENT OF STRESS URINARY INCONTINENCE IN ELDERLY WOMEN. THE AIM OF THE MULTICENTER, PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL STUDY WAS TO TEST THE HYPOTHESIS THAT ELDERLY WOMEN UNDERGOING TENSION-FREE VAGINAL TAPE SURGERY (TVT) WILL HAVE A BETTER QUALITY OF LIFE (QOL) AND SATISFACTION COMPARED TO NON-TREATED WOMEN DESPITE AGE- AND TECHNIQUE-RELATED POTENTIAL MORBIDITY. A TOTAL OF 69 ENROLLED WOMEN AGED OVER 70 YEARS INITIALLY CONSENTED TO BE RANDOMIZED TO EITHER UNDERGO IMMEDIATE TVT SURGERY OR WAIT FOR 6 MONTHS BEFORE SUBMITTING TO THE SAME SURGERY (CONTROL GROUP). THE TRIAL WAS CONDUCTED BY UROLOGISTS IN EACH INSTITUTION, WITH ENROLLMENT STARTING IN OCTOBER 2002 AND ENDING IN MARCH 2005. THE TVT SETS USED WERE MANUFACTURED BY GYNECARE (SOMMERVILLE, NJ). A 16 FRENCH FOLEY CATHETER WAS INSERTED AT THE END OF THE PROCEDURE AND LEFT IN SITU UNTIL THE PATIENTS RECOVERED COMPLETELY FROM THE ANESTHESIA. OUT OF 87 PATIENTS WHO WERE ASKED TO PARTICIPATE IN THIS CLINICAL TRIAL, 69 ACCEPTED. A TOTAL OF 35 PATIENTS WERE RANDOMIZED TO UNDERGO IMMEDIATE TREATMENT: 1 PATIENT WAS FOUND TO REQUIRE A DIFFERENT PROCEDURE THAN TVT BECAUSE OF A SMALL URETHRAL DIVERTICULUM, 1 PATIENT WAS LOST TO FOLLOW-UP, AND 2PATIENTS HAD TO BE EXCLUDED FROM THE ANALYSIS BECAUSE OF INCOMPLETE DATA. THIRTY-FOUR WOMEN WERE RANDOMIZED TO THE CONTROL GROUP: 4 WERE LOST TO FOLLOW-UP AND 3 WERE EXCLUDED FROM THE ANALYSIS BECAUSE OF INCOMPLETE DATA. THIS LEFT 31 PATIENTS IN THE IMMEDIATE SURGERY GROUP AND 27 SUBJECTS IN THE CONTROL GROUP. REPORTED COMPLICATIONS INCLUDE: GYNECARE (ETHICON). BLADDER PERFORATION (N=7). TREATMENT: MANAGED WITH AN INDWELLING FOLEY CATHETER FOR 24 HOURS. URINARY RETENTION (N=4). TREATMENT: 2 PATIENTS FOLEY CATHETER WAS KEPT IN PLACE FOR 6 DAYS, ONE PATIENT UNDERWENT TVT RELEASE WITHIN 2 DAYS OF THE INITIAL SURGERY BY URETHRAL MOBILIZATION DILATATION/ UNDER SEDATION. ANOTHER PATIENT UNDERWENT TVT RELEASE WITHIN 6 DAYS OF SURGERY WITH OPENING OF THE PREVIOUS INCISION AND TAPE RELEASE UNDER SEDATION AND LOCAL ANESTHESIA. URINARY TRACT INFECTION (N=1). TREATMENT: NOT REPORTED. DE NOVO URGENCY (N=1). TREATMENT: NOT REPORTED. IN CONCLUSION, THE STUDY DEMONSTRATES THAT AT 6 MONTHS POST-RANDOMIZATION, THE GROUP OF ELDERLY WOMEN WHO UNDERWENT IMMEDIATE TVT SURGERY HAD SIGNIFICANTLY IMPROVED QOL, PATIENT SATISFACTION AND LESS URINARY PROBLEMS COMPARED TO THE CONTROL GROUP WAITING FOR THE SAME SURGERY. THE RATES OF INTRA OPERATIVE AND POST-OPERATIVE COMPLICATIONS WERE SIMILAR TO THOSE OBSERVED IN YOUNGER GROUPS OF WOMEN. DESPITE AN AGE-RELATED HIGHER RISK FROM SURGERY, INVASIVE TREATMENT OF SUI IN ELDERLY WOMEN IS BETTER THAN NO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221105 GYNECARE MESH UNKNOWN MESH, SURGICAL FTM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention