BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22046031 · Received May 19, 2025

    Report

    Report Number
    9617229-2025-08185
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 7, 2025
    Report Date
    July 17, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191607469
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A5, A6, B5, B6, D6A, H6.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN OR WILL BE INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON(S) FOR REOPERATION IS/ARE: RUPTURE. CONTINUED E1 PHONE NUMBER: (B)(6) . CLARIFICATION TO PARTIAL D6A IMPLANT DATE: 2010 WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING SYSTEM IDENTIFIED THAT THERE WAS ANOTHER RECORD FOR UNITS MANUFACTURED ON LOT NUMBER 1832877: (B)(6): A25 NO APPARENT ADVERSE EVENT. DEVICE RETURNED TO DEVICE ANALYSIS. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01- 004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE REVISION 6.0. THE REVIEW OF ALL POTENTIAL TREND EVALUATIONS FOR BREAST IMPLANTS CLOSED DURING THE PAST 12 MONTHS INDICATES THAT NO CONFIRMED COMPLAINT TRENDS HAVE BEEN OBSERVED FOR THE EVENT (B)(6) MATERIAL RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE" CONFIRMED VIA MRI AND ULTRASOUND. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE" HEALTHCARE PROFESSIONAL ALSO REPORTED "COMPLETELY REMOVED FIBROADENOMA" WHICH IS NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED AND NOT REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MRI AND ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE" CONFIRMED VIA MRI AND ULTRASOUND. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE" HEALTHCARE PROFESSIONAL ALSO REPORTED "COMPLETELY REMOVED FIBROADENOMA" WHICH IS NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED AND NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164544 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1832877 5060191607469

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention