BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21930447 · Received April 29, 2025

    Report

    Report Number
    9617229-2025-07032
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    March 13, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628030374
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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: CAPSULAR CONTRACTURE BAKER GRADE IV. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS OF RUPTURE AND CAPSULAR CONTRACTURE WAS RECEIVED ON JUNE 05, 2025, WITH LOT NUMBER 3242983. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS SURGICAL DAMAGE AND MISSING PIECE OF SHELL ASSESSED AS INCONCLUSIVE. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURES, CREASES AND WEAR ABRASION WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. HEALTHCARE PROVIDER NOTED "DAMAGE CAUSED BY EXPLANT" OF "YES-SIDE RUPTURED WHEN REMOVED"(NOT DEVICE RELATED). THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. HEALTHCARE PROVIDER NOTED "DAMAGE CAUSED BY EXPLANT" OF "YES-SIDE RUPTURED WHEN REMOVED"(NOT DEVICE RELATED). THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428249 INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3242983 10888628030374

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention