BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23795255 · Received December 12, 2025

    Report

    Report Number
    9617229-2025-21748
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    March 1, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191606615
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTO ANALYSIS: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF VISIBILITY/PALPABILITY AND CAPSULAR CONTRACTURE REQUESTED ON NOVEMBER 25,2025. WITH LOT NUMBER 2933588 AND CATALOG NUMBER N-TRF415. VISIBILITY/PALPABILITY: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED. 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. 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE III.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CHANGE OF SHAPE AND PAIN" AND "CAPSULAR CONTRACTURE BAKER GRADE III". THE DEVICE WAS EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2711842 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2933588 5060191606615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention