BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23143968 · Received September 25, 2025

    Report

    Report Number
    9617229-2025-16272
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    February 27, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628032729
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5; B6; D6B; D9; H3; H6

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE III.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS OF CAPSULAR CONTRACTURE AND CREASE/FOLDING OF IMPLANT WAS RECEIVED ON OCTOBER 29, 2025, WITH LOT NUMBER 1242339. PER THE INVESTIGATION PROCEDURE, THE DEVICE IS ANALYZED THROUGH VISUAL INSPECTION MICROSCOPIC INSPECTION IF OPENINGS ARE OBSERVED AND A WEIGHT VERIFICATION. PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. ¿ CREASE / FOLDING OF IMPLANT: OBSERVED. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (DEFORMATION) IS FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED ANY CREASES AND "CREASES IN IMPLANT FROM CAPSULE FORMATION." DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III CONFIRMED VIA PHYSICAL EXAMINATION. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III CONFIRMED VIA PHYSICAL EXAMINATION. LATER, HEALTHCARE PROFESSIONAL REPORTED "CREASES". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED. DEVICE HAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597178 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1242339 10888628032729

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention