BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21971452 · Received May 6, 2025

    Report

    Report Number
    9617229-2025-07365
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    February 7, 2024
    Report Date
    May 6, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628032965
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2025-0000008. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ANXIETY ¿ PRODUCT/PROCEDURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. VISIBILITY/PALPABILITY: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. SYMMASTIA: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. UNSATISFACTORY RESULT: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE DEFORMATION WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. THE EVENT OF "SYMMASTIA" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: SYMMASTIA.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE "CHANGES IN THE SHAPE OF ...BREASTS", "UNACCEPTABLE COSMETIC APPEARANCE OF THE BREASTS", AND "SYMMASTIA." DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896730 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3044945 10888628032965

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention