BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22108805 · Received May 29, 2025

    Report

    Report Number
    9617229-2025-08851
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    May 1, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628007574
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, H.6.

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H6 ADVERSE EVENT PROBLEM: SUPPLEMENTAL MEDWATCH #1 UN-REPORTED THIS RECORD AFTER HEALTHCARE PROFESSIONAL REPORTED "0 HOLES OBSERVED" ON THE EXPLANTED RIGHT SIDE DEVICE. THIS RECORD IS NOW REPORTABLE AGAIN DUE TO THE REPORT OF IMPLANTS BEING FOUND "FLIPPED", CAPTURED AS A150202 MALPOSITION OF DEVICE. REASON FOR REOPERATION: SUSPECTED RUPTURE; IMPLANTS FOUND "INTACT BUT FLIPPED" DURING SURGERY DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ CHANGES IN SLEEP HABITS: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. ¿ CREASE/FOLDING OF IMPLANT: OBSERVED CREASES ON THE DEVICE. ¿ FLIPPING: OBSERVED CREASES ON THE DEVICE. AS PER THE INVESTIGATION PROCEDURE, DEFORMATION WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S 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: RUPTURE.

    Description of Event or Problem · 0

    IT HAS BEEN DETERMINED THAT THE EVENT OF RUPTURE DID NOT OCCUR. THEREFORE, THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UNREPORTED.

    Description of Event or Problem · 0

    PATIENT'S SPOUSE REPORTED RIGHT SIDE "POSSIBLE RUPTURE" DIAGNOSED VIA ULTRASOUND. HEALTHCARE PROFESSIONAL LATER REPORTED "DESPITE ULTRASOUND READ OF [RIGHT SIDE] IMPLANT RUPTURE, THEY WERE INTACT BUT FLIPPED", "LIKELY THIS WAS A FOLD ISSUE", "DEFECT IN THE IMPLANT EVEN IF THERE WAS NO FRANK RUPTURE", "IMPLANT MALPOSITION", "ROBUST CREASE NOTED ON MEDIAL QUADRANT", "0 HOLES OBSERVED", "BOTTOMING OUT", AND "HIGH RIDING NIPPLES". DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE REPORTED POSSIBLE RUPTURE CONFIRMED BY ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709177 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1252389 10888628007574

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention