BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 24719394 · Received March 30, 2026

    Report

    Report Number
    9617229-2026-05554
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 15, 2023
    Report Date
    March 27, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURER REPORT NUMBER: 9617229-2023-15451. CLARIFICATION TO B3 DATE OF EVENT: PARTIAL DATE FEBRUARY 2023. CLARIFICATION TO D1-D4 DEVICE INFORMATION: DEVICE INFORMATION FOR BOTH SIDES WAS PROVIDED, BUT IT IS UNKNOWN WHICH DEVICE BELONGS TO WHICH SIDE. A PARTIAL CATALOG NUMBER HAS BEEN POPULATED IN THE RECORD AS IT IS THE ONLY MATCHING INFORMATION FOR BOTH DEVICES: DEVICE 1: INSPIRA TSF; SERIAL NUMBER: (B)(6); LOT NUMBER: 2923361 AND CATALOG NUMBER: N-TSF325. DEVICE 2: INSPIRA TSF; SERIAL NUMBER: (B)(6); LOT NUMBER: 2967071 AND CATALOG NUMBER: N-TSF345. CONTINUED E.1. PHONE NUMBER: (B)(6). 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

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE." HEALTHCARE PROFESSIONAL LATER REPORTED "MASTALGIA AND BREAST ASYMMETRY", ¿BECAME BIG¿, AND ¿FELL AS LITTLE STONE.¿ THE EVENTS OF ¿SIMPLE CYSTS, REGULAR AND WITHOUT CONTRAST ENHANCEMENT, SMALLER THAN 3 MM¿, ¿SOLID NODULE" ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774693 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention