BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 24174156 · Received January 24, 2026

    Report

    Report Number
    9617229-2026-01564
    Event Type
    Injury
    Date Received
    January 24, 2026
    Date of Event
    November 1, 2022
    Report Date
    February 10, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191606547
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A.2., A.4., A.6.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: GRADE OF CAPSULAR CONTRACTURE IV.

    Description of Event or Problem · 0

    PATIENT REPORTED "ENCAPSULATION, PAIN". LATER THE HCP PROVIDED AN ULTRASOUND STATING "BREAST IMPLANT WITHOUT ALTERATIONS" AND "INTACT BREAST IMPLANT, NO ABNORMAL CONTRAST UPTAKE. BI RADS 2". LATER, PER ULTRASOUND IT WAS REPORTED "CONTRACTURE OF PROSTHESIS. RETROGLANDULAR PROSTHESES. BI-RADS 2". LATER, PER PFN HCP REPORTED "GRADE OF CAPSULAR CONTRACTURE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED "ENCAPSULATION, PAIN". LATER THE HCP PROVIDED AN ULTRASOUND STATING "BREAST IMPLANT WITHOUT ALTERATIONS" AND "INTACT BREAST IMPLANT, NO ABNORMAL CONTRAST UPTAKE. BI RADS 2". LATER, PER ULTRASOUND IT WAS REPORTED "CONTRACTURE OF PROSTHESIS. RETROGLANDULAR PROSTHESES. BI-RADS 2". LATER, PER PFN HCP REPORTED "GRADE OF CAPSULAR CONTRACTURE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166157 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2750268 5060191606547

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention