BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 24208418 · Received January 29, 2026

    Report

    Report Number
    9617229-2026-01889
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    October 29, 2025
    Report Date
    March 18, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191606783
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ RUPTURE: OBSERVED BROKEN DEVICE THROUGH MICROSCOPIC INSPECTION ASSESSED AS SURGICAL IMPACT OPENING AND BROKEN DEVICE ASSESSED AS SURGICAL DAMAGE. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. ¿ GRANULOMA: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (NON PENETRATING NICK) ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS.

    Additional Manufacturer Narrative · 0

    CONTINUED: A.4. WEIGHT: 54.8 KG E.1.: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF "GRANULOMA AND 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: RUPTURE, GRANULOMA AND CAPSULAR CONTRACTURE, BAKER GRADE III.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL THROUGH DISTRIBUTOR REPORTED RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE III, "THE OUTLINE AND ECHOGENICITY OF THE IMPLANTS ARE ABNORMAL", "IMPLANTS ARE DEFORMED", "CAPSULE COMPLEX ¿ ABNORMAL SAC WITH FEATURES OF SEGMENTAL DAMAGE " AND "LYMPH NODES WITH SILICON CONTENT ¿ SO-CALLED SILICONOMA". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL THROUGH DISTRIBUTOR REPORTED RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE III, "THE OUTLINE AND ECHOGENICITY OF THE IMPLANTS ARE ABNORMAL", "IMPLANTS ARE DEFORMED", "CAPSULE COMPLEX ¿ ABNORMAL SAC WITH FEATURES OF SEGMENTAL DAMAGE " AND "LYMPH NODES WITH SILICON CONTENT ¿ SO-CALLED SILICONOMA". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274115 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2906263 5060191606783

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention