BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22159073 · Received June 6, 2025

    Report

    Report Number
    9617229-2025-09367
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    June 4, 2024
    Report Date
    July 7, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: RUPTURE AND CAPSULAR CONTRACTURE GRADE UNKNOWN.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING INDICATES THAT THERE WERE NO OTHER RECORDS RELATED TO THIS EVENT FOR UNITS MANUFACTURED ON LOT NUMBER 1853169. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01- 004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE REV 6.0. THE REVIEW OF ALL POTENTIAL TREND EVALUATIONS FOR BREAST IMPLANTS CLOSED DURING THE PAST 12 MONTHS INDICATES THAT NO CONFIRMED COMPLAINT TRENDS HAVE BEEN OBSERVED FOR THE EVENT (A0412 MATERIAL RUPTURE). ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, A4, B3, B5, B6, D1, D2A, D2B, D3, D4, D6A, G1, G4, H4, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY, RUPTURE WITH INTRACAPSULAR SILICONE DIFFUSION, CAPSULAR CONTRACTURE (BAKER GRADE UNSPECIFIED). THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND IS UNKNOWN IF IT WAS REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE I. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618752 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1853169

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Required Intervention