BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 25032081 · Received April 29, 2026

    Report

    Report Number
    9617229-2026-07864
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON(S) FOR REOPERATION IS/ARE: SEROMA-LATE AND CAPSULAR CONTRACTURE GRADE III-IV. THE REPORTED EVENT OR EVENTS ARE PHYSIOLOGICAL COMPLICATIONS, AND DEVICE ANALYSIS TYPICALLY DOES NOT HELP ALLERGAN DETERMINE THE CAUSE. CLARIFICATION TO D6A IMPLANT DATE: PATIENT WAS IMPLANTED WITH THIS DEVICE FOR 13 YEARS. CONTINUED E.1. PHONE NUMBER: (B)(6). ARTICLE CITATION: JAEGER, MARIE ET AL. ¿OUTCOME ANALYSIS OF 852 BREAST IMPLANT CHECK ASSESSMENTS: THE ADDED VALUE OF CLINICIAN-OPERATED ULTRASOUND.¿ PLASTIC AND RECONSTRUCTIVE SURGERY. GLOBAL OPEN VOL. 14,3 E7513. 26 MAR. 2026, DOI:10.1097/GOX.0000000000007513.

    Description of Event or Problem · 0

    LITERATURE REVIEW TITLED "OUTCOME ANALYSIS OF 852 BREAST IMPLANT CHECK ASSESSMENTS: THE ADDED VALUE OF CLINICIAN-OPERATED ULTRASOUND¿ REPORTED ¿SEROMA¿ AND CAPSULAR CONTRACTURE, BAKER GRADE III-IV. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE STATUS UNKNOWN. THIS ARTICLE INVOLVED A 51-YEAR-OLD PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097255 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention