BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22778472 · Received August 11, 2025

    Report

    Report Number
    9617229-2025-13562
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    December 15, 2022
    Report Date
    January 21, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191601788
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2023-05980. 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 SYSTEM IDENTIFIED THAT THERE WAS ANOTHER RECORD FOR UNITS MANUFACTURED ON LOT NUMBER 2760585: 2744727: CAPSULAR CONTRACTURE AND RUPTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WAS 1 ADDITIONAL COMPLAINT OF RUPTURE FOR THIS LOT NUMBER, THE DEVICE HAS NOT BEEN RETURNED TO CONFIRM THE EVENT OR TO DETECT POTENTIAL WORKMANSHIP. THE SEARCH CRITERIA FOR THESE QUERIES ARE MENTIONED IN QPP07-01-004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE AND REVISION 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 AND A010402 MIGRATION. THE EVENT OF "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN" 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: CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, SILICONE MIGRATION, DEVICE RUPTURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6(B), H6.

    Description of Event or Problem · 0

    PATIENT REPORTED "PAIN", "RUPTURE AND CAPSULAR CONTRACTURE" DIAGNOSED VIA ULTRASOUND AND MAMMOGRAM. PATIENT LATER REPORTED "RUPTURED WITH LEAKING INTO LYMPH NODES". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN WITH PAIN. IT WAS LATER REPORTED "RUPTURED WITH LEAKING INTO LYMPH NODES". THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903805 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2760585 5060191601788

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention