BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23724276 · Received December 5, 2025

    Report

    Report Number
    9617229-2025-21068
    Event Type
    Injury
    Date Received
    December 5, 2025
    Report Date
    March 6, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H.6 E CODE E180102 BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. AT THIS TIME, HISTOPATHOLOGICAL MARKERS OF CD30+ AND ALK- HAVE NOT BEEN PROVIDED AND ALCL HAS NOT BEEN CONFIRMED. THIS IS A SUSPECTED ALCL CASE. LAB ANALYSIS RESULTS: PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ LYMPHOMA ¿ ALCL - SUSPECTED: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (DEFORMATION AND CREASE) 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 E.1 PHONE NUMBER: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INVESTIGATION RESULTS: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES INVOLVED IN THIS WORK ORDER WERE RELEASED IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. ADDITIONALLY, NO ER/ NCR(S) WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED WITH THIS LOT AND THE COMPLAINT. ACCORDING TO THE COMPLAINT REVIEW THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS IN THE DEVICE ANALYSIS LABORATORY YET. HOWEVER, THE REPORTED EVENT OF LYMPHOMA ¿ ALCL - SUSPECTED IS CLASSIFIED AS MEDICAL AND IT IS UNABLE TO OBSERVE, THEREFORE IT IS UNABLE TO BE CONFIRMED. A REVIEW OF THE CURRENT RISK DOCUMENTS WAS PERFORMED AND THE EVENT OF BIA-ALCL IS A KNOWN HAZARD FOR BREAST IMPLANTS. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH LYMPHOMA ¿ ALCL - SUSPECTED WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE. THE EVENT OF LYMPHOMA-ALCL-SUSPECTED 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. THE REASON FOR REOPERATION: LYMPHOMA-ALCL-SUSPECTED, HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE NOT BEEN PROVIDED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED ALCL". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED. HISTOPATHOLOGICAL MARKERS OF CD30+ AND ALK- HAVE NOT BEEN PROVIDED, HENCE THE REPORT OF ALCL HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED ALCL". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED. HISTOPATHOLOGICAL MARKERS OF CD30+ AND ALK- HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867704 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2358143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L