BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3023802 · Received March 26, 2013

    Report

    Report Number
    2024601-2013-00185
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    November 7, 2012
    Report Date
    January 27, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELLING ADDRESSES SEROMA AND ALCL: ANAPLASTIC LARGE CELL LYMPHOMA. BASED ON INFO REPORTED TO FDA AND FOUND IN MEDICAL LITERATURE, A POSSIBLE ASSOCIATION HAS BEEN IDENTIFIED BETWEEN BREAST IMPLANTS AND THE RARE DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA (ALCL), A TYPE OF NON-HODGKIN'S LYMPHOMA. WOMEN WITH BREAST IMPLANTS MAY HAVE A VERY SMALL, BUT INCREASED RISK OF DEVELOPING ALCL IN THE FLUID OR SCAR CAPSULE ADJACENT TO THE IMPLANT. ALCL HAS BEEN REPORTED GLOBALLY IN PTS WITH AN IMPLANT HISTORY THAT INCLUDES ALLERGAN'S AND OTHER MFRS' BREAST IMPLANTS. YOU SHOULD CONSIDER POSSIBILITY OF ALCL WHEN YOU HAVE A PT WITH LATE ONSET, PERSISTENT PERI-IMPLANT SEROMA. IN SOME CASES, PTS PRESENTED WITH CAPSULAR CONTRACTURE OR MASSES ADJACENT TO THE BREAST IMPLANT. WHEN TESTING FOR ALCL, COLLECT FRESH SEROMA FLUID AND REPRESENTATIVE PORTIONS OF THE CAPSULE, AND SEND FOR PATHOLOGY TESTS TO RULE OUT ALCL. IF YOUR PT IS DIAGNOSED WITH PERI-IMPLANT ALCL, DEVELOP AN INDIVIDUALIZED TREATMENT PLAN IN COORDINATION WITH A MULTI-DISCIPLINARY CARE TEAM. BECAUSE OF THE SMALL NUMBER OF CASES WORLDWIDE, THERE IS NO DEFINED CONSENSUS TREATMENT REGIMENT FOR PERI-IMPLANT ALCL. FOR MORE COMPLETE AND UP-TO-DATE INFO ON FDA'S ANALYSIS AND REVIEW OF THE ALCL IN PTS WITH BREAST IMPLANTS PLEASE VISIT: HTTP://WWW.FDA.GOV/MEDICALDEVICES/PRODUCTSANDMEDICALPROCEDURES/IMPLANTSAND PROSTHETICS/BREASTIMPLANTS/UCM239995.HTM.

    Additional Manufacturer Narrative · 1

    ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF ALLERGAN¿S DECISION TO INITIATE THE REMEDIAL ACTION. ALLERGAN HAS INITIATED AN INVESTIGATION TO ADDRESS LATE MDRS SUBMITTED RELATED TO 2011068-7/2/19-001-R.

    Description of Event or Problem · 1

    ALLERGAN REP REPORTED PHYSICIAN REPORTS THAT A PT HAS BEEN DIAGNOSED WITH ALCL. THE PT PRESENTED WITH A RIGHT SIDE SWOLLEN BREAST, ASPIRATION PERFORMED, THERE WAS FLUID BUT NO BLOOD.

    Description of Event or Problem · 1

    ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123928 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN NA 1507531

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention