BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 153 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3883660 · Received June 18, 2014

    Report

    Report Number
    2024601-2012-01246
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    September 12, 2005
    Report Date
    January 22, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS INITIALLY SUBMITTED EASR Q4 ON (B)(4) 2010, Q1 (B)(4) 2010, Q2 ON (B)(4) 2010, Q4 ON (B)(4) 2011. ALLERGAN SILICONE DEVICE LABELING ADDRESSES THE FOLLOWING EVENTS (PER CORE STUDY AT 7 YEARS): PRIMARY RECONSTRUCTION PTS: SEROMA RATE = 0%. SWELLING RATE = 7.1%. CAPSULAR CONTRACTURE RATE = 17.1%. "PTS SHOULD BE ADVISED THAT CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA AND SEROMA." "AFTER BREAST IMPLANT SURGERY THE FOLLOWING MAY OCCUR AND/OR PERSIST WITH VARYING INTENSITY AND/OR FOR VARYING LENGTH OF TIME: HEMATOMA/SEROMA." (ALLERGAN LABELING FOR SILICONE IMPLANT). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE CORE STUDY, AND IN THE LABELING FOR SILICONE IMPLANTS.

    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

    HEALTHCARE PROFESSIONAL REPORTED THIS CASE OF ALCL VIA ADJUNCT STUDY FORM. THE PT WAS DIAGNOSED WITH LEFT BREAST CANCER IN 1995. RECONSTRUCTION SURGERY OCCURRED ON (B)(6) 2002 WITH A STYLE 153 IMPLANT. SYMPTOMS OF AN ENLARGED LEFT BREAST AND CAPSULAR CONTRACTURE OCCURRED. A LEFT SIDE SEROMA WAS TREATED WITH DRAINAGE. THE SEROMA RECURRED AND SHE WAS EXPLANTED ON (B)(6) 2005; REPLACED WITH A MENTOR DEVICE, STYLE UNK. BIOPSY OF THE SEROMA FLUID AND OF THE LEFT BREAST CAPSULE WAS PERFORMED ON (B)(6) 2005, AND AT THAT TIME SHE WAS DIAGNOSED WITH ANAPLASTIC LARGE CELL T CELL LYMPHOMA. RADIATION THERAPY BEGAN ON (B)(6) 2005. SHE WAS DOING FINE AT HER FOLLOW UP WITH THE PHYSICIAN IN 2007.

    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
    356957 STYLE 153 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN NA 569899

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention