BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9148223 · Received October 2, 2019

    Report

    Report Number
    9617229-2019-13599
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    July 1, 2019
    Report Date
    May 7, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    -
    Removal / Correction Number
    011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES. ADDITIONAL, CHANGED, OR CORRECTED DATA: A.4, B.5, B.6, B.7, D.7, D.11, G.1, H.6, H.7, H.9. DATE OF DIAGNOSIS- (B)(6) 2019.

    Description of Event or Problem · 0

    TREATMENT INCLUDED 3 "DRAINAGES" OF SEROMA, "CAPSULECTOMY + PEXIA." AN ANATOMOPATHOLOGICAL TEST WAS PERFORMED ON THE LAST DRAINAGE AND RESULTS REVEALED MARKERS "C19-0980, CD 30 POSITIVE, CD2, CD4, CD8 POSITIVE, CD 3, CD56, CD20 NEGATIVE." IMMUNOHISTOCHEMICAL EXAM CONFIRMED PRESENCE OF "ALK-1: NEGATIVE" MARKER. MRI SHOWED "MASS ADHERED TO THE IMPLANT, IN RELATION TO KNOWN ANAPLASTIC LYMPHOMA, INFILTRATING THE CAPSULE. BIRADS 6." THE DEVICE HAS BEEN EXPLANTED AND REPLACEMENT DEVICES WERE NOT INSERTED. THE STATUS OF THE PATIENT'S SYMPTOMS WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE REASON FOR REOPERATION: LYMPHOMA ALCL. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED LEFT SIDE CHRONIC SEROMA AND LUMPS. PER EXAM, IT WAS DIAGNOSED ANAPLASTIC T CELL LYMPHOMA, ASSOCIATED WITH BREAST IMPLANTS. THE DEVICE REMAINS IMPLANTED. PATHOLOGICAL MARKERS CONFIRMING ALCL LYMPHOMA HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941703 CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1389101

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CALCIUM, VITAMIN D, IBANDRONATO 10 MG.