BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 8023314 · Received October 31, 2018

    Report

    Report Number
    9617229-2018-08491
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    July 17, 2017
    Report Date
    October 31, 2018
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: DI NAPOLI A, PEPE G, GIARNIERI E, CIPPITELLI C, BONIFACINO A, MATTEI M, ET AL. (2017) CYTOLOGICAL DIAGNOSTIC FEATURES OF LATE BREAST IMPLANT SEROMAS: FROM REACTIVE TO ANAPLASTIC LARGE CELL LYMPHOMA. PLOS ONE 12(7): E0181097. HTTPS://DOI.ORG/10.1371/JOURNAL.PONE.0181097. THE EVENTS OF LYMPHOMA - ALCL AND SEROMA/SEROMA - LATE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING: POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY INCLUDE: IMPLANT RUPTURE, CAPSULAR CONTRACTURE, REOPERATION, IMPLANT REMOVAL, PAIN, CHANGES IN NIPPLE AND BREAST SENSATION, INFECTION, SCARRING, ASYMMETRY, WRINKLING, IMPLANT DISPLACEMENT/MIGRATION, IMPLANT PALPABILITY/VISIBILITY, BREASTFEEDING COMPLICATIONS, HEMATOMA/SEROMA, IMPLANT EXTRUSION, NECROSIS, DELAYED WOUND HEALING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, CALCIUM DEPOSITS, AND LYMPHADENOPATHY. BASED ON INFORMATION 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 PATIENTS WITH AN IMPLANT HISTORY THAT INCLUDES ALLERGAN¿S AND OTHER MANUFACTURERS¿ BREAST IMPLANTS. YOU SHOULD CONSIDER THE POSSIBILITY OF ALCL WHEN YOU HAVE A PATIENT WITH LATE ONSET, PERSISTENT PERI-IMPLANT SEROMA. IN SOME CASES, PATIENTS 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 PATIENT 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 REGIMEN FOR PERI-IMPLANT ALCL.

    Description of Event or Problem · 1

    IN THE ARTICLE "CYTOLOGICAL DIAGNOSTIC FEATURES OF LATE BREAST IMPLANT SEROMAS: FROM REACTIVE TO ANAPLASTIC LARGE CELL LYMPHOMA," THE FOLLOWING WAS REPORTED: 4 PATIENTS WITH CD30 + AND ALK - BI-ALCL, PRESENTING AS A SEROMA. TWO PATIENTS EXPERIENCED THIS ON THE LEFT SIDE. TWO PATIENTS EXPERIENCED THIS ON THE RIGHT SIDE. ARTICLE ALSO REPORTED 45 PATIENTS WHO HAD A REACTIVE SEROMA (WITHOUT ALCL). IN THESE PATIENTS THE AVERAGE TIME TO SEROMA DEVELOPMENT WAS 60 MONTHS (RANGE, 6 - 137), DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863952 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention