BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 5725674 · Received June 15, 2016

    Report

    Report Number
    9617229-2016-00061
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    April 23, 2014
    Report Date
    May 20, 2016
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 06/15/2016. (B)(4). THESE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE SERIAL OR LOT NUMBER WAS NOT AVAILABLE. EXACT IMPLANT DATE COULD NOT BE SPECIFIED. THE DEVICE WILL NOT BE RETURNED. DEVICE LABELING ADDRESSES: 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

    VOLUNTARY MEDWATCH 5061844 REPORTED "ALCL BREAST IMPLANT ASSOCIATED," SIDE UNSPECIFIED. DEVICE DESCRIPTION PROVIDED AS, "MCGHAN TEXTURED BREAST IMPLANT SALINE." FOLLOW-UP WITH HEALTH PROFESSIONAL REPORTS, ¿AUGMENTATION OF MCGHAN TEXTURED SALINE IMPLANT 360 CC IMPLANTED SUB MUSCULAR.¿ ULTRASOUND FOUND, ¿CONTIGUOUS WITH THE MEDIAL ASPECT OF THIS PATIENT¿S LEFT BREAST IMPLANT THERE APPEARS TO BE AN ELLIPTICAL FLUID COLLECTION¿AREAS OF DENSE SHADOWING ARE SEEN WITHIN THE TWELVE O¿CLOCK RAY OF THE LEFT BREAST, THESE CORRESPOND WITH PREVIOUSLY IDENTIFIED BENIGN APPEARING CALCIFICATIONS WITHIN THIS REGION OF THE LEFT BREAST.¿ PHYSICIAN REFERRAL NOTE, DESCRIBES A ¿BREAST MASS¿ THAT THE PHYSICIAN BELIEVES IS A ¿INFLAMMATORY RESPONSE TO A BREAST IMPLANT IN THE LEFT BREAST.¿ ULTRASOUND OF THE LEFT BREAST STATES ¿PALPABLE LUMP IN THE LEFT BREAST, SWELLING/ITCHING ALONG THE SURGICAL SCAR.¿ FINDINGS STATE, ¿SMALL BENIGN OIL CYSTS AGAIN IMAGED AT THE 11:00 AND 12:00 POSITIONS OF THE LEFT BREAST, BENIGN. THERE IS FLUID ABOUT THE PERIPHERY OF THE IMPLANT.¿ OPERATIVE REPORT STATES ¿[PATIENT] WHO PRESENTED TO MY OFFICE WITH SWELLING AND DISCOMFORT OF THE LEFT BREAST. [PATIENT] WAS DIAGNOSED WITH A LEFT BREAST SEROMA. WE SENT IT FOR CULTURE AND CYTOLOGY, BOTH OF WHICH WERE NEGATIVE.¿ DEVICE WAS REMOVED AND NOT REPLACED. PATIENT HAD ¿CAPSULECTOMY AND BIOPSY,¿ IN ADDITION TO CHEMOTHERAPY. ADDITIONAL OPERATIVE REPORT, FOLLOWING PRIOR DEVICE REMOVAL, DETAILS REMOVAL OF A ¿LEFT BREAST MASS, CHEST WALL MASS,¿ DESCRIBED AS ¿VERY LARGE, IT WAS OVER 3 CM. IT WAS VERY HARD, FAIRLY WELL CIRCUMSCRIBED.¿ SURGICAL PATHOLOGY REPORT NOTES, ¿LARGE CELLS ARE POSITIVE FOR CD30¿NEGATIVE FOR ALK1.¿ DIAGNOSIS PROVIDED AS, ¿BREAST IMPLANT ¿ ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA.¿ ALCL DIAGNOSIS OCCURRED APPROXIMATELY 5 MONTHS AFTER EXPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381382 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention