BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 7300930 · Received February 27, 2018

    Report

    Report Number
    9617229-2018-01471
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 25, 2018
    Report Date
    February 27, 2018
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICLE CITATION: ¿BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN A LI-FRAUMENI PATIENT: A CASE REPORT¿, RICARDO GARCIA PASTORELLO, FELIPE D¿ALMEIDA COSTA, CYNTHIA A. B. T. OSÓRIO, FABIANA B. A. MAKDISSI, STEPHANIA MARTINS BEZERRA, MARINA DE BROT, ANTONIO HUGO J. F. M. CAMPOS, FERNANDO AUGUSTO SOARES, AND JOSÉ VASSALLO, DIAGNOSTIC PATHOLOGY (2018) 13:10 DOI 10.1186/S13000-018-0688-X THE EVENTS 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 ADDRESSES: "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. SEROMA: 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."

    Description of Event or Problem · 1

    THROUGH JOURNAL ARTICLE ¿BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN A LI-FRAUMENI PATIENT: A CASE REPORT¿ PHYSICIAN REPORTED PATIENT ¿WITH LI-FRAUMENI SYNDROME WHO PRESENTED WITH LATE RIGHT-SIDED RECURRENT BREAST SWELLING AFTER PROPHYLACTIC ADENOMASTECTOMY WITH IMPLANT RECONSTRUCTION. IMAGING SCANS REVEALED AN HETEROGENEOUS MASS ADJACENT TO THE IMPLANT FIBROUS CAPSULE. A BIOPSY OF THE LESION RENDERED THE DIAGNOSIS OF A BIA-ALCL.¿ PATIENT SYMPTOMS ADDITIONALLY INCLUDED SKIN RASH AND IMAGING STUDIES REVEALED FLUID COLLECTIONS ADJACENT TO THE IMPLANT. PATIENT UNDERWENT RIGHT MODIFIED RADICAL MASTECTOMY WITH BREAST IMPLANT EXCISION AND AXILLARY REGION DISSECTION. MICROSCOPIC EVALUATION OF THE RESECTION SPECIMEN SHOWED THE IMPLANT CAPSULE INFILTRATED BY THE NEOPLASM. ALL DISSECTED LYMPH NODES WERE UNINVOLVED BY ATYPICAL CELLS. THIS RECORD IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143840 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention