BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 8649277 · Received May 29, 2019

    Report

    Report Number
    9617229-2019-05522
    Event Type
    Injury
    Date Received
    May 29, 2019
    Report Date
    June 19, 2019
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF LYMPHOMA ALCL AND ENLARGED MASS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION IS LYMPHOMA ALCL AND ENLARGED MASS.

    Description of Event or Problem · 0

    THROUGH LITERATURE ARTICLE "A RARE CASE OF A TRANSGENDER FEMALE WITH BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA TREATED WITH RADIOTHERAPY AND A REVIEW OF THE LITERATURE", IT WAS REPORTED A CASE OF A PATIENT WITH A HISTORY OF BREAST AUGMENTATION WITH BILATERAL SILICONE IMPLANTS. NINE YEARS LATER, THE PATIENT "DEVELOPED PRURITUS AND HYPERPIGMENTATION OF THE SKIN OVERLYING HER RIGHT BREAST BUT DID NOT SEEK MEDICAL CARE." SEVENTEEN YEARS LATER, THE PATIENT PRESENTED WITH AN ENLARGING RIGHT BREAST MASS. PATHOLOGY CONFIRMED BREAST IMPLANT¿ ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (ANN ARBOR STAGE IIE, TNM STAGE III BIA-ALCL). ULTRASOUND GUIDED RIGHT BREAST BIOPSY REVEALED ATYPICAL T-CELLS POSITIVE FOR CD30. ALTHOUGH THE AUTHORS DO NOT CLEARLY SPECIFY THAT THE ALK WAS NEGATIVE, IT IS CLEARLY SPECIFIED IN THE INTRODUCTION THAT THEY REALIZE THE DIAGNOSIS REQUIRES BOTH CD30 AND ALK TO BE APPROPRIATE. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: "A RARE CASE OF A TRANSGENDER FEMALE WITH BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA TREATED WITH RADIOTHERAPY AND A REVIEW OF THE LITERATURE", NABA ALI, KUNAL SINDHU, AND RICHARD L. BAKST, JOURNAL OF INVESTIGATIVE MEDICINE HIGH IMPACT CASE REPORTS VOLUME 7: 1¿5 © 2019. AMERICAN FEDERATION FOR MEDICAL RESEARCH DOI: 10.1177/2324709619842192 JOURNALS.SAGEPUB.COM/HOME/HIC. THE EVENT OF LYMPHOMA ALCL IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION IS LYMPHOMA ALCL. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. [(B)(4)].

    Description of Event or Problem · 1

    THROUGH LITERATURE ARTICLE "A RARE CASE OF A TRANSGENDER FEMALE WITH BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA TREATED WITH RADIOTHERAPY AND A REVIEW OF THE LITERATURE", IT WAS REPORTED A CASE OF A PATIENT WITH A HISTORY OF BREAST AUGMENTATION WITH BILATERAL SILICONE IMPLANTS. NINE YEARS LATER, THE PATIENT "DEVELOPED PRURITUS AND HYPERPIGMENTATION OF THE SKIN OVERLYING HER RIGHT BREAST BUT DID NOT SEEK MEDICAL CARE." SEVENTEEN YEARS LATER, THE PATIENT PRESENTED WITH AN ENLARGING RIGHT BREAST MASS. PATHOLOGY CONFIRMED BREAST IMPLANT¿ ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (ANN ARBOR STAGE IIE, TNM STAGE III BIA-ALCL). ULTRASOUND GUIDED RIGHT BREAST BIOPSY REVEALED ATYPICAL T-CELLS POSITIVE FOR CD30. ALTHOUGH THE AUTHORS DO NOT CLEARLY SPECIFY THAT THE ALK WAS NEGATIVE, IT IS CLEARLY SPECIFIED IN THE INTRODUCTION THAT THEY REALIZE THE DIAGNOSIS REQUIRES BOTH CD30 AND ALK TO BE APPROPRIATE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442193 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention