BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 20593621 · Received November 1, 2024

    Report

    Report Number
    9617229-2024-23642
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: SCATENA C, NACCARATO AG, VANNUCCHI M, ET AL. FIBRIN ASSOCIATED LARGE B-CELL LYMPHOMA ACCIDENTALLY IDENTIFIED IN A BREAST IMPLANT CAPSULE: A MOLECULAR REPORT OF A RARE ENTITY. PATHOLOGICA 2024; 116:242-248. HTTPS://DOI.ORG/10.32074/1591-951X-944 CONTINUED E1 -- ADDRESS 2: DEPARTMENT OF TRANSLATIONAL RESEARCH AND NEW TECHNOLOGIES IN MEDICINE AND SURGERY. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE III.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "FIBRIN ASSOCIATED LARGE B-CELL LYMPHOMA ACCIDENTALLY IDENTIFIED IN A BREAST IMPLANT CAPSULE: A MOLECULAR REPORT OF A RARE ENTITY" AUTHORS REPORT "A HEALTHY, IMMUNOCOMPETENT [PATIENT] HAD A RIGHT SKIN-SPARING MASTECTOMY AND IMPLANT-BASED RECONSTRUCTION PERFORMED FOR MULTICENTRIC LOBULAR CARCINOMA. THIRTEEN YEARS LATER, [THE PATIENT] DEVELOPED PAIN IN THE RIGHT BREAST AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE, BAKER GRADE III. THE PATIENT UNDERWENT A SURGICAL PARTIAL CAPSULECTOMY WITH IMPLANT REPLACEMENT. THE CAPSULE WAS SENT FOR ANALYSIS TO THE LABORATORY OF PATHOLOGY. HISTOLOGIC EVALUATION REVEALED SMALL CLUSTERS OF LARGE, ATYPICAL, AND PLEOMORPHIC LYMPHOCYTES WITH PROMINENT NUCLEOLI DISTRIBUTED WITHIN THE CAPSULE AND ASSOCIATED WITH FIBRIN DEPOSITS AND NECROSIS. A TARGETED NEXT GENERATION SEQUENCING (TNGS) ANALYSIS WAS PERFORMED USING ILLUMINA DNA PREP WITH ENRICHMENT SOLUTION (ILLUMINA MISEQ SEQUENCING PLATFORM) WITH A CUSTOM PANEL OF 83 GENES, COVERING THE MOST FREQUENTLY MUTATED GENES IN T AND B CELL LYMPHOMA. SEQUENCING ANALYSIS REVEALED TWO PATHOGENIC MUTATIONS IN DNMT3A (P.K754E) AND (P.R577G) WITH VARIANT ALLELE FREQUENCIES (VAF) OF 15% AND 5% RESPECTIVELY. FURTHERMORE, A VARIANT OF UNKNOWN SIGNIFICANCE (VUS) WAS DETECTED IN EXON 10 OF JAK2 GENE (P.G417S, VAF 38%). THESE FINDINGS LED TO THE DIAGNOSIS OF BIA-FA-LBCL, WHICH IS NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631912 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention