BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15341418 · Received September 1, 2022

    Report

    Report Number
    9617229-2022-16108
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    November 12, 2021
    Report Date
    September 1, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: MARTINEZ NUNEZ P, PEREZ GONZALEZ M, JUAREZ CORDERO A, "LATE SEROMA OF THE BREAST IN ASSOCIATION WITH COVID-19 INFECTION: TWO CASE REPORTS." EUR J PLAS SURG. 2021; 45:671-674. HTTPS://DOI.ORG/10.1007/S00238-021-01898-Y. (B)(4). THE EVENT OF "SEROMA-LATE" 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: SEROMA-LATE.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "LATE SEROMA OF THE BREAST IN ASSOCIATION WITH COVID-19 INFECTION: TWO CASE REPORTS¿ REPORTS A PATIENT WHO PRESENTED WITH SIGNIFICANT VOLUME INCREASE OF LEFT BREAST, ASSOCIATED WITH A FEELING OF INTENSE PRESSURE AT THE SAME LOCATION. AT THE TIME OF PRESENTATION, PATIENT COMPLAINED OF HAVING RESPIRATORY SYMPTOMS THAT HAD DEVELOPED ALMOST SIMULTANEOUSLY TO THE CHANGES TO THEIR BREAST. "A SARS-COV-2 COVID-19 PCR TEST OF A NASOPHARYNGEAL SWAB WAS POSITIVE, CONFIRMING THE DIAGNOSIS OF COVID-19" WHICH IS NOT RELATED TO THE DEVICE. AN ULTRASOUND-GUIDED PUNCTURE OF THE BREAST YIELDED 180 CC OF PERIPROSTHETIC SEROUS FLUID. ANALYSIS OF THE FLUID SHOWED AN ACUTE INFLAMMATORY RESPONSE WITH ABUNDANT NEUTROPHILS; IMMUNOHISTOCHEMICAL ANALYSIS EXCLUDED BIA-ALCL. THE SEROMA RECURRED WHILE THERE WAS WORSENING OF THE PATIENT¿S RESPIRATORY SYMPTOMS. THE PATIENT¿S CONDITION IMPROVED, THE PERIPROSTHETIC COLLECTION WAS SURGICALLY DRAINED; THERE WERE NO FURTHER RELAPSES. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574784 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention