BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 468 SALINE FILLED BREAST IMPLANT

    MDR report key: 2800314 · Received October 9, 2012

    Report

    Report Number
    2024601-2012-01057
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    August 22, 2012
    Report Date
    January 27, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING ADDRESSES BREAST LUMPS: DISTINGUISHING THE IMPLANT FROM BREAST TISSUE DURING BREAST SELF-EXAMINATION: YOU SHOULD PERFORM BREAST SELF-EXAMINATION MONTHLY ON YOUR IMPLANTED BREAST. IN ORDER TO DO THIS EFFECTIVELY, YOU SHOULD ASK YOUR SURGEON TO HELP YOU DISTINGUISH THE IMPLANT FROM YOUR BREAST TISSUE. ANY NEW LUMPS OR AN ABNORMAL FINDING ON THE MAMMOGRAM SHOULD BE EVALUATED WITH A BIOPSY. IF A BIOPSY IS PERFORMED, CARE MUST BE TAKEN TO AVOID PUNCTURING THE IMPLANT. ((B)(6) PT PLANNER, SALINE). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE (B)(6) STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Additional Manufacturer Narrative · 1

    ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF ALLERGAN¿S DECISION TO INITIATE THE REMEDIAL ACTION. ALLERGAN HAS INITIATED AN INVESTIGATION TO ADDRESS LATE MDRS SUBMITTED RELATED TO 2011068-7/2/19-001-R.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS A CASE OF LYMPHOMA VIA VOLUNTARY REPORT ((B)(4)). ALCL ASSOCIATED WITH A SALINE TYPE BREAST IMPLANT. ABOUT 2 YEAR HISTORY OF RECURRENT EFFUSION SURROUNDING THE PROSTHESIS BEFORE REMOVAL. LYMPHOMA CELLS CONFIRMED TO THE FIBRINOUS EFFUSION, WITHOUT MEASURABLE MASS, IMPLANT CAPSULE OR SOFT TISSUE INVASION OR LYMPHADENOPATHY. PROGNOSIS IS FAVORABLE. DATES OF USE 2 YEARS. REASON FOR USE: RECURRENT BREAST ABSCESS." MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFO REGARDING THIS CASE. ANY ADDITIONAL INFO REGARDING THIS CASE WILL BE FORWARDED.

    Description of Event or Problem · 1

    ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE 468 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN NA 546894

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R NO INFO