BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 2210614 · Received August 10, 2011

    Report

    Report Number
    2024601-2011-00664
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    November 11, 2010
    Report Date
    November 22, 2010
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON (B)(6) 2011. PT EDUCATION LABELING ADDRESS LUMP/MASS AND CYST: FOLLOWING BREAST AUGMENTATION, YOU SHOULD CONTINUE TO PERFORM A BREAST SELF-EXAMINATION MONTHLY. THIS MAY BE MORE DIFFICULT WITH A BREAST IMPLANT IN PLACE. TO CONTINUE TO PERFORM A MONTHLY BREAST SELF EXAMINATION EFFICIENTLY, YOU SHOULD ASK YOUR SURGEON TO HELP YOU IDENTIFY THE DIFFERENCE BETWEEN THE IMPLANT AND YOUR BREAST TISSUE. BEING ABLE TO IDENTIFY THE IMPLANT FROM BREAST TISSUE WILL DECREASE THE NECESSITY OF EXCESSIVE SQUEEZING OF THE IMPLANT DURING EXAMINATION. ANY NEW LUMPS SHOULD BE EVALUATED WITH A BIOPSY, AS APPROPRIATE. IF A BIOPSY IS PERFORMED, BE SURE TO INFORM THE MEDICAL PROFESSIONAL PERFORMING THE BIOPSY THAT YOU HAVE BREAST IMPLANTS SO THAT CARE WILL BE TAKEN TO AVOID INJURING THE IMPLANT. DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS. THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE (B)(4) STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Description of Event or Problem · 1

    RECEIVED AN ABSTRACT ENTITLED, "PRIMARY ANAPLASTIC LARGE CELL LYMPHOMA OF THE BREAST OCCURRING IN PTS WITH SILICONE BREAST IMPLANTS", WILL BE PUBLISHED IN THE FINAL ARTICLE ENTITLED LEUKEMIA AND LYMPHOMA, AUG 2011;52(8):1481-1487. WITHIN THE ARTICLE, THIS PT IS IDENTIFIED AS PT 6. SHE IS A COSMETIC (AUGMENTATION) PT WHO WAS FOUND TO HAVE A NODULE IN THE INFRAMAMMARY FOLD OF THE LEFT BREAST, WHICH GREW OVER SEVERAL MONTHS, BUT WAS NEGATIVE BY MAMMOGRAM. SHE HAD HER LEFT IMPLANT REMOVED AND THE TISSUE IN THE FIBROUS CAPSULE WAS DIAGNOSED AS ALCL. THE PT WAS TREATED WITH 6 CYCLES OF CHOP, BUT EXPERIENCED TUMOR REGROWTH WITHIN 2 WEEKS OF COMPLETION. ICE SALVAGE WAS GIVEN WITH RADIATION BUT WAS INEFFECTIVE. FINALLY, SHE RECEIVED AN AUTOLOGUS TRANSPLANT USING (CBV) CYCLOPHOSPHAMIDE, CARMUSTINE AND ETOPOSIDE CONDITIONING REGIMEN AND HAD BEEN IN REMISSION FOR 7.5 YEARS AT LAST F/U. THIS MW IS FOR THE LEFT SIDE. REFER TO MFR REPORT 2024601-2011-00674 FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention