BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 2338306 · Received November 9, 2011

    Report

    Report Number
    2024601-2011-00902
    Event Type
    Injury
    Date Received
    November 9, 2011
    Date of Event
    January 1, 2005
    Report Date
    April 25, 2010
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS. DEVICE LABELING ADDRESSES: 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.

    Description of Event or Problem · 1

    A REPORT OF LYMPHOMA OF THE BREAST CAPSULE IN SILICONE IMPLANT-RECONSTRUCTED PT, PUBLISHED IN "THE AMERICAN SURGEON SEPT 2010 VOL 76 PG 1030-31 WAS REVIEWED AND ADD'L INFO HAS BEEN REQUESTED BY THE AUTHOR. THE AUTHOR HAS NOT RESPONDED TO THIS DATE. "WITHIN THE ARTICLE THE AUTHOR NOTES A "(B)(6) WOMAN WITH A TISSUE DIAGNOSIS OF ADENOCARCINOMA OF THE LEFT BREAST UNDERWENT A LEFT MODIFIED RADICAL MASTECTOMY WITH PROPHYLACTIC RIGHT BREAST SIMPLE MASTECTOMY IN 1999. THIS WAS IMMEDIATELY FOLLOWED BY PRIMARY RECONSTRUCTION WITH SILICONE IMPLANTS. THE LYMPH NODE BASIN WAS FREE OF DISEASE AND THE PT RECEIVED NO CHEMOTHERAPY OR RADIATION THERAPY." "SIX YEARS LATER, SHE PRESENTED TO HER PRIMARY CARE WITH A LUMP IN HER RECONSTRUCTED RIGHT BREAST. ON EXAMINATION, SHE HAD A 3CM NON-TENDER, MOBILE CYSTIC MASS IN THE RIGHT BREAST AT THE 9 O'CLOCK POSITION. COMPRESSION OF THE IMPLANT CAUSED ENLARGEMENT OF THE LESION. SHE DID NOT REPORT NIPPLE DISCHARGE OR RETRACTION, THE SKIN AND AREOLA COMPLEX WERE NORMAL AND THERE WERE NO PALPABLE LYMPH NODES. HER PRIMARY CARE PHYSICIAN PERFORMED A NEEDLE ASPIRATION OF THE MASS, WHICH WAS ORANGE IN COLOR WITH CYTOLOGIC FEATURES OF ADENOCARCINOMA. SHE UNDERWENT BILATERAL IMPLANT REMOVAL, EXCISION OF THE CYSTIC MASS AND BIOPSIES OF BOTH CAPSULES. THE LEFT BREAST IMPLANT WAS INTACT AND THE CAPSULE WAS NORMAL IN APPEARANCE. THE RIGHT BREAST IMPLANT WAS INTACT AS WELL. HOWEVER, THE ANTERIOR AND POSTERIOR WALLS OF THE CAPSULE WERE COATED WITH A NECROTIC HETEROGENEOUS MATERIAL. INITIAL BIOPSIES OF THE RIGHT BREAST CAPSULE SHOWED POORLY DIFFERENTIATED ADENENOCARCINOMA. IT WAS IMMUNOPOSITIVE FOR CD30, EMA AND T-CELL MARKERS CD45RO, CD43. FINAL PATHOLOGY OF THE MASS, AFTER REVIEW BY A SECOND PATHOLOGIST AT A UNIVERSITY HOSPITAL, WAS ANAPLASTIC LARGE CELL LYMPHOMA, ALK-, T CELL PHENOTYPE." THE POST OP RECOVER WAS UNEVENTFUL. THE PT HAD A COURSE OF CHOP PROTOCOL. "OUR PT'S LYMPHOMA WAS DISCOVERED AS A CYSTIC LESION INVOLVING THE RIGHT BREAST CAPSULE. THE PRELIMINARY CYTOLOGIC FEATURE OF THE LESION WAS POORLY DIFFERENTIATED ADENENOCARCINOMA, SIMILAR TO THE PRIOR DIAGNOSIS OF THE LEFT BREAST.."ONLY AFTER IMMUNOHISTOCHEMISTRY OF THE SPECIMEN WAS SHE CORRECTLY DIAGNOSED WITH ALCL T-CELL LYMPHOMA AND TREATED WITH CHOP CHEMOTHERAPY PROTOCOL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention NO INFORMATION| NO INFORMATION