BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 3935226 · Received June 23, 2014

    Report

    Report Number
    2024601-2014-00342
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    August 15, 2012
    Report Date
    May 25, 2014
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER OF THE DEVICE IS UNKNOWN. THEREFORE, THIS FIELD IN THE MEDWATCH HAS BEEN CORRECTED TO REFLECT THIS.

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT ON: 06/23/2014. DEVICE LABELING FOR SILICONE BREAST IMPLANTS ADDRESSES THE EVENTS AS FOLLOWS: POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY INCLUDE: CAPSULAR CONTRACTURE, REOPERATION..." "PAIN OF VARYING INTENSITY AND LENGTH OF TIME MAY OCCUR AND PERSIST FOLLOWING BREAST IMPLANT SURGERY." THERE WERE NO EVENTS OF LYMPHOMA/ALCL REPORTED IN THE CORE STUDY FOR SILICONE BREAST IMPLANTS. DEVICE LABELING FOR SALINE BREAST IMPLANTS ADDRESSES THE EVENTS AS FOLLOWS: "POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH BREAST IMPLANT SURGERY. THE RISKS INCLUDE: ADDITIONAL SURGERY, CAPSULAR CONTRACTURE, INFECTION... BREAST PAIN..., AND INABILITY TO ADEQUATELY VISUALIZE BREAST LESIONS WITH MAMMOGRAPHY>" THERE WERE ALSO NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE A95/R95 STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Description of Event or Problem · 1

    THE FOLLOWING REPORTED CASED REPORT WAS REVIEWED FROM "DAILY MAIL ONLINE: ALCL AND BREAST IMPLANTS", WHICH OUTLINES A CASE OF A (B)(6) YEAR OLD PT DIAGNOSED WITH ALCL, UNCONFIRMED AT THIS TIME. THE PT'S HISTORY IS AS FOLLOWS: AFTER DELIVERY OF TWO CHILDREN, THE PT HAD PRIMARY BREAST AUGMENTATION 2002, MFR OF DEVICES UNK. THE ONLY INFO KNOWN IS THAT THESE IMPLANTS WERE TEXTURED. IN APPROX 2008, THE PT HAD ANOTHER CHILD "DOCTORS INITIALLY DIAGNOSED MASTITIS, A COMMON INFECTION IN NURSING MOTHERS, BUT AFTER ANTIBIOTICS FAILED TO RESOLVE THE PROBLEM, SHE WAS REFERRED TO A CONSULTANT FOR FURTHER TESTS." CAPSULAR CONTRACTURE WAS DIAGNOSED. "ALTHOUGH UNCOMFORTABLE, DOCTORS REASSURED HER IT WASN'T HARMFUL." NO TREATMENT WAS PERFORMED AT THAT TIME. ONE YEAR LATER SWELLING OCCURRED. IN (B)(6) 2012, THE DEVICES WERE EXPLANTED; WITH NO MFR IDENTIFIED WITHIN THE ARTICLE. THE ONLY DEVICE INFO FOR THIS REVISION AUGMENTATION IS THAT THE DEVICES WERE SMOOTH. N O STYLE OR SERIAL INFO WAS GIVEN. THE PT STATED THAT AT THAT TIME "MY BREASTS WERE SOFT AND COMPLETELY NORMAL." TWO DAYS LATER, A "PEA SIZED LUMP WAS FOUND UNDER HER RIGHT ARM. IN (B)(6) 2012, THE LUMP HAD DOUBLES IN SIZE AND WAS PAINFUL. ALCL WAS DIAGNOSED. SHE UNDERWENT RADIOTHERAPY AND CHEMOTHERAPY. IMPLANTS AT THIS TIME REMAIN INTACT. "SINCE FINISHING TREATMENT LAST JULY, SHE HAS BEEN GIVEN THE ALL-CLEAR, BUT STILL HAS QUARTERLY CHECKUPS."

    Description of Event or Problem · 1

    ARTICLE "THE DAILY MAIL ONLINE- ALCL AND BREAST IMPLANTS" OUTLINES A CASE OF A PATIENT DIAGNOSED WITH ALCL. THE ARTICLE REPORTS THAT FOLLOWING SURGERY, THE "[PATIENT] FOUND A HARD PEA-SIZED LUMP ON THE SIDE OF [THE] RIGHT BREAST UNDER THE ARM." THE LUMP "DOUBLED IN SIZE AND WAS PAINFUL." PATIENT WAS INITIALLY DIAGNOSED WITH CANCER AND "IT WAS ONLY WHEN [THE PATIENT] WENT FOR TREATMENT THAT [PATIENT] DISCOVERED [THEY] HAD ALCL" PATIENT UNDERWENT RADIOTHERAPY AND CHEMOTHERAPY " DEVICE REMAINS IMPLANTED. EVENT WILL BE CAPTURED AS LYMPHOMA AS PATHOLOGICAL MARKERS HAVE NOT BEEN RECEIVED TO CONFIRM ALCL.

    Description of Event or Problem · 1

    ARTICLE "THE DAILY MAIL ONLINE: ALCL AND BREAST IMPLANTS" OUTLINES A CASE OF A PATIENT DIAGNOSED WITH ALCL. THE ARTICLE REPORTS THAT FOLLOWING SURGERY, THE "[PATIENT] FOUND A HARD PEA-SIZED LUMP ON THE SIDE OF [THE] RIGHT BREAST UNDER THE ARM.¿ THE LUMP "DOUBLED IN SIZE AND WAS PAINFUL." PATIENT WAS INITIALLY DIAGNOSED WITH CANCER AND ¿IT WAS ONLY WHEN [THE PATIENT] WENT FOR TREATMENT THAT [PATIENT] DISCOVERED [THEY] HAD ALCL." PATIENT UNDERWENT RADIOTHERAPY AND CHEMOTHERAPY.¿ DEVICE REMAINS IMPLANTED. EVENT WILL BE CAPTURED AS LYMPHOMA AS PATHOLOGICAL MARKERS HAVE NOT BEEN RECEIVED TO CONFIRM ALCL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366802 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R