BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 168 SALINE FILLED BREAST IMPLANT

    MDR report key: 3896045 · Received June 12, 2014

    Report

    Report Number
    2024601-2014-00316
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    December 15, 2013
    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
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING ADDRESS THE EVENT OF SEROMA AS: FOR PRIMARY AUGMENTATION PTS, SEROMA RATE = 1.6%. PRIMARY RECONSTRUCTION PTS = 1.0%. (OTHER COMPLICATIONS.) SWELLING = 7.1%. DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN (B)(4) 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

    RECEIVED NOTIFICATION FROM MEDICAL AFFAIRS A CASE OF ALCL. THE HEALTHCARE PROFESSIONAL REPORTS A "(B)(6) PT WHO RECEIVED COSMETIC AUGMENTATION IN 1969 WITH PERMANENT SILICONE IMPLANTS. DUE TO CAPSULAR CONTRACTURE, HAD EXCHANGED TO PERMANENT SALINE IMPLANTS IN 1997. IN (B)(6) 2013, DEVELOPED A DELAYED SEROMA IN THE LEFT BREAST. FNA DEMONSTRATED BIA-ALCL. UNDERWENT BILATERAL EXPLANTATION AND CAPSULECTOMIES IN (B)(6) 2013. THE PT WAS NOTED TO HAVE A MASS ON THE MEDIAL ASPECT OF THE LEFT CAPSULE. POSTOPERATIVE PATHOLOGY CONFIRMED BIA-ALCL AND MARGINS WERE POSITIVE. RETURNED TO THE OPERATING ROOM IN (B)(6) 2014 FOR BILATERAL COMPLETION CAPSULECTOMY. NO RESIDUAL BIA-ALCL ON PATHOLOGY. NOW REMAINS DISEASE FREE." THE PT ALSO HAS A HISTORY OF RIGHT BREAST CANCER THAT WAS TREATED WITH MASTECTOMY AND NODAL DISSECTION, PLACEMENT OF A TISSUE EXPANDER IMMEDIATELY IN 2003. SHE DID NOT GET CHEMOTHERAPY OR RADIATION AND SUBSEQUENTLY SHE WAS PLACED ON ENDOCRINE TREATMENT FOR 5 YEARS. THE NOTIFICATION ALSO PROVIDED A DATE OF THE EXPLANTATION AND THE CAPSULECTOMY THAT TOOK PLACE ON THE (B)(6) 2014. IT NOTES 168-330 FILLED TO 325CC PLACED SUB-MUSCULARLY. THE DATE OF THE DIAGNOSIS WAS (B)(6) 2014. IT PROVIDES THE LYMPHOMA CELLS ARE POSITIVE FOR CD30 (DIFFUSE AND STRONG) AND CD43 (WEAK) AND ARE NEGATIVE FOR CD3, CD20, CD45, ALK-1, CD68, E-CADHERIN, MOC31, GATA3, ER, PR, AE1/AE3, PAN-CK, CK7, CAM5.2, MELANOMA COCKTAIL AND S-100. THE CD3 AND CD20 STAINS HIGHLIGHT BACKGROUND, RARE, SCATTERED, SMALL T-CELLS AND B-CELLS, RESPECTIVELY. THE CD45 STAIN HIGHLIGHTS SCATTERED HEMATOPOIETIC CELLS. CD68 INFO WAS NOT PROVIDED. T(2,5) ALSO NEGATIVE. THE PATHOLOGY REPORT HAS BEEN REQUESTED, BUT NOT PROVIDED. IF/THEN THIS INFO IS PROVIDED IT WILL BE FORWARDED. THE MEDICAL SAFETY TEAM HAS DETERMINED THAT COMBINED RESULTS OF IMMUNE-CHEMICAL, HISTOLOGICAL AND CYTOLOGICAL ANALYSIS OF SPECIMENS ARE SCIENTIFICALLY ACCEPTABLE CRITERIA WITH WHICH TO DIAGNOSE ALCL. HOWEVER, IF THERE IS ADD'L INFO OR ANY LABS RELATED TO, BUT NOT LIMITED TO ANY COMBINED RESULTS OF IMMUNE-CHEMICAL, HISTOLOGICAL AND CYTOLOGICAL ANALYSIS OF SPECIMENS ARE SCIENTIFICALLY ACCEPTABLE CRITERIA WITH WHICH TO DIAGNOSE ALCL THE FILE WILL BE REVIEWED AND UPDATED.

    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
    347690 STYLE 168 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention HORMONE REPLACEMENT THERAPY