BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 163 SALINE FILLED BREAST IMPLANT

    MDR report key: 2150825 · Received June 2, 2011

    Report

    Report Number
    2024601-2011-00419
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 24, 2011
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED (B)(4) 2011. EXTENSION GRANTED BY (B)(4) UNTIL (B)(4) 2011. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF SEROMA AS FOLLOWS: THE (B)(4) STUDY: A 3 YEAR AND 5 YEAR CUMULATIVE FIRST OCCURRENCE (B)(4) ADVERSE EVENT RATES (95% CONFIDENCE INTERVAL), BY PATIENT: SEROMA 2.6% THROUGH 3 YEARS, 2.6% THROUGH 5 YEARS. "IF UNUSUAL SYMPTOMS OCCUR AFTER SURGERY, SUCH AS FEVER OR NOTICEABLE SWELLING OR REDNESS IN ONE BREAST, YOU SHOULD CONTACT YOUR SURGEON IMMEDIATELY." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF CAPSULAR CONTRACTURE AS FOLLOWS: THROUGH 3 YEARS, 9%, THROUGH 5 YEARS 11%. "THE SCAR TISSUE OR CAPSULE THAT NORMALLY FORMS AROUND THE IMPLANT MAY TIGHTEN AND SQUEEZE THE IMPLANT AND IS CALLED CAPSULAR CONTRACTURE. ADDITIONAL SURGERY IS NEEDED IN CASE WHERE PAIN/FIRMNESS IS SEVERE. THIS SURGERY RANGES FROM REMOVAL OF THE IMPLANT CAPSULE TISSUE TO REMOVAL AND POSSIBLY REPLACEMENT OF THE IMPLANT ITSELF. CAPSULAR CONTRACTURE MAY HAPPEN AGAIN AFTER THESE ADDITIONAL SURGERIES." LABELING REVIEW: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PATIENTS IN THE (B)(4) 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

    HEALTH PROFESSIONAL REPORTS ANAPLASTIC LARGE CELL LYMPHOMA, SEROMA, AND GRANULOMATOUS MASS: ALL LOCATED IN PATIENT'S RIGHT BREAST. PATIENT HAS A HISTORY OF PREEXISTING BILATERAL BREAST CANCER AND PRIMARY BREAST RECONSTRUCTION, MCGHAN SALINE STYLE 163-360 DEVICES IMPLANTED BILATERALLY IN 1999. THE PATIENT PRESENTED WITH SYMPTOMS OF ACUTE, LOCALIZED SWELLING OF RIGHT BREAST. RECONSTRUCTION OF THE CAPSULE WAS PERFORMED IN (B)(6) 2011. SEROMA DRAINED; FLUID SENT FOR CYTOLOGY AND BIOPSY TAKEN OF TISSUE MASS ON (B)(6) 2011. FINDINGS CONSISTENT WITH ANAPLASTIC LARGE CELL LYMPHOMA. DENSE FIBROSIS CONTAINING ATYPICAL CELLS CD30 POSITIVE, ALK NEGATIVE. THE PATIENT HAD SUBSEQUENT EXPLANT SURGERY AND CAPSULECTOMY ON (B)(6) 2011. OTHER TREATMENTS INCLUDING CHEMOTHERAPY OR RADIATION ARE UNKNOWN AT THIS TIME. THE PATIENT IS DOING WELL. EXPLANTED DEVICE HAS NOT BEEN RETURNED TO ALLERGAN.

    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 163 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention