BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17904334 · Received October 10, 2023

    Report

    Report Number
    9617229-2023-16936
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    January 1, 2015
    Report Date
    January 26, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607490
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6, H10. VISUAL ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG NUMBER THROUGH THE PHOTOS PROVIDED. GEL BLEED: NOT OBSERVED. INFLAMMATION/IRRITATION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. OTHER-MEDICAL-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. MYALGIA-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. PAIN-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. DEPRESSION-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. HEADACHE-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. VARIED INJURIES-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AUTOIMMUNE/CONNECTIVE TISSUE DISORDERS-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. FIBROMYALGIA-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. FLU-LIKE SYMPTOMS-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: GEL BLEED.

    Description of Event or Problem · 0

    PATIENT'S REPRESENTATIVE REPORTED: "PATIENT IMPLANTED ALLERGAN DEVICES. THAT ARE DEFECTIVE. MANY HEALTH PROBLEMS CAME UP AFTER THE IMPLANT SURGERY. FIRST THERE WERE PROBLEMS. NOT RELATED TO THE DEVICES..THEN PATIENT HAD AN EPILECTICAL ATTACK AFTER 15 YEARS WITHOUT THEM. IN THIS PERIOD PATIENT STARTED TO HAVE OTHER SYMPTOMS LIKE MUSCLE AND BONES PAIN, ALLERGIC SYMPTOMS, CATAPLEXY, DEPRESSION, HEADACHE AND OTHERS. IN THE MEANTIME MAST CELL ACTIVATION SYNDROME (MCAS) WAS DIAGNOSED AND THERE WAS A SUSPECT ALSO OF AUTOIMMUNE INFLAMMATORY SYNDROME INDUCED BY ADJUVANTS (ASIA). THE ASIA SYNDROME IS INDICATED IN SCIENTIFICAL STUDY AS RELATED TO BREAST IMPLANTS. PATIENT IN FACT HAD A LOT OF SYMPTOMS, THAT ARE CORRESPONDING TO THE BREAST IMPLANT ILLNESS (BII). OTHER MEDICAL EXAMS WERE PERFORMED AND MANY TOXIC SUBSTANCES WERE FOUND IN THE PATIENT'S BODY (FOR THE SILICONE GEL BLEEDING). "HIGH-GRADE FIBROSIS WITH EVIDENCE OF FOREIGN MATERIAL IN THE PSEUDOCAPSULE THE BREASTS ON BOTH SIDES." DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RECORD RELATES TO RIGHT SIDE.

    Description of Event or Problem · 0

    PATIENT'S REPRESENTATIVE REPORTED: "PATIENT IMPLANTED ALLERGAN DEVICES. THAT ARE DEFECTIVE. MANY HEALTH PROBLEMS CAME UP AFTER THE IMPLANT SURGERY. FIRST THERE WERE PROBLEMS. NOT RELATED TO THE DEVICES..THEN PATIENT HAD AN EPILEPTICAL ATTACK AFTER 15 YEARS WITHOUT THEM. IN THIS PERIOD PATIENT STARTED TO HAVE OTHER SYMPTOMS LIKE MUSCLE AND BONES PAIN, ALLERGIC SYMPTOMS, CATAPLEXY, DEPRESSION, HEADACHE AND OTHERS. IN THE MEANTIME MAST CELL ACTIVATION SYNDROME (MCAS) WAS DIAGNOSED AND THERE WAS A SUSPECT ALSO OF AUTOIMMUNE INFLAMMATORY SYNDROME INDUCED BY ADJUVANTS (ASIA). THE ASIA SYNDROME IS INDICATED IN SCIENTIFICAL STUDY AS RELATED TO BREAST IMPLANTS. PATIENT IN FACT HAD A LOT OF SYMPTOMS, THAT ARE CORRESPONDING TO THE BREAST IMPLANT ILLNESS (BII). OTHER MEDICAL EXAMS WERE PERFORMED AND MANY TOXIC SUBSTANCES WERE FOUND IN THE PATIENT'S BODY (FOR THE SILICONE GEL BLEEDING). "HIGH-GRADE FIBROSIS WITH EVIDENCE OF FOREIGN MATERIAL IN THE PSEUDOCAPSULE THE BREASTS ON BOTH SIDES." DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RECORD RELATES TO RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336408 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2651793 05060191607490

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention