BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 12961363 · Received December 8, 2021

    Report

    Report Number
    1645337-2021-13622
    Event Type
    Injury
    Date Received
    December 8, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 17, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON JANUARY 19, 2022 INDICATED THAT THE PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT#: 3507300MC, SN#: (B)(6), R/ CAT#: 3507300MC, SN#: (B)(6)ON (B)(6) 2022. THE HEALTH CARE PROFESSIONAL CONFIRMED PRODUCT TO BE MENTOR, AND THE LEFT IMPLANT LOT IS 5852931 400CC ¿ R RUPTURED NOT ABLE TO READ. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UPON RECEIVE OF THE DEVICE, THE DEVICE IDENTITY REVEALED AS: CAT#: 3504001BC, LOT#: 5836414. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION COMPLETED ON FEBRUARY 15 , 2022: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MPP GEL 400CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN TWO PARTS. IN ADDITION, SHELL ABRASION WAS FOUND ON THE EDGES OF THE RUPTURED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. AT PRESENT, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS. (ASSESSING THE RISKS OF BREAST IMPLANTS AND FDA¿S VISION FOR THE NATIONAL BREAST IMPLANT REGISTRY). IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: NA. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH TWO UNKNOWN MENTOR SILICONE BREAST IMPLANTS HAS EXPERIENCED RIGHT-SIDED IMPLANT RUPTURE, AND UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING AUTOIMMUNE PAIN AND INFLAMMATION OF THE BODY. THE MRI EXAMINATION CONFIRMED THE RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861743 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5836414

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| O