BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS SMOOTH

    MDR report key: 17855957 · Received October 2, 2023

    Report

    Report Number
    1645337-2023-11599
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    September 7, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 3, 2023, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT WAS ALSO DIAGNOSED WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV), PTOSIS, BREAST PAIN, AND ABDOMINAL SKIN REDUNDANCY. THE PATIENT UNDERWENT BILATERAL CAPSULECTOMY, MASTOPEXY, BILATERAL BREAST IMPLANT REPLACEMENT WITH THE FOLLOWING DEVICES: (LEFT) 500CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505001BC LOT: 9912053 SN: (B)(6) AND (RIGHT) 500CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505001BC LOT: 9928774 SN: (B)(6) . THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. COMPLICATIONS ON THE RIGHT BREAST WILL BE REPORTED UNDER MRN: 1645337-2023-11925.

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, 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 COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MATERIAL RUPTURE. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON OCTOBER 24, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON OCTOBER 25, 2023, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: 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 GEL SMOOTH 500CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED INCOMPLETE. ADDITIONALLY, SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE RUPTURE. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE WAS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE FOLLOWING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE SUCH AS TOO SMALL BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IN SOME CASES, THE BREAST IMPLANTS MAY ALSO WEAR OUT OVER TIME. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULES, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CAPA ACTIVITY WAS NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    ON OCTOBER 30, 2023, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICES WERE UNKNOWN MENTOR SMOOTH GEL IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNSPECIFIED MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, DURING AN IN-OFFICE VISIT, WITH SPONTANEOUS LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819704 UNKNOWN GEL IMPLANTS SMOOTH PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention