BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 17471012 · Received August 7, 2023

    Report

    Report Number
    1645337-2023-09155
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    March 14, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000327
    PMA / PMN Number
    P030053
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 11, 2023, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE IMPACTED DEVICE. MENTOR DETERMINED THAT THE IMPACTED DEVICE WAS A 400CC MENTOR MEMORYGEL BREAST IMPLANT WITH CATALOG NUMBER 3504001BC. THE IMPACTED DEVICE INFORMATION, INCLUDING LOT NUMBER 5813203, HAS BEEN UPDATED IN SECTION D OF THIS REPORT. ON AUGUST 24, 2023, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. ON AUGUST 26, 2023, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MPP GEL 400CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN TWO (2) PARTS. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE RUPTURE COULD NOT BE IDENTIFIED. THEREFORE A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR, AND THE THICKNESS WAS WITHIN MANUFACTURING SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING THINGS MAY CAUSE THE IMPLANT TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS; STRESSING THE IMPLANT DURING IMPLANTATION AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL; EXCESSIVE FORCE TO THE CHEST (E.G. DURING CLOSED CAPSULOTOMY); TRAUMA; COMPRESSION DURING MAMMOGRAPHIC IMAGING; AND SEVERE CAPSULAR CONTRACTURE. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CAPA ACTIVITY WAS NOT REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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: 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO UNSPECIFIED GEL BREAST PROSTHESES AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322335 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5813203 00081317000327

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention