BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 19112628 · Received April 15, 2024

    Report

    Report Number
    1645337-2024-04500
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 25, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000327
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE, 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 APRIL 22, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON APRIL 29, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION. 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. ADDITIONALLY AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGE OF THE TEAR. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. THE INSTRUCTIONS FOR USE STATES THAT RUPTURES CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: STRESSING THE IMPLANT DURING IMPLANTATION OR OTHER PROCEDURES AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL. BREAST IMPLANTS MAY ALSO WEAR 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, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. DURING THE SURGERY, THE RIGHT BREAST IMPLANT WAS DISCOVERED TO BE RUPTURED. THE REPLACEMENT DEVICES WERE: (RIGHT) 275CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3502751BC LOT: 9542826 SN: (B)(6) AND (LEFT) 250CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3502501BC LOT: 9982101 SN: (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136494 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6676609 00081317000327

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention