BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 19054602 · Received April 5, 2024

    Report

    Report Number
    1645337-2024-04164
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    January 22, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000556
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON APRIL 10, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION (PRE-OP HISTORY & PHYSICAL) REGARDING THE EVENT. IT WAS REPORTED THAT THE PATIENT ALSO EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 2) ON THE LEFT SIDE. PALPATION SHOWED A FIRMNESS CONSISTENT WITH THE LEVEL OF HER CAPSULAR CONTRACTURE. IN ADDITION, IT WAS CONFIRMED THAT THE CORRECT BREAST PROSTHESIS WITH LOT NUMBER 6941837 HAS BEEN RETURNED FOR PRODUCT INVESTIGATION. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE AND CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED A DEVICE FOR EVALUATION THAT DOES NOT MATCH THE INITIAL REPORTED DEVICE. MENTOR WILL MAKE FOLLOW UP ATTEMPTS TO CLARIFY THE RETURNED DEVICE. 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: 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON MAY 03, 2024, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SMOOTH HPG, 600CC BREAST IMPLANT WAS FOUND TO BE RUPTURED WITHIN SHELL ABRASION AND RECEIVED IN TWO PARTS. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE IS 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, 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 , AND REPLACED WITH A MENTOR BREAST TISSUE EXPANDER WITH SERIAL NUMBER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624908 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6941837 00081317000556

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention