BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 22522429 · Received July 16, 2025

    Report

    Report Number
    1645337-2025-07834
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    May 1, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317004165
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 02, 2025, THE MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT'S REPLACEMENT DEVICE. IT WAS REPORTED THAT THE PATIENT'S REPLACEMENT DEVICE WAS A 340CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3507340MC) WITH LOT NUMBER 2083702. ON SEPTEMBER 04, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION REPORTING THAT THE PATIENT ALSO EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE RIGHT SIDE. ON SEPTEMBER 11, 2025, THE MENTOR ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION, BOTH OF WHICH HAD THE SAME LOT NUMBER AND NO IDENTIFYING SIDE DESIGNATIONS. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED A RUPTURE AND CAPSULAR CONTRACTURE ON THE RIGHT BREAST IMPLANT. ON SEPTEMBER 29, 2025, MENTOR COMPLETED AN EVALUATION ON A RETURNED DEVICES AS IT WAS IMPOSSIBLE TO DETERMINE WHICH DEVICE CORRESPONDED TO THE RIGHT-SIDED BREAST IMPLANT. THE ANALYSIS FOR ONE DEVICE (DEVICE B) IS BEING INCLUDED IN THIS REPORT. SEE ASSOCIATED REPORT FOR THE OTHER DEVICE EVALUATION. DEVICE EVALUATION SUMMARY (DEVICE B): DURING VISUAL EVALUATION OF THE DEVICE B, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND IT IDENTIFIED THREE TEARS (A, B AND C) ON THE ANTERIOR VIEW, MEASURING ALL THE TEARS APPROXIMATELY LESS THAN 0.1 CM. IN ADDITION, NO OTHER AREAS OF GEL EXPOSURE WERE DETECTED DURING THE ANALYSIS. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURES (A, B AND C), AND PARALLEL STRIATIONS WERE FOUND IN THE WHOLE AREA OF THE THREE TEARS. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT THE IMPLANT COULD HAVE BEEN DAMAGED DURING OR SUBSEQUENT TO IMPLANTATION. THE PRODUCT INSERT DATA SHEET CAUTIONS TO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES. REGARDING THE REPORTED CAPSULAR CONTRACTURE CONDITION, THERE ARE NOT ENOUGH DETAILS TO DETERMINE THE FACTORS THAT MAY HAVE CAUSED THIS CONDITION. CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST MIGHT BE THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. FURTHER, CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA: 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).

    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: RUPTURE. SECTION D6B. EXPLANTATION DATE: (B)(6) 2025. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 340CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN IMAGING REPORT. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150525 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9529140 00081317004165

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention