BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 19519403 · Received June 12, 2024

    Report

    Report Number
    1645337-2024-07065
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    March 5, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000532
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 12, 2025, THE MENTOR FAILURE ANALYSIS LAB 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. ON MARCH 28, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT WAS ALSO DIAGNOSED WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNSPECIFIED) AND MASTODYNIA. THE PATIENT'S IMPLANTS WERE REPLACED WITH THE FOLLOWING DEVICES: (LEFT) 520CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB520 LOT: 9995973 SN: (B)(6) AND (RIGHT) 520CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB520 LOT: 2013904 SN: (B)(6). THE PATIENT'S RUPTURE WAS INITIALLY DIAGNOSED VIA MRI, ON (B)(6) 2024, SO THE DATE OF EVENT WAS UPDATED.

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.  IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN.  AS A RESULT, 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. 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.  REASON FOR DEVICE EXPLANT AND/OR REOPERATION: THE PATIENT HAS NOT UNDERGONE EXPLANTATION OR REOPERATION AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON APRIL 10, 2025, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SMOOTH HPG, 500CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN TWO (2) PARTS. MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. THEREFORE, A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR, AND THE THICKNESS WAS WITHIN MANUFACTURING SPECIFICATIONS. MENTOR ALSO PERFORMED A MANUFACTURING RECORD EVALUATION RELATED TO THE REPORTED COMPLAINT FOR THE FINISHED DEVICE LOT NUMBER. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED AS PART OF THIS EVALUATION. 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 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. 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. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. THE CONTRALATERAL DEVICE WAS ALSO RECEIVED (LOT NUMBER 7475375). THE PATIENT DID NOT REPORT ANY ISSUE WITH THIS DEVICE. THEREFORE, NO FURTHER ANALYSIS OF THE CONTRALATERAL DEVICE IS REQUIRED. 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 Manufacturer Narrative · 0

    ON FEBRUARY 11, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION THAT INDICATED THAT THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MATERIAL RUPTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393519 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6877565 00081317000532

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other| R