BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BOOST BREAST IMPLANT

    MDR report key: 21222873 · Received January 23, 2025

    Report

    Report Number
    1645337-2025-00614
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    May 1, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317027072
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. 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 (B)(6) 2025, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SMO RO HIGH PRO BOOST GEL440CC RETURNED DEVICE. 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. 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: SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION. 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 TWO 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, PATIENT INITIALLY EXPERIENCED HARDENING, PAIN AND DISPLACEMENT IN THE RIGHT BREAST. THE PATIENT WAS PUT ON SINGULAIR AND OTHER MEDICATION BUT THE CAPSULAR CONTRACTURE STILL PROGRESSED TO BAKER GRADE IV. EVENTUALLY THE PATIENT DEVELOPED A LARGE SCAB ON THE LOWER POWER OF THE RIGHT BREAST AND WHEN THE SCAB CAME OFF, THE RIGHT BREAST IMPLANT BECAME EXPOSED. FURTHER EXAMINATION DIAGNOSED THE PATIENT WITH BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, ON (B)(6) 2024, THE PATIENT UNDERWENT BILATERAL MESH PLACEMENT, VERTICAL MASTOPEXY, FAT GRAFTING, AND EXCHANGE TO THE FOLLOWING DEVICES: (RIGHT) 325CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB325 LOT: 9717083 SN: (B)(6) AND (LEFT) 325CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB325 LOT: 9984567 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524314 MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9909398 00081317027072

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention