BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BOOST BREAST IMPLANT

    MDR report key: 22031885 · Received May 15, 2025

    Report

    Report Number
    1645337-2025-05349
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 14, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    81317027126
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED ON MAY 22, 2025, THE PATIENT ALSO UNDERWENT BILATERAL CAPSULECTOMY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION COMPLETED ON JUNE 11, 2025: 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 GEL635CC 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. THE CONTRALATERAL DEVICE WAS ALSO RECEIVED (LOT NUMBER 9942135). 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: SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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. 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: CAPSULAR CONTRACTURE GRADE IV. 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

    A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION INVOLVING MENTOR MEMORYGEL BOOST, 635CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE IV POST-OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOWS: L) 3507504BC SN: (B)(6) , R) 3508004BC SN: (B)(6) ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73453 MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9986249 81317027126

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention