BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 16932102 · Received May 15, 2023

    Report

    Report Number
    1645337-2023-05731
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    October 28, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000464
    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 AUGUST 21, 2023, MENTOR RECEIVED A NEW DATE OF EXPLANT. . ADDITIONAL INFORMATION ALSO INDICATED THE DEVICE WAS FOUND INTACT UPON EXPLANTATION. RELEVANT FIELDS AND CODING HAVE BEEN UPDATED ON SEPTEMBER 6, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. DEVICE EVALUATION 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 SMOOTH HPG, 300CC RETURNED DEVICE. MOST WOMEN UNDERGOING AUGMENTATION OR RECONSTRUCTION WITH A MAMMARY PROSTHESIS WILL EXPERIENCE SOME PAIN POSTOPERATIVELY. WHILE PAIN NORMALLY SUBSIDES IN MOST WOMEN AS THEY HEAL FROM SURGERY, IT CAN BECOME A CHRONIC PROBLEM IN OTHER WOMEN. CHRONIC PAIN CAN BE ASSOCIATED WITH A VARIETY OF FACTORS. SURGEONS SHOULD INSTRUCT THEIR PATIENTS TO INFORM THEM IF THERE IS SIGNIFICANT PAIN OR IF PAIN PERSISTS. PAIN IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. A SECOND PRODUCT WAS RECEIVED (6844075). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, CAPA ACTIVITY WAS NOT REQUIRED. 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: BREAST PAIN, 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. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE AND BREAST PAIN ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS INDICATED THE PATIENT NOTICED THE RUPTURE FOLLOWING AN IMPACT TO HER BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352919 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503004BC 6802961 00081317000464

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention