BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 12035989 · Received June 21, 2021

    Report

    Report Number
    1645337-2021-07000
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 2, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000105
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 23, 2021, MENTOR RECEIVED ADDITIONAL INFORMATION PROVIDING AN UPDATED DATE OF IMPLANT. RELEVANT FIELDS HAVE BEEN UPDATED. ON JULY 7, 2021, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JULY 13, 2021, MENTOR COMPLETED EVALUATION OF THE DEVICE. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE GEL MOD-RND 325CC BREAST IMPLANT HAD A CREASE/FOLD ON THE POSTERIOR VIEW. ADDITIONALLY, A TEAR WAS NOTED WITHIN THE CREASE AND EXTENDING TO THE ANTERIOR VIEW, MEASURING APPROXIMATELY 16.0 CM. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. THE INSTRUCTIONS FOR USE STATE THAT RUPTURES CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: STRESSING THE IMPLANT DURING IMPLANTATION OR OTHER PROCEDURES AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL. BREAST IMPLANTS MAY ALSO WEAR OVER TIME. A SECOND PRODUCT WAS RECEIVED (LOT-5894663). 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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 MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH MENTOR GEL IMPLANTS ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930214 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507325BC 6421108 00081317000105

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention