BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 15595339 · Received October 13, 2022

    Report

    Report Number
    1645337-2022-12174
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    September 12, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317004110
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE BREAST IMPLANT WAS FOUND TO BE RUPTURED. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN AN AREA OF THE TEAR ON THE ANTERIOR ASPECT, MEASURING APPROXIMATELY 0.1 CM. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. THE CAUSE OF THE RUPTURE IN THE REMAINING AREA OF THE TEAR COULD NOT BE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 THE 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 (6881095). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PAIN, RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 235CC MENTOR MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN IN HER RIGHT BREAST. DURING EXPLANT SURGERY, IT WAS DISCOVERED THAT THE IMPLANT WAS RUPTURED. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS DUE TO THE RUPTURE THAT WAS DISCOVERED DURING THE REVISION SURGERY. THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781061 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507235MC 6852264 00081317004110

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention