BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9873562 · Received March 24, 2020

    Report

    Report Number
    1645337-2020-04748
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    June 8, 2018
    Report Date
    March 5, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000273
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON APRIL 7, 2020, MENTOR BECAME AWARE THAT THE PATIENT FIRST BECAME AWARE OF THE ISSUE ON (B)(6) 2018, AFTER A MAMMOGRAM DETERMINED A POSSIBLE LEFT IMPLANT RUPTURE. THE PATIENT WAS 46-YEARS OLD AT THAT TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, THE PRODUCT INVESTIGATION WAS COMPLETED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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. DEVICE INVESTIGATION SUMMARY: DURING VISUAL EVALUATION OF THE SAMPLE NO APPARENT DAMAGE OR ANOMALIES WERE OBSERVED. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND NO GEL BLEED WAS DETECTED. UNFORTUNATELY, AFTER A THOROUGH ANALYSIS WE WERE UNABLE TO CONFIRM YOUR REPORTED EVENT. IF YOU FEEL THIS NEEDS TO BE SUBMITTED FOR ADDITIONAL REVIEW, PLEASE PROVIDE ANY ADDITIONAL SUPPORTING DOCUMENTATION FOR REVIEW. (I.E., POST OP DEVICE PHOTOS, VIDEOS, AND/OR PRE-OPERATIVE SCANS). IN ADDITION, ALL RETURN KITS ARE NOW ASSIGNED AND PRE-LABELED FOR EACH UNIQUE CASE. PLEASE CONFIRM THE CORRECT DEVICE WAS RETURNED IN THE PRE-LABELED RETURN KIT. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. 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. GRANULOMAS ARE NONCANCEROUS NODULES THAT ARE A COMMON TISSUE REACTION TO THE PRESENCE OF A VARIETY OF FOREIGN MATERIALS, SUCH AS SILICONE. A SECOND PRODUCT WAS RECEIVED (LOT-6822242). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE, GRANULOMA, GEL LEAK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED LEFT BREAST CAPSULAR CONTRACTURE; BAKER GRADE III, AND FREE SILICONE WAS NOTED POSTERIOR OF CHEST WALL VIA MRI. AS ARE RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2020 WITH THE FOLLOWING DEVICES: (LEFT) 275CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3502751BC LOT: 7308256 SN: (B)(4) AND (RIGHT) 250CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3502501BC LOT: 7292755 SN: (B)(4). DURING THE EXPLANTATION SURGERY, IT WAS DISCOVERED THAT THE LEFT BREAST IMPLANT SUFFERED FROM GEL BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337218 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3502751BC 6842985 00081317000273

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention