BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8928491 · Received August 23, 2019

    Report

    Report Number
    1645337-2019-17678
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    December 25, 2014
    Report Date
    July 26, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317001072
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON JUNE 12, 2020, MENTOR BECAME AWARE THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE, BREAST LUMP AND GENERALIZED ILLNESS. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON JUNE 9, 2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON JUNE 12, MENTOR BECAME AWARE THAT THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL AND REPLACEMENT WITH 300CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG NUMBER 3503004BC, SERIAL NUMBERS (B)(6) ON THE RIGHT SIDE AND (B)(6) ON THE LEFT SIDE ON (B)(6) 2020. ON JUNE 26, 2020, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. 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. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS 6871745 LOT 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. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A POSTOPERATIVE RIGHT-SIDED BREAST MASS AND BILATERAL CAPSULAR CONTRACTURE. IN (B)(6) 2018, A NEEDLE BIOPSY WAS PERFORMED AND THE BREAST MASS WAS DETERMINED TO BE BENIGN. HOWEVER, AFTER AN MAMMOGRAM ((B)(6) 2019) AND AN ULTRASOUND ((B)(6) 2019), THE PATIENT¿S PHYSICIAN RE-CONFIRMED THE BREAST MASS. ADDITIONALLY, THE PATIENT ALSO EXPERIENCED SEVERAL OTHER SYMPTOMS WITHIN THE PAST 3-4 YEARS, WHICH INCLUDE: SIMPLE SCRATCH CAUSES OVERWHELMING BLEEDING, BREASTS ITCHING, TORSO RASH, DAILY HEADACHES, NECK SORENESS, MUSCLE SORENESS, LYMPH NODES SEEM ENLARGED, BODY ODOR, BODY SWEATING, INSOMNIA, LIGHT SENSITIVITY, WEIGHT LOSS, AND FOOD TASTING BITTER. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720034 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3544375 6871745 00081317001072

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R