BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7423975 · Received April 11, 2018

    Report

    Report Number
    1645337-2018-02228
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    December 15, 2017
    Report Date
    March 14, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317001065
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD ( DHR) OF LOT NUMBER 5568885 WAS REVIEWED ON 4/21/2018 AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WITH THE FIELD EXPERIENCE REPORT ON 5/19/2018. BILATERAL CAPSULAR CONTRACTURE (BAKER'S GRADE UNKNOWN) WAS INDICATED (SEE 1645337-2018-03646 FOR CONTRALATERAL PROSTHESIS REPORT). THE EVENT DATE HAS BEEN UPDATED. WHEN THE DEVICE WAS EXPLANTED, BILATERAL PROSTHESIS REPLACEMENT WITH 350CC MENTOR MEMORYSHAPE BREAST IMPLANT(RIGHT), AND A 295CC MENTOR MEMORYSHAPE BREAST IMPLANT(LEFT) WAS ALSO PERFORMED. THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 519/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 352CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG #3544325, SERIAL #(B)(4), LOT #258444. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 6/26/2018. THE BILATERAL CAPSULAR CONTRACTURE REPORTED WAS BAKER'S GRADE IV. THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2018. IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT(RIGHT), AND A 325CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT). RIGHT SIDED RUPTURE WAS DIAGNOSED BY MAGNETIC RESONANCE IMAGING ON (B)(6) 2017. BILATERAL CAPSULAR CONTRACTURE WAS ALSO INDICATED. THE DEVICE WAS RECEIVED WITH CLOUDY GEL. RED MATERIAL WAS OBSERVED WITHIN THE DEVICE, AND GEL, RED AND WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. UPON RECEIPT THE DEVICE WAS SEVERELY RENTED. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES DISCOVERED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT AND CREASE OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE WHITE AND RED MATERIAL OBSERVED. BECAUSE THE PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ACCORDING TO THE INFORMATION PROVIDED, THE PRODUCT EVALUATION TEAM CONCLUDED 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 AND RUPTURE ARE KNOWN COMPLICATIONS ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT. RUPTURE WAS DIAGNOSED BY MAGNETIC RESONANCE IMAGING ON (B)(6) 2017. AS A RESULT, DEVICE REPLACEMENT WITH GEL IMPLANTS IS PLANNED FOR (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265967 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5568885 00081317001065

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention