BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8606039 · Received May 13, 2019

    Report

    Report Number
    1645337-2019-11754
    Event Type
    Injury
    Date Received
    May 13, 2019
    Report Date
    April 18, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000488
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6871726 ON 5/15/2019, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 6/11/2019. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED IT WAS REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE. DURING EVALUATION OF THE SAMPLE SOME CREASES WERE OBSERVED ON THE ANTERIOR AND POSTERIOR VIEWS. NO ADDITIONAL ANOMALIES WERE OBSERVED. BASED ON THE FACTS OF THE CASE, THE CAPSULAR CONTRACTURE IS UNRELATED TO THE BREAST IMPLANT AND RELATED TO THE PATIENT CONDITION. POSTOPERATIVE FORMATION OF A FIBROUS TISSUE CAPSULE AROUND A MAMMARY PROSTHESIS IS A NORMAL PHYSIOLOGIC RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT AND OCCURS IN ALL PATIENTS IN VARYING DEGREES. IN SOME CASES, CONTRACTURE OF THE FIBROUS CAPSULE MAY OCCUR. THIS PHENOMENON IS REFERRED TO AS CAPSULAR CONTRACTURE. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT DUE TO THE EXTERNAL CAUSE. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. 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: BAKER'S GRADE IV CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND A 350CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED BILATERAL BAKER¿S GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 400CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED. SEE 1645337-2019-11753 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398761 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6871726 00081317000488

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention