BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7470137 · Received April 27, 2018

    Report

    Report Number
    1645337-2018-02497
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    February 14, 2018
    Report Date
    April 2, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000105
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED WITH CLEAR GEL. DURING EVALUATION CREASES ON BOTH ANTERIOR AND POSTERIOR ASPECT WERE OBSERVED. LEAK TESTING WAS PERFORMED ACCORDING WITH MENTOR PROCEDURES AND IT REVEALED A RENT, MEASURING APPROXIMATELY 0.1 CM, OVER A CREASE AREA. RUPTURE COMPLAINT WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PRODUCT EVALUATION CONCLUDED THAT THE RENT 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. CAPSULAR CONTRACTURE IS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. A ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. SOME BREAST PTOSIS IS A NORMAL COMPONENT OF THE MATURE BREAST. AUGMENTATION ALONE, WITHOUT CONSIDERATION OF THE PTOSIS CAN PRODUCE A LESS THAN DESIRABLE COSMETIC RESULT KNOWN AS A "ROCK IN SOCK" DEFORMITY OR AN INCREASED PTOTIC APPEARANCE. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. A COMPLAINT OF CAPSULAR CONTRACTURE WAS ALSO REPORTED. ACCORDING TO THE INFORMATION PROVIDED, PRODUCT EVALUATION 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 IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE PATIENT¿S BREAST PROSTHESIS WAS SUBMITTED TO MENTOR WITH A COMPLAINT OF BREAST PTOSIS. SOME BREAST PTOSIS IS A NORMAL COMPONENT OF THE MATURE BREAST. PTOSIS IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 6/6/2018, 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. ON 6/6/2018, MENTOR BECAME AWARE THAT REPLACEMENT DEVICES WERE THE FOLLOWING: (LEFT) MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE CATALOG: 3502375 LOT: 6885749 SN: (B)(4) AND (RIGHT) MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE CATALOG: 3502375 LOT: 7414564 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, 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. CONCOMITANT PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL, CATALOG #3507325BC, LOT #221417. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESES. LEFT BREAST PROSTHESIS RUPTURE WAS CONFIRMED BY PHYSICAL EXAMINATION. GRADE 4 CAPSULAR CONTRACTURE ON THE LEFT BREAST AND GRADE 2 CAPSULAR CONTRACTURE ON THE RIGHT BREAST WERE ALSO IDENTIFIED. PTOSIS WAS ALSO DETERMINED ON THE RIGHT BREAST. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SALINE BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311982 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 221417 00081317000105

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention