BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8926584 · Received August 23, 2019

    Report

    Report Number
    1645337-2019-17653
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    June 11, 2017
    Report Date
    July 24, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000297
    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

    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 (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: CAPSULAR CONTRACTURE AND RUPTURE. CONCOMITANT PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 325CC, CATALOG # 3503251BC, SERIAL # (B)(4), LOT # 6003215. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 8/23/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING EVALUATION THE SAMPLE, SOME CREASES WERE OBSERVED ON POSTERIOR AND ONE OF THEM EXPANDING TO ANTERIOR ASPECT, A TEAR WAS OBSERVE WITHIN CREASE ON POSTERIOR ASPECT MEASURING APPROXIMATELY 1.4 CM NO OTHER ANOMALIES WERE OBSERVED. A CREASE/FOLD FAILURE MAY BE THE RESULT OF THE CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE CAUSED BY THE CAPSULAR CONTRACTURE. 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. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT AS THERE ARE NO INDICATION THAT THE ISSUE FOUND IS RELATED TO THE MANUFACTURING PROCESS. IT IS MOST LIKELY THAT THE CREASE/FOLD WAS CREATED DUE TO THE STRESS CAUSE BY THE CAPSULAR CONTRACTURE WHICH RESULTING IN A TEAR AT A LATER DATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL BREAST IMPLANT 325CC AND EXPERIENCED BAKER GRADE IV CAPSULAR CONTRACTURE AND RUPTURE ON THE LEFT SIDE POST-OPERATIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS 545CC, CATALOG NUMBER SMPX545, SERIAL NUMBER (B)(4) ON THE LEFT SIDE AND (B)(4) ON THE RIGHT SIDE ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721204 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6003215 00081317000297

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention