BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8818307 · Received July 23, 2019

    Report

    Report Number
    1645337-2019-15808
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    June 25, 2019
    Report Date
    October 14, 2020
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    UDI-DI
    00081317000303
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020 MENTOR BECAME AWARE THAT THE DEVICE REPORTED IN THIS COMPLAINT WAS MANUFACTURED IN FRANCE. THE PEROUSE BREAST IMPLANTS THAT ARE MANUFACTURED AND DISTRIBUTED UNDER THE MENTOR BRAND BUT ARE NOT APPROVED FOR IMPORT INTO THE UNITED STATES DO NOT MEET THE CRITERIA FOR MDR REPORTING AS A SAME OR SIMILAR DEVICE TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. SPECIFICALLY, THE DEVICES DIFFER IN MANUFACTURING PROCESSES AND DEVICE SPECIFICATIONS. THEREFORE, EVENTS THAT INVOLVE THESE DEVICES WOULD NOT NEED TO BE REPORTED AS ASRS/PSRS OR MDRS. PHONE NUMBER (B)(6). MANUFACTURING SITE PHONE NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: DURING EVALUATION OF THE SAMPLE IT WAS OBSERVED TO BE INTACT. NO ANOMALIES WERE OBSERVED. 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. AN INVESTIGATION OF THE RETURNED DEVICE WAS PERFORMED, AND MENTOR COULD NOT UNCOVER A DEVICE FAILURE THAT WE COULD CONNECT TO THE REPORTED MEDICAL SYMPTOMS, HOWEVER COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED BY QUALITY ASSURANCE TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE REPORTED IN THIS COMPLAINT WAS MANUFACTURED IN LEIDEN, NETHERLANDS. THE LEIDEN BREAST IMPLANTS THAT ARE MANUFACTURED AND DISTRIBUTED UNDER THE MENTOR BRAND BUT ARE NOT APPROVED FOR IMPORT INTO THE UNITED STATES DO NOT MEET THE CRITERIA FOR MDR REPORTING AS A SAME OR SIMILAR DEVICE TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. SPECIFICALLY, THE DEVICES DIFFER IN MANUFACTURING PROCESSES AND DEVICE SPECIFICATIONS. THEREFORE, EVENTS THAT INVOLVE THESE DEVICES WOULD NOT NEED TO BE REPORTED AS ASRS/PSRS OR MDRS.  HOWEVER, SINCE THIS EVENT HAS ALREADY BEEN REPORTED TO FDA, ADDITIONAL INFORMATION WILL CONTINUE TO BE REPORTED AS APPLICABLE. ON 8/8/2019, UPON RECEIVE OF THE DEVICE THE LOT NUMBER BECAME EVIDENT AS 7011091. ON 8/8/2019, 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. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY WITH MENTOR MEMORYGEL, 350CC SILICONE BREAST IMPLANTS WHICH THE RIGHT SIDE HAS ISSUE WITH CAPSULAR CONTRACTURE BAKER GRADE IV AFTER IMPLANTATION. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH ANOTHER MENTOR GEL DEVICES ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611248 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 3503501BC 7011091 00081317000303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention