BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX CP LUMERA MOD GEL

    MDR report key: 11609601 · Received April 2, 2021

    Report

    Report Number
    1645337-2021-03533
    Event Type
    Injury
    Date Received
    April 2, 2021
    Report Date
    March 8, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE SUSPECT MEDICAL'S POSSIBLE LOT NUMBERS WERE THE FOLLOWING: 5653268 AND 5649704. ON (B)(6) 2021, 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. PER THE RETURNED DEVICES AND ADDITIONAL INFORMATION, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICES WERE THE FOLLOWING: (LEFT) SILTEX CP LUMERA MOD GEL 415CC CATALOG: 3241357 LOT: 5649704 SN: (B)(6), AND (RIGHT) SILTEX CP LUMERA MOD GEL 415CC CATALOG: 3241357 LOT: 5653268 SN: (B)(6). THE PATIENT'S AGE, DATE OF BIRTH, AND CORRECT DATE OF IMPLANTATION WERE ALSO PROVIDED AND HAS BEEN POPULATED ACCORDINGLY. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Additional Manufacturer Narrative · 0

    ON JUNE 10, 2021, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE, VISUAL ANOMALIES, OR DISCOLORATION WERE OBSERVED ON THE CONTOUR PROFILE MODERATE GEL - LUMERA, 415CC RETURNED DEVICE. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES, AND NO LEAK SITES WERE DETECTED DURING THE ANALYSIS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE BREAST IMPLANT WAS RETURNED WITHOUT DETECTABLE DISCOLORATION OR DISINTEGRATION. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. INFECTION, MANIFESTED BY SWELLING, TENDERNESS, PAIN, AND FEVER, MAY APPEAR IN THE IMMEDIATE POSTOPERATIVE PERIOD OR AT ANY TIME AFTER INSERTION OF THE IMPLANT. IN THE ABSENCE OF CLASSIC SYMPTOMS, SUBACUTE OR CHRONIC INFECTIONS MAY BE DIFFICULT TO DIAGNOSE. IF THE INFECTION DOES NOT SUBSIDE PROMPTLY WITH THE APPROPRIATE TREATMENT, REMOVAL OF THE IMPLANT IS INDICATED. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY. PER A DATABASE QUERY, THIS IS THE ONLY REPORTED COMPLAINT OF INFECTION AGAINST THIS LOT NUMBER. THE MENTOR MICROBIOLOGY DEPARTMENT HAS PROVIDED INFORMATION ON THE STERILITY LOT FOR THE IMPLANTED DEVICE, INDICATING THAT IT MET ALL STERILIZATION PARAMETERS REQUIRED TO PROVIDE A 10E-6 STERILITY ASSURANCE LEVEL PRIOR TO RELEASE FOR DISTRIBUTION. PRODUCT EVALUATION CONCLUDED THE REPORTED INFECTION OCCURRED FROM A SOURCE OTHER THAN THE DEVICE. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. AT THE PRESENT TIME, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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: GENERALIZED ILLNESS, BREAST PAIN, INFECTION. (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO UNSPECIFIED MENTOR GEL TEXTURED IMPLANTS, SUFFERED BREAST IMPLANT ILLNESS, SEVERE PAIN, AND INFECTION, POST-PROCEDURE. THE GEL WAS REPORTEDLY BLEEDING INTO THE PATIENT'S BODY, AND PATHOLOGY REPORTS SHOWED THAT THE IMPLANTS WERE CAUSING THE INFECTION. AS A RESULT, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. DURING THE SURGERY, A SMALL CAPSULE DEFECT WAS IDENTIFIED, BUT IT WAS NOT SPECIFIED WHICH SIDE IT WAS ON. THE PATIENT HAD FLUID AROUND THE IMPLANTS, WHICH WAS CULTURED AND REPORTEDLY GREW SERRATIA MARCESCENS. THE PATIENT UNDERWENT BILATERAL TOTAL EN BLOC CAPSULECTOMIES AND REMOVAL WITHOUT REPLACEMENTS. THE PATIENT HAS THE IMPLANTS IN A STERILE CONTAINER AND THEY ARE DISCOLORED AND DISINTEGRATING. THE PATIENT WAS VERY SICK BUT IS NOW HEALING. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507111 SILTEX CP LUMERA MOD GEL PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5649704

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention