BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10855311 · Received November 17, 2020

    Report

    Report Number
    1645337-2020-14702
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    June 7, 2016
    Report Date
    October 26, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 15-DEC-2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. IT WAS INITIALLY REPORTED THAT THE SUSPECT MEDICAL DEVICE IS AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS. ADDITIONAL INFORMATION RECEIVED STATES THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESIS, CATALOG #3505001BC, LOT #5729961, SERIAL # (B)(6) , UDI #(B)(4), PMA #P030053. 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. ON 21-DEC-2020, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED AN AUTOIMMUNE DISORDER AND SHE UNDERWENT A CARDIAC ABLATION. DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. THE LAY COMMUNITY, THE POPULAR PRESS AND MEDICAL LITERATURE HAS RAISED THE POSSIBILITY THAT THERE MAY BE AN ASSOCIATION BETWEEN CERTAIN IMMUNOLOGICAL-BASED DISEASES AND SILICONE IMPLANTS. THE DISEASES MOST COMMONLY MENTIONED INCLUDE SCLERODERMA, RHEUMATOID ARTHRITIS AND SYNDROMES WHICH MIMIC SYSTEMIC LUPUS ERYTHEMATOSUS. AVAILABLE INFORMATION DOES NOT PERMIT PRECISE QUANTIFICATION OF RISK. NEUROLOGICAL PROBLEMS HAVE BEEN REPORTED IN A SMALL NUMBER OF BREAST IMPLANT PATIENTS WHO ALSO EXHIBIT IMMUNOLOGICAL SYMPTOMS. MENTOR HAS COMPLETED EXTENSIVE BIOCOMPATIBILITY STUDIES ON THE POLYMER MATERIALS USED IN MANUFACTURE AND FINISHED DEVICES. NONE OF THESE STUDIES HAVE SHOWN ANY INDICATION OF INDUCING IMMUNE RESPONSES. STUDIES ON CARCINOGENICITY, MUTAGENICITY, HEMOLYSIS, DNA TRANSFERS, RESPONSES TO PARTICULATE FORMATION, ETC. HAVE ALL SHOWN THESE MATERIALS TO BE SAFE. EVIDENCE SUGGESTS THAT SUCH DISEASES OR CONDITIONS ARE NO MORE COMMON IN WOMEN WITH BREAST IMPLANTS THAN IN WOMEN WITHOUT IMPLANTS. CONCERN OVER THE ASSOCIATION OF BREAST IMPLANTS TO THE DEVELOPMENT OF AUTOIMMUNE OR CONNECTIVE TISSUE DISEASES, SUCH AS LUPUS, SCLERODERMA, OR RHEUMATOID ARTHRITIS, WAS RAISED BECAUSE OF CASES REPORTED IN LITERATURE WITH SMALL NUMBERS OF WOMEN WITH IMPLANTS. SCIENTIFIC EXPERT PANELS AND LITERATURE REPORTS HAVE FOUND NO EVIDENCE OF A CONSISTENT PATTERN OF SIGNS AND SYMPTOMS ASSOCIATED WITH THESE DISEASES IN WOMEN WITH BREAST IMPLANTS. ADDITIONALLY, HAVING RHEUMATOLOGICAL SIGNS AND SYMPTOMS DOES NOT NECESSARILY MEAN A PATIENT HAS A CONNECTIVE TISSUE DISORDER OR AUTOIMMUNE DISEASE. PER THE FDA¿S ¿UPDATE ON THE SAFETY OF SILICONE GEL-FILLED BREAST IMPLANTS¿ PUBLISHED IN JUNE 2011, ¿THERE IS NO APPARENT ASSOCIATION BETWEEN SILICONE GEL-FILLED BREAST IMPLANTS AND CONNECTIVE TISSUE DISEASE, BREAST CANCER, OR REPRODUCTIVE PROBLEMS.¿ FURTHERMORE, THE INSTITUTE OF MEDICINE (IOM) OF THE NATIONAL ACADEMY OF SCIENCE RELEASED A FINAL REPORT STATING ¿A REVIEW OF SEVENTEEN EPIDEMIOLOGICAL REPORTS OF CONNECTIVE TISSUE DISEASE IN WOMEN WITH BREAST IMPLANTS WAS REMARKABLE FOR ITS CONSISTENCY IN FINDING NO ELEVATED RISKS OR ODDS RATIO FOR AN ASSOCIATION OF IMPLANTS WITH DISEASE¿THERE IS NO EVIDENCE THAT SILICONE IMPLANTS ARE RESPONSIBLE FOR ANY MAJOR DISEASES OF THE WHOLE BODY. WOMEN ARE EXPOSED TO SILICONE CONSTANTLY IN THEIR DAILY LIVES. THERE IS NO PLAUSIBLE EVIDENCE OF A NOVEL AUTOIMMUNE DISEASE CAUSED BY IMPLANTS. BASED ON THESE REPORTS, THE MENTOR PRODUCT EVALUATION (PE) TEAM IS UNABLE TO CONFIRM THAT THE REPORTED COMPLAINTS ARE DEVICE RELATED; HOWEVER, MENTOR CONTINUES TO INCLUDE EXTENSIVE DISCUSSIONS ON ALLEGED SILICONE RESPONSES IN ITS PRODUCT INSERT DATA SHEETS SO THAT THE PATIENT AND PHYSICIAN ARE FULLY INFORMED OF ANY POTENTIAL RISKS. MENTOR BELIEVES ITS CURRENT CONTROLS ARE ADEQUATE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY MENTOR QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. 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: BREAST PROSTHESES REMOVED BECAUSE OF AUTOIMMUNE REACTION. REASON FOR SURGICAL INTERVENTION WAS TO TREAT PATIENT'S SVT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH UNSPECIFIED MENTOR SALINE BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING SUPRAVENTRICULAR TACHYCARDIA (SVT), HEART PALPITATIONS, SHORTNESS OF BREATH, FLU-LIKE SYMPTOMS, ACHY MUSCLES, GLOBUS SENSATION, TMJ, HEADACHES, LOW IRON LEVELS, NECK AND SHOULDER PAIN, RESTLESS LEG SYNDROME, PAINFUL AND SWOLLEN HANDS, POSITIVE ANA, CHRONIC FATIGUE, EAR RINGING, AND LEFT BREAST PAIN. THE PATIENT REPORTED THAT SHE UNDERWENT CARDIAC ABLATION TO TREAT THE SVT. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319334 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5729961

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention