BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8791927 · Received July 15, 2019

    Report

    Report Number
    1645337-2019-15365
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    January 1, 2014
    Report Date
    August 15, 2019
    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 08/15/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH THE SUSPECT MEDICAL DEVICE. THE PATIENT¿S RACE IS WHITE AND HER ETHNICITY IS NOT HISPANIC/LATINO. THE PATIENT FIRST NOTICED SYMPTOMS IN 2014. DATE OF EVENT HAS BEEN UPDATED TO (B)(6) 2004. PATIENT DOB IS 09/15/1974. PATIENT AGE AT THE TIME OF EVENT IS 39 YEARS OLD THE EXPLANTATION DATE IS (B)(6) 2019. ON 08/19/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE SUSPECT MEDICAL DEVICE IS A MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESIS, CATALOG #3505001BC, LOT #6510233, SERIAL #(B)(4), 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. -THE IMPLANTATION DATE IS (B)(6) 2012. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 11/01/2019, THE MENTOR FAILURE ANALYSIS LAB 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 12/17/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING EVALUATION OF THE DEVICE A CREASE WAS OBSERVED ON THE ANTERIOR VIEW AND NO ADDITIONAL ANOMALIES WERE OBSERVED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. A CREASE/FOLD FAILURE WITH A LEAKAGE 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 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, PRODUCT EVALUATION 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. 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. 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: AUTOIMMUNE REACTION TO BREAST PROSTHESES, BILATERAL BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST PROSTHESES IMPLANTATION WITH UNSPECIFIED MENTOR BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC AUTOIMMUNE ILLNESSES. IN ADDITION, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE IV) IN BOTH BREASTS. 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 ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585312 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6510233

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention