BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 7715642 · Received July 24, 2018

    Report

    Report Number
    1645337-2018-04479
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    June 3, 2018
    Report Date
    July 3, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317005247
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 08/02/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE GEL CONTAINED IN THE DEVICE APPEARS CLEAR. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. UPON VISUAL EXAMINATION, THE DEVICE APPEARS INTACT. NO OTHER ANOMALIES WERE DISCOVERED. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. PER THE FDA, BASED ON AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO CONFIRM WITH STATISTICAL CERTAINTY THAT BREAST IMPLANTS CAUSE ALCL. BECAUSE ALCL IS SO RARE, EVEN IN BREAST IMPLANT PATIENTS, A DEFINITIVE STUDY WOULD NEED TO COLLECT DATA ON HUNDREDS OF THOUSANDS OF WOMEN FOR MORE THAN 10 YEARS. EVEN THEN, CAUSALITY MAY NOT BE CONCLUSIVELY ESTABLISHED. MENTOR ADHERES TO FDA REPORTABILITY GUIDELINES FOR ALL COMPLAINTS OF ALCL AND LYMPHOMA. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 2/28/19, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE GEL CONTAINED IN THE DEVICE APPEARS CLEAR. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. UPON VISUAL EXAMINATION, THE DEVICE APPEARS INTACT. NO OTHER ANOMALIES WERE DISCOVERED. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S5, THIS IS LIFE THREATENING CONDITION AND NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. PER THE FDA, BASED ON AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO CONFIRM WITH STATISTICAL CERTAINTY THAT BREAST IMPLANTS CAUSE ALCL. BECAUSE ALCL IS SO RARE, EVEN IN BREAST IMPLANT PATIENTS, A DEFINITIVE STUDY WOULD NEED TO COLLECT DATA ON HUNDREDS OF THOUSANDS OF WOMEN FOR MORE THAN 10 YEARS. EVEN THEN, CAUSALITY MAY NOT BE CONCLUSIVELY ESTABLISHED. MENTOR ADHERES TO FDA REPORTABILITY GUIDELINES FOR ALL COMPLAINTS OF ALCL AND LYMPHOMA. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE PE WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD ( DHR) OF LOT NUMBER 6891385 REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: GEL MENTOR MEMORYSHAPE BREAST IMPLANT 685CC , CATALOG NUMBER 3341452, SERIAL NUMBER (B)(4), LOT NUMBER 6897745. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WITH HISTORY OF INVASIVE DUCTAL CARCINOMA IN HER LEFT BREAST WHO UNDERWENT RECONSTRUCTION WITH GEL MENTOR MEMORYSHAPE BREAST IMPLANT 620CC ON (B)(6) 2015 IN HER LEFT BREAST AND (B)(6) 2015 IN HER RIGHT SIDE WITH GEL MENTOR MEMORYSHAPE BREAST IMPLANT 685CC PRESENTED WITH ITCHING AND SWELLING OF HER LEFT BREAST THAT WAS A LATE ONSET SEROMA. ADDITIONALLY, THE PATIENT'S RIGHT SIDE BREAST IMPLANT FLIPPED. THE PATIENT WAS DIAGNOSED WITH CD30+ , ALK - BIA ALCL IN HER LEFT BREAST ON (B)(6) 2018. THE LYMPHOMA CELLS WERE FOUND OUTSIDE THE CAPSULE, IN THE SUBCUTANEOUS TISSUE, AND AROUND THE LYMPH NODE. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH NON MENTOR GEL IMPLANTS ON (B)(6) 2018. FOLLOW UP IS IN PROGRESS. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS CONSIDERED SERIOUS AND REPORTABLE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556392 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6891385 00081317005247

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention