BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10107306 · Received June 1, 2020

    Report

    Report Number
    1645337-2020-06742
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    January 30, 2020
    Report Date
    May 12, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317003809
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 28-DEC-2020, MENTOR COMPLETED A SECOND INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION REPORTED, A RUPTURE OCCURRED IN THE BREAST IMPLANT. DURING A VISUAL INSPECTION, THE DEVICE WAS FOUND TO BE RUPTURED, IT WAS RECEIVED IN TWO PIECES. A CREASE/FOLD WAS ALSO OBSERVED WITHIN THE TEAR. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A CREASE FOLD RUPTURE OF THE IMPLANT SHELL, WHICH IS A KNOWN INHERENT RISK OF GEL-FILLED MAMMARY PROSTHESIS. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN A RUPTURE IN A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. A SECOND PRODUCT WAS RECEIVED WITH LOT #6893133. NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE. THEREFORE, NO FURTHER ANALYSIS IS REQUIRED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS 6860823 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. RUPTURE 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 · 0

    ON 24-JUN-2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT¿S RACE IS WHITE AND HER ETHNICITY IS NOT HISPANIC/LATINO. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST. ON (B)(6) 2021, MENTOR COMPLETED AN ADDITIONAL INVESTIGATION ON THE SUSPECT MEDICAL DEVICE TO ADDRESS THE RECENTLY REPORTED CAPSULAR CONTRACTURE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION REPORTED, THE PATIENT EXPERIENCED A RUPTURE IN THE BREAST IMPLANT AND DEVELOPED CAPSULAR CONTRACTURE. DURING A VISUAL INSPECTION, THE DEVICE WAS FOUND TO BE RUPTURED, IT WAS RECEIVED IN TWO PIECES. A CREASE/FOLD WAS ALSO OBSERVED WITHIN THE TEAR. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A CREASE FOLD RUPTURE OF THE IMPLANT SHELL, WHICH IS A KNOWN INHERENT RISK OF GEL-FILLED MAMMARY PROSTHESIS. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN A RUPTURE IN A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST WAS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. A SECOND PRODUCT WAS RECEIVED (LOT #6893133). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF LOT #6860823 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. RUPTURE AND CAPSULAR CONTRACTURE 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 · 0

    ON 09-JUN-2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON 21-JUN-2020, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION REPORTED, A RUPTURE OCCURRED IN THE BREAST IMPLANT. DURING A VISUAL INSPECTION, THE DEVICE WAS FOUND TO BE RUPTURED. PLEASE NOTE THAT THE PRODUCT EVALUATION LAB COULDN'T IDENTIFY A CONCLUSION DUE TO THE SPECIFIC NATURE OF THIS RUPTURE AND INSUFFICIENT PAPERWORK. THE EVALUATION WAS LIMITED TO NON-DESTRUCTIVE TESTING. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS 6860823 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. RUPTURE 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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RIGHT BREAST PROSTHESIS RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES ON (B)(6) 2020

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571148 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504251BC 6860823 00081317003809

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention