BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10121630 · Received June 4, 2020

    Report

    Report Number
    1645337-2020-06927
    Event Type
    Injury
    Date Received
    June 4, 2020
    Date of Event
    July 1, 2019
    Report Date
    May 13, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000105
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 223026 NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 7/6/2020, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. ON 7/28/2020, DURING THE VISUAL EVALUATION, AN ANOMALY WAS OBSERVED IN THE ANTERIOR AND EXTENDING TO THE POSTERIOR VIEW ON THE DEVICE CONSISTENT WITH A CREASE/FOLD. AN AREA OF SHELL ABRASION WAS OBSERVED IN THE POSTERIOR VIEW. A TEAR WAS ALSO OBSERVED WITHIN THE SHELL ABRASION, MEASURING APPROXIMATELY 0.4 CM 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. 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. CAPSULAR CONTRACTURE COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 325CC ON THE LEFT SIDE AND WITH MENTOR MEMORYGEL BREAST IMPLANT 350CC ON THE RIGHT SIDE AND EXPERIENCED WATERFALL DEFORMITY AND BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITH MENTOR MEMORYGEL BREAST IMPLANT 300CC ON THE LEFT SIDE AND MENTOR MEMORYGEL BREAST IMPLANT 325CC ON THE RIGHT SIDE ON (B)(6) 2020. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583349 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507325BC 223026 00081317000105

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention