BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9321439 · Received November 14, 2019

    Report

    Report Number
    1645337-2019-23818
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    April 1, 2019
    Report Date
    October 24, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 1/2/2020, IT WAS REPORTED TO MENTOR THAT THE DATE OF REMOVAL WAS ON (B)(6) 2020. ON 1/12/2020, IT WAS REPORTED TO MENTOR THAT THE AFFECTED DEVICE WAS MENTOR MEMORYGEL BREAST IMPLANT 325CC, CATALOG NUMBER: 3507325BC, LOT NUMBER: 267245. THE IMPLANT WAS RUPTURED. THE REPLACEMENT DEVICES WERE MENTOR MEMORYGEL BREAST IMPLANT 250CC. ON 1/16/2020, 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 DATE OF IMPLANTATION WAS ON (B)(6) 2004. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 4/23/2020, DURING VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE ANTERIOR VIEW OF THE DEVICE CONSISTENT WITH A CREASE/FOLD. A TEAR MEASURING APPROXIMATELY 4.0 CM WAS ALSO OBSERVED WITHIN THE CREASE/FOLD. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. TRAUMA IS A KNOWN INHERENT RISK OF GEL-FILLED MAMMARY PROSTHESIS. 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 (PRODUCT CODE 3503001BC AND LOT NUMBER 5940353). 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 267245 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 QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, THE CONCLUSION CODE CAUSE NOT ESTABLISHED (4315) WAS REMOVED FOR PROPER CODIFICATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. CONCOMITANT MEDICAL PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 3000CC, CATALOG NUMBER 3503001BC, SERIAL NUMBER (B)(4), LOT NUMBER 5940353. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A GEL MENTOR BREAST IMPLANT OF UNKNOWN TYPE AND EXPERIENCED RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT BREAST IMPLANT. THE PATIENT SUFFERED FROM A SKIING ACCIDENT IN (B)(6) 2019 (CHEST INJURY). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114995 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 267245

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other