BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 12901783 · Received November 30, 2021

    Report

    Report Number
    1645337-2021-13166
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 16, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000334
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 03, 2021, THE MENTOR ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED A RUPTURE WITH A MENTOR GEL BREAST IMPLANT AND DEVELOPED CAPSULAR CONTRACTURE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT WAS RUPTURED IN TWO PIECES. IN ADDITION, A CREASE/FOLD WAS IDENTIFIED AT THE EDGES OF THE RUPTURE. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE WAS CONSISTENT WITH NORMAL WEAR. INSTRUCTIONS FOR USE STATE THAT RUPTURES CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT ARE MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: STRESSING THE IMPLANT DURING IMPLANTATION OR OTHER PROCEDURES AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL. BREAST IMPLANTS MAY ALSO 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 IMPLANT CAPSULES AND EFFUSION TO PATHOLOGY FOR EXAMINATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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: CAPSULAR CONTRACTURE/RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT HAD UNDERGONE A BILATERAL PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF TWO 450CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, AS WELL AS BILATERAL RUPTURING OF THE BREAST PROSTHESES AFTER AN OFFICE VISIT WITH THEIR HCP. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021. CAPSULAR CONTRACTURE AND THE RUPTURES WERE CONFIRMED DURING EXPLANTATION. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2021-13167 FOR THE CONTRALATERAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787385 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504501BC 5617672 00081317000334

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention