BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 18275470 · Received December 6, 2023

    Report

    Report Number
    1645337-2023-14341
    Event Type
    Injury
    Date Received
    December 6, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000273
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 19, 2023, MENTOR RECEIVED ADDITIONAL INFORMATION. LOT 5843098 WAS CLARIFIED AS THE LEFT DEVICE. THE PATIENT'S DATE OF IMPLANT WAS ADDED AS (B)(6) 2008. ON DECEMBER 16, 2023, MENTOR RECEIVED THE DEVICE FOR EVALUATION. ON DECEMBER 21, 2023, MENTOR COMPLETED A VISUAL INSPECTION OF THE RETURNED DEVICE. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN THREE (3) PARTS. AS THE AUTHORIZATION FORM FOR EXAMINATION WAS NOT RECEIVED THE PRODUCT EVALUATION LAB COULDN'T IDENTIFY A CONCLUSION DUE TO THE SPECIFIC NATURE OF THIS RUPTURE. THE EVALUATION WAS LIMITED TO NON-DESTRUCTIVE TESTING. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING THINGS MAY CAUSE THE IMPLANT TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS; STRESSING THE IMPLANT DURING IMPLANTATION AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL; EXCESSIVE FORCE TO THE CHEST (E.G. DURING CLOSED CAPSULOTOMY); TRAUMA; COMPRESSION DURING MAMMOGRAPHIC IMAGING; AND SEVERE CAPSULAR CONTRACTURE. 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, 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. 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. 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 PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT AND AN UNSPECIFIED 275CC MENTOR SMOOTH GEL IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNSPECIFIED NON-MENTOR BREAST IMPLANTS ON (B)(6), 2023. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE PATIENT¿S PROSTHESES WERE RUPTURED. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED DUE TO THE RUPTURES DISCOVERED DURING THE REVISION SURGERY. ALTHOUGH THE LOT NUMBER WAS RECEIVED FOR ONE OF THE IMPLANTED DEVICES, THE SIDES OF IMPLANTATION WERE NOT DISCLOSED TO MENTOR. THE DEVICES WILL BE IDENTIFIED AS SIDE A AND SIDE B. NO DATE OF IMPLANTATION WAS PROVIDED. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR SIDE A. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14342 FOR THE CONTRALATERAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071313 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5843098 00081317000273

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention