BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 12346001 · Received August 19, 2021

    Report

    Report Number
    1645337-2021-09386
    Event Type
    Injury
    Date Received
    August 19, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000471
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. IN ADDITION TO THE RUPTURE REPORTED INITIALLY, THE PATIENT ALSO HAD A BREAST CYST THAT WAS REMOVED DURING SURGERY. BILATERAL REPLACEMENT WITH MENTOR GEL WAS PERFORMED WITH EXPLANT. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE/CYST THE FOLLOWING STATEMENT WAS ADDED TO THE DEVICE EVALUATION SUMMARY: A BREAST CYST IS A FLUID-FILLED SAC WITHIN THE BREAST. ONE BREAST CAN HAVE ONE OR MORE BREAST CYSTS. THEY ARE OFTEN DESCRIBED AS ROUND OR OVAL LUMPS WITH DISTINCT EDGES. BREAST CYSTS ARE USUALLY AND TYPICALLY DO NOT REQUIRE TREATMENT, BUT THEY CAN BE DRAINED USING FINE-NEEDLE ASPIRATION IF THE CYST IS LARGE OR UNCOMFORTABLE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JANUARY 31, 2022, MENTOR BECAME AWARE THAT PATIENT ALSO EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN IN ADDITION TO RIGHT SIDE RUPTURE, AND CYST. ON FEBRUARY 10, 2022, DEVICE RE-EVALUATION WAS COMPLETED, AND SUMMARY WAS UPDATED AS FOLLOWS: MENTOR CONDUCTED VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SMOOTH HPG, 325CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN FOUR PARTS. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN AN AREA OF THE TEAR ON THE POSTERIOR ASPECT, MEASURING APPROXIMATELY 0.4 CM. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. THE CAUSE OF THE RUPTURE IN THE REMAINING AREA OF THE TEAR COULD NOT BE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A BREAST CYST IS A FLUID-FILLED SAC WITHIN THE BREAST. ONE BREAST CAN HAVE ONE OR MORE BREAST CYSTS. THEY ARE OFTEN DESCRIBED AS ROUND OR OVAL LUMPS WITH DISTINCT EDGES. BREAST CYSTS ARE USUALLY AND TYPICALLY DO NOT REQUIRE TREATMENT, BUT THEY CAN BE DRAINED USING FINE-NEEDLE ASPIRATION IF THE CYST IS LARGE OR UNCOMFORTABLE. 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 MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE, CYST, AND CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE IMPACTED PRODUCT WAS RECEIVED BY THE FAILURE ANALYSIS LAB ON AUGUST 25, 2021. THE LOT NUMBER WAS CLARIFIED WITH RECEIPT OF THE DEVICE (7418452). THE SERIAL NUMBER WAS RECEIVED WITH RECEIPT OF THE DEVICE (7418452-018). THE INVESTIGATION OF THE IMPACTED PRODUCT WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON SEPTEMBER 2, 2021. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN FOUR 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. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 WAS PERFORMED FOR THE FINISHED DEVICE 7418452 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: (B)(6) 2017. EXPIRATION DATE: JAN/08/2022. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 6990263 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: (B)(6) 2015. EXPIRATION DATE: OCT/21/2020. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD 325CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED UNILATERAL RUPTURE POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B(6) 2021. THE RUPTURE WAS CONFIRMED WITH EXPLANT. THE RUPTURE WAS STATED TO BE UNILATERAL, HOWEVER TWO DIFFERENT DEVICE LOT/SERIAL NUMBERS WERE PROVIDED TO MENTOR THAT COULD BELONG TO THE RUPTURED DEVICE. THIS IS REFLECTED IN D4. IF ADDITIONAL CLARIFICATION IS RECEIVED IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239895 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503254BC 7418452 00081317000471

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention