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MENTOR MEMORYGEL SILICONE GEL BREAST IMPLANTS Device Tracking Silicone gel breast implants are subject

May 09, 2020

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  • Product Insert Data Sheet

    MENTOR® MEMORYGEL™ SILICONE GEL BREAST IMPLANTS

    CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

    STERILE

    102929-001 Rev. C LAB100054097v3 Effective December 2013

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    TABLE OF CONTENTS

    INTRODUCTION.......................................................................................................................................................................................... 5 DIRECTIONS TO THE PHYSICIAN .......................................................................................................................................................... 5 PATIENT COUNSELING INFORMATION ................................................................................................................................................. 5 INFORMED DECISION ........................................................................................................................................................................... 5 DEVICE TRACKING................................................................................................................................................................................ 6

    DEVICE DESCRIPTION ............................................................................................................................................................................... 6 PHYSICIAN TRAINING ........................................................................................................................................................................... 7

    INDICATIONS FOR USE .............................................................................................................................................................................. 8

    CONTRAINDICATIONS ............................................................................................................................................................................... 8

    WARNINGS ................................................................................................................................................................................................. 8 AVOID IMPLANT DAMAGE DURING SURGERY AND OTHER MEDICAL PROCEDURES ......................................................................... 8 MICROWAVE DIATHERMY ..................................................................................................................................................................... 9

    PRECAUTIONS ........................................................................................................................................................................................... 9 SPECIFIC POPULATIONS ...................................................................................................................................................................... 9 SURGICAL PRECAUTIONS .................................................................................................................................................................. 10

    Device Integrity ........................................................................................................................................................................... 10 Surgical Technique ...................................................................................................................................................................... 10 Implant Selection ......................................................................................................................................................................... 10 Incision Site Selection ................................................................................................................................................................. 11 Implant Placement Selection ....................................................................................................................................................... 11 Maintaining Hemostasis/Avoiding Fluid Accumulation ................................................................................................................ 11 Recording Procedure ................................................................................................................................................................... 11 Postoperative Care ...................................................................................................................................................................... 11 Explantation ................................................................................................................................................................................. 12

    INFORMATION TO BE DISCUSSED WITH THE PATIENT ......................................................................................................................... 12 RUPTURE ............................................................................................................................................................................................ 12 EXPLANTATION .................................................................................................................................................................................. 13 REOPERATION .................................................................................................................................................................................... 13 INFECTION .......................................................................................................................................................................................... 13 BREAST EXAMINATION TECHNIQUES ................................................................................................................................................ 13 MAMMOGRAPHY ................................................................................................................................................................................ 13 LACTATION ......................................................................................................................................................................................... 14 AVOIDING DAMAGE DURING OTHER TREATMENT ............................................................................................................................. 14 SMOKING ............................................................................................................................................................................................ 14 RADIATION TO THE BREAST .............................................................................................................................................................. 14 INSURANCE COVERAGE ..................................................................................................................................................................... 14 MENTAL HEALTH AND ELECTIVE SURGERY ...................................................................................................................................... 14 LONG-TERM EFFECTS ........................................................................................................................................................................ 15

    GENERAL ADVERSE EVENTS ASSOCIATED WITH BREAST IMPLANT SURGERY ................................................................................ 15 RUPTURE ............................................................................................................................................................................................ 15 CAPSULAR CONTRACTURE ............................................................................................................................................................... 17 REOPERATION .................................................................................................................................................................................... 17 IMPLANT REMOVAL ........................................................................................................................................................................... 17 PAIN .................................................................................................................................................................................................... 17 CHANGES IN NIPPLE AND BREAST SENSATION ................................................................................................................................ 17

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    INFECTION .......................................................................................................................................................................................... 18 HEMATOMA/SEROMA ........................................................................................................................................................................ 18 UNSATISFACTORY RESULTS .............................................................................................................................................................. 18 BREASTFEEDING COMPLICATIONS ................................................................................................................................................... 18 ADDITIONAL COMPLICATIONS ........................................................................................................................................................... 18

    OTHER REPORTED CONDITIONS ..................................................................