SIENTRA SILICONE GEL BREAST IMPLANTS · PDF fileDirections for Use SIENTRA SILICONE GEL BREAST IMPLANTS Smooth Round, Textured Round and Textured Shaped Revision Date: March 6,

Directions for Use

SIENTRA SILICONE GEL BREAST IMPLANTS

Smooth Round, Textured Round and Textured Shaped

Revision Date: March 6, 2012

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

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TABLE OF CONTENTS

TABLE OF CONTENTS .................................................................................................. i INTRODUCTION..............................................................................................................1

DIRECTIONS TO THE PHYSICIAN .............................................................................1 PATIENT COUNSELING INFORMATION ..................................................................1 INFORMED DECISION ..................................................................................................1 DEVICE TRACKING ......................................................................................................2

DEVICE DESCRIPTION .................................................................................................3 INDICATIONS FOR USE ................................................................................................3 CONTRAINDICATIONS .................................................................................................4 WARNINGS .......................................................................................................................4

AVOID DAMAGING THE IMPLANT DURING SURGERY AND OTHER MEDICAL PROCEDURES ............................................................................................4

MICROWAVE DIATHERMY ........................................................................................5 PRECAUTIONS ................................................................................................................5

SPECIFIC POPULATIONS .............................................................................................5 SURGICAL PRECAUTIONS ..........................................................................................5 Surgical Technique ...........................................................................................................5 Implant Selection ..............................................................................................................6 Incision Site Selection .......................................................................................................6 Implant Placement Selection .............................................................................................6

INFORMATION TO BE DISCUSSED WITH THE PATIENT ...................................7 RUPTURE ........................................................................................................................7 EXPLANTATION ............................................................................................................7 REOPERATION ...............................................................................................................8 BREAST EXAMINATION TECHNIQUES ....................................................................8 MAMMOGRAPHY ..........................................................................................................8 LACTATION ....................................................................................................................8 AVOIDING DAMAGE DURING OTHER TREATMENT ............................................9 SMOKING ........................................................................................................................9 RADIATION TO THE BREAST .....................................................................................9 INSURANCE COVERAGE .............................................................................................9 MENTAL HEALTH AND ELECTIVE SURGERY .......................................................9 LONG-TERM EFFECTS .................................................................................................9

GENERAL ADVERSE EFFECTS ASSOCIATED WITH BREAST IMPLANT SURGERY ........................................................................................................................10

RUPTURE ......................................................................................................................10 CAPSULAR CONTRACTURE .....................................................................................11 REOPERATION .............................................................................................................11 IMPLANT REMOVAL ..................................................................................................11 PAIN ...............................................................................................................................12 CHANGES IN NIPPLE AND BREAST SENSATION .................................................12 INFECTION ...................................................................................................................12 UNSATISFACTORY RESULTS ...................................................................................12 BREAST FEEDING COMPLICATIONS ......................................................................13

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ADDITIONAL COMPLICATIONS ..............................................................................13 OTHER REPORTED CONDITIONS ...........................................................................13

CONNECTIVE TISSUE DISEASE DIAGNOSES OR SYNDROMES .......................13 CONNECTIVE TISSUE DISEASE SIGNS AND SYMPTOMS ..................................14 CANCER ........................................................................................................................14 Breast Cancer ..................................................................................................................14 Brain and Nervous System Cancers ................................................................................14 Lympho-Hematopoietic Cancers ....................................................................................14 Anaplastic Large Cell Lymphoma (ALCL) ....................................................................15 Respiratory/Lung Cancer ................................................................................................15 Reproductive System Cancers ........................................................................................15 Other Cancers ..................................................................................................................15 NEUROLOGICAL DISEASE, SIGNS, AND SYMPTOMS .........................................16 SUICIDE .........................................................................................................................16 EFFECTS ON CHILDREN ............................................................................................16 POTENTIAL HEALTH CONSEQUENCES OF GEL BLEED ....................................16

SIENTRAS CLINICAL STUDY ...................................................................................17 OVERVIEW ...................................................................................................................17 RUPTURE INFORMATION ON SIENTRAS IMPLANTS ........................................21 PRIMARY AUGMENTATION AND REVISION-AUGMENTATION PATIENTS ..21 PATIENT ACCOUNTING AND FOLLOW-UP RATES .............................................21 EFFECTIVENESS OUTCOMES ...................................................................................22

Primary Augmentation Patients ............................................................................ 22 Revision-Augmentation Patients .......................................................................... 22

SAFETY OUTCOMES ..................................................................................................23 Primary Augmentation Patients ............................................................................ 23 Revision-Augmentation Patients .......................................................................... 25

REASONS FOR REOPERATION .................................................................................26 Primary Augmentation Patients ............................................................................ 26 Revision-Augmentation Patients .......................................................................... 27

REASONS FOR IMPLANT REMOVAL ......................................................................28 Primary Augmentation Patients ............................................................................ 28 Revision-Augmentation Patients .......................................................................... 29

OTHER CLINICAL FINDINGS ....................................................................................29 Cancer ................................................................................................................... 29 Connective Tissue Disease ................................................................................... 30 CTD Signs and Symptoms .................................................................................... 30 Lactation Complications ....................................................................................... 30 Reproduction Complications ................................................................................ 31 Suicide................................................................................................................... 31

PRIMARY RECONSTRUCTION AND REVISION-RECONSTRUCTION PATIENTS ...................................................................................................