SIENTRA SILICONE GEL BREAST IMPLANTS

Directions for Use

SIENTRA SILICONE GEL BREAST IMPLANTS

Smooth Round, Textured Round and Textured Shaped

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

Revision Date: March 6, 2012

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 SIENTRA'S CLINICAL STUDY...................................................................................17 OVERVIEW ...................................................................................................................17 RUPTURE INFORMATION ON SIENTRA'S 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 .....................................................................................................................31 PATIENT ACCOUNTING AND FOLLOW-UP RATES .............................................31 EFFECTIVENESS OUTCOMES...................................................................................31 Primary Reconstruction Patients........................................................................... 31 Revision-Reconstruction Patients ......................................................................... 32

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SAFETY OUTCOMES ..................................................................................................32 Primary Reconstruction Patients........................................................................... 32 Revision-Reconstruction Patients ......................................................................... 34

REASONS FOR REOPERATION.................................................................................35 Primary Reconstruction Patients........................................................................... 35 Revision-Reconstruction Patients ......................................................................... 36

REASONS FOR IMPLANT REMOVAL ......................................................................36 Primary Reconstruction Patients........................................................................... 36 Revision-Reconstruction Patients ......................................................................... 37

OTHER CLINICAL FINDINGS ....................................................................................38 Rupture.................................................................................................................. 38 Cancer ................................................................................................................... 38 Connective Tissue Disease (CTD)........................................................................ 38 CTD Signs and Symptoms.................................................................................... 38 Lactation Complications ....................................................................................... 39 Reproduction Complications ................................................................................ 39 Suicide................................................................................................................... 39

INSTRUCTIONS FOR USE ...........................................................................................39 PREOPERATIVE PATIENT PROCEDURES ..............................................................39 INSTRUCTIONS FOR OPENING AND INSPECTING THE STERILE PACKAGE.40 INTRAOPERATIVE CONSIDERATIONS ..................................................................40 POSTOPERATIVE CONSIDERATIONS .....................................................................41

MANAGING A RUPTURED IMPLANT .....................................................................41 ADDITIONAL PRODUCT-SPECIFIC INFORMATION ..........................................41

RETURNED MERCHANDISE POLICY ......................................................................41 EXPLANTED DEVICE RETURNS AND REPORTING .............................................42 PRODUCT REPLACEMENT POLICY AND LIMITED WARRANTIES ..................42 PRODUCT ORDERING ................................................................................................42 ACCESS TO ELECTRONIC INFORMATION ............................................................42 REPORTING PROBLEMS ............................................................................................42 DEVICE MANUFACTURER ........................................................................................43 REFERENCES .................................................................................................................44

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INTRODUCTION

DIRECTIONS TO THE PHYSICIAN

The information contained in this Directions for Use (DFU) is intended to provide an overview of essential information about Sientra Silicone Gel Breast Implants (also referred to as the "Implants") including a device description, the indications for use, contraindications, warnings, precautions, important factors for a patient to consider, adverse effects, other reported conditions, and a summary of the Sientra Clinical Study of Silicone Gel Breast Implants (also referred to as the "Study").

Patient Counseling Information

You should review this document and the patient labeling prior to counseling the patient about Sientra Silicone Gel Breast Implants and breast implant surgery. Please familiarize yourself with the content of this document and resolve any questions or concerns prior to proceeding with the use of this device. As with any surgical procedure, breast implantation is not without risks. Breast implantation is an elective procedure, and the patient must be well counseled and understand the risk/benefit relationship.

Before making the decision to proceed with surgery, you or your designated patient care coordinator should instruct the patient to read the document titled: Patient Educational Brochure: Breast Augmentation/Reconstruction with Sientra Silicone Gel Breast Implants (patient labeling), and discuss with the patient the warnings, precautions, important factors to consider, complications, and the Study results listed in the patient labeling. You should advise the patient of the potential complications and that medical management of serious complications may include additional surgery and explantation.

Please refer to the INFORMATION TO BE DISCUSSED WITH THE PATIENT section of this document for additional patient counseling information.

Informed Decision

Each patient should receive Sientra's Patient Educational Brochure: Breast Augmentation/Reconstruction with Sientra Silicone Gel Breast Implants during the patient's initial visit/consultation, to allow the patient sufficient time to read and adequately understand the important information on the risks, follow-up recommendations, and benefits associated with silicone gel breast implant surgery.

Allow the patient at least 1-2 weeks to review and consider this information before deciding to have primary breast surgery. In the case of revision surgery, it may be necessary to perform surgery sooner.

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