With Sientra Breast Implants PATIENT EDUCATIONAL BROCHURE

1. How To Use This Educational Brochure 10 2. General Information About Breast Augmentation With Breast Implants 11 2.1 What Gives The Breast Its Shape? 11 2.2 What Is A Silicone Gel Breast Implant? 12 2.3 How Do Breast Implants Work In Breast Augmentation? 12 3. Deciding Whether To Have Breast Augmentation Surgery With Implants 12 3.1 Am I Eligible For Augmentation With Silicone Gel Breast Implants? 13 3.5 What Are The Alternatives To Implantation With Silicone Gel-Filled Breast Implants? 17 4. Risks Associated With Breast Implants 18 4.1 What Are The Potential Complications? 22 4.2 What Are...

8. Sientra's Clinical Study Results 51 8.2 What Are The 3-Year Follow-Up Rates? 53 8.4 What Were The 3-Year Complication Rates? 54 8.5 What Are The Main Reasons For Reoperation? 56 8.6 What Are The Main Reasons For Implant Removal? 59 8.7 What Are Other Clinical Data Findings? 60 9. What To Do If You Have A Problem 63 10. Where To Find More Information 64 11. Sientra's Implant Tracking Program 65 11.1 Breast Implant Tracking 66 11.2 Device Identification Card 66 12. Important Contact Information 67 14. Acknowledgement Of Informed Decision 69 15. Device Tracking And Limited Warranty Enrollment...

Glossary Abdomen Anaplastic Large Cell Lymphoma (ALCL) ALCL is not breast cancer; it is a rare type of non-Hodgkin’s lymphoma (cancer of the immune system). The pigmented or darker colored area of skin surrounding the nipple. Uneven appearance between a woman’s left and right breasts in terms of their size, shape, or breast level. Thinning or diminishing of tissue or muscle. Autoimmune Disease An autoimmune disease is a disease in which the body’s immune system attacks its own cells or tissues by mistake, causing damage and dysfunction. Autoimmune diseases can affect connective tissue in the...

Breast Augmentation A surgical procedure to increase breast size and to treat such conditions as sagging or drooping of the breast (ptosis) or breasts of different size, shape, or placement (asymmetry). The first time a breast implant is placed to increase breast size or treat such conditions as ptosis or asymmetry, it is referred to as “primary augmentation.” Any time there is another surgery to replace the implant, it is referred to as “revisionaugmentation.” Breast Implant Any surgically implanted artificial device intended to replace missing breast tissue or to enhance a breast. Breast Mass...

Scar tissue that forms around the breast implant. Capsulotomy (Closed) An attempt to break the scar tissue capsule around the implant by pressing or pushing on the outside of the breast. This method does not require surgery but may rupture the implant and is contraindicated (meaning that the procedure is improper and should not be performed). Capsulotomy (Open) A surgery to create an incision or opening in the capsule (scar tissue). Chest Wall The system of structures outside the lungs that move as a part of breathing, including bones (the rib cage) and muscles (diaphragm and abdomen). Congenital...

Movement of the implant from the usual or proper place. Skin breakdown with the implant pressing through the skin or surgical incision. Fibrocystic Breast Disease Common, benign (noncancerous) changes in the tissues of the breast. The term “disease” is misleading, and many doctors prefer the term “change.” The condition is so commonly found in breasts, it is believed to be a variation of normal. Other related terms include “mammary dysplasia,” “benign breast disease,” and “diffuse cystic mastopathy.” A chronic condition characterized by widespread pain in muscles and joints. It may include fatigue,...

Inframammary Fold The crease under the breast where the breast and chest meet. Inframammary Incision An incision made in the fold below the breast. The production and secretion of milk by the breast glands. Local Complications Complications that occur in the breast or chest area. Lymph Nodes Lymph nodes are glands that play an important part in the body’s defense against infection. They produce lymph, which travels throughout the body in the lymph system, and filters impurities from the body. Common areas where the lymph nodes can be felt with the fingers include: groin, armpit, neck, under the...

Death of cells or tissues. Palpability is when the implant can be felt through the skin. Visibility is when the implant can be seen through the skin. Major muscle of the chest. The areola is the pigmented or darker colored area of skin surrounding the nipple. Periareolar refers to the area just around the areola. Around the belly button. Plastic Surgery Surgery intended to enhance or improve the appearance of the body. A metallic element used to help make both silicone elastomer (the rubbery material of the breast implant shell) and silicone gel. After surgery. Information that warns the reader...

Rosenberg Self-Esteem A questionnaire that measures overall self-esteem. Scale Rupture Saltwater (A solution made of water and a small amount of salt). Scar Revision A surgical procedure to improve the appearance of a scar. Formation of tissue at an incision site; all wounds heal by the formation of a scar. Similar to a bruise, a seroma occurs when the watery portion of the blood collects around a surgical incision or around a breast implant. The Short Form 36 Health Scale; a questionnaire intended to measure physical, mental, and social health. Sientra Clinical Study The clinical Study that...

Silicone Elastomer A type of silicone that has elastic properties similar to rubber. Silicones - Low Molecular Small silicone molecules that may be present in gel Weight (“Low Molecular bleed/gel diffusion. Weight [LMW] Silicones”) Subglandular Placement When the implant is placed under and within the breast glands (breast tissue) but on top of the chest muscles. Submuscular Placement When the implant is placed underneath the chest muscles. Surgical Incision A cut made to body tissue during surgery. Any perceptible change in the body or its functions that indicates disease or a phase of a disease....