Patient Label Reconstruction
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Breast Reconstruction With Sientra Silicone Gel Breast Implants Pat i e n t E d u c at i o n a l B r o c h u r e

1. How To Use This Educational Brochure 15 2. General Information About Breast Reconstruction With Breast Implants 16 2.1 What Gives The Breast Its Shape? 16 2.2 What Is A Silicone Gel Breast Implant? 17 2.3 How Do Breast Implants Work In Breast Reconstruction? 17 3. Deciding Whether To Have Breast Reconstruction Surgery With Silicone Gel Breast Implants? 18 3.5 What Are The Alternatives To Implantation With Silicone Gel-Filled Breast Implants? 23 4. Risks Associated With Breast Implants 23 4.1 What Are The Potential Complications? 27 4.2 What Are Other Reported Conditions? 36 5. Benefits...

7. Caring For Yourself After Breast Implant Surgery 61 7.1 Postoperative Care In The Hours And Days After Surgery 61 7.2 Postoperative Care In The First Weeks After Surgery 62 7.3 Caring For Yourself In The Months And Years After Surgery 63 7.4 Monitoring Your Implants For Rupture 65 8. Sientra's Clinical Study Results 67 8.2 What Are The 3-Year Follow-Up Rates? 68 8.4 What Are The 3-Year Complication Rates? 69 8.5 What Are The Main Reasons For Reoperation? 72 8.6 What Are The Main Reasons For Implant Removal? 74 8.7 What Are Other Clinical Data Findings? 76 9. What To Do If You Have A...

Glossary Abdomen The part of the body between the upper chest (breasts) and the pelvis (hips); often called the stomach. Anaplastic Large Cell ALCL is not breast cancer; it is a rare type of Lymphoma (ALCL) non-Hodgkin’s lymphoma (cancer of the immune system). Areola The pigmented or darker colored area of skin surrounding the nipple. Asymmetry Uneven appearance between a woman’s left and right breasts in terms of their size, shape, or breast level. Atrophy Thinning or diminishing of tissue or muscle. Autoimmune Disease An autoimmune disease is a disease in which the body’s immune system...

Body Esteem Scale A series of questions asking about a person’s feelings about his or her body. 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 “revision-augmentation.” Breast Implant Any surgically...

Capsular Contracture Tightening of the scar tissue (also called a capsule) that normally forms around the breast implant during the healing process after surgery. In some women, the scar tissue (capsule) squeezes the implant. When this occurs, it is called capsular contracture. This results in firmness or hardening of the breast. Capsular contracture is classified by a scale named Baker Grade. Capsule 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...

CORE Clinical Study The major clinical study that supports the approval of a medical product (such as breast implants). For Sientra’s breast implants, the CORE study includes augmentation, reconstruction, and revision (revision-augmentation and revisionreconstruction) patients. Information on the safety and effectiveness of the implants are collected every year for 10 years after study participants get their implants. Delayed Reconstruction Breast reconstruction that takes place weeks, months, or years after a mastectomy. Delayed Wound Healing Unusually slow progress in the healing of a...

Free TRAM Flap A TRAM (transverse rectus abdominus musculocutaneous) flap (section of skin, muscle and other tissue from the abdomen) that is disconnected from (completely cut away from) the blood vessels in the rest of the body before being relocated to the breast area for reconstruction. The blood vessels must then be surgically reconnected when the flap is placed at the breast. Gel Bleed/Gel Diffusion When silicone gel leaks or “bleeds” or “diffuses” through the implant shell. Granuloma Noncancerous lumps that can form around foreign material, such as silicone. Like any lump, it should...

Latissimus Dorsi Two triangular muscles running from the spinal column (backbone) to the shoulder. Latissimus Dorsi Flap A section of muscle and tissue on a person’s back, consisting of the latissimus dorsi muscle, skin, fat, connective tissue, and vascular [blood vessels] tissue. Latissimus Dorsi Flap Reconstruction Breast reconstruction using a patient’s own tissue (a latissimus dorsi flap) from the side of the back to create the new breast or provide enough skin and breast tissue to cover a breast implant. Local Complications Complications that occur in the breast or chest area. Lymph...

Surgical procedure to raise and reshape sagging breasts. Metastatic Disease A stage of cancer after it has spread from its original site to other parts of the body. Migration/Gel Migration Movement of silicone material outside the breast implant to other areas of the body. MRI (Magnetic Resonance Imaging) MRI uses a magnetic field to create a 3-dimensional picture of a body part or organ. MRI is the imaging method that currently has the best ability to detect rupture of silicone gel breast implants. Necrosis Death of cells or tissues. Oncologist A medical doctor who specializes in...

Platinum A metallic element used to help make both silicone elastomer (the rubbery material of the breast implant shell) and silicone gel. Post-Mastectomy After a mastectomy. Postoperative After surgery. Precautions Information that warns the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Prosthesis Any artificial device used to replace or represent a body part. Ptosis Sagging or drooping of the breast. Bleeding at the surgical site that causes discoloration and varies in degree and length of time. This is expected following breast...