Sientra Silicone Gel Breast Implants
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Breast Implants Quick Facts About Breast

About This Brochure This brochure is intended to provide you with a high level overview of the facts about breast implant surgery with Sientra’s FDA-Approved Silicone Gel Breast Implants. This brochure is not intended to replace consultation with your surgeon. For a complete review of the benefits and risks of breast implant surgery, please read the appropriate Patient Educational Brochure, Breast Augmentation with Sientra Silicone Gel Breast Implants or Breast Reconstruction with Sientra Silicone Gel Breast Implants, available from your surgeon and posted on www.sientra.com. You may also...

TABLE 1 Complication Rates Reported through 3 Years Complication Primary Augmentation N=1,115 patients Revision Augmentation N=362 patients Primary Reconstruction N=229 patients Revision Reconstruction N=82 patients Implant removal with replacement Implant removal without replacement Capsular Contracture (Baker Grade III/IV) Implant Rupture MRI Cohort Non-MRI Cohort Other Complications Occurring in 1% or more of Patients1,2 Asymmetry Breast mass/cyst/ lump Breast pain Delayed wound healing Hypertrophic/ abnormal scarring Implant extrusion Implant malposition Implant visibility Nipple...

Table 1 presents the complication rates reported in Sientra’s Clinical Study through 3 years. Implant Removal Breast implants may be removed (with or without replacement) in response to a complication or to improve the cosmetic result. In Sientra’s Clinical Study, through 3 years, the most common reason for implant removal in all four Study cohorts was patient request for an implant size or style change (ranging from 40% to 56% of all implant removals). Figures 1 through 4 below present the reasons for implant removal in Sientra’s Clinical Study through 3 years. Figure 1. Reasons for...

Figure 2. Reasons for Implant Removal Revision-Augmentation Cohort Patient Request for Size/ Style Change Implant Malposition Capsular Contracture Breast Cancer Figure 3. Reasons for Implant Removal Primary Reconstruction Cohort Patient Request for Size/ Style Change Delayed Wound Healing 11

Figure 4. Reasons for Implant Removal through 3 Years Revision-Reconstruction Cohort (n=30 implants) Patient Request for Size/ Style Change Asymmetry Implant Malposition Pain Trauma Breast Cancer Capsular Contracture Hematoma/Seroma Infection Wrinkling/Rippling For a more detailed review of potential complications, please refer to Section 4, Risks Associated With Breast Implants, of the appropriate Patient Educational Brochure for breast augmentation or reconstruction with Sientra’s Silicone Gel Breast Implants. Important Factors To Consider Before you have surgery, you should have a...

CAUTION: Notify your doctor if you have any of the following conditions as the risks of breast implant surgery may be higher if you have any of these conditions • A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease), Conditions that interfere with wound healing and/or blood clotting, Reduced blood supply to breast tissue, Chemotherapy or radiation to the breast following implantation, or Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. If you have been...

Many of the changes to your breast that may occur as a result of breast implant surgery will be permanent and cannot be undone. Breast implants may interfere with your ability to produce milk (lactate) for breast-feeding. Mammography for detecting breast cancer (or cancer recurrence) may be more difficult with breast implants in place. Be sure to notify the technologist that you have breast implants prior to the procedure. Your implants could rupture without you noticing any change in your breasts (called a “silent” rupture). Because silent ruptures can occur and because they are difficult...

Breast Implant Surgery – Understanding The Procedure Before your breast implant surgery, you and your plastic surgeon will discuss the implant placement and surgical incision options, as well as your expected postoperative care. IMPLANT PLACEMENT Your surgeon will consult with you and suggest where the breast implant is to be placed. Implants are placed beneath your breast tissue, either on top of the chest muscle (subglandular placement) or underneath part or all of the chest muscle (submuscular placement). Figure 5: Implant Placement Breast before augmentation Breast after subglandular...

INCISION SITES Your surgeon will suggest the best incision site option for your particular surgery. There are three common incision sites to consider: Figure 6: Incision Sites Transaxillary (in the armpit) Periareolar (around the nipple) Inframammary (under the breast at the crease where the breast meets the body) POSTOPERATIVE CARE In the weeks after your breast implant surgery, the skin over your breasts may feel tight as it adjusts to your new breast size. After your stitches are removed, your doctor may tell you to massage your incision site(s) with a cream or lotion to keep the skin...

Breast Implants Are Not Lifetime Devices Breast implants are not expected to last for the rest of your life, and breast implantation may not be a one-time surgery. It is likely that you will need other surgery related to your breast implants over the course of your life. Patients may require a reoperation for a number of reasons, including size and/or style change, implant removal (with or without replacement), capsular contracture procedures, incision and drainage, implant repositioning, scar revision, or to address some of the complications mentioned in Table 1 on page 5. Additional...

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