ROUND GOES GUMMY. High gel fi ll ratio and our most cohesive gel together at last. 1-3, * *Most cohesive in the US.

Transcription

1 N atrelle INSPIRA COHESIVE ROUND GOES GUMMY High gel fi ll ratio and our most cohesive gel together at last. 1-3, * *Most cohesive in the US. Please see inside for Indications and Important Safety Information.

2 Breast shaping goes more cohesive Now you can shape the breasts with the same high gel fi ll ratio and fullness you expect from Natrelle INSPIRA, but with a more cohesive round gel implant. 1-3 In vivo signifi cance has not been established. Bench Testing Comparing Gel Cohesivity of Natrelle INSPIRA Cohesive, Mentor MemoryGel, and Sientra Style 106 Breast Implants ex Vivo (Sientra style 107 was not available for testing) Less elastic deformation = cohesive 2, * Less cohesive cohesive cohesive 3.3 mm 5.2 mm 6.7 mm Elastic Deformation (mm) Natrelle INSPIRA Cohesive Sientra Style 106 Mento r MemoryGe l 51% more cohesive than Mentor MemoryGel. 37% more cohesive than Sientra style 106. * Methodology Breast implant gel was measured for material properties using the BTC The BTC-2000 applies a controlled vacuum, or negative pressure, to the gel while measuring the dynamic response of material deformation using a synchronized target laser. The gel for each device (n = 8 per group) was tested at 3 sites, all at or near the apex of the implant (anterior side). From those measurements, the gel cohesivity was calculated and the relative change was determined. Natrelle, Natrelle INSPIRA, and Natrelle 410 Shaped Silicone-Filled Breast Implants Important Information INDICATIONS Indicated for women for the following: Breast augmentation for women at least 22 years old for silicone-filled implants. Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Breast implant surgery should not be performed in: Women with active infection anywhere in their body. Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions. Women who are currently pregnant or nursing.

3 Breast shaping goes more form stable The most form-stable round implant in our collection, Natrelle INSPIRA Cohesive is proven to hold its shape. 4,5 In vivo signifi cance has not been established. Bench Testing Comparing Form Stability of Natrelle INSPIRA Cohesive, Mentor MemoryGel, and Sientra Style 106 Breast Implants ex Vivo (Sientra style 107 was not available for testing) Lower overall changes in height and projection = form stable 4,6, * Less form stable form stable form stable 38.1% 52.9% 71.9% Total Net Percentage Change Natrelle INSPIRA Cohesive Sientra Style 106 Mentor MemoryGel 47% more form stable than Mentor MemoryGel. 28% more form stable than Sientra style 106. * Methodology Breast implant devices (n = 6 per group) were placed in a horizontal orientation on a sliding stage; the width and maximum projections of the implants were measured using fi xed calipers. The devices were then placed in a vertical-supported orientation using a 90º angle, and the width and maximum projections were measured again. From those measurements, the retention of dimension was calculated and the relative change was determined. Natrelle Silicone-Filled Breast Implants IMPORTANT SAFETY INFORMATION (continued) WARNINGS Breast implants are not lifetime devices or necessarily a one-time surgery. Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Use care when using surgical instruments in proximity with the breast implant. For more information, please see the full Directions for Use. PRECAUTIONS Safety and effectiveness have not been established in patients with the following: Autoimmune diseases (eg, lupus and scleroderma). A compromised immune system (eg, currently receiving immunosuppressive therapy). Planned chemotherapy following breast implant placement. Planned radiation therapy to the breast following breast implant placement. Conditions or medications that interfere with wound healing and blood clotting. Reduced blood supply to breast tissue. Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery. Please see additional Natrelle Silicone-Filled Breast Implants Important Safety Information inside.

4 Shaping by design It s what s inside that counts. Natrelle INSPIRA Cohesive is made to retain its shape. Designed to stay in place. Natrelle INSPIRA Cohesive features highly cohesive gel that holds together. Designed to maintain upper pole fullness.* The highly cohesive gel in Natrelle INSPIRA Cohesive is designed to prevent downward movement, helping the implant maintain a form-stable upper pole. 4, * Even when the implant is cut ex vivo, the gel stays in place. *Based on implant performance testing; clinical signifi cance has not been established. Even when the implant is held upright, it retains its shape. Cohesive Gel In vivo signifi cance has not been established. Natrelle Silicone-Filled Breast Implants IMPORTANT SAFETY INFORMATION (continued) ADVERSE EVENTS Key adverse events are reoperation, implant removal with or without replacement, implant rupture, and capsular contracture Baker Grade III/IV. Other potential adverse events that may occur with breast implant surgery include: asymmetry, breast pain, breast/skin sensation changes, capsular calcifi cation, delayed wound healing, hematoma, hypertrophic scarring/scarring, implant extrusion, implant malposition, implant palpability/visibility, infection, nipple complications, redness, seroma, swelling, tissue/skin necrosis, wrinkling/rippling. For more information see the full Directions for Use at To report a problem with Natrelle, Natrelle INSPIRA, and Natrelle 410 Shaped Silicone-Filled Breast Implants, please call Allergan at Natrelle, Natrelle INSPIRA, and Natrelle 410 Shaped Silicone-Filled Breast Implants are available by prescription only. Natrelle 133 Tissue Expanders with/without Suture Tabs and with Magna-Site Injection Sites Important Information Indications Natrelle 133 Tissue Expanders are indicated for: Breast reconstruction following mastectomy. Treatment of underdeveloped breasts. Treatment of soft tissue deformities. Please see Natrelle 133 Tissue Expanders Important Safety Information on following pages.

5 Shaping the future with you The Natrelle Collection is where breast shaping begins. Natrelle INSPIRA Cohesive Round Gel Breast Implants Our most cohesive round gel breast implant. 2,3 Natrelle INSPIRA Round Gel Breast Implants #1 selected smooth round gel implant in the US. 7, * *Based on surgeon survey data, May 2016 (N = 100). Natrelle 410 Anatomically Shaped Breast Implants #1 selected anatomically shaped implant in the US. 8, Based on US market share data through June 2016 (N = 104). Natrelle 133 Tissue Expanders #1 selected tissue expander. 8, Based on US market share data through June 2016 (N = 104). Natrelle 133 Tissue Expanders IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Natrelle 133 Tissue Expanders SHOULD NOT be used in patients: Who already have implanted devices that would be affected by a magnetic fi eld (e.g., pacemakers, drug infusion devices, artifi cial sensing devices). Whose tissue at the expansion site is determined to be unsuitable. Who have an active infection or a residual gross tumor at the expansion site. Undergoing adjuvant radiation therapy. Whose physiological condition (e.g., sensitive over or underlying anatomy, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use of certain drugs (including those that interfere with blood clotting or affect tissue viability) poses an unduly high risk of surgical and/or postoperative complications. Who are psychologically unsuitable. WARNINGS DO NOT use Natrelle 133 Tissue Expanders in patients who already have implanted devices that would be affected by a magnetic fi eld (see Contraindications), because the MAGNA-SITE integrated injection site contains a strong rare-earth, permanent magnet. Diagnostic testing with Magnetic Resonance Imaging (MRI) is contraindicated in patients with Natrelle 133 Tissue Expanders in place. DO NOT alter the tissue expander or use adulterated fi ll. Fill only with sterile saline for injection as described in INSTRUCTIONS FOR USE. DO NOT expose to contaminants. DO NOT expand if the pressure will compromise wound healing or vasculature of overlying tissue, or beyond patient or tissue tolerance. Stop fi lling immediately if tissue damage, wound dehiscence, abnormal skin pallor, erythema, edema, pain, or tenderness are observed. Active infection anywhere may increase risk of periprosthetic infection. Postoperative infections should be treated aggressively. Unresponsive or necrotizing infection may require premature removal. Natrelle 133 Tissue Expanders are temporary, single use only devices, and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires four to six months. When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs. Please see additional Natrelle 133 Tissue Expanders Important Safety Information on back cover.

6 GO ROUND GO GUMMY GO WITH Natrelle INSPIRA Cohesive Natrelle INSPIRA Cohesive has a high gel fill ratio* an implant feature surgeons (n = 39) cite as a top attribute. 1,9 Highly cohesive gel is designed to stay in place and maintain upper pole fullness. 4, *, The most cohesive round gel breast implant in the Natrelle Collection. 2,3 Choosing the right Natrelle INSPIRA Cohesive breast implant is convenient, with the same available sizes, projections, and systematic diameter sizing as Natrelle INSPIRA. *Clinical signifi cance has not been established. Based on implant performance testing. Ready to go gummy? Ask your Allergan sales representative for a live cohesivity demonstration so you can see and feel the difference with Natrelle INSPIRA Cohesive. Natrelle 133 Tissue Expanders IMPORTANT SAFETY INFORMATION (continued) PRECAUTIONS Active infections may need to be treated and resolved before surgery. Allergan relies on the surgeon to know and follow proper surgical procedures and carefully evaluate patient suitability using standard practice and individual experience. Avoid damage to the tissue expander and use a sterile back-up in case of damage. Pay careful attention to tissue tolerance and hemostasis during surgery. Expansion should proceed moderately and never beyond patient or tissue tolerance. Avoid contamination in any postoperative procedure. ADVERSE REACTIONS Defl ation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue fl ap, and infl ammatory reaction. For more information, please visit To report a problem with Natrelle, please call Allergan at Natrelle 133 Tissue Expanders are available by prescription only. References: 1. Data on fi le, Allergan. 2. Data on fi le, Allergan, August 31, 2016; Study Report MD16064-DV. 3. Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Breast Implants: Smooth & BIOCELL Texture Directions for Use, Data on fi le, Allergan, September 6, 2016; Study Report MD16062-DV. 5. Data on fi le, Allergan, March 2, 2016; Study Report MD16002-DV. 6. Data on fi le, Allergan, August 1, 2014; TR-1123 Protocol. 7. Data on fi le, Allergan, May 2016; Plastic Surgery Monthly Tracker: Breast Implants & Tissue Expanders. 8. Data on fi le, Allergan, June 2016; Breast Implant + Tissue Expander Share Tracker. 9. Data on fi le, Allergan, March 2016; Plastic Surgery A&Us: PLS and Patients Allergan. All rights reserved. All trademarks are the property of their respective owners. Natrelle.com NAT /