Sientra® High-Strength Cohesive Gel Implants

ing and Indexing: Please visit www.aestheticsurgeryjournal.com and click on the Abstracting/Indexing link on the right-hand side to view a full list of databases in which this journal is indexed. Copyright Permission: Permission requests to photocopy or otherwise reproduce material published in this journal should be submitted to [email protected]. Permission may also be requested by contacting the Copyright Clearance Center via their Web site at http://www.copyright.com, or via e-mail at [email protected]. Advertising: Current advertising rates and specifi cations may be obtained by contacting [email protected]. Acceptance of advertising in this journal in no way implies endorsement of the advertised product or service by Oxford University Press or the journal’s affl iated society(ies). No endorsement is intended or implied. Oxford University Press reserves the right to reject any advertising it deems as inappropriate for this journal. Supplements, reprints, and corporate sales: For requests from industry and companies regarding supplements, bulk article reprints, sponsored subscriptions, translation opportunities for previously published material, and corporate online opportunities, please e-mail [email protected] or visit http://www.oupmediainfo.com/. Nonmember Change of Address: Six weeks’ advance notice must be given when notifying of change of address. Please send the old address label along with the new address to the Oxford University Press offi ce address above to ensure proper identifi cation. Please specify name of journal. Printed on acid-free paper Introduction to the Sientra High-Strength Cohesive Gel Implants Supplement Felmont F. Eaves III, MD, FACS; and Renato Saltz, MD, FACS Welcome to the Aesthetic Surgery Journal supplement devoted to Sientra (Santa Barbara, CA) fifth-generation cohesive round and shaped silicone gel implants. Implant technology has most certainly advanced over the past 2 decades, and with recent United States (US) Food and Drug Administration (FDA) approval, plastic surgeons in the US now have the opportunity to offer their patients new technologies that have been available in much of the world for some time. As such, the articles in this supplement will be of particular interest to surgeons within the US who are just beginning to gain experience with these new devices. The 4 articles in this supplement address 2 key foci related to these devices: the first is to communicate long-term data related safety and efficacy, and the second is to share clinical experience. From a standpoint of evidence-based medicine, these 4 articles provide a ready example of how different levels of evidence can communicate different types of valuable information. The articles by Stevens et al (LOE=3) and Haws et al, (LOE=2) respectively, assess the 8-year follow-up data and the magnetic resonance imaging (MRI) and rupture data from the US clinical trials for FDA approval of both round and shaped high-strength cohesive silicone gel implants. Both are large, prospective studies that provide important information concerning the long-term incidence of key clinical endpoints, including implant rupture, capsular contracture, and reoperation. Large, long-term studies such as these reassure both surgeons and patients alike to the safety and efficacy of silicone breast implants. Furthermore, by quantifying risk levels in large, prospective studies with mandatory reporting, these data allow surgeons to more accurately communicate the risks and benefits of surgery to patients considering placement of these devices. Because the levels of complications were low, many of the potentially clinically-relevant factors related to outcomes did not rise to clinical significance; none-the-less, these studies address important questions about the role of surgeon-specific factors in gaining long-term success in both aesthetic and reconstructive breast surgery. The 2 included panel discussions (LOE 5), on the other hand, provide valuable information concerning strategies, patient selection, surgical technique, and other considerations that will help surgeons incorporate these devices into their clinical practice and take full advantage of their unique characteristics. This type of information— the “pearls” of judgment and experience—is not readily assessed by large prospective cohort studies or randomized, controlled trials, yet it is key to clinical success. US readers will find this information particularly valuable as an entire generation of US surgeons has grown up with smooth, round saline and fourth-generation silicone gel implants. Textured round and shaped highly cohesive silicone gel implants require different approaches and techniques that are most readily learned through the sharing of information among surgeons, such as the experiences shared by the panelists after implantation of more than 2000 round and 700 shaped devices. As Guest Editors of this supplement, we are very familiar with the developments and FDA approval of Sientra’s round and shaped breast implants containing highstrength cohesive silicone gel. We welcome the addition of this line of implants for aesthetic and reconstructive breast surgery. For a very long time, the devices of only 2 manufacturers (INAMED/Allergan, Irvine, CA and Mentor/ Johnson & Johnson, Santa Barbara, CA) were available in the US. Silimed, the third largest global manufacturer of silicone implantable devices is well established in the international community, where for more than 30 years surgeons have had access to their silicone breast implants. We thank the authors for bringing this information to the readers of Aesthetic Surgery Journal. Dr Eaves is a Professor of Surgery, Division of Plastic Surgery, Emory University; Medical Director of the Emory Aesthetic Center and Emory Ambulatory Surgery Center, Atlanta, Georgia; and Evidence-Based Medicine Section Co-Editor for Aesthetic Surgery Journal. Dr Saltz is a plastic surgeon in private practice in Salt Lake City, Utah. Corresponding Author: Dr Felmont F. Eaves III, Emory Aesthetic Center, 3200 Downwood Circle, Suite 640, Atlanta, GA 30327, USA. E-mail: [email protected] Supplement Article Aesthetic Surgery Journal 2015, Vol 35(S1) S1–S2 © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: [email protected] DOI: 10.1093/asj/sjv029 www.aestheticsurgeryjournal.com