BREAST RECONSTRUCTION

Transcription

1 BREAST RECONSTRUCTION PATIENT PLANNER SHAPE THAT HOLDS. SATISFACTION THAT LASTS.

2 TABLE OF CONTENTS Page Pre-breast reconstruction surgery...3 About breast reconstruction...6 The surgery...14 Post-breast reconstruction care...17 Frequently asked questions...18 Patient surgery record...21 Warranty...22 Glossary...25 Bolded words appearing for the first time within this brochure have been defined in the glossary.

3 PRE-BREAST RECONSTRUCTION SURGERY WHAT GIVES THE BREAST ITS SHAPE The breast consists of milk ducts and glands, surrounded by fatty tissue that provides its shape and feel. Beneath the breast is the chest muscle (pectoralis major pec muscle). FATTY TISSUE RIBS PECTORALIS PEC MUSCLES MILK DUCT AND GLANDS Having breast cancer surgery could significantly change the shape of the breast depending on a number of factors. These factors include how much breast tissue is removed in a partial or complete mastectomy, how much skin is removed at the time of surgery, and how much tissue reaction or scarring there is in the remaining breast and skin in response to breast removal surgery, chemotherapy or radiation therapy. 1 THE OVERALL BREAST RECONSTRUCTION JOURNEY Being diagnosed with breast cancer is a difficult situation to be in, however, patients nowadays are benefiting from significant medical advances to help them deal with breast cancer. STATE OF THE NATION 1 in 9 Canadian women will develop breast cancer in their lifetime 2 39% invasive breast cancer MASTECTOMIES ARE COMMON* 3 29 % non-invasive breast cancer *Data reflects the Canadian average of women treated surgically for breast cancer between 2007 and Mastectomy and reconstruction breast surgery rates vary across various Canadian regions. 3

4 Breast reconstruction helps recreate the shape of your breasts following breast cancer surgery. Breast reconstruction techniques have developed greatly in the past few years and there are a variety of options. Breast implant technology and safety have also improved considerably. 4 OVER THE PAST DECADE, MORE WOMEN ARE CHOOSING BREAST RECONSTRUCTION 5 ~80% MORE LIKELY TO HAVE IMMEDIATE BREAST RECONSTRUCTION* ~2x MORE LIKELY TO HAVE IMPLANT RECONSTRUCTION WOMEN WHO CHOOSE BREAST RECONSTRUCTION, STAY HAPPY WITH THEIR CHOICES 6 >93% SATISFIED WITH IMPLANT RECONSTRUCTION THROUGH 10 YEARS *Percent of patients undergoing immediate breast reconstruction after prophylactic mastectomy and mastectomy for in situ breast cancer increased from 8.9% in 2002/2003 to 16.0% in 2011/2012 (78.5%; p>0.001). Rates of immediate breast reconstruction did not increase in women with invasive breast cancer. THE DECISION TO HAVE BREAST RECONSTRUCTION IS AN IMPORTANT AND PERSONAL ONE. WHILE IT IS NOT FOR EVERYONE, BREAST RECONSTRUCTION CAN HAVE A POSITIVE IMPACT ON MANY WOMEN S EMOTIONAL WELL-BEING. 1 TO MAKE THE RIGHT DECISION FOR YOU, ENSURE YOU HAVE A THOROUGH UNDERSTANDING OF ALL THE OPTIONS AVAILABLE TO YOU. 4

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6 ABOUT BREAST RECONSTRUCTION Timing of breast reconstruction surgery: Immediate vs. delayed 7 There are a number of factors that can influence the timing of when breast reconstruction may be carried out. Discuss the various options with your surgeon to decide which route is best for you. IMMEDIATE RECONSTRUCTION The breast reconstruction process starts at the same time as the breast cancer surgery Requires longer surgical time, but helps avoid the experience of having only one or no breasts DELAYED RECONSTRUCTION The breast reconstruction process starts after the breast cancer surgery Allows for more time to think about your breast reconstruction options, but you may need to wait for several weeks or months before being able to return to your natural body shape 6

7 Options for breast reconstruction surgery: With body tissue vs. with implants 7,8 Breast reconstruction can be carried out with the aid of a breast implant, by using your own tissue or using a combination of the two. Talk to your surgeon about the options relevant to you. WITH OWN TISSUE (AUTOLOGOUS RECONSTRUCTION) Uses your own fat, skin, or muscle tissue to make a breast Section of tissue or flap may be taken from areas such as the abdomen or back: TRAM flap (pedicle or free) procedure uses fat, skin, and muscle from the abdomen WITH AN IMPLANT (ALLOPLASTIC RECONSTRUCTION) Uses a breast implant, placed under the muscle Usually requires stretching of the skin with an inflatable tissue expander first, before placing the final implant DIEP flap procedure uses fat and skin from the abdomen without the muscle Latissimus dorsi flap uses skin and muscle from the upper back COMBINATION OF BOTH In some cases, both may be required to obtain satisfactory results 7

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9 HELP FIND THE RIGHT FIT FOR YOU Everyone s body is different. Even the smallest difference is important when it comes to selecting the right kind of breast implant. Before your surgeon recommends an implant, he or she will perform a series of comprehensive measurements, and evaluate your skin and breast tissue characteristics in a process known as biodimensional planning. These measurements play a key role in determining what kind of implant fits your unique shape. 9,10 Your surgeon may consider: 9 The shape and size of your breasts Your skin and breast tissue characteristics The location of the incision and the implant Your goals and desires for surgery Careful pre-operative planning is important because a breast implant that is too large for your tissue can result in excessive stretching of the skin and can contribute to the need for future corrective surgeries. It can also speed up the effects of gravity and result in earlier drooping or sagging, or may even be noticeable under your skin. 9,10 Work with your surgeon to achieve your desired results that suit your lifestyle. It is important to consider how both the size and shape of the breast implant fits your body. Choosing a breast implant involves so much more than just choosing a cup size or volume. The size and shape of the breast implant should be as unique as your body type. The image below shows the same implant volume on 3 different body shapes: HEIGHT: 178 cm WEIGHT: 64 kg HEIGHT: 167 cm WEIGHT: 61 kg 9 HEIGHT: 156 cm WEIGHT: 60 kg

10 PRE-OPERATIVE CHECKLIST REVIEW THIS CHECKLIST WITH YOUR SURGEON TO HELP YOU PREPARE FOR YOUR SURGERY Patient self-assessment Completed by you prior to surgery for discussion with the surgeon Discussion items checklist Topics that you may wish to discuss with the surgeon prior to surgery Patient surgery record Important pre- and post-operative appointments and related information recorded by you THE NATRELLE COLLECTION The NATRELLE Collection offers a variety of profiles and sizes. Additionally, NATRELLE implants are manufactured under strict quality control guidelines to greatly reduce the possibility of complications. To help your surgeon restore your body to its natural shape, NATRELLE INSPIRA and 410 offer a wide range of different implant options. 11 Your plastic surgeon will discuss with you the implant design that will help you achieve the best results that are right for you. NATRELLE INSPIRA NATRELLE

11 The next generation round The original shaped style Round-shaped implants are designed to fill out the existing breast tissue by adding volume to the upper pole of the breast, giving a more rounded look. 12 Teardrop-shaped, or anatomical, implants are shaped more naturally to follow the body s natural lines. 12 Width Selecting the proper implant width is critical to help ensure your long-term satisfaction with your breast surgery. NATRELLE breast implants are available in different diameters, so your surgeon will be able to find the right match to fit the width of your breast, creating a more natural look. 9,10 Volume Breast implants are measured by volume [cubic centimetres (cc) or grams], not cup size. Selecting the right volume for your body is key to achieving your desired look. NATRELLE offers a wide range of volumes, so you and your surgeon can find the volume that you are looking for. 9,10 Projection Projection means the distance your implants will extend forward from your chest wall. A higher projection can be a way to give the impression of a larger breast size. NATRELLE 410 also offers different heights of where the implant projects the most. 9,10 NATRELLE INSPIRA : 5 Projections 11 LOW PROJECTION LOW PLUS PROJECTION MODERATE PROJECTION FULL PROJECTION EXTRA FULL PROJECTION NATRELLE 410: 4 Projections 11 LOW PROJECTION MODERATE PROJECTION FULL PROJECTION EXTRA FULL PROJECTION 11

12 Gel NATRELLE offers 3 different choices of silicone gels, which vary in firmness. 9 You should consult with your surgeon on which of these gel fillers may best suit your needs. TruForm 1 TruForm 2 TruForm 3 Soft Slightly Firm Firm The softest gel Available with NATRELLE INSPIRA A slightly firmer gel, offering shape control with natural movement and feeling Available with NATRELLE INSPIRA, NATRELLE 410 The firmest gel for ultimate shape and control Available with NATRELLE 410 Texture NATRELLE implants are also offered with a unique texturing called BIOCELL, which has been designed to help maintain the implant in place and help patients achieve a one-breast feel, where the implant and breast feel unified. 9,13 Your surgeon will determine whether smooth or textured implants are the right option for you. Tissue expanders NATRELLE 410 implants have been specifically designed to work hand-in-glove with NATRELLE 133 tissue expanders a temporary, inflatable silicone balloon-type device that is gradually filled with saline (salt water solution) to stretch the skin and create the room needed for the permanent implant. 14 This process is similar to what occurs naturally to your abdominal skin during pregnancy. SIDE VIEW WITH BREAST TISSUE REMOVED SIDE VIEW WITH THE EXPANSION OF THE SKIN USING A TISSUE EXPANDER NATRELLE 133 TISSUE EXPANDERS ARE MADE TO MATCH NATRELLE 410 IMPLANTS. 12

13 NATRELLE 133 Pre- vs post-reconstruction: Real NATRELLE patients BEFORE Individual results may vary. AFTER 1 YEAR BEFORE AFTER 3 MONTHS Individual results may vary. AFTER 2 YEARS 13

14 THE SURGERY RECONSTRUCTION WITH IMPLANTS: ONE-STAGE VS TWO-STAGE BREAST RECONSTRUCTION One-stage reconstruction 1 The procedure is carried out in one single operation, involving placement of a breast implant. Some patients are appropriate candidates for this type of surgery, and this should be discussed with your surgeon. Two-stage reconstruction 1 A breast implant is inserted after a skin expansion process. The procedure is carried out in two operations. FIRST STAGE: During expansion The tissue expander is put in the place of your former breast tissue and inflated gradually. If required, follow-up therapy like chemotherapy or radiotherapy is performed at this time. SECOND STAGE: Result with final implant before nipple and areola reconstruction The temporary expander is replaced with a permanent breast implant after chemotherapy and/ or radiotherapy, when your surgeon deems it safe to do so and when there is sufficient space. 14

15 RECONSTRUCTION INCISION SITES 15 In reconstructive surgery, the incision placement and length is decided by your surgeon, and largely influenced by the type of cancer surgery you have. Most implants in breast reconstruction use the mastectomy scar either immediately (during the mastectomy procedure) or after tissue expansion. THE PLACEMENT OF YOUR BREAST IMPLANTS 16 Your breast implant can be placed either wholly or partially under the pectoralis major pec muscle (submuscular or dual plane, respectively), or on top of the muscle and under the breast glands (subglandular). For breast reconstruction after mastectomy, the implant is generally placed below the pectoralis major muscle. Your surgeon will decide what the best placement option is for you. BREAST BEFORE MASTECTOMY BREAST AFTER SUBGLANDULAR RECONSTRUCTION BREAST AFTER SUBMUSCULAR RECONSTRUCTION 15

16 ASK THE RIGHT QUESTIONS! Asking your surgeon the right questions and sharing any concerns you may have are important steps in getting the individual results that are right for you, and helping return your body to its natural shape. Please consider the following important questions for discussion at your next consultation: What breast reconstruction options do I have? What should I expect to happen the day of the surgery and how long before reconstruction is complete? What are the risks and/or common side effects? How should I prepare for the surgery recovery? How much time is needed for the recovery process and when can I resume my regular daily activities? What happens if the cancer returns or develops in the other breast? 16

17 POST-BREAST RECONSTRUCTION CARE WHAT TO EXPECT DURING YOUR RECOVERY Your experiences during recovery are directly affected by what happens during your surgery. Shorter recovery times are now more common, thanks to advances in surgical techniques. During the immediate healing process (up to 3 months), it is generally recommended that you wear a post-operative surgical bra or breast binder to help stabilize the implants. Additionally, you will be required to refrain from vigorous exercise or other activities. 10,17 For more information on what you can expect during and after your surgery, speak with your surgeon. POST-OPERATIVE CHECKLIST REVIEW THIS CHECKLIST WITH YOUR SURGEON TO ENSURE YOU HAVE RECEIVED ALL OF YOUR REQUIRED INFORMATION AFTER YOUR SURGERY Device identification card(s) Supplied to you following surgery Device tracking form Completed and returned by you to Allergan, if applicable Information for your healthcare providers Completed by you to give to the primary care physician 17

18 FREQUENTLY ASKED QUESTIONS Are silicone implants safe to use? Silicone is used safely in many medical devices and products, including pacemakers and heart valves, artificial joints, medical tubing, as well as everyday household items like baking pans, detergents and fabrics. 18,19 Silicone gel-filled breast implants are arguably the most studied medical devices in the world there have been decades of research evaluating the safety and effectiveness of silicone implants. 19 Silicone implants have been used extensively throughout the world, and are thought to look and feel natural. 20 What are the potential complications with silicone implants? Rupture Breast implants are not lifetime devices. 9 Breast implants can rupture when the shell develops a tear or hole. Ruptures are more likely to occur the longer the implant is implanted. If your surgeon determines you have signs of rupture, you should discuss with him or her having the implant and any gel removed, with or without replacement of the implant. After 6 years with NATRELLE 410 implants, only 1 in 33 implants inserted ruptured. After 10 years, only 1 in 17 implants inserted ruptured. 21 Capsular contracture The scar tissue (capsule) that normally forms around the implant may tighten and squeeze the implant making your breast feel firmer and sometimes painful. This is called capsular contracture. Capsular contracture occurs more commonly in revision-reconstruction than in primary-reconstruction. 21 At 6 years after primary-reconstruction with NATRELLE 410 implants, about 1 in 9 patients experienced capsular contracture. After 10 years, about 1 in 7 experienced capsular contracture. 21 Anaplastic large cell lymphoma (ALCL) Anaplastic large cell lymphoma (ALCL) is an extremely rare type of cancer that begins in the cells of the immune system. 22 It can occur in children and adults, including women with or without breast implants. Over the last two decades, there have been rare reports of ALCL occurring in women with breast implants. This has led the medical community to recognize a new and different type of ALCL, referred to as Breast Implant- Associated ALCL or BIA-ALCL for short. 18

19 BIA-ALCL should not be confused with breast cancer, and recent studies have found no causal link between breast implants and the development of primary breast cancer. 23 Since BIA-ALCL was first identified, fewer than 200 total cases have been reported globally. 24 In addition, most cases of BIA-ALCL resolve after a surgical procedure to remove the breast implant. 25 Very rarely, chemotherapy or radiation treatment may be needed. 23 For more information, consult your doctor. Do breast implants increase the likelihood of breast cancer reoccurring? Reports in the medical literature indicate that patients with breast implants are not at a greater risk than those without breast implants for developing breast cancer. 16 You need to continue to consult a physician to carry out normal checks in order to detect possible recurrences of breast cancer. If a mammography is scheduled, you need to inform the radiologist of your breast reconstruction surgery in order to adapt the mammographic procedure to get the best possible views of the breast tissue. Nevertheless, several studies demonstrated that women with breast implants had no increased risk of breast cancer being discovered at later stages than other women. Can breast implants impact a mother s ability to breastfeed? Breast reconstruction may significantly impact your ability to breastfeed. 26 Please ask your surgeon for more information. How much do breast implants generally cost? In Canada, breast reconstruction after a mastectomy is covered by Health Canada. However, breast implants are not lifetime devices and will need to be replaced. 9 Speak with your surgeon to discuss the options available to you. 19

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21 PATIENT SURGERY RECORD USE THIS SECTION TO RECORD IMPORTANT DATES AND CONTACT INFORMATION RELATED TO YOUR BREAST SURGERY Surgery date: Surgery location: Contact person at surgery location: Contact phone number: Post-operative appointment date: NOTES 21

22 WARRANTY ASSURANCE FOR YOU, FROM ALLERGAN Allergan is pleased to offer the ConfidencePlus TM and ConfidencePlus TM Premier Warranty Programs as part of our long-term commitment to ensuring you remain confident in the integrity of your NATRELLE gel-filled breast implants. For surgeries on/after January 1, 2015 Benefit Rupture and deflation Product replacement Capsular contracture Baker grade III/IV, double capsule, and late seroma Free contralateral implant replacement (on request) Round silicone gel upgrade (from saline) Financial assistance* Operating room, anesthesia, and surgical fee coverage Saline Silicone Non-cancellable terms Enrolment fee ConfidencePlus TM warranties apply to cases of loss of shell integrity resulting in implant rupture or implant deflation, capsular contracture Baker grade III/IV, double capsule and late seroma that require surgical intervention. *Subject to review and approval by Allergan after submission of all required documentation. **Within 45 days of surgery. 22

23 FOR COMPLETE NATRELLE CONFIDENCEPLUS TM WARRANTY PROGRAM DETAILS AND RESTRICTIONS, OR TO PURCHASE THE PREMIER WARRANTY OPTION, PLEASE VISIT ConfidencePlus TM Lifetime ConfidencePlus TM Premier Lifetime 5 years 10 years ü ü Up to $1,200 Deflation only within 10 years Up to $3,500 Rupture only within 10 years ü Free ü ü Up to $3,500 Deflation only within 10 years Up to $3,500 Rupture only within 10 years ü $200 USD** 23

24 OUR LONG-STANDING COMMITMENT TO CREATING A NATURAL LOOK AND FEEL #1 MEDICAL AESTHETICS COMPANY YEARS AS A GLOBAL LEADER IN BREAST AESTHETICS* 16 YEARS IN BUSINESS 79 COUNTRIES WORLDWIDE $1,140,000,000 USD INVESTED IN RESEARCH & DEVELOPMENT IN 2014 ACROSS ALLERGAN S ENTIRE PORTFOLIO OF PRODUCTS *Based on Global Aesthetic Market Study XI, January

25 GLOSSARY THE DEFINED WORDS IN THIS GLOSSARY HAVE BEEN BOLDED THE FIRST TIME THEY APPEAR WITHIN THIS BROCHURE. 25

26 Alloplastic: The use of an implant for breast reconstruction. Anaplastic large cell lymphoma (ALCL): A type of lymphoma, which is a cancer that begins in the cells of the immune system and can also occur in the breasts. A variety of ALCLs may occur in women with or without breast implants. When associated with implants, ALCL is often referred to as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). ALCL is not the same as primary breast cancer. Areola: The pigmented or darker-coloured area of skin surrounding the nipple of the breast. Augmentation: To make something larger in size. Autologous: The use of your own tissue (fat, skin, or muscle) for breast reconstruction. Axillary nodes: Nodes located in the armpit area. Bilateral: Affecting the right and left sides of the body (i.e., both breasts). BRCA: A gene associated with breast cancer. Specifically, mutations in the BRCA1 (breast cancer gene 1) and BRCA2 (breast cancer gene 2) gene increase a woman s risk of developing breast cancer. Breast augmentation: A surgical procedure to increase breast size. For this brochure, it refers to the placement of a breast implant. Breast reconstruction: A surgical procedure 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. Capsular contracture: A tightening of the tissue capsule surrounding an implant, resulting in firmness or hardening of the breast, and squeezing of the implant if severe. Capsular contracture is classified by Baker grades, where grades III or IV are the most severe, and often results in the need for additional surgery because of pain and possible abnormal appearance. Capsular contracture can be a risk for rupture. 26

27 Capsule: Scar tissue which forms around the breast implant. cc: Cubic centimetre the measurement used for breast volume. Contralateral: Opposite side. DCIS (ductal carcinoma in situ): Abnormal cells in the milk. DIEP flap: A tissue section (flap) of fat and skin from the abdomen, without the muscle, used for autologous reconstruction. Donor site: The location in the body where tissue (fat, skin, or muscle) is taken for autologous reconstruction. Double capsule: The implant and breast are found as 2 separated layers, or capsules, rather than as one unified capsule. Drain: Tubes placed at the site of implant(s) post-surgery in order to remove any excess fluid buildup. Dual plane: Placement of breast implants partially underneath the chest muscles. Graft: A surgical procedure used to recreate the nipple or areola. Hematoma: A collection of blood within a space. Incision: A cut made to the body tissue during surgery. Inframammary: Below the breast. An inframammary incision is an incision made in the fold below the breast. Invasive breast cancer: When breast cancer moves beyond just the milk ducts of the breast and into surrounding normal tissue it is considered invasive. Latissimus dorsi flap: A tissue section (flap) of skin and muscle from the upper back used for autologous reconstruction. Lumpectomy: Surgery used to remove cancer or abnormal tissue from the breast. 27

28 Mammograms: A type of X-ray examination of the breast used to detect cancer. Mastectomy: Partial or full removal of the breast tissue, which is done to remove cancer cells from the body. Non-invasive breast cancer: When breast cancer stays within the milk ducts and does not move into the breast and into surrounding normal tissue it is considered non-invasive. One-stage reconstruction: Breast reconstruction procedure that is carried out in one operation that involves the placement of the breast implant. Pectoralis: Major muscle of the chest; also known as pec. Periareolar: Around the darkened or pigmented area surrounding the nipple of the breast. Post-operatively: After surgery. Pre-operatively: Before surgery. Primary-reconstruction: The first time a breast implant is placed for the purpose of breast reconstruction. Prophylactic: A treatment or procedure used to prevent disease from occurring. With prophylactic mastectomy, the breast is surgically removed to reduce the risk of breast cancer. Reconstruction: A procedure done to reshape or rebuild something that has been damaged. Revision-augmentation: The correction or improvement of a primary-augmentation. For this brochure, it refers to the surgical removal and replacement of breast implants. Revision-reconstruction: The correction or improvement of primary-augmentation. For this brochure, it refers to the surgical removal and replacement of breast implants. 28

29 Rupture: A tear or hole in the implant shell. Saline implants will deflate when they rupture. Saline: A liquid solution that is made up of water and a small amount of salt. Seroma: A buildup of the watery portion of the blood in a tissue location. Subglandular placement: Placement of breast implants underneath and within the breast glands, but on top of the chest muscles. Submuscular placement: Placement of breast implants wholly or partially underneath the chest muscles. Symmetry: Having proportion of shape, size, and position between the two breasts. Tissue expander: A temporary, inflatable silicone balloon-type device that is gradually filled with saline (salt water solution) to stretch the skin and create the room needed for the permanent implant. TRAM flap: A tissue section (flap) of fat, skin, and muscle from the abdomen used for autologous reconstruction. For a pedicle TRAM flap, the tissue flap is left attached to its original blood supply and moved to the breast area through a tunnel under the skin. For a free TRAM flap, the tissue flap is removed completely and reattached to the blood supply in the breast area. Transaxillary: Axillary pertains to the armpit area. A transaxillary incision is an incision made in the armpit. Two-stage reconstruction: Breast reconstruction procedure that is carried out in two separate operations that involves the placement of the breast implant after a skin expansion process. Unilateral: Affecting either the right or left side of the body (i.e., one breast). 29

30 REFERENCES 1. Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Eng Med 2008;359(15): Canadian Cancer Society s Advisory Committee on cancer statistics. Canadian cancer statistics Toronto, ON: Canadian Cancer Society, Canadian Institute for Health Information. Breast cancer surgery in Canada, to Ottawa: CIHI, Maxwell GP and Gabriel A. The evolution of breast implants. Plast Reconstr Surg 2014;134:12S-17S. 5. Zhong T et al. Barriers to immediate breast reconstruction in the Canadian universal health care system. J Clin Oncol 2014;32: Health Canada. Summary Basis of Decision (SBD) for NATRELLE Highly Cohesive Silicone-Filled Breast Implants Retrieved from sbd_smd_2013_natrelle_cohesive_88573-eng.php. 7. Sullivan SR et al. True incidence of all complications following immediate and delayed breast reconstruction. Plast Reconstr Surg 2008;122: Dutra AK et al. Immediate breast reconstruction using autologous skin graft associated with breast implant. JPRAS 2011; NATRELLE Silicone-Filled Breast Implants Directions for Use. Allergan, Tebbets JB and Adams WP. Five critical decisions in breast augmentation using five measurements in 5 minutes: The high five decision support process. Plast Reconstr Surg 2005;116(7): NATRELLE Pocket Catalog. Allergan, Allergan Technical File; Clinical review for single lumen silicone gelfilled breast implants. Allergan, Barone FE et al. The biomechanical and histopathologic effects of surface texturing with silicone and polyurethane in tissue implantation and expansion. Plast Reconstr Surg 1992;90(1): Brown MH et al. Cohesive silicone gel breast implants in aesthetic and reconstructive breast surgery. Plast Reconstr Surg 2005;116: McCormick DM. Breast augmentation surgery. ebook: Clinton Gilkie, Bondurant S et al. Safety of silicone breast implants. Washington, DC. National Academy of Science;

31 17. Maxwell GP et al. Benefits and limitations of macrotextured breast implants and consensus recommendations for optimizing their effectiveness. Aesthetic Surg J 2014;34(6): Yoshida SH et al. Silicon and silicone: theoretical and clinical implications of breast implants. Regul Toxicol Pharmacol 1993;17(1): Grigg M et al. Information for women about the safety of silicone breast implants. Washington, D.C. National Academies Press; Spear SL et al. Breast implants: Saline or silicone? Aesthetic Surg J 2010;30: Maxwell GP et al. Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study. Aesthetic Surg J 2015; 35(2): National Cancer Institute. NCI dictionary of cancer terms. Retrieved from: Accessed April 22, US Food and Drug Administration. Anaplastic large cell lymphoma (ALCL) in women with breast implants: Preliminary FDA findings and analyses. Retrieved from: downloads/medicaldevices/productsandmedicalprocedures/ ImplantsandProsthetics/BreastImplants/UCM pdf. Published January Accessed April 7, Brody GS et al. Anaplastic large cell lymphoma occurring in women with breast implants: Analysis of 173 cases. Plast Reconstr Surg 2015;135: Clemens MW et al. Breast implant-associated anaplastic large cell lymphoma: Staging, disease progression, and management strategies. Plast Reconstr Surg 2015;135(4): Schiff M. The impact of cosmetic breast implants on breastfeeding: A systematic review and meta-analysis. Int Breastfeed J 2014;9: Medical Insight, Inc. Global Aesthetic Market Study XI: Acceleration in some segments offset by slowdown in others, January

32 EDUCATE YOURSELF ABOUT THE RISKS AS WELL AS THE REWARDS Breast reconstruction surgery is not without risks and complications. The decision whether or not to have surgery and which procedure is right for you should be discussed with a trained and certified plastic surgeon. For a full listing of risks and complications, please visit: FOR MORE INFORMATION, TALK TO YOUR DOCTOR. BA-NAT-BROCHURE-002-E November 2015 APC21FV Allergan. All rights reserved. and TM marks owned by Allergan.