Breast. Reconstruction

Transcription

1 Breast Reconstruction

2 For over 20 years, Mentor has been recognised throughout the world as a leading manufacturer of the highest quality breast implants

3 Be confident. Be informed. MAKE A GOOD DECISION. There is a lot to learn when you are considering breast reconstruction or breast replacement surgery. This brochure is intended to help you build a solid foundation of knowledge as you begin this important process. It is packed with facts about the surgery itself, the latest information about MENTOR MemoryGel TM Silicone Gel-Filled and MENTOR Saline-Filled Breast Implant options and more. For over 20 years, Mentor has been recognised throughout the world as a leading manufacturer of the highest quality breast implants. We offer two basic types: MemoryGel TM and Saline-Filled Breast Implants. innovative product designs and groundbreaking research. Mentor has a record of continually producing leading-edge, FDA-approved (saline and round-shaped gel) and CE-Marked breast reconstruction products.

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5 TABLE OF CONTENTS Introduction 1 Anatomy of the Breast 3 Breast Cancer Basics 4 Stages of Breast Cancer 7 What is a Mastectomy? 9 Breast Reconstruction Timing 10 Breast Reconstruction Options 11 About Breast Implants 18 MENTOR Tissue Expanders 25 Your Recovery 27 PatientSafe Coverage Limited Warranty 29 Breast Reconstruction Resources 34 Breast Implant Safety Study Information 35 Questions to Ask Your Plastic Surgeon 37 Glossary 39 Mentor A Company That Cares 43 Important Safety Information Back Cover

6 INTRODUCTION There are many choices involved in the breast reconstruction process. Perhaps the most important question to ask is: Is breast reconstruction right for you? For tens of thousands of breast cancer survivors, the answer has been yes. Today, most women who have mastectomies are good candidates for breast reconstruction. After a mastectomy, women choose to have breast reconstruction for many different reasons. Some no longer feel whole, or they do not feel as feminine. Others do not want to bother with the day-to-day hassle of wearing an external breast prosthesis. For many women, breast reconstruction is a good way to feel better about themselves and make a fresh new start in life. Faster and Easier Breast Reconstruction For women who choose breast reconstruction, new surgical procedures are available that are less time consuming and easier, while usually providing good results. One of these new surgical techniques is called single-stage breast reconstruction, which is explained in this brochure

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8 ANATOMY OF THE BREAST The breast consists of milk ducts and glands, surrounded by fatty tissue that provides its shape and feel. The chest muscle (pectoralis major muscle) is located beneath the breast. Factors such as pregnancy (when milk glands are temporarily enlarged), rapid weight loss and the effects of gravity as you age can combine to stretch your skin, which may cause your breast to droop or sag. Pectoralis Major Muscle Pectoralis Minor Muscle Fatty Tissue Milk Lobes, Glands Milk Ducts Nipple and Areola Soft Tissue Ribs Mentor Worldwide LLC the shape of the breast to a greater or lesser degree, depending on: How much breast tissue is removed in a partial or complete mastectomy; How much skin is removed at the time of your surgery; and How much tissue reaction or scarring there is in the remaining breast and skin in response to chemotherapy or radiation therapy

9 BREAST CANCER BASICS Breast Cancer Facts Simply stated, breast cancer is an uncontrolled growth of breast cells. Breast cancer is a disease in which malignant (cancer) cells form in the tissues of the breast. It differs by individual, age group, and even the kinds of cells within the tumors themselves. How Does Breast Cancer Occur? Cancer is a result of mutations, or abnormal changes, in the genes responsible for regulating the growth of cells and keeping them healthy. The genes are in each cell s nucleus, which acts as the control room of each cell. Normally, the cells in our bodies replace themselves through an orderly process of cell growth: healthy new cells take over as old ones die out. But over time, mutations can turn on certain genes and turn off others in a cell. That changed cell gains the ability to keep dividing without control or order, producing more cells just like it and forming a tumor. Breast Cancer is Caused by a Genetic Abnormality According to cancer societies, only 5 to 10% of cancers are due to an abnormality inherited from your mother or father. About 90% of breast cancers are due to genetic abnormalities that happen as a result of the aging process and the strain of life in general

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11 Did you Know That Not All Tumors are Cancerous? A tumor can be benign (not dangerous to health) or malignant (has the potential to be dangerous). Benign tumors are not considered cancerous: their cells are close to normal in appearance, they grow slowly, and they do not invade nearby tissues or spread to other parts of the body. Malignant tumors are cancerous. The Term "Breast Cancer" Refers to a Malignant Tumor that has Developed from Cells in the Breast. Usually breast cancer either begins in the cells of the lobules, which are the milkproducing glands, or the ducts, the passages that drain milk from the lobules to the nipple. Less commonly, breast cancer can begin in the stromal tissues, which include the fatty Over Time, Cancer Cells can Invade Nearby Healthy Breast Tissue and Make their way into the Underarm Lymph Nodes, Small Organs that Filter out Foreign Substances in the Body. If cancer cells get into the lymph nodes, they then have a pathway into other parts of the body. The breast cancer s stage refers to how far the cancer cells have spread beyond the original tumor

12 STAGES OF BREAST CANCER Determining the stage of your breast cancer is fundamental for planning your treatment and understanding the most likely outcome. If you have been diagnosed with breast cancer, your surgeon will decide what additional tests may outside the breast. About Stages The cancer stage shown as a number from 0 to IV is based on the size of the tumor and whether the cancer has spread to the lymph nodes. To determine your cancer stage, your surgeon will ask questions about your medical history, perform a careful physical examination and review all prior tests as well as the results from the biopsy of the tumor or suspected area. Additional tests, such as X-rays and blood work, may be needed. In general, the stage is not fully known until after the operation to remove the tumor in your breast and sample the lymph nodes under your arm. Breast cancer staging is complicated, changes as doctors learn more about breast cancer. Stages 0 to IV: What They Mean Once the surgery is completed, your surgeon can determine the stage of your cancer. Breast cancer stages range from 0 to IV, with many subcategories. Lower numbers indicate earlier stages of cancer, while - 7 -

13 Stage 0 This stage describes noninvasive breast cancer. It has not spread within the breast or to other parts of the body. Stage I This stage is an early stage of invasive breast cancer in which: The tumor measures no more than 2 cm in diameter No lymph nodes are involved the cancer has not spread outside the breast Stage II This stage, subdivided into IIA and IIB, describes invasive breast cancers in which one of the following is true: The tumor measures less than 2 cm but has spread to lymph nodes under the arm No tumor is found in the breast but cancer is found in the axillary lymph nodes The tumor is between 2 cm and 5 cm and may have spread to lymph nodes under the arm The tumor is larger than 5 cm but has not spread to any lymph nodes Stage III Stage III breast cancers are subdivided into three categories IIIA, IIIB, and IIIC based on a number of different criteria. By (metastasised) to distant sites. For example, a stage IIIA tumor is larger than 5 cm and has spread to one to three lymph nodes under the arm. Other stage IIIA tumors may be any size and have spread into multiple lymph nodes. The lymph nodes - 8 -

14 clump together and attach to one another or to the surrounding tissue. In stage IIIB breast cancer, a tumor of any size has spread to tissues near the breast the skin and chest muscles and may have spread to lymph nodes within the breast or under the arm. Stage IIIB also includes but aggressive type of breast cancer. Stage IIIC cancer is a tumor of any size that has spread: To 10 or more lymph nodes under the arm To lymph nodes above or beneath the collarbone and near the neck To lymph nodes within the breast itself and to lymph nodes under the arm Stage IV Stage IV breast cancer has spread to other, distant parts of the body, such as the lungs, liver, bones or brain. WHAT IS A MASTECTOMY? A mastectomy is when breast tissue is removed due to the presence of a cancerous or precancerous growth. The amount of tissue removed during a mastectomy is not always the same; it will vary based on the size and stage of your cancer, your body type and your personal preferences. Mastectomy Incision - 9 -

15 BREAST RECONSTRUCTION TIMING Breast reconstruction can be done during the same operation as your mastectomy. This is called immediate reconstruction. Or it can be done weeks, months or even years after your mastectomy. This is called delayed reconstruction. Based on your personal circumstances, you and your surgeon can decide which method is best for you. Immediate Reconstruction The advantage of having immediate breast reconstruction is that your breast is reconstructed during the same operation as your mastectomy. Therefore, you have only one operation and recovery period. This means you can avoid the experience of having only one or no breasts. Delayed Reconstruction The advantage of delayed reconstruction is from cancer and rebuild your strength. Delaying breast reconstruction also gives you more time to consider your options and make a well-informed decision about breast reconstruction

16 BREAST RECONSTRUCTION OPTIONS There are different ways to reconstruct your breast. The method you and your surgeon choose will be based on several factors, including: Your health and lifestyle Your body type Your breast size Your personal choice The amount of remaining skin and tissue Breast reconstruction can be done using your own body tissue, by using breast implants or by using a combination of your own tissue with a breast implant(s). Using Your Own Tissue For Breast Reconstruction Latissimus Dorsi Flap One method for reconstructing your breast with your own tissue is called the Latissimus Dorsi Flap. During this procedure, a section of your skin and muscle is removed from your back or from under your arm and then moved to the breast area, where it is used to reconstruct your breast. The skin and muscle from your back area is normally quite thin, this method is sometimes used with a breast implant to give your new breast a fuller look and a more natural shape. Latissimus Dorsi Flap With or Without Breast Implants The tissue is tunneled to the mastectomy and used to create a breast mound. 3. An implant can also be used to create the breast mound

17 The TRAM Flap Another way to reconstruct your breast using your own tissue is called a TRAM Flap. This procedure involves removing fat and muscle from the stomach area and placing it in the chest area to reconstruct your breast. Sometimes it s possible for the blood supply and connection to the stomach area to be preserved. When it s not, blood vessels from the stomach tissue must be attached to the chest area using microsurgery. The TRAM Flap (Pedicle or Free) 1. Mastectomy is performed and the donor site is marked Final result. Sample Tram Flap Reconstruction Photos: Courtesy of Dr. Loren Eskenazi, San Francisco, California, USA Before After By discussing all your options with your surgeon, you will be able to make a decision that is right for you. The DIEP Flap Another method for reconstructing your breast with your own tissue is called DIEP Flap. DIEP (Deep Inferior Epigastric Perforator) is similar to the TRAM Flap procedure, however, it does not remove muscles, only skin, fat, and blood vessels are removed from the stomach area

18 Breast Reconstruction with Implants During a mastectomy, the surgeon removes skin and tight. Before a long-term implant can be placed, the breast tissue needs to be stretched to make space for it. This process is called tissue expansion. It can typically be done in either two stages or in one stage (single-stage). Two-Stage Breast Reconstruction A two-stage breast reconstruction with implants is a very popular option. This procedure can be done either at the time of mastectomy or at a later stage (delayed). How It Works Stage 1: A temporary breast tissue expander is placed in the chest. Over a period of weeks, with saline, which is similar to saltwater. During this process, your skin will gradually stretch and grow to make room for the implant as it expands. Your body will slowly adjust to the growth of the implant in the same manner a woman s body adjusts to the gradual growth of her abdomen when she is pregnant. Stage 2: Once the breast-shaped pocket is created, the tissue expander is removed and the breast implant is placed in the pocket. In reconstruction following a mastectomy, a breast implant is most often placed sub-muscularly. The surgery to replace the tissue expander with a breast implant (implant exchange) is usually done under general anesthesia in an operating room. It may require a brief hospital stay or be done on an outpatient basis. Sample Two-Stage Breast Reconstruction Using a MENTOR Breast Tissue Expander Followed by a Round Saline Implant. Photos: Courtesy of Dr. Gary Talbot, Little Rock, Arkansas, USA After: 6 months post-op

19 TWO-STAGE BREAST RECONSTRUCTION First Surgery Second Surgery The tissue expander is placed in position. The implant is then placed in the expanded pocket. The injection dome is located. Expansion begins by injecting saline through the dome. Completed procedure. The tissue expander is now removed. SILTEX CONTOUR PROFILE TM Tissue Expander

20 Single-Stage Breast Reconstruction Mentor is one of the few companies that manufactures breast implants that can be used as both a tissue expander and a long-term breast implant. These implants are used in single-stage breast reconstruction. This procedure is becoming more popular with surgeons as it means patients only need to have one operation to reconstruct their breast, instead of two or more. How It Works A combination expander/breast implant is placed in the chest at the time of mastectomy. is placed near the implant. Over a period of weeks or months, saline is injected into the port to expand the implant and grow tissue. When the implant remains in place. Single-Stage Reconstruction with Expander/Implant Photos: Courtesy of Dr. Kay Young, San Francisco, California, USA Before After: 3 weeks post-op After: 1 year post-op SILTEX TM Round SPECTRUM TM Breast Implant SILTEX TM Round BECKER TM 25 Breast Implant

21 SINGLE-STAGE BREAST RECONSTRUCTION Expansion Procedure with BECKER TM or SPECTRUM TM Adjustable Breast Implants The expander/breast implant is placed in position. It is then expanded by injecting saline through the dome for up to 6 months Final volume is achieved. The dome is then removed 5. Nipple reconstruction is is achieved

22 Mentor is proud of the quality built into each of our breast implants, and you can be assured that behind your decision to use our products is a company that understands your hopes and desires and a company that truly cares

23 ABOUT BREAST IMPLANTS A breast implant is a sac (implant shell) of silicone silicone gel or saline, that is surgically implanted under your breast tissue or under your chest muscle. Mentor makes two basic types: Breast Implants. MENTOR gel-filled breast implants are called MemoryGel TM Breast Implants MemoryGel TM Breast Implants feature a unique as a solid unit rather than a liquid. The gel holds together uniformly, while retaining the natural give that resembles actual breast tissue. The natural look and feel. MemoryGel TM Implants are available in a wide range of shapes, sizes,

24 Breast Implant shapes and sizes Depending on the desired shape you wish to achieve, you and your surgeon may choose either a round or contoured implant. Both shapes MENTOR contoured gel-filled breast implants are called CONTOUR PROFILE TM Gel (or CPG TM ) Breast Implants. Contoured implants have a teardrop shape and can provide patients with a more natural look and feel. Breast implants are measured in cubic centimeters, or cc s, not in cup sizes. The size of the implant used depends on the size and shape of the individual woman s chest. Your surgeon will also evaluate your existing breast and skin tissue to determine if you have enough to cover the breast implant you are considering. If you desire a breast implant size that is too large for your tissue, your surgeon may warn you that the breast implant edges may be visible or palpable following your surgery. Also, excessively large breast implants may speed up the effects of gravity on the breast, and can result in droop or sag at an earlier age. A recent report indicates that larger sized implants (greater than 350 cc) may be too large for many women, increasing the risk of developing complications such as extrusion, hematoma, infection, palpable implant folds and visible skin wrinkling. Surgical intervention could be required to correct these complications Henriksen, T.F., et al Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors. Ann. Plast. Surg. 54(4):

25 Mentor also offers an adjustable gel breast implant called (Round) SPECTRA TM Adjustable Gel Breast Implant. The SPECTRA TM has the advantages of a silicone gel breast implant with an adjustable saline inner-lumen that can be adjusted both intraand postoperatively. In addition to size and shape, breast implants are amount of forward projection off the chest wall). Generally, the larger you want your cup size, the larger the breast implant your surgeon will like to achieve, you and your surgeon may choose a round or contoured implant. Implant sufaces Breast implants are available with either a smooth or textured surface. Mentor has a textured breast implant surface called SILTEX TM Together with your surgeon, you can decide texture is right for you

26 All Cohesive, All the Time TM All of the MENTOR MemoryGel TM Breast Implants use a gel that is cohesive, safe and aesthetically pleasing. We offer three degrees of cohesive Cohesive I TM the softest-feeling gel Cohesive II TM Cohesvie III TM SILTEX Round Smooth Round MemoryGel SPECTRA TM Adjustable Breast Implant Smooth Round MemoryGel TM Breast Implant Gel Breast Implant MENTOR CONTOUR PROFILE TM Gel Breast Cohesive III TM, to maintain their natural shape. CONTOUR PROFILE TM Gel (CPG TM )MemoryGel TM Breast Implant Cohesive III TM

27 WHY THIS PICTURE MATTERS TO YOU: We have cut a MemoryGel TM Smooth Round MemoryGel TM Breast Implant, Cohesive I TM Breast Implant in half to demonstrate how the gel material can hold together uniformly. It does this because of a cohesive, gelatin-like substance that acts as a solid rather than a liquid maintaining its shape. Here's a summary of MENTOR MemoryGel TM Breast Implants product features: Are CE-Marked Are approved by the United States Food and Drug Administration (FDA)(Round-Shaped Only) a natural give that feels like breast tissue Come in round and CONTOUR PROFILE TM Implant shapes Come in various projection options to give you just the look you want Are available with either a smooth or textured surface (SILTEX TM ) Covered by the Mentor Lifetime Product Replacement Policy and our PatientSafe Coverage Limited Warranty

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29 Saline Breast Implants Saline-filled breast implants are filled with a saltwater solution during surgery that is similar to the fluid that makes up most of the human body. For many women, deciding what breast size they want is the most difficult part about choosing implants. Saline comes in round and CONTOUR PROFILE TM shape, in smooth and SILTEX TM surface. Mentor also offers an adjustable Saline Breast Implant called the SPECTRUM TM Adjustable Saline Breast Implant. MENTOR Round and CONTOUR PROFILE TM SPECTRUM TM Implants are the only salinefilled breast Implants with a removable fill tube that lets your physician adjust the size of your implants for up to six months after your procedure by either adding or removing saline through the fill tube. SILTEX TM Round Saline Breast Implant Smooth Round Saline Breast Implant SILTEX TM CONTOUR PROFILE TM Saline Breast Implant SILTEX TM CONTOUR PROFILE TM SPECTRUM TM Breast Implant

30 MENTOR TISSUE EXPANDERS CONTOUR PROFILE TM Breast Tissue Expander The CONTOUR PROFILE TM Breast Tissue Expander is used in a two-stage breast reconstruction procedure to expand the skin and create a shaped pocket for implantation. This product is designed to expand primarily in the lower portion of the breast, so the resulting pocket will accommodate the implant and slope like a mature breast. It also has an integral injection dome that allows your surgeon to add saline solution to the expander and gradually stretch the breast tissue over several months. Expansion is typically performed in an For some patients, the secondary surgery for the expander/breast implant exchange can be avoided by using a breast implant that is postoperatively adjustable, or is a combination of postoperatively adjustable implants can be increased or reduced. This helps you to achieve

31 SILTEX TM BECKER TM Tissue Expander/Breast Implants The BECKER TM is the only gel product that gives you the option of a single or two-stage breast reconstruction. These unique products have an inner lumen containing saline that allows for tissue expansion and an outer lumen of gel that is designed to provide a softer feeling implant. The remote injection dome makes volume adjustments simple and are easily removed when expansion is complete. Smooth and SILTEX TM Round SPECTRUM TM Breast Implants The SILTEX TM SPECTRUM TM Implant functions as both a tissue expander or a long-term saline breast implant and it also gives you the option of a single or two-stage breast reconstruction. It can be placed with minimal volume during your being increased over time, which expands the remote injection dome that will be removed remains in place as the long-term breast implant. SILTEX TM Round SPECTRUM TM Breast Implant SILTEX TM Round BECKER TM 25 Breast Implant SILTEX TM CONTOUR PROFILE TM Breast Tissue Expander

32 YOUR RECOVERY Every woman s recovery is different. In general, you will probably feel a little sore for several days following your breast reconstruction surgery. when you will experience the most discomfort. Your breasts will be swollen and very tender. Although every woman s recovery is different, you should be able to resume light activities in approximately one week. An important part of your recovery may involve wearing a postoperative bra or compression garment. These are designed to provide you with extra support while you heal. Your doctor also follow while you recover. If any problems occur after your breast implant surgery, contact your surgeon immediately

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34 PATIENTSAFE COVERAGE LIMITED WARRANTY A personal commitment to your wellbeing Your decision to use MENTOR Breast Implants for your breast reconstruction is a personal, long-term decision. Our relationship with you does not end with your surgery. We make a long-term commitment to our patients and we stand behind the integrity of our products. All MENTOR Breast Implants come with a Lifetime Product Replacement Policy 2 at no additional charge. Also, once you receive MENTOR Silicone Gel-Filled Breast Implants, you are automatically enrolled in the Mentor PatientSafe Coverage. Lifetime Product Replacement Policy Automatically applies to all recipients of MENTOR Breast Implant products Provides that regardless of the age of occurs, you are eligible for a no-charge replacement breast implant product of any size in a similar style 2. Lifetime Product Replacement Policy: Mentor will provide replacement MENTOR Breast Implants of any size in the same or similar style as the originally implanted product free of charge for the lifetime of the patient. Upon surgeon s request, a different implant style may be selected (subject to a charge of the difference between product list prices)

35 The Mentor PatientSafe Coverage is free of charge to all patients who are implanted with MENTOR Silicone Gel-Filled Breast Implant products. Automatic enrollment operating room, anesthesia, and surgical charges incurred in any revision surgery carried out within 10 years of the date of the original implant not covered by insurance will be provided 3. Products covered The Mentor PatientSafe Coverage applies to MENTOR Silicone Gel-Filled Breast Implants that are implanted in the following countries: Benelux, Denmark, France, Germany, Italy, Spain, Sweden and the UK after October 1, Czech Republic and Norway after February 1, Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Bulgaria, Burkina Faso, Croatia, Cyprus, Egypt, Estonia, Finland, Georgia, Greece, Hungary, Iceland, Ireland, Israel, Ivory Coast, Jordan, Kuwait, Latvia, Lebanon, Lichtenstein, Lithuania, Macedonia, Malta, Morocco, Oman, Pakistan, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Slovakia, Slovenia, South Africa, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates (UAE) and Yemen after June 1, And provided implants have been: Implanted in accordance with the Mentor package insert, current to the date of instructions published by Mentor surgeons, in accordance with accepted surgical procedures 3. Operating room and anesthesia charges to be given payment priority. In order Patient claim form. Financial assistance does not imply a loan to the patient

36 Events covered The Mentor Lifetime Replacement policy and PatientSafe Coverage only apply to: Cases of loss of shell integrity resulting in implant rupture that require surgical intervention additional events should be covered. Events not covered The Mentor Lifetime Replacement policy and PatientSafe Coverage do not apply to: Removal of intact implants due to capsular contracture, wrinkling, or rippling Loss of implant shell integrity resulting from reoperative procedures, open capsulotomy, or closed compression capsulotomy procedures Removal of intact implants for size alteration Surgery on the opposite breast to replace an intact implant You may also obtain a copy of the complete Mentor PatientSafe Coverage limited warranty by going to or by writing to: Mentor Medical Systems CV Zernikedreef CL, Leiden The Netherlands Phone THIS IS A LIMITED WARRANTY ONLY AND IS SUBJECT TO THE TERMS AND CONDITIONS SET FORTH IN THIS DOCUMENT AND EXPLAINED IN GREATER DETAIL IN THE APPLICABLE MENTOR LIMITED WARRANTY. ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS, ARE EXCLUDED, TO THE EXTENT PERMITTED BY LAW. THE TERMS IN EFFECT WHEN ORIGINAL IMPLANTATION OCCURS WILL APPLY AT THE TIME OF CLAIM

37 PatientSafe claimform In order to assess your eligibility for PatientSafe Coverage for MENTOR Implants, Mentor Medical Systems CV needs to collect the following information through its local operations or from your surgeon. Please ensure that you complete this form and return it to your surgeon who will then forward it to the appropriate local Mentor representative. Name: Address: Date and place of surgery: Name of surgeon: Implant Style and Size used: Lot#: Serial#: Data protection Mentor will use this information to communicate with you and to assess your eligibility for PatientSafe Coverage only. Mentor will not share this information with parties other than your health provider or local Mentor contact, unless required for legal or regulatory compliance or litigation. Mentor will retain the information for the duration of your use of the Silicone period is required or permitted by law. and that you agree with the collection and use of your personal information as described above, by signing below. If you have any questions, or if you wish to request access, correction, or deletion of any personal information, please contact us directly at: Mentor Medical Systems CV Zernikedreef CL, Leiden The Netherlands Phone Date Signature

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39 BREAST RECONSTRUCTION RESOURCES The following list of resources may help you to reconstruction decision. Cancerworld France Breast Cancer Information French Society of Plastic Surgeons Germany Breast Cancer Information German Association of Plastic Surgeons Italy Breast Cancer Information Italian Society of Plastic Surgeons Spain Spanish Cancer Association Spanish Society of Plastic Surgeons United Kingdom Breast Cancer Care British Association of Plastic Surgeons For the most comprehensive information about reconstructive surgery, we invite you to visit

40 BREAST IMPLANT SAFETY STUDY INFORMATION For the past several years, there have been many reports in the media about women with breast implants who have autoimmune disease or breast cancer. Also during this time, many respected medical professionals and institutions safety of breast implants. Mentor is pleased to be able to provide the public with up-to-date information about breast implant studies. Institute of Medicine In June 1999, the National Academy Institute of Medicine issued a report that included the following conclusion: In an overall consideration of the epidemiological evidence, the committee noted that because there are more than 1.5 million adult women of all ages in the United States with silicone breast implants, some of these women would be expected to develop connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions. Evidence suggests that such diseases or conditions are no more common in women with breast implants than in women without implants. The full text of the publication, Information for Women About the Safety of Silicone Breast Implants A Report of a Study by the Institute of Medicine 4, is available online at 4. Bondurant, Stuart; Ernster, Virginia L.; Herdman, Roger; The Safety of Silicone Breast Implants. (US). Committee on the Safety of Silicone Breast Implants National Academies Press, 2000 Medical Reference can be found: books?id=h1owckaig-oc&dq=isbn:

41 Independent Review Group The Independent Review Group (IRG) on Silicone Breast Implants was assembled by the Chief health issues associated with silicone gel breast implants. Members of the IRG were selected for their independent views, their knowledge and understanding of the issues, and lack of any Led by Professor Roger D. Sturrock, MD, FRCP, evidence of an association between silicone connective tissue disease. The complete report is available online at 5. European Committee on Quality Assurance In July 1998, the European Committee on Quality Assurance and Medical Devices in Plastic Surgery released a report that contained the following conclusions: clinical, immunological, epidemiological data, cause any autoimmune nor connective tissue diseases. Their report also stated, Updated studies continue to show that silicone gel-filled implants do not cause cancer nor other malignant disease. The entire declaration can be found online at www. doc MHRA Website. Accessed June 22, The European Committee on Quality Assurance and Medical Devices in Plastic Surgery Website. Accessed June 22,

42 QUESTIONS TO ASK YOUR PLASTIC SURGEON What are all my options for breast reconstruction? What are the possible risks and complications for each type of breast implant surgery, and how common are they? What if my cancer recurs or occurs in the other breast? Will reconstruction interfere with my cancer treatment? How many steps are there in each procedure, and what are they? How long will it take to complete my reconstruction? How much experience do you have with each procedure? Do you have before-and-after photos I can look at for each procedure? What results are reasonable for me? What will my scars look like? What kind of changes in my implanted breast can I expect over time? What kind of changes in my implanted breast can I expect with pregnancy? cosmetic outcome of my implanted breast? Can I talk with other patients about their experience? For staged reconstruction, what is the estimated total cost of each procedure? How much will my health insurance carrier cover, especially any complication that may require surgery? How much pain or discomfort will I feel, and for how long? Will I need to replace my implant at some point? How long will I be in the hospital? Will I need blood transfusions, and can I donate my own blood? When will I be able to resume my normal activities (sexual activity or athletic activity)? Who is the manufacturer of my breast implant? Does the manufacturer have a product warranty?

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44 GLOSSARY Aspiration: means of suction. BECKER TM : The BECKER TM Adjustable Breast Implant is the only gel product that gives you the option of a single or two-stage breast reconstruction. This unique product has an inner lumen containing saline that allows for tissue expansion and an outer lumen of gel that is designed to provide a softer feeling implant. The remote injection dome makes volume adjustments simple and are easily removed when expansion is complete. Biocompatible: Being biologically compatible by not producing a toxic response in living tissue. Breast Implant: that can be placed in the body for simulated breast tissue. Breast Reconstruction: A surgical procedure that rebuilds a removed breast. Buttocks Flap Reconstruction: A breast reconstruction transferred to the chest to create a breast mound. Capsular Contraction: A tightening of the scar tissue surrounding an implant. CPG TM : MENTOR CONTOUR PROFILE TM Gel Breast Implant. Delayed Reconstruction: Breast reconstruction that takes place weeks, months or years after a mastectomy. A DIEP Flap: is a type of Breast reconstruction in which blood vessels called Deep Inferior Epigastric Perforators (DIEP), and the skin and fat connected to them are removed from the lower abdomen and transferred to the chest to reconstruct a breast after mastectomy Envelope: The outer lining of an implant which traps Expander/Mammary Implant: A breast implant that also acts as a tissue expander, stretching the tissues, but then also remains in place as a breast implant

45 Fibrous Tissues: Connective tissues composed mostly of Flap: A portion of tissue, which may include muscle, fat and skin, with its blood supply moved from one part of the body to another. Flap Reconstruction: Rebuilding of a removed breast Glandular: Relating to a gland. Hemorrhage: Abnormal internal or external discharge of blood. Immediate Reconstruction: Breast reconstruction that takes place during the same surgical procedure as a mastectomy. Inpatient Surgery: A surgical procedure in which the patient is required to stay overnight in a hospital. Latissimus Dorsi Flap Reconstruction: Breast reconstruction that utilises the patient's own tissue transferred from the latissimus dorsi muscle, located in the back, to build a breast mound. Lumpectomy: Surgical removal of a cancerous tumor along with a small margin of surrounding tissue. Lymph Nodes: Structures in the lymphatic system that that contribute to the body's immune system. Mastectomy: The removal of breast tissue due to the presence of a cancerous or precancerous growth. Mastopexy: Breast lift to tighten the breast by removing skin that the forces of gravity and the effects of aging have caused to sag. MemoryGel TM Breast Implants: implant. Milk Ducts: Tubes for the passage of secreting milk. Surgical removal of the breast, some fat and most of the lymph nodes in the armpit, leaving the chest wall muscles largely intact. Opaque: Not transparent; impenetrable by visible light rays and x-rays

46 Outpatient Surgery: A surgical procedure in which the patient is not required to stay overnight in a hospital. Pectoralis Major: A muscle located in the upper chest which provides support for the breasts and is necessary for arm movements. Postoperatively Adjustable Implant: An implant that allows the volume to be adjusted, after implantation, Prosthesis Ptosis: Sagging. Breast ptosis is usually the result of normal aging and the pull of gravity or changes caused by pregnancy or weight loss. Radical Mastectomy: Removal of the breast, underlying muscles and underarm lymph nodes. Saline: A solution that is made up of water and a small amount of salt. Approximately 71% of an adult's body weight consists of this saltwater solution. Sensory Nerves: The nerves that conduct afferent impulses from sensory receptors to the brain or spinal cord. Sepsis: The presence of various microorganisms, their poisonous products or their toxins in the blood or tissue. Silicone: A material that is widely used in medical implants, composed primarily of silicon, carbon, hydrogen and oxygen. Silicone Gel: Silicone produced in a semisolid, similar in consistency to a normal breast. SILTEX TM : Mentor's textured breast implant surface. Simple Mastectomy: Removal of the breast only. SPECTRA TM : Mentor's adjustable gel breast implant. Thrombosis: The formation or development of a blood clot. Tissue Expander: An adjustable implant that can be mastectomy site. Tram Flap Reconstruction: Breast reconstruction that utilises the patient's own lower abdominal tissue and muscle to build a breast mound

47 MENTOR A COMPANY THAT CARES Founded in 1969, Mentor is a leading supplier of medical products in over 100 countries throughout the world. As the world s leading maker of high-quality breast implants, our years of experience result in quality products that you can rely on. MENTOR Gel-Filled Breast Implants are made at our state-of-the-art manufacturing plant in Leiden, The Netherlands. This advanced manufacturing facility is the largest of its kind in the world. It features many groundbreaking engineering advances that are new to the breast implant industry. Mentor conducts research, development and manufacturing at several facilities throughout Europe and the United States. The company also has sales and distribution outlets around the implant manufacturer to achieve CE-marking for its products. Mentor is proud of the quality built into each of our breast implants, and you can be assured that behind your decision to use our products is a company that understands your hopes and desires and a company that truly cares

48 IMPORTANT SAFETY INFORMATION: MENTOR MemoryGel TM and MENTOR Saline-Filled Breast Implants are indicated for breast augmentation in women who are at least 18 years old or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or precancer of their breast who have not received adequate treatment for those conditions or are pregnant or nursing. There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation is likely not a one-time surgery. You may need additional unplanned surgeries on your breast because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production. The most common complications with MemoryGel TM Breast Implants include reoperation, capsular contracture, asymmetry, and breast pain. A lower risk of complication is implant rupture, which is most often silent (meaning neither you nor your doctor will know you have a rupture). have not been fully established. Screenings such as mammography, MRI, or ultrasound are recommended after initial implant surgery to assist in detecting implant rupture. The most common complications with MENTOR Saline-Filled Breast Implants include reoperation, implant removal, capsular contracture, CONTOUR PROFILE TM Tissue Expanders and Smooth Round Tissue Expanders with Remote Dome are used for breast reconstruction following mastectomy. These expanders are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. You should not have an MRI while the CONTOUR PROFILE TM Tissue Expander or Smooth Tissue Expander with Remote Dome is implanted. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas or where severe surgical reduction of the area has previously been performed. Patients are reminded to discuss the indications, contraindications, MENTOR Breast Implants with their surgeons or review detailed risk information on line at It is important that you understand the risks associated with breast implant surgery when considering MENTOR Breast Implants. Corporate Headquarters Santa Barbara, CA USA Tel: Local Address Here Mentor Worldwide LLC Rev G 9/13 NOT FOR DISTRIBUTION IN USA. APPROVED FOR EMEA REGION.