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1 Looking for answers about breast reconstruction? Start here. Start today. { 1 }

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3 Taking the mystery out of breast reconstruction If you or someone you care about is considering breast reconstruction as a result of a mastectomy, there is a great deal of information you will want to learn. If you re looking for a place to begin for a clear perspective about the revolutionary options available to women today, this is that place. Mentor Worldwide LLC is the worldwide manufacturer of high quality breast implants for over 20 years This brochure includes important basic and mustknow information. We have also included patients most frequently asked questions to give you a picture of typical concerns of those faced with the questions surrounding breast reconstruction. Mentor s accomplished history is filled with industry firsts, innovative product designs and groundbreaking research. While other manufacturers have come and gone, Mentor has a record of continually producing leading-edge, Food and Drug Administration-approved breast reconstruction products. Next stop: For more comprehensive information including breast cancer basics; diagnosis and detection; what to know before and after reconstruction; coping and support; as well as research, news, recovery and more, visit the most complete source on breast reconstruction on the web, Prepared with solid information, the important next step is a consultation with a qualified plastic surgeon.

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5 TABLE OF CONTENTS 1. An introduction 3. The 10 most important things you need to know about breast reconstruction 5. Facts about breast reconstruction with implants: Details and options. 9. Which type of MENTOR Breast Implant is the best choice: Silicone Gel or Saline? 13. Mentor Product Replacement Policy and Limited Warranties 17. Important Safety Information 21. Making the right decision at the right time 23. Frequently asked questions about breast implants 27. Resources to keep at your fingertips

6 Tens of thousands of breast cancer survivors have chosen to have breast reconstruction.

7 AN INTRODUCTION Feeling in control: Mastectomy and possible breast reconstruction Many women seek breast reconstruction after losing a breast due to cancer or other disease because they feel a lack of wholeness or a loss of femininity. For others, it is about choosing to go forward with their lives without the hassle and worry associated with wearing a breast prosthesis. Understanding one s motivation is the first step. Learning the pros and cons of the many options available is the second. Tens of thousands of breast cancer survivors have chosen to have breast reconstruction. However, like any elective surgery, a decision as important as this one should be based on each woman s unique situation in concert with the advice of a qualified surgeon. For family and friends, becoming an educated supporter is the gift you can give the woman you care about. Let s begin the journey to understanding and educated decision-making { 1 }

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9 THE 10 MOST IMPORTANT THINGS YOU NEED TO KNOW ABOUT BREAST RECONSTRUCTION 1. Most women are good candidates for breast reconstruction but not all. A woman s medical situation, breast shape and size, general health, lifestyle and goals will determine the type of breast procedure that is available to her. 2. There are 3 options. A tissue expander, followed by a breast implant. A flap which is done by surgically moving an area of skin, fat and muscle from one area of the body to another. An external prosthesis. Some women choose to go a different route and, instead of reconstruction, wear an external breast form (prosthesis) inside their bra. 3. There are more breast implant options than any time in history. Breast implants now come in a choice of fill (silicone and saline), surface texture, size and profile. 4. Breast reconstruction can be done at the time or after a mastectomy. Immediate or delayed reconstruction (performed weeks, months or even years after a mastectomy) is a choice that a woman needs to make with her heart and with her physician. 5. Nipple reconstruction is normally a separate outpatient procedure after the initial reconstruction surgery is complete. { 3 }

10 6. Healing after breast reconstruction may be affected by previous surgery, chemotherapy, radiation, smoking, alcohol use, diabetes, some medicines, and other factors. 7. A surgeon may recommend breast implantation of the opposite, uninvolved breast in order to make them more alike. Or he or she may suggest breast reduction (reduction mammoplasty) or breast lift (mastopexy) to improve the symmetry between the breasts. 8. The breast reconstruction process will require multiple procedures. The actual number of surgeries and recovery time will vary woman to woman. 9. It takes a team of physicians to assure the best result. A woman s general surgeon, breast reconstruction surgeon, and oncologist should work as a team to plan the mastectomy and reconstruction procedure. 10. A woman s support network will have everything to do with a successful outcome. The perspective of family, friends, support organizations, and breast cancer support groups are vital in the decision-making process and after the procedure too. Learn more about the emotional and physical aspects of breast cancer and breast reconstruction by visiting { 4 }

11 FACTS ABOUT BREAST RECONSTRUCTION WITH IMPLANTS: DETAILS AND OPTIONS. A woman s surgeon is the best guide to determine whether breast reconstruction should be performed at the same time as the mastectomy or some months or years afterward. Right timing is the first decision a woman will make. Choosing the optimal breast implant is the next most important decision. Tissue expansion: preparing the body for breast reconstruction This method of breast reconstruction involves the use of a tissue expander and a breast implant. It is done at the time of a mastectomy, although the actual breast reconstruction is done at a later time. Stage 1: Placing the expander during a mastectomy A tissue expander is a balloon-like device made from elastic silicone rubber. During a mastectomy, the general surgeon removes skin and breast tissue, leaving the chest tissues flat and tight. To create a breast-shaped space for the breast implant, a tissue expander is placed under the remaining chest tissues. The tissue expander creates a new breast-shaped pocket for the breast implant: The tissue expander is inserted, unfilled, and over time sterile saline fluid is added by inserting a small needle through the skin and into the tissue expander s filling port. As the tissue expander fills, the tissues over the expander begin to stretch, similar to the gradual expansion of a woman s abdomen during pregnancy. The use of acellular dermis Your surgeon may choose to use an acellular dermis allograft which provides additional tissue coverage and reinforces the muscle during the tissue expansion { 5 }

12 Mastectomy Incision Expander/Implant with Remote Injection Dome Tissue Expander with Integral Injection Dome Final Result process. FlexHD Acellular Hydrated Dermis is the latest generation allograft made from donated human tissue. It provides support in breast reconstruction, acting as a sling to support your tissue expander or implant. It may also be used in reconstruction of the nipple. Stage 2: Placing the breast implant After the tissue expander is removed, the breast implant is placed in the pocket. In reconstruction following a mastectomy, a breast implant is most often placed sub-muscularly (under the muscle). 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. Typically, the women can resume normal daily activities after two to three weeks. Tissue Expander with Remote Injection Dome Tissue Expander with Integral Injection Dome { 6 }

13 MENTOR Tissue Expanders MENTOR CONTOUR PROFILE Tissue Expanders The MENTOR CONTOUR PROFILE Tissue Expanders are 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 the surgeon to add saline solution to the expander and gradually stretch the breast tissue over several months. Secondary surgery can be avoided: For some patients, the secondary surgery for expander/breast implant exchange can be avoided by using an implant that is postoperatively adjustable, or is a combination type expander/mammary implant. In a simple office procedure after surgery, the fluid volume of postoperatively adjustable implants can be increased or reduced. This helps achieve the final breast size desired by the woman. MENTOR Smooth and MENTOR SILTEX SPECTRUM Adjustable Saline Breast Implants MENTOR SPECTRUM Implants function as both a tissue expander and a long-term saline breast implant. It can be placed with minimal volume during your initial surgery, with the fluid volume gradually being increased over time, which expands the breast s tissues. This implant contains a fill tube and remote injection dome that can be removed when the final volume is reached. It is then left in place as the long-term breast implant. { 7 }

14 Is there pain after a tissue expander placement? The chest skin is usually numb from the mastectomy, so there may not be much pain at all from the placement of the tissue expander or the needle sticks that follow to fill it with solution. A woman may experience feelings of pressure, tightness and discomfort after each filling of the expander. These feelings stop after several days, once the tissue expands, but they may last for a week or more. The tissue expansion process typically lasts four to six months. { 8 }

15 WHICH TYPE OF MENTOR BREAST IMPLANT IS THE BEST CHOICE: SILICONE GEL OR SALINE? The quick answer is either depending on each woman s anatomy, needs and desired outcome. Both types of MENTOR Breast Impants are clinically-advanced, FDA approved to be safe and have been tested and used by millions of women worldwide. Let s start at the beginning. What is a breast implant? A breast implant is a sac (implant shell) made of silicone elastomer filled with either silicone gel or saline, which is surgically implanted under the breast tissue or under the chest muscle. MENTOR MemoryGel Silicone Breast Implants A beautiful choice, trusted by millions of women (and their physicians) worldwide MENTOR MemoryGel Breast Implants feel more like natural breast tissue without compromising reliability or safety. After decades of research and testing, MENTOR MemoryGel Breast Implants were FDA approved in November of 2006 for women in the US. They come in either a textured or smooth surface shell and are available in a wide range of sizes and profiles to fit your body. What about safety? The Institute of Medicine (IOM) provides clarity. After reviewing years of research concerning silicone gel-filled breast implants, the IOM found that Evidence suggests diseases or { 9 }

16 conditions such as connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions are no more common in women with breast implants than in women without implants. 1 MENTOR Smooth Round Moderate Profile Breast Implant MENTOR Smooth Round Moderate Plus Profile Breast Implant MENTOR Smooth Round High Profile Breast Implant MENTOR SiLTEX Round Moderate Profile Breast Implant Research continues MENTOR SiLTEX Round Moderate Plus Profile Breast Implant MENTOR SiLTEX Round High Profile Breast Implant For information about the significant body of clinical evidence demonstrating the safety and effectiveness of silicone filled breast implants along with information about ongoing clinical studies, please visit com/researchnewsresources/pages/ research.aspx THIS PICTURE TELLS THE MENTOR MEMORYGEL STORY BEST We have cut a MENTOR MemoryGel 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 so there is no risk of leakage. What is important about this? MENTOR MemoryGel maintains its shape. 1 The complete IOM report is available online at { 10 }

17 MENTOR Saline Implants Another excellent FDA-approved Mentor option MENTOR Saline-Filled Breast Implants also come in a variety of shapes, sizes, profiles and surface textures each with the revolutionary self-sealing valve. Saline implants are inserted into the body without their fluid filling. Once placed, the implant is filled to the pre-determined size with saltwater solution similar to the fluid that makes up most of the human body. When the fill-tube is removed, the implant automatically seals itself. MENTOR Smooth Round Moderate Profile Breast Implant MENTOR Smooth Round Moderate Plus Profile Breast Implant MENTOR Smooth Round High Profile Breast Implant MENTOR SILTEX Round Moderate Profile Breast Implant MENTOR SILTEX CONTOUR PROFILE Moderate Breast Implant MENTOR SILTEX CONTOUR PROFILE High Breast Implant MENTOR SPECTRUM Adjustable Saline Implants Lasting flexibility: The size can be made larger or smaller for up to six months. Mentor s line of SPECTRUM Breast Implants makes the process easier because the size can be adjusted after surgery. In fact MENTOR SPECTRUM Breast Implants are the only postoperatively adjustable saline-filled breast implants that allow your physician to adjust the size of your implant for up to six months after your procedure. MENTOR Smooth Round SPECTRUM Adjustable Breast Implants MENTOR SILTEX Round SPECTRUM Adjustable Breast Implants MENTOR SILTEX CONTOUR PROFILE SPECTRUM Adjustable Breast Implants { 11 }

18 Mentor s Lifetime Product Replacement Policy provides for the free lifetime product replacement of its MENTOR MemoryGel and Saline-Filled Breast Implants, worldwide. { 12 }

19 MENTOR PRODUCT REPLACEMENT POLICY AND LIMITED WARRANTIES Mentor proudly stands behind the products we manufacture with a product replacement policy and limited warranty programs. It s important to understand that when undergoing breast reconstruction, breast implantation may not be a one-time surgery. Mentor s Lifetime Product Replacement Policy Mentor s Lifetime Product Replacement Policy provides for the free lifetime product replacement of MENTOR MemoryGel and Saline-Filled Breast Implants, worldwide. When implant replacement is required, and the Mentor Product Replacement Policy applies, Mentor will provide, throughout the patient s lifetime, the same or similar MENTOR Breast Implant at no cost. If a more expensive product is requested, Mentor will invoice your surgeon for the price difference. MENTOR Saline-Filled Breast Implants Mentor Standard Advantage Limited Warranty ($1,200 financial assistance) This warranty is free of charge to all patients who are implanted with MENTOR Saline-Filled Implant products. Here is an overview of the details: Lifetime product replacement policy 1 10 years and up to $1,200 financial assistance for operating room, anesthesia, and surgical charges not covered by insurance 2 1 Lifetime Product Replacement Policy: Mentor will provide replacement MENTOR product 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). Refer to the Mentor Advantage Limited Warranty for eligibility and program details. 2 Operating room and anesthesia charges to be given payment priority. In order to qualify for financial assistance, you will need to sign a Release form. { 13 }

20 Free contralateral (opposite side) implant replacement upon surgeon request Non-cancelable terms The Mentor Enhanced Advantage Limited Warranty ($2,400 financial assistance) This optional limited warranty is available for saline-filled breast implant products and, to be eligible, must be purchased for an enrollment fee of $100 within 45 days from implantation 3. Here is an overview of the details: Lifetime product replacement policy 1 10 years and up to $2,400 financial assistance for operating room, anesthesia, and surgical charges not covered by insurance from the date of implant 2 Free contralateral (opposite side) implant replacement upon surgeon request Non-cancelable terms MENTOR MemoryGel Breast Implants Mentor is the first to offer the Premier Advantage Warranty ($3,500 financial assistance) It offers up to $3,500 in financial assistance, $1,100 MORE than our Enhanced warranty: Lifetime product replacement policy 1 This warranty applies to expenses occurring from a confirmed rupture for up to 10 years from the date of implant surgery 1 Lifetime Product Replacement Policy: Mentor will provide replacement MENTOR product 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). Refer to the Mentor Advantage Limited Warranty for eligibility and program details. 2 Operating room and anesthesia charges to be given payment priority. In order to qualify for financial assistance, you will need to sign a Release form. 3 One warranty payout per enrollment fee; enrollment in the program for replacement device will require additional $100 enrollment fee. { 14 }

21 The warranty pays up to $3,500** financial assistance for operating room, anesthesia, and surgical charges not covered by insurance and applies only to implant surgeries conducted after May 1, Free contralateral (opposite side) implant replacement upon surgeon request Non-cancelable terms And, good to know, this additional warranty coverage is free Please retain your records With the Mentor Standard, Enhanced, and Premier Advantage Limited Warranties, it s important for you to maintain your own records to ensure validation of your enrollment. Your surgeon may only be required to retain your records for a limited period of time depending upon the laws of your state. 4 Please note: If you had breast surgery prior to May 1, 2009, your warranty coverage is what was offered at the time of your original surgery. ** From Warranty { 15 }

22 Health Insurance Coverage Good news, most carriers cover reconstruction. In general, private insurance that covers medically necessary mastectomies will also cover breast reconstructive surgery. Insurance coverage for re-operation procedures or additional surgeon visits following reconstruction may not be covered, depending on the policy. For example, a re-operation may include temporary removal of the implant to facilitate the oncologist s ongoing surveillance for breast cancer recurrence. Documentation: When you talk to your health insurance carrier, keep a record of your conversations and all written communications. Because coverage policies vary and can change over time, no guidance can be given with respect to coverage under any particular health plan. We recommend that you contact your health plan provider to obtain specific information regarding its coverage policies before deciding to proceed with reconstructive surgery. { 16 }

23 IMPORTANT SAFETY INFORMATION MENTOR MemoryGel and Saline-filled Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MemoryGel and at least 18 years old for Saline - or for breast reconstruction. Breast implant surgery should not be performed in women: With active infection anywhere in their body With existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions Who are currently pregnant or nursing. Safety and effectiveness have not been established in patients with automimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. 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. There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation is likely not a one-time surgery. You may need additional unplanned surgeries on your breasts 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 MENTOR { 17 }

24 MemoryGel 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). MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. The most common complications with MENTOR Saline-filled Breast Implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain and implant deflation. Detailed information regarding the risks and benefits associated with MENTOR Breast Implants is provided in two brochures, Important Information for Reconstruction Patients about MENTOR MemoryGel Silicone Gel-Filled Breast Implants and Saline-Filled Breast Implants, Making an Informed Decision, available from your surgeon or on line at It is important that you read and understand these brochures when considering MENTOR Breast Implants CONTOUR PROFILE Tissue Expanders are used for breast reconstruction following mastectomy. This expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. CONTOUR PROFILE Tissue Expanders should not be used in patients where an MRI may be needed. 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. Detailed information about indications, contraindications, warnings and precautions associated with the use of CONTOUR PROFILE Tissue Expanders are provided in the Product Insert Data Sheet available online at { 18 }

25 Keep your breast implant ID card for later reference When you have breast augmentation, you will be given a device identification card with the style and serial number of your breast implant(s). This will be given to you right after your surgery. It is important that you keep a copy of this card because you may need to refer to the information at a later date. To learn more about MENTOR MemoryGel and Saline-Filled Breast Implants and MENTOR CONTOUR PROFILE Tissue Expanders, visit { 19 }

26 { 20 }

27 MAKING THE RIGHT DECISION AT THE RIGHT TIME When is it best to have breast reconstruction? The same considerations apply to postmastectomy breast reconstruction and reconstruction following breast trauma or reconstruction for congenital anomalies. This decision to have immediate or delayed reconstruction is one of the most important and will be made after consultation between the woman and her cancer treatment team. Immediate reconstruction Pro s Because the reconstruction begins at the time of the mastectomy, the woman wakes up with a breast mound in place so she never experiences a completely flat chest. It eliminates an additional surgical procedure which saves her from going through anesthesia and recovery a second time. Con s There may be a higher risk of capsular contracture, extrusion, and other complications associated with immediate reconstruction as a result of postoperative radiation and chemotherapy treatment. The initial operative time and recovery period may also be longer because of the combined surgeries. Immediate reconstruction may involve placement of a breast implant only, but typically includes a first step the placement of a tissue expander, which is used to expand { 21 }

28 remaining skin following removal of tissue and skin during cancer surgery. The tissue expander is then eventually replaced with a breast implant. Delayed reconstruction Pro s By waiting to have the reconstructive surgery sometime after mastectomy, a woman can delay the decision and the surgery itself until other treatments, such as radiation therapy and chemotherapy, are completed. Delayed reconstruction may be advisable if the surgeon anticipates healing problems with the mastectomy or if the woman just needs more time to consider options. Con s As mentioned above, delayed reconstruction is likely to increase the number of surgical procedures. { 22 }

29 FREQUENTLY ASKED QUESTIONS ABOUT BREAST IMPLANTS What is silicone? Silicone is derived from silicon, a semi-metallic or metal-like element that in nature combines with oxygen to form silicon dioxide, or silica. Beach sand, crystals and quartz are silica which is the most common substance on earth. Heating silica with carbon at a high temperature can produce silicon. Further processing can convert the silicon into silicone, which can be a liquid, a gel or a rubbery substance. Various silicones are used in lubricants and oils, as well as in silicone elastomers. Silicone can be found in many common consumer items, such as chewing gum, nail polishes, suntan and hand lotions, antiperspirants, bath soaps and processed foods. Are silicone gel-filled implants safe? Yes. MENTOR MemoryGel Silicone Gel-Filled Breast Implants have been successfully used and trusted for over 20 years by millions of women worldwide. Mentor currently has seven silicone gel breast implant clinical studies in progress. More than 200,000 women have participated in Mentor s studies in order to provide a significant body of clinical evidence demonstrating the safety and effectiveness of silicone filled breast implants. Additionally The Institute of Medicine, in a highly respected study, concluded that, There is no evidence that silicone implants are responsible for any major diseases of the whole body. 1 How does the silicone gel used today differ from the silicone used in years past? Silicone gel-filled breast implants have undergone changes in the last three decades to meet 1 The complete IOM report is available online at { 23 }

30 increasingly sophisticated consumer expectations. The very first silicone breast implants used thick shells and contained firm gel. Then, a second generation of implants with thinner shells and less firm gel was introduced in the late 1970s to address concerns of patients and surgeons who believed that implants were too firm, palpable and visible. In the mid 1980s, concerns related to rupture rates of the second generation thinner-shelled implants led manufacturers to introduce a third generation of implants. The shell and gel of these third generation implants are slightly thicker but still soft. Today, these third generation silicone gel filled breast implants are typically referred to as cohesive gel implants. Mentor s products have kept pace with the ever-evolving expectations of surgeons and women who desire a soft gel to retain the natural feel that resembles actual breast tissues and is safe for the body. Do MENTOR Breast Implants include latex? No. Because latex allergies are so common, Mentor never uses latex in the manufacturing of any of its breast implants. Is there platinum in breast implants? The manufacture of silicone breast implant shells and gel-filling materials uses platinum as a catalyst. Because very small amounts of platinum remain in the product following its manufacture, concerns have been raised that platinum may enter the body and cause adverse effects either by diffusing through the intact shell, or through an implant rupture. However, in 2006, the United States Food and Drug Administration (FDA) released the following conclusion about platinum: Based on the existing literature, FDA believes that the platinum contained { 24 }

31 in breast implants is in the zero oxidation state, which would pose the lowest risk, and thus that the small amounts of platinum that leak through the shell do not represent a significant risk to women with silicone breast implants. * How much do breast implants weigh? You can use this formula to estimate the weight of your MENTOR MemoryGel and Saline-Filled Breast Implants: 1 ounce = 30 cc s. Example: A 300 cc implant = 10 ounces Implant weight will vary with implant size. How do cc s compare to cup size? cc volumes do not accurately translate to bra cup sizes. How do breast implants affect mammography? It is important to know that with breast implants, routine mammography screening may be more difficult. The implant may interfere with finding breast cancer during mammography and generally requires additional x-rays and more potential exposure to radiation. A woman should be sure to continue to undergo routine mammography screenings and to inform the mammography technician that implants are present. What is the average life expectancy of a breast implant? Breast implants don t last a lifetime. While implant duration varies from woman to woman, implants need to be replaced at some time. Replacement is often prompted by choice, such as a desired size change, or implant style change. Some women undergo breast implant replacement because of a complication, such as saline deflation or gel rupture. *source: { 25 }

32 Do implants influence the occurrence of breast cancer? No. Patients with breast implants have not been found to be at a greater risk of developing breast cancer than those without breast implants. For more information about DO s and DON Ts before and after breast reconstruction along important lifestyle issues ( such as when can a woman resume exercise?) visit { 26 }

33 RESOURCES TO KEEP AT YOUR FINGERTIPS Turn to Mentor with any questions you may have can answer most questions about breast reconstruction. For additional information or questions about MENTOR Breast Implants, please call MENTOR-8. Other sources: Mentor Worldwide LLC Institute of Medicine Report on the Safety of Silicone Implants Food and Drug Administration INFO-FDA or You can find important information in the FDA breast implant consumer handbook, which is available through the phone number or Web site provided above. { 27 }

34 American Society of Plastic Surgeons Breast Cancer Resources National Cancer Institute CANCER American Cancer Society (Reach to Recovery) ACS Women s Information Network Against Breast Cancer 866-2WINABC ( ) Breast Cancer Network of Strength (formerly Y-ME National Organization for Breast Cancer Information and Support) (800) Books LaTour, Kathy. The Breast Cancer Companion, From Diagnosis Through Recovery: Everything You Need to Know for Every Step Along the Way. Avon Books, New York, Bruning, Nancy. Breast Implants, Everything You Need to Know. Hunter House, Inc. California, { 28 }

35 { 29 }

36 Important Safety Information: MENTOR MemoryGel and Saline-filled Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MemoryGel and at least 18 years old for Saline - or for breast reconstruction. Breast implant surgery should not be performed in women: With active infection anywhere in their body With existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions Who are currently pregnant or nursing. Safety and effectiveness have not been established in patients with automimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. 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. There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation is likely not a onetime surgery. You may need additional unplanned surgeries on your breasts 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 MENTOR MemoryGel 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). MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. The most common complications with MENTOR Saline-filled Breast Implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain and implant deflation. Detailed information regarding the risks and benefits associated with MENTOR Breast Implants is provided in two brochures, Important Information for Reconstruction Patients about MENTOR MemoryGel Silicone Gel-Filled Breast Implants and Saline-Filled Breast Implants, Making an Informed Decision, available from your surgeon or on line at It is important that you read and understand these brochures when considering MENTOR Breast Implants. CONTOUR PROFILE Tissue Expanders are used for breast reconstruction following mastectomy. This expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. CONTOUR PROFILE Tissue Expanders should not be used in patients where an MRI may be needed. 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. Detailed information about indications, contraindications, warnings and precautions associated with the use of CONTOUR PROFILE Tissue Expanders are provided in the Product Insert Data Sheet available online at Mentor Drive Santa Barbara, CA USA (805) Customer Service: (800) Fax: (805) { 30 } Mentor Worldwide LLC Rev B

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