Discover your. Breast

Transcription

1 Discover your Breast Augmentation Options

2 We are proud to Be the ONLY BREAST IMPLANT Company that manufactures in the usa. WHy Does THAT MATTer To you? For over 25 years, Mentor has been recognized worldwide as a leading manufacturer of the highest quality breast implants. An implant you can trust, proudly made in the usa.

3 We re here to help you make a ConfiDent, informed DeCision. This brochure contains the latest information about breast implants for augmentation or revision surgery to help you prepare for your process ahead. inside you will find basic information about breast augmentation and the different options available from Mentor. clarifying your own appearance goals and identifying the questions you ll want to ask along the way are important steps in considering breast augmentation. ready To GeT started? For over 25 years, Mentor has been recognized worldwide as a leading manufacturer of the highest quality breast implants. our rich 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, FDA approved breast augmentation products. We are dedicated to providing proven, safe, and effective products and service.

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5 Table of Contents 1 It All Begins With You 3 Breast Anatomy 101 surgery: The Details 7 Implant Sizes 11 Implant Types and Profile 12 Which type of Mentor implant is right for you? 14 MENTOR MemoryShape Breast Implants 16 MENTOR MemoryGel Breast Implants 19 MENTOR Saline Filled Breast Implants MENTOR SPECTRUM Adjustable Saline Breast Implant 20 Facts about Silicone Gel Filled Breast Implants 24 Mentor Product Replacement Policy and Limited Warranties 27 Selecting the Right surgeon for You 30 Frequently Asked Questions About Breast Implants 37 Breast Augmentation Resources

6 it all Begins With you How a woman feels about her body has a lot to do with her overall self-confidence that s no secret. When breast size or shape is an issue, many women turn to breast augmentation to increase their confidence, look better in their clothes, and bottom line present the image they want to the world. What is your reason for exploring breast surgery? Do you want to enlarge your breasts to make your body more proportional or your breasts more balanced in size? is your goal to reshape and enlarge your breasts because they have lost their shape due to pregnancy and breastfeeding?

7 your reasons are as unique as you are. That s why it s important to have a good understanding about your personal needs and expectations, and be able to express them to your surgeon. Together you can discuss the options available to you and choose just the right implants for your body and desired outcome. Learning about the breast augmentation procedure is the first step in your journey to a beautiful new you. { 1 }

8 THe TecHnicAL DeFiniTion of A BreAsT implant: A breast implant is a sack (implant shell) made of silicone elastomer filled with either silicone gel or saline, that is surgically implanted under your breast tissue or under your chest muscle. { 2 }

9 Breast anatomy 101 Pectoralis Major Muscle Pectoralis Minor Muscle Fatty Tissue Milk Lobes, Glands Milk Ducts nipple and Areola soft Tissue ribs 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 cause changes in your breasts over time. implants are used to make breasts larger; however, implants alone may not adequately lift the breast. Additional procedures may be recommended to achieve your goals. Procedures such as a mastopexy may be suggested at the time of your breast augmentation to lift the breast. surgery: the Details The surgical setting and anesthesia Most often, augmentation surgery is performed on an outpatient basis in a specialized operating room located in a hospital, a surgery center, or a surgical suite in the surgeon s office. General anesthesia is commonly use but local anesthesia with sedation is also an option. { 3 }

10 Important: Your surgeon should give you specific instructions before surgery Ask about any tests or presurgical examinations that you ll need prior to surgery. Also ask how long you need to be without food or your routine medications prior to surgery, and for any other directions you should follow. Incision and placement options Your surgeon will be your best guide when it comes to the pros and cons of the incision site specifically recommended for you. A few facts: Size of incision The incision size for a gel breast augmentation will be larger than the incision size of a saline breast augmentation. Location of incision There are three common incision sites: Around the nipple (periareolar) Within the breast fold (inframammary) Under the arm (axillary) Axillary Incision Periareolar Incision Inframammary Incision Types of incisions Periareolar This incision is typically well concealed, but since it also involves cutting through the breast tissue, it is associated with a higher likelihood of breastfeeding difficulties, as compared to the other incision sites. 1 Cutting through the tissue may increase the chance that there will be a change in breast or nipple sensation. Inframammary This is the most commonly used incision site at the present time. This incision is 1 Hurst, N.M. Lactation after augmentation mammoplasty. Obstet. Gynecol. 1996;87(1):30-4. { 4 }

11 generally less concealed than the periareolar and may cause fewer breastfeeding difficulties than the periareolar incision site. Axillary This incision is less concealed than the periareolar and may cause fewer breastfeeding difficulties than the periareolar incision site. When the incision is made under the arm, the surgeon may use a probe fitted with a miniature camera, along with minimally invasive, very small instruments, to create a pocket for the breast implant. umbilical (belly button) An incision made through the umbilical channel. This incision site has not been studied in the Mentor core study. Another consideration: implant placement The breast implant can be placed either partially under the pectoralis major muscle (submuscular) or on top of the muscle and under the breast glands (subglandular). it is important to fully understand the advantages and disadvantages of the implant s placement. Take a look at the benefits and negative features of each implant placement option. Your surgeon will recommend the approach best-suited to your body type and goals. submuscular PLAceMenT surgery and recovery may be longer recovery may be more painful reoperation may be more difficult Less visible and palpable implants easier imaging during mammography exam May be preferable if you have thin or weakened breast tissue subglandular PLAceMenT surgery and recovery may be shorter recovery may be less painful May provide easier access for reoperation More visible and palpable implants More difficult imaging during mammography exam May not be recommended if you have thin or weakened breast tissue submuscular Placement subglandular Placement { 5 }

12 PosToPerATive care Give yourself time to relax and heal take care of yourself after surgery Most women feel a bit tired and sore for several days following surgery. your breasts may remain swollen and sensitive to physical contact for a month or longer. you may also experience a feeling of tightness in the breast area as your skin adjusts to your new breast size. The feeling in the breasts and nipple area also may be diminished during this time of swelling and immediate postsurgery recovery. you should talk to your surgeon about potential complications that may follow your breast augmentation surgery. Postoperative care can vary you may be told to use a specific postoperative bra, compression bandage, or jog bra for extra support and positioning while you heal. some surgeons may not want you to wear a bra at all for a period of time following your surgery. When can you resume your normal activities? Talk to your surgeon about your lifestyle and what activities you may want to refrain from while your body heals. you can probably return to work within a few days. your surgeon will probably want you to avoid strenuous activities for a couple of weeks that could raise your pulse or blood pressure, or require strenuous use of your arms and chest. your surgeon may also recommend breast massage exercises. 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. { 6 }

13 What about an implant s size? Breast implants are not measured in bra cup sizes Breast implants are measured in cubic centimeters, or cc s, not in cup sizes. This is because the size of the implant used depends on the size and shape of the individual woman s chest. your surgeon will evaluate your existing breast and skin tissue He or she needs to determine if you have enough breast and skin tissue to cover the breast implant you are considering, or in some cases such as after pregnancy, too much extra skin. if you want a breast implant size that is too large for your tissue, your surgeon may warn you that the breast implant edges may become visible following your surgery. What else determines if the implant can be detected by feel? implant placement, size and the amount of skin and tissue coverage over an implant also determine how easily an implant can be felt. For example, implants placed subglandularly (above the chest muscle) tend to be more conspicuous than implants placed submuscularly (below the chest muscle). { 7 }

14 how Will i KnoW WhiCh size is right for me? During your office consultation, your surgeon may use different tools to help you select the right product for your new look. one such tool is the MenTor volume sizing system. These prosthetic sizing devices are uniquely designed to be placed onto your breast to create a realistic preview of your new size. your surgeon may also use the MenTor BodyLogic system to assist in making informed product selection decisions NATuRAL LOOK AuGMENTED LOOK { 8 }

15 based on the precise measurements of your body. in addition to measurements, your surgeon may use illustrations such as the ones below to better understand the final look that you desire*. TyPe 1 A gentle filling out of the breast in a way that is completely natural with no excess fullness in the upper pole of the breast. A larger implant could potentially be used, but desired outcome is a conservative augmentation. TyPe 2 Largest implant that can be used without creating a breast which has an unnatural look. Desired outcome is to avoid obvious look of a breast augmentation. TyPe 3 - Large breast augmentation resulting in a mildly unnatural look such as a noticeably rounded contour in the upper pole of the breast. TyPe 4 Largest implant possible, knowing that it will create a distorted unnatural look and obvious breast augmentation. *These tools are meant to assist you in selecting the right implant to achieve the patient s desired results. How you use these toolswill depend upon your personal preferences and experience. The MENTOR Volume Sizing System does not dictate a specific implant, but provides guidance in selecting a range of devices that will increase the likelihood of patient satisfaction. The MENTOR Volume Sizing System is not intended to replace your independent professional judgment. { 9 }

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17 DECIDING ON an Implant Type and profile is as important as size Round or Shaped? Gel or Saline? Smooth or Textured? The following pages provide detail about each type of implant to help you understand your choices. There are three basic types of implants: round gel, shaped gel, and saline filled. In addition to shape, breast implants are available in two shell surfaces, smooth or SILTEX Imprinted Texture, and a variety of profiles. Profile refers to the amount of forward projection of the implant off the chest wall. Higher profile implants create a more prominent silhouette than a lower profile breast implant. SHAPED SILICONE GEL IMPLANTS are the newest available option. MENTOR MemoryShape Breast Implants are teardrop-shaped and made of a highly cohesive silicone gel that maintains the implant s shape. Much like the silhouette of a natural breast, they gently slope to a full projection point in the lower portion of the implant. Also, a teardropshaped implant is thinner at the top, therefore it gradually blends into the upper chest. Round Silicone Gel implants are available as MENTOR MemoryGel Breast Implants. These implants are filled with a proprietary softer cohesive gel, relative to MemoryShape Breast Implants that resembles the natural feel of breast tissue. MemoryGel Implants come in both smooth and textured surfaces, and a range of profiles. High profile implants provide the greatest forward projection for a more prominent silhouette, and are designed for a narrower chest area. Saline-Filled Implants are filled with a saltwater solution similar to the fluid that makes up most of the human body. They have a slightly firmer feel than gel implants. They are available in both smooth and textured surfaces and a range of profiles. { 11 }

18 WhiCh type of mentor Breast implant is right for you? Here is a summary look at some of the features of MenTor MemoryGel Breast implants, MenTor Memoryshape Breast implants, and saline-filled implants. This side-by-side comparison can help you determine which implant type is right for you. your plastic surgeon is another excellent resource with whom to discuss your options. HoW Do MenTor s MenTor MeMorysHAPe BreAsT implant FDA approved Made in the usa Fill YES YES Filled with a highly cohesive gel for durable shape retention designed to give a youthful feel. Volume Projection options Shell surface options Warranty set fill volume for predictable results. Teardrop-shaped to match the natural slope of a breast with full projection point at the lower portion of the implant. imprinted with MenTor siltex Texture designed to keep your implants in place. covered by the Mentor replacement Policy, Mentor Warranty, and enhanced Warranty. { 12 }

19 seeing is believing. cross section of a MenTor Memoryshape Breast implant illustrating cohesive gel fill. silicone AnD saline implants compare? MenTor MeMoryGeL BreAsT implant YES YES Filled with a proprietary cohesive gel that holds together uniformly while retaining the natural give that resembles breast tissue. set fill volume for predictable results. Four projection options: Moderate classic, Moderate Plus, High and ultra High Profiles. Two shell surfaces available: smooth and textured (MenTor siltex Texture). covered by the Mentor replacement Policy, Mentor Warranty, and enhanced Warranty. saline FiLLeD BreAsT implant YES YES Filled with a saltwater solution similar to the fluid that makes up most of the human body; slightly firmer feel than gel. Flexible fill volume, allowing the surgeon to adjust the volume during the procedure. Three projection options: Moderate, Moderate Plus, and High Profiles. Two shell surfaces available: smooth and textured (MenTor siltex Texture). covered by the MenTor standard & enhanced Advantage Limited Warranties and Lifetime replacement Policy. { 13 }

20 MENTOR MemoryShape Breast Implants A new addition to our family of products Our MemoryShape Implants give your surgeon an additional choice to help you achieve a naturallooking silhouette. Trusted and Proven With over 10 years of surgical use, and available in more than 70 countries worldwide*, MemoryShape Breast Implants are a leading choice for women who could benefit from an implant that helps create the natural shape of the breast. 2 Youthful firmness The cohesive gel that Mentor uses is formulated unlike any other to give your breasts a youthful feel. Gentle texture Each MemoryShape Implant features SILTEX Texture, a gentle imprinting process designed to help keep your implants in place. Are MemoryShape Implants right for you? As with all breast implant choices, you and your surgeon will take into consideration your unique features, as well as your desired outcomes in order to give you the beautiful result you re looking for. Following are some of the factors that may guide you and your surgeon s decision to choose MemoryShape Implants. * Referred to as MENTOR CPG Gel Breast Implants outside the United States. 2 Data on file at MENTOR Worldwide LLC. { 14 }

21 If you re considering augmentation with MemoryShape Breast Implants: Do you have a certain look in mind? Teardrop-shaped implants are made to match the silhouette of a natural breast with more fullness at the bottom than at the top. If this is the look you want, MemoryShape Implants may be right for you. If you want a look that is more round at the top of your breast, you should discuss MemoryGel Round Breast Implants with your surgeon. Is the feel of the breast implant most important to you? MemoryShape Implants are filled with a highly cohesive silicone gel that helps the implant create a natural breast silhouette. Although this gel is pliant, it may feel firm. If it is a top priority that your implant have a soft feel, ask your surgeon about MemoryGel Breast Implants. They are a round breast implant option with a slightly softer feel. {{ 15 }}

22 Do you have sufficient tissue coverage? An important consideration in determining if Memoryshape Breast implants may be a good choice for you is the amount of breast tissue coverage you have. During your consultation, your surgeon will evaluate your breast tissue to determine if Memoryshape implants are well suited to you. Do you have an incision site preference? When placing a breast implant, there are three common incision sites: around the nipple (periareolar), within the breast fold (inframammary), and underneath the arm (axillary). Memoryshape implants may be placed using any of these incision sites. However, the most common incision site is within the breast fold. Teardrop-shaped implants may require a larger incision than round implants. mentor memorygel Breast implants smooth round Moderate classic Profile implant smooth round Moderate Plus Profile implant smooth round High Profile implant smooth round ultra High Profile implant siltex roundmoderate classic Profile implant siltex roundmoderate Plus Profile implant siltex round High Profile implant siltex round ultra High Profile implant { 16 }

23 A trusted choice After decades of research and testing, MemoryGel Breast implants were approved by the FDA for women in the us. MemoryGel implants have now been successfully used and trusted for over 25 years by millions of women worldwide. Why? Because our implants feel like natural breast tissue without compromising reliability or safety. MemoryGel implants come in either a textured or smooth surface shell and are available in a wide range of sizes and profiles to fit your body. { 17 }

24 A PicTure is WorTH A THousAnD WorDs We have cut a MenTor MemoryGel Breast implant in half to demonstrate how the gel material holds together uniformly. MemoryGel silicone Gel is a cohesive, gelatin-like substance that does not pour or separate like a liquid, but acts more like a solid. our adherence to strict quality manufacturing requirements has resulted in silicone shells that have been tested and shown to possess excellent strength, resilience and elasticity. We re proud of our MemoryGel implants and it s easy to see why: MemoryGel Breast implants are one of the most studied medical devices in the world We conduct rigorous, multi-level testing at every step of manufacturing The uniquely formulated cohesive gel creates the soft, natural feel preferred by millions of women { 18 { 18 } }

25 mentor saline Breast implants another option MenTor saline Filled Breast implants also come in a variety of shapes, sizes, profiles, and surface textures. saline implants are inserted into the body without fluid. once placed, the implant is filled to the predetermined size. smooth round Moderate Profile implant smooth round Moderate Plus Profile implant smooth round High Profile implant siltex round Moderate Profile implant siltex contour ProFiLe Moderate implant siltex contour ProFiLe High implant mentor spectrum adjustable saline Breast implants An innovative line of adjustable implants often, the most difficult decision for most women regarding breast augmentation is choosing the breast size. The innovative line of spectrum implants makes the decision-making process easier because the size can be adjusted after surgery. in fact, spectrum implants are the only postoperatively adjustable saline filled breast implants that allow your surgeon to adjust the size of your implant for up to six months after your procedure. smooth round spectrum implant siltex round spectrum implant siltex contour ProFiLe spectrum implant { 19 }

26 facts about silicone gel filled Breast implants The History of silicone Did you know silicone has been used in hundreds of thousands of medical devices for over 50 years? catheters, heart valves, pacemakers, artificial joints and tissue expanders just to name a few you are familiar with. surgeons have trusted silicone for years because they know it is reliable, easy to sterilize, biocompatible, and flexible when used in both implantable and nonimplantable medical devices. MenTor silicone Gel Filled Breast implants first became available in the united states in April in 1992, the Food and Drug Administration called for a moratorium (removal from the marketplace) to the sale and use of silicone filled breast implants, limiting patient access to silicone filled breast implants and requiring implant manufacturers to collect clinical study data. shortly after the start of the moratorium the FDA decided to allow breast reconstruction patients as well as women with existing breast implants the option to receive silicone filled breast implants through a clinical study the Mentor Adjunct study to collect data about device performance and safety from This study has been one of the largest clinical device studies conducted in the world, with more than 150,000 patients participating. in september 2000, the core study to demonstrate long-term safety and effectiveness of the silicone gel breast implants began enrollment. This was designed to follow women undergoing primary augmentation, primary reconstruction, or revision for 10 years after initial implantation. Based on the pivotal core study data, and supported by the Adjunct study data, the FDA approved the Premarket Application (PMA) for MemoryGel Breast implants in november The same silicone breast implant material was used in both studies. { 20 }

27 a major study of silicone breast implants sponsored by the us government found: no evidence for health concerns in 1997, the Department of Health and Human services requested the institute of Medicine (iom) of the national Academy of sciences to conduct a comprehensive evaluation of the safety of breast implants. The iom panel of independent scientific experts included members of the medical, scientific and educational communities with experience in radiology, women s health, neurology, oncology, silicone chemistry, rheumatology, immunology, epidemiology internal medicine, and plastic surgery. The results After reviewing years of evidence and research concerning silicone gel filled breast implants, the iom found that Evidence suggests diseases or 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. The complete iom report is available online at { 21 }

28 silicone used ToDAy versus silicone of THe PAsT silicone gel filled breast implants have undergone changes over time to meet increasingly sophisticated consumer expectations. The very first silicone breast implants used thick shells and contained firm gel. The second generation of implants introduced in the late 1970 s had thinner shells and used less firm gel 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 were slightly thicker but still soft. Today these third generation silicone gel filled breast implants are typically referred to as cohesive gel implants. Fourth generation implants, including MemoryGel Breast implants were introduced in the mid 1990s with further refinements in the manufacturing process. Today newer, fifth generation implants are available, such as with Memoryshape Breast implants, which are filled a uniquely formulated cohesive gel that provides shape retention. An APProvAL BAseD on science: The FDA said Approved in november of 2006, the FDA approved MenTor MemoryGel Breast implants for breast augmentation and reconstruction. After nearly two decades of research and testing with surgeons and patients all over the world, MenTor MemoryGel Breast implants became available to women in the us. { 22 }

29 AnoTHer important reason To TrusT MenTor: MenTor Breast implants are the only breast implants made in the us. Their strict quality manufacturing requirements exceed the us standards. nothing could be more important than the quality of the breast implant that you and your surgeon choose Mentor is the world leader in breast implant manufacturing, research, and testing. For over 35 years, we have adhered to the highest standards of safety in manufacturing, testing, and clinical trials for saline and silicone breast implants for use in both breast augmentation and breast reconstruction. Because of this, we are consistently recognized by surgeons for outstanding product integrity. Millions of women worldwide have used MenTor MemoryGel Breast implants. Mentor is committed to conducting long-term, far-reaching clinical studies. Mentor is committed to conducting its own longterm, far-reaching clinical studies. Throughout the years, Mentor has done extensive safety evaluations of both saline filled breast implants and gel filled breast implants. Mentor is and will remain committed to providing objective, clinical information about breast implant safety. { 23 }

30 mentor product replacement policy and limited Warranties Mentor proudly stands behind the products we manufacture with a product replacement policy and Mentor warranty. it s important to understand that when undergoing breast augmentation, breast implantation may not be a one-time surgery. MenTor ProDucT replacement PoLicy Mentor Product replacement Policy provides for the free lifetime product replacement of its MemoryGel Breast implants, Memoryshape Breast implants, 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 MenTor Breast implant at no cost. if a more expensive product is requested, Mentor will invoice your surgeon for the price difference. MenTor MeMoryGeL BreAsTiMPLAnTs AnD MeMorysHAPe BreAsT implants THe MenTor WArrAnTy Offers up to $3,500 in financial assistance. Here s what s included: Automatic enrollment in our Product Replacement Policy * Applies to certain expenses occurring from a confirmed, qualifying rupture for up to 10 years from the date of implant surgery Pays up to $3,500 4 financial assistance for certain operating room, anesthesia, and surgical charges not covered by insurance and applies only to implant surgeries conducted on or after october 6, 2014 replacement product for up to 3 years following a primary 5 implant surgery, whether augmentation or reconstruction, in the event of capsular contracture Baker Grade iii & iv, double capsule, and late-forming seroma. see full warranty for additional details { 24 }

31 Free contralateral (opposite side) implant replacement upon surgeon request Plus, this warranty coverage is Free THe MenTor enhanced WArrAnTy Offers up to $3,500 in financial assistance plus more. Requires enrollment within 45 days. Here s what s included: Automatic enrollment in our Product Replacement Policy * Applies to certain expenses occurring from a confirmed, qualifying rupture for up to 10 years from the date of implant surgery Pays up to $3,500 4 financial assistance for certain operating room, anesthesia, and surgeon fees not covered by insurance for replacement surgery resulting from a Baker Grade iii capsular contracture, Baker Grade iv capsular contracture, double capsule, or late-forming seroma for up to 10 years from the date of primary implant surgery occurring on or after date of implant october 6, 2014 replacement product for up to 10 years following a primary 5 implant surgery, whether augmentation or reconstruction, in the event of capsular contracture Baker Grade iii & iv, double capsule, and late-forming seroma. see full warranty for additional details Free contralateral (opposite side) implant replacement upon surgeon request Must be purchased for an enrollment fee of $200 within 45 days from implantation For full program details including qualifications, visit * Product replacement Policy for MenTor Gel-filled Breast implants: in the event of unexpected rupture (loss of shell integrity), Mentor will provide replacement of a MenTor Product of any size in the same style as the implant being replaced) free of charge for the lifetime of the patient. upon the surgeon s request, a different implant style may be selected (subject to a charge of the difference between product list prices). 4 operating room and anesthesia charges to be given payment priority. in order to qualify for financial assistance, you will need to sign a release before Mentor will make payment to you or on your behalf. 5 Primary means the very first original implantation of the MenTor MemoryGel Breast implant or Memoryshape Breast implant. Prior implant(s), regardless of type, style, or manufacturer, preclude inclusion in the Mentor enhanced Warranty for both replacement product and financial assistance. in the event of primary reconstruction with use of a tissue expander, the temporary tissue expander does not qualify as an implant. { 25 }

32 MenTor saline FiLLeD BreAsT implants MenTor standard ADvAnTAGe LiMiTeD WArrAnTy Offers up to $1,200 in financial assistance. This warranty is free of charge to all patients who are implanted with MenTor saline Filled Breast implants. Here is an overview of the details: Automatic enrollment in our Lifetime Product Replacement Policy 1 coverage for 10 years (qualified deflation) and up to $1,200 financial assistance for certain operating room, anesthesia, and surgical charges not covered by insurance 2 Free contralateral (opposite side) implant replacement upon surgeon request enrollment in this warranty is Free and automatic; registration is encouraged MenTor enhanced ADvAnTAGe LiMiTeD WArrAnTy Offers up to $2,400 financial assistance This optional 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: Automatic enrollment in our Lifetime Product Replacement Policy 1 coverage for 10 years (qualified deflation) and up to $2,400 financial assistance for certain operating room, anesthesia, and surgical charges not covered by insurance 2 Free contralateral (opposite side) implant replacement upon surgeon request 1 Lifetime Product replacement Policy for MenTor saline Breast implants: in the event of a deflation, Mentor will provide replacement MenTor Product of any size in the same style (as the implant being replaced) 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 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 before Mentor will make payment to you or on your behalf. 3 one warranty payout per enrollment fee; enrollment in the program for replacement device will require additional $100 enrollment fee. 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. { 26 }

33 selecting the right surgeon for you What could be more important? Gather names; do your research into each surgeon s training, experience and results; schedule consultations with surgeons; ask questions; see before-and-after photos; and then use your own best judgment to make your choice. Do you relate to the surgeon? Do you feel at ease? In addition to medical experience, a surgeon s communication skills can be an important factor in choosing the right surgeon for you. After the consultation, ask yourself: Did he or she take the time to answer your questions or did you feel rushed? Was the staff courteous, helpful and genuinely caring? Your questions and considerations are valid. You may want to meet with more than one surgeon. The surgeon will expect you to ask questions even sensitive ones. A tip bring your questions in writing so you don t forget anything important. { 27 }

34 Here are some questions you may want to ask: How many breast augmentation procedures do you perform each year? How many years have you been doing these procedures? Have you obtained training certification from Mentor to use MemoryGel Breast Implants and MemoryShape Breast Implants? Are you board certified, and if so, with which board? In which state(s) are you licensed to practice surgery? (Note that some states provide information on disciplinary action and malpractice claims/ settlements to prospective patients, either by request or on the Internet.) What is the most common complication you encounter with breast augmentation? What is your reoperation rate with breast augmentation, and what is the most common type of reoperation you perform? Do you perform this surgery in a hospital or at an independent surgery center? (Note that hospitals require the demonstration of evidence of appropriate training in specific procedures before allowing surgeons to operate in their facilities.) { 28 }

35 You ll also want to ask questions about the procedure itself during your initial consultation: What are the risks and complications associated with having breast implants? (Highlight any risks and complications in this brochure and bring a copy with you.) How many operations can I expect over my lifetime on my implanted breasts? If I choose to have the implants removed at a later date, how will my breasts look? What shape, size, surface texturing, incision site and placement site do you recommend for me? How will my ability to breastfeed be affected? How can I expect my implanted breasts to look over time? How can I expect my implanted breasts to look after pregnancy or after breastfeeding? What are my options if I m dissatisfied with the cosmetic outcome of my implanted breasts? What alternate procedures or products are available if I choose not to have breast implants? Do you have before and after photos for each procedure? I d like to be a size B (or C or D) cup size. Do you think that s appropriate for my body type? What results are reasonable for me to expect? Turn to Mentor provides a list of qualified surgeons in your area. Just click on find a surgeon and in minutes you ll have several surgeons to contact. You can also find a list of surgeons by contacting a number of respected professional organizations, such as: The American Society of Plastic Surgeons (ASPS) The American Society for Aesthetic Plastic Surgery (ASAPS) Your local medical society { 29 { 29 } }

36 FREQUENTLY ASKED QUESTIONS ABOUT BREAST IMPLANTS For the most comprehensive information about breast implant surgery, we invite you to visit the Mentor aesthetic website: What is a breast implant? When someone says breast implant, they are describing a silicone shell that is filled with either silicone gel or saline solution. Breast augmentation and reconstruction surgeons insert these implants under breast tissue or under the chest muscle to create a fuller looking and feeling bust line. 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. Silica 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? After decades of research and testing, MemoryGel Breast Implants and MemoryShape Breast Implants are FDA approved for augmentation and reconstruction. Mentor has conducted rigorous safety evaluations of our gel filled breast implants, including two 10-year Core studies to provide even more information to patients and surgeons. Each Core study is a prospective, 10-year, multicenter clinical study conducted to examine the safety and effectiveness of MENTOR Silicone Gel Breast Implants. As we have for many years, Mentor will remain committed to providing objective information about breast implant safety. { 30 }

37 What are MENTOR MemoryGel Breast Implants? MemoryGel Breast Implants are Mentor s most popular line of breast implants. They are pre-filled with Mentor s proprietary cohesive silicone gel. MemoryGel Breast Implants hold safely and uniformly together to deliver a natural feel that closely resembles natural breast tissue. How do MemoryShape Breast Implants differ from MemoryGel Breast Implants? MemoryShape Implants, are teardrop-shaped and made of a more highly cohesive silicone gel, designed to impart a natural silhouette and give you a youthful feel. In comparison MemoryGel Implants are round and made of a slightly less cohesive silicone gel which resembles the natural give of breast tissue. What is gel cohesiveness and why is it important? Gel cohesiveness is determined by the amount of cross-linking within the silicone gel filler. The more cross-linking, the more cohesive the gel and the more it helps to maintain its shape. As such, highly cohesive silicone gel filled breast implants are able to retain their molded, teardrop-shape whereas MemoryGel Implants (round) are more pliable. Why are MemoryShape Implants teardrop-shaped? They are shaped to match the silhouette of a natural breast with more fullness at the bottom than at the top. Also, a teardrop-shaped implant is thinner at the top, therefore it gradually blends into the upper chest. I ve heard it s okay for round implants to shift, but not shaped implants. How do shaped implants stay in the proper position? MemoryShape Breast Implants have orientation marks to help your surgeon place them correctly during surgery, and their textured surface is specially designed to help keep them in place. Choose a surgeon you feel comfortable with and who is experienced at placing shaped implants. Why Choose MemoryShape Implants? Our greatest satisfaction is our patients satisfaction. Women who had breast augmentation or reconstruction procedure with MemoryShape Implants reported a three-fold increase in satisfaction scores, with improvements in self-esteem, appearance and quality of life. 2 2 Data on file at MENTOR Worldwide LLC. { 31 }

38 We re proud to provide our surgeons with the product innovation and training support to help make this possible. What are Saline Filled Breast Implants? Saline Filled Breast Implants are silicone shells filled with saline (a saltwater solution) that is very similar to the bodies natural fluid which makes up most of the human body. Saline implants are inserted into the body without fluid and then filled with the saline fluid through a fill tube during the surgery to adjust and achieve optimal volume. Certain MENTOR Saline Filled Breast Implants also allow for adjustments after surgery. Do MENTOR Breast Implants include latex? No. Because latex allergies are so common, Mentor Breast Implants are not made with natural rubber in the manufacturing of any of its breast implants. Is there active platinum in breast implants? The manufacture of silicone breast implant shells and gel-filling materials uses platinum as a catalyst. { 32 }

39 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 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 MemoryGel Breast Implants 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. { 33 }

40 How do breast implants affect mammography? 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. If you are of the proper age for mammography screening, you should continue to undergo routine mammography screenings as recommended by your primary care surgeon. When you do, be sure to inform the mammography technician that you have implants. What is the average life expectancy of a breast implant? It s important to know that 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. Do implants influence the occurrence of breast cancer? Patients with breast implants have not been found to be at a greater risk of developing breast cancer than those without breast implants. Should I be at my ideal weight before I have a breast implant procedure? You should be close to your ideal weight when you have breast implant surgery. Why? Because women who lose or gain a significant amount of weight after receiving breast implants sometimes alter the results in unpredictable and/or undesirable ways. Will my breasts still move like normal breasts? The goal is to create soft and natural moving breasts. Achieving this depends upon multiple factors. For some women, implants are firmer and more fixed in their position than their natural breasts. I m over 50 years of age. Am I too old to get breast implants? Your general health is far more important than your age. Women over the age of 50 can and do get implants. You are never too old to look your best. Will getting breast implants cause stretch marks on my breasts? Rarely, but it can happen. If you want to take every precaution to avoid stretch marks you have a few { 34 }

41 options that can reduce their likelihood. You can choose a smaller size breast implant to minimize the stretching of your skin or choose a SPECTRUM Adjustable Saline Breast Implant so you can slowly stretch your skin over time. Will I lose nipple sensation? There can be an increase or decrease in nipple sensation after your breast implant surgery. A small number of women experience intense sensitivity and others, no feeling. These effects can be temporary or permanent. What will happen during pregnancy? Every woman has different results with breast implants before or after a pregnancy. If you become pregnant after receiving breast implants, your breasts will grow and go through all the usual changes associated with pregnancy. The amount of enlargement will vary from woman to woman, and the size of your implants will be a factor. Will I be able to breastfeed? Many women with breast implants successfully breastfeed their babies. Some breastfeeding difficulties have been reported following breast surgery particularly when a surgeon uses a periareolar (around the nipple) incision. It is important that you let your surgeon know if you are planning or considering getting pregnant postsurgery. How long should I wait to resume exercise and other strenuous activities after breast implant surgery? Because recovery periods vary from woman to woman, your surgeon will determine how much recovery time you may need and when to resume normal activities. As a rule of thumb, the first few days are the most uncomfortable. Most women return fully to their regular lives after four to six weeks. Be careful about resuming strenuous activities that could raise your pulse and blood pressure, or require strenuous use of your arms and chest through the entire recovery process. Be sure to check with your surgeon before returning to your workouts. What affect does smoking have on the healing process following surgery? Smoking can compromise recovery by causing blood vessels to constrict, reducing blood flow and the oxygen it carries to the surgical area. Your tissues need { 35 }

42 this blood and oxygen supply to heal properly. When your blood supply is reduced, tissues heal more slowly and irregularly. That s why many surgeons ask patients to refrain from smoking for one to five weeks prior to and after surgery. It is important that you ask your surgeon what his or her specific recommendation for you would be. When can I wear an underwire bra again? Most surgeons ask women to wait three months before wearing underwire bras after breast implant surgery because the body continues to form scar tissue around the implant for that time. Be sure to ask your surgeon for a recommendation. Can I go to tanning salons, infrared saunas or sunbathe if I have breast implants? These activities will not hurt the breast implants in any way, however, they may make scar tissue more visible. When can I fly and/or scuba dive? Once fully recovered, you can feel free to scuba dive and fly in airplanes with some minor considerations since there may be slight expansion and contraction of the shell with changes in pressure. With saline-filled implants, this may result in a minimal amount of air bubbles in the implant, and you may feel or hear fluid sounds (gurgling). This should correct itself within 24 to 48 hours. Are MENTOR Breast Implants covered by a warranty? Your peace of mind is important to us. All MENTOR Products come with the Mentor Lifetime Product Replacement Policy which provides for the free lifetime product replacement of our gel filled 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. Please visit Breast-Implants/breast-implant-warranty.aspx to learn more about the terms of our Limited Warranties and Product Replacement Policy. { 36 }

43 Breast Augmentation Resources For additional information or questions about MENTOR Breast Implants, please call MENTOR-8. Here are additional resources that can provide more information: augmentation/downloads.htm Mentor Brochures: Important Information for Augmentation Patients About MENTOR MemoryGel Breast Implants Patient Educational Brochure - Breast Augmentation with MENTOR MemoryShape Breast Implants Quick Facts about Breast Augmentation & Reconstruction with MENTOR MemoryShape Breast Implants Saline filled Breast Implant Surgery: Making an Informed Decision Mentor Worldwide, LLC Mentor 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. American Society of Plastic Surgeons { 37 { 37 } }

44 IMPORTANT SAFETY INFORMATION The MENTOR Collection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR MemoryGel Breast Implants or MENTOR MemoryShape Breast Implants, and at least 18 years old for MENTOR Saline Breast Implants. 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 autoimmune 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 may not be 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. Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation with MemoryGel Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. The most common complications with MENTOR MemoryShape Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. The most common complications for breast augmentation with MENTOR Saline-fi lled Breast Implants include reoperation, implant removal, capsular contracture, breast pain, and implant defl ation. Detailed information regarding the risks and benefi ts associated with MENTOR Breast Implants is provided in several educational brochures. For MemoryGel Implants: Important Information for Augmentation Patients about MENTOR MemoryGel Breast Implants. For MemoryShape Implants: Patient Educational Brochure Breast Augmentation with MENTOR MemoryShape Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR MemoryShape Breast Implants. For MENTOR Saline-fi lled Implants: Saline-Filled Breast Implants: Making an Informed Decision. These brochures are available from your surgeon or visit It is important that you read and understand these brochures when considering MENTOR Breast Implants. 201 Mentor Drive santa Barbara, ca usa (805) customer service: (800) Fax: (805) Mentor Worldwide LLc