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DISCOVER YOUR

BREASTRECONSTRUCTIONOPTIONS

®

with MENTOR® Breast Implants

For over 30 years,Mentor has beenrecognized worldwideas a leading manufacturerof breast implants.

MENTOR® MemoryGelTM

Breast Implants are theleading choice ofmillions of womenworldwide1.

The information contained in this material is foreducational purposes only and is not a substitutefor medical advice. You should talk to your doctorabout what to expect and follow your surgeon'sadvice regarding activities after surgery.

1. Mentor Worldwide LLC. Mentor Worldwide as of June, 2017.

There’s a lot to learn when you’re consideringbreast reconstruction or breast replacementsurgery with breast implants. This brochure willhelp you build a solid foundation of understandingas you begin this important process of choosingfrom the most up-to-date product options fromMentor. Our CPG™ Gel Breast Implants andMemoryGel™ Breast Implants are options for youto consider and discuss with your surgeon.

Our rich history is filled with industry firsts,innovative product designs and ground breakingresearch. Some manufacturers have comeand gone, Mentor has a record of continuallyproducing leading-edge, FDA approved breastreconstruction products. We are dedicated toproviding patients and surgeons with proven safeand effective products and service.Like all things in life-the best decisions aremade when you base them on your personalneeds, desires, expectations, and facts.

MAKE A GOOD DECISION

WE’ RE HERE TO HELP YOUMAKE A CONFIDENT,INFORMED DECISION

TABLE OF CONTENTS

1 An Introduction

Reconstruction Overview

Immediate Reconstruction

Delayed Reconstruction

Product Overview

Which type of MENTOR® Breast Implantis right for you?

MENTOR® CPG™ Gel Breast Implants

MENTOR® MemoryGel™ Breast Implants

Silicone Safety

Mentor Lifetime Product Replacement PolicyWarranty and Mentor Patient Safe CoverageLimited Warranty

Frequently Asked QuestionsAbout Breast Implants

Resources

Important Safety Information

2

2

6

8

12

14

16

19

22

23

30

32

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AN INTRODUCTIONMany women feel that reconstructionis an important next step in theirrecovery and overall healing.For some, reconstruction can be a means ofregaining a sense of wholeness and confidence intheir appearance that may have been lost or impactedduring treatment. For others, the reason is morepractical - they simply don’t like the hassle or worryassociated with wearing a prosthesis. Being informedabout your options will help you and your surgeonmake the right choices.

It is important to note that any breast reconstructionprocess will require multiple procedures and theactual number of surgeries and recovery times vary.

Detailed information regarding the risks and benefitsassociated with MENTOR® Breast Implants isprovided in several educational brochures. It isimportant that you read and understand thesebrochures when considering MENTOR® BreastImplants. Breast implants are not lifetime devices.You may need additional unplanned surgeries on yourbreasts because of complications or unacceptablecosmetic outcomes. The most common complicationsare reoperation, implant removal and capsularcontracture. A lower risk of complication is rupture.Your doctor will monitor you in the years after yoursurgery to look for these potential complications.

Why choose Reconstruction?Tens of thousands of breast cancer patients haveelected to have breast reconstruction surgery.Breast reconstruction rebuilds your breast shape andfeel after a mastectomy. Choosing breast reconstructionis very personal. Many studies have suggestedthat breast reconstruction constitutes a “reversemastectomy” through the restoration of body image,self-esteem, and sexuality. The psychosocial benefitsof breast reconstruction for those who desire it have

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been well established. Breast reconstruction proceduresvary depending on the results you desire alongwith your particular situation and other physical andpsychological factors. Ask your surgeon for a detailedexplanation of which option is most suitable for youand your lifestyle, as well as the risks of the surgery.It is essential to be well informed before decidingwhether to have reconstruction surgery and whichimplant is right for you.

Keep a list of questions you may have and review themwith your surgeon during those consultations.

RECONSTRUCTIONOVER VIEWYOUR OPTIONS -IMMEDIATE OR DELAYED Breast reconstruction can be accomplished atthe time of your mastectomy (immediatereconstruction) or at some point afterward(delayed reconstruction). The reconstructionprocedure and products that are right for you willvary depending on your desired outcome, personalpreferences, and physical factors.

IMMEDIATE RECONSTRUCTIONImmediate breast reconstruction begins at the time ofyour mastectomy. After the surgeon removesyour breast tissue, the reconstructive surgeon willthen place a breast implant or tissue expander.

One-StageImmediate one-stage reconstruction is when yoursurgeon places a breast implant immediately afteryour mastectomy. Women who have had a nipplesparing mastectomy (when the nipple is not removed)leaving the majority of the breast-skin, may have thepossibility of one-stage reconstruction.

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Two-StageImmediate two-stage reconstruction starts withthe placement of a breast tissue expander afterthe surgeon removes the breast tissue. Theexpander is gradually filled with sterile saline by yoursurgeon in an outpatient clinic setting. The volume willbe increased in the tissue expander over time causingthe surrounding tissue to stretch and allow new skinto be created to obtain the desired result. The tissueexpander is then replaced by a breast implant sometime later. This procedure allows for the mostflexibility in shaping the breast.

Mastectomy incision Implant with remoteinjection dome

Implant with remoteinjection dome beforeincision closure

Final result

Immediate ReconstructionProduct OptionsOnce you have learned that you are a candidate forimmediate breast reconstruction surgery, decidingwhich products to use to achieve your desired resultsis the next step in your journey. Continue reading tolearn more about your product options.

One-Stage Reconstruction

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MENTOR® BREAST TISSUE EXPANDERSTissue expanders are used in two-stage immediate breast reconstruction surgery to expand the skin andcreate a shaped pocket for the implant to occupy.

MENTOR® BREAST IMPLANTSBreast Implants can be used during both one-stage and two-stage immediate breast reconstruction surgery. A breast implant is a sack (implant shell) made of siliconeelastomer-filled with silicone gel- is surgicallyimplanted under your breast tissue or under yourchest muscle to increase breast mass.Mentor offers silicone that adhere to the higheststandards of safety on the market today.2

SILTEX™ BECKER™ EXPANDER/BREAST IMPLANTSThe BECKER™ Expander/Implant is the only gel productthat gives you the option of a single or two-stage breastreconstruction. These unique products have an innerlumen containing saline solution that allows for tissueexpansion and an outer lumen of gel that is designedto provide a softer feeling implant. The remoteinjection dome makes volume adjustments simpleand can be easily removed when expansion is complete.BECKER™ Expander/Breast Implants are a technologicaladvancement in terms of offering your surgeon theability to create exact outcomes in size, shape and fill,without compromising the natural give of silicone gel.

MENTOR® SPECTRUM™ ADJUSTABLESALINE BREAST IMPLANTMany one-stage immediate breast reconstruction surgeries involve the placement of a single adjustable implant. The volume of the SPECTRUM™ Implant can be expanded postoperatively over a period of several months, until your desired size is achieved.

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2. ISO: Non-active surgical implants — Mammary implants — Particular requirements. 14607. Second edition. 2007-02-15

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DELAYED RECONSTRUCTIONUnlike immediate breast reconstruction, delayedbreast reconstruction does not begin at the time ofyour mastectomy. Delayed breast reconstructionsurgery may begin weeks, months, or even yearsafter your mastectomy. Your surgeon willbegin reconstructive surgery at whatever time youand your care team decides is best given your uniquesituation. Two-stage reconstruction is the onlyprocedural option if you elect to have delayedreconstruction surgery, because the skin overyour chest will have contracted and lost thebreast shape in the intervening time.

Two-stage delayed breast implant reconstructioninvolves a combination of procedures to gradually expandthe skin on your chest into the shape of a breastand create a pocket for the breast implant to occupy.Delayed breast reconstruction starts with the placementof a breast tissue expander. The breast tissueexpander is gradually filled with sterile saline fluidto expand and grow your skin. Several months laterthe tissue expander is replaced with a breast implant,after enough new skin has been created to obtain thebest result.

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Delayed Reconstruction Product OptionsBelow is a brief discussion of your product options forbreast tissue expanders and breast implants.For delayed reconstruction talk to your surgeon todecide which products will yield the best reconstructionresults given your specific needs.

MENTOR® BREAST TISSUE EXPANDERSTissue expanders are used in two-stage delayed breastreconstruction surgery to expand the skin andcreate a shaped pocket for the implant to occupy.

MENTOR® BREAST IMPLANTSWhen your breast tissues have expanded to create enough room, the tissue expander will be removed and a breast implantwill be placed. Mentor Breast Implants go through a series of controlled tests to insure that only products that meet or exceed our standards leave our facility.

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Tissue expander withintegral injection Dome

1. Mentor Worldwide LLC. Mentor Worldwide as June, 2017.

PRODUCT OVERVIEWMentor is a world leader in breast implantmanufacturing1. Mentor Breast Implants go through a series of controlled tests to insure that only products that meet or exceed our standards leave our facility. Explore this section to learn more about the wide variety of breast implant styles that Mentor offers. You can also review safety and warranty information, as well as read answers to frequently asked questions.

MENTOR® BREAST TISSUE EXPANDERS Tissue expanders are used in both immediate anddelayed breast reconstruction surgery to expandthe skin and create a shaped pocket for the implantto occupy. After your surgeon removes your breasttissue, the surgeon will then insert the unfilledtissue expander.

CONTOUR PROFILE™ Breast Tissue Expanders MENTOR® CONTOUR PROFILE™ Expanders aredesigned to expand primarily in the lower portion ofthe breast, so the resulting pocket will accommodateyour selected breast implant and slope like a maturebreast. The addition of a SILTEX™ Texture texturizedshell promotes a reduction in shifting with the goal tominimize capsular contracture. CONTOUR PROFILE™expanders also have an integral injection dome thatallows your surgeon to add saline solution to theexpander and gradually stretch the breast tissue overa period of several months. The tissue expander isremoved when your breast tissues can accommodatethe breast implant you and your care team haveselected.

SILTEX™ BECKER™ Expander/Breast Implants The BECKER™ Expander/Implant is the only gel product thatgives you the option of a single or two-stage breastreconstruction. These unique products have an innerlumen containing saline solution that allows for tissueexpansion and an outer lumen of gel that is designed toprovide a softer feeling implant. The remote injectiondome makes volume adjustments simple and can be easilyremoved when expansion is complete. BECKER™Expander/Breast Implants are a technological advancementin terms of offering your surgeon the ability to create exactoutcomes in size, shape and fill, without compromising thenatural give of silicone gel. The tissue expander isremoved when your breast tissues can accommodatethe breast implant you and your care team haveselected.

Mentor produces silicone breast implants:Silicone breast implants are silicone shells that arefilled with silicone gel. Your surgeon will help you decide which implant options are right for you based on your body type, desired outcomes, and expectations.

MENTOR® BREAST IMPLANTS

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BREAST IMPLANTFEATURESSizeBreast implant size is measured in cubic centimeters(often referred to as cc’s). The larger the implant,the higher the volume of cc’s will be. For example, a300cc implant is larger than a 250cc implant. Breastimplant sizes do not correspond to traditional bracup sizes. Your surgeon is the best resource fordetermining what size implant is best for your body.

ProfileThe profile of a breast implant refers to the level offorward projection from the chest wall in relationto the base width of the implant. In other words, theprofile indicates the distance the implant will projectfrom your body. A higher profile breast implant willcreate a more prominent silhouette than a lowerprofile breast implant.

ShapeMENTOR® Silicone Implants are available in twodistinct shapes: teardrop and round. MENTOR® CPG™ Gel Breast Implants are teardrop shaped,tapered at the top and gently sloping to mimic thesilhouette of a natural breast. MENTOR® MemoryGel™Breast Implants are round and, therefore, able to shiftslightly once positioned without distorting the shapeof the breast. Talk to your surgeon to explore differentshape options and learn about which one may beright for you.

SILTEX™ BECKER™ EXPANDER/BREAST IMPLANTSand SPECTRUM™ ADJUSTABLE SALINEBREAST IMPLANTS can be adjusted after surgery,and are available in both round and contouredshapes. The SILTEX™ BECKER™ EXPANDER/BREASTIMPLANTS and SPECTRUM™ Adjustable Implant functionas both a tissue expander and a long-term saline breastimplant. It can be placed with minimal volume during

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MENTOR® CPG™ Gel Breast Implants

Surface Texture

SILTEX™ BECKER™ EXPANDER/BREAST IMPLANT

your initial surgery, with the fluid volume graduallybeing increased over time, which expands thebreast’s tissues. This implant contains a fill tube andremote injection dome that should be removed whenthe final volume is reached. The implant is then leftin place as the long-term breast implant.

MENTOR® Breast implant shells are offered witheither a smooth or textured surface shell. SILTEXTM

Imprinted Texture helps reduce the chance ofcapsular contracture and was designed to preventshaped implants from shifting in position.Talk to your surgeon to decide whichsurface texture is best for you.

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WHICH TYPE OF MENTOR®

BREAST IMPLANT IS RIGHTFOR YOU?This side-by-side comparison of MemoryGel® Breastimplants and CPG™ Gel Breast Implants may help youdetermine which implant type is right for you. Yoursurgeon is another excellent resource with whom todiscuss your options. You and your surgeon will discusswhich option is the best for you based on yourdesired outcomes.

How do MENTOR® Silicone BreastImplants, round and shaped or teardropBreast implantscompare?

Filled with a proprietary cohesive gel thatholds together uniformly while retaining thenatural give that resembles breast tissue.

Set fill volume for predictable results.

Six projection options: Moderate, Moderate Plus, Moderate Plus Xtra, High, High Xtra and Ultra High Profiles

Two shell surfaces available: smoothand textured (SILTEXTM Texture).

MENTOR® Lifetime Product ReplacementPolicy Warranty and MENTOR® Patient SafeCoverage Limited Warranty

MENTOR® MEMORYGEL™ BREAST IMPLANTS

Fill

Volume

Projection options

Shell surface options

Warranty

For full warranty program details and qualifications, visit www.mentorwwllc.eu

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MENTOR® CPG™ GEL BREASTIMPLANTS

Fill Filled with a highly cohesive gel for durableshape retention designed to give ayouthful feel.

Volume Set fill volume for predictable results.

Projection options Teardrop-shaped to resemble the naturalslope of a breast with full projection pointat the lower portion of the implant.

Shell surface options Imprinted with MENTOR® SILTEXTM

Texture designed to keep yourimplants in place.

Warranty MENTOR® Lifetime Product ReplacementPolicy Warranty and MENTOR® Patient SafeCoverage Limited Warranty

For full warranty program details and qualifications, visit www.mentorwwllc.eu

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MENTOR® CPG™ GelBREAST IMPLANTSOur MENTOR® CPG™ Gel Breast Implants give yoursurgeon an additional choice to help you achieve anatural-looking silhouette.

With over 10 years of surgical use, and available inmore than 70 countries worldwide, MENTOR® CPG™ GelBreast Implants are a leading choice for women whocould benefit from an implant that helps create thenatural shape of the breast.

Trusted and Proven

The cohesive gel that Mentor uses is formulatedunlike any other to give your breasts a youthful feel.

Youthful firmness

Each MENTOR® CPG™ Gel Breast Implants featuresSILTEX™ Texture, a gentle imprinting processdesigned to help keep your implants in place.

Gentle texture

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Are CPG™ Gel Breast Implants right foryou?As with all breast implant choices, you and yoursurgeon will take into consideration your uniquefeatures, as well as your desired outcomes inorder to give you the result you’re looking for.

Teardrop - shaped implants are made to matchthe silhoue�e of a natural breast with morefullness at the bo�om than at the top. If this isthe look you want, CPG™ Gel Breast Implants may beright for you.

CPG™ Gel Breast Implants are filled with a highlycohesive silicone gel that helps the implantcreate a natural breast silhoue�e. Although thisgel is pliant, it may feel firmer to you than yournatural breast tissue.

An important consideration in determiningwhich implant will be right for you is the amountof breast tissue coverage you have. During yourconsultation, your surgeon will evaluate yourbreast tissue and determine which implants arewell suited to you.

When placing a breast implant, there arethree common incision sites: around the nipple(periareolar), within the breast fold(inframammary) and underneath the arm(axillary). MENTOR® CPG™ Gel Breast Implants maybe placed using any of these incision sites. However,the most common incision site is within the breastfold. Shaped implants may require a largerincision than round implants.

If you’re considering reconstructionwith MENTOR™ CPG™ Gel Breast Implants:

Do you have a certain look in mind?

Is the feel of the breast implant mostimportant to you?

Do you have sufficient tissue coverage?

Do you have an incision site preference?

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Smooth Round ModerateProfile Implant

Smooth Round ModeratePlus Profile Implant

Smooth RoundHigh Profile Implant

SILTEXTM Round ModeratePlus Profile Implant

SILTEXTM Round ModerateProfile Implant

SILTEXTM RoundHigh Profile Implant

MENTOR® MEMORYGEL™BREAST IMPLANTSA trusted choiceMemoryGel™ Breast implants have been successfullyused and trusted for over 30 years by millions of womenworldwide. Why? Because our implants feel like naturalbreast tissue - without compromising reliability orsafety.* MemoryGel™ Breast implants come in either atextured or smooth surface shell and are available in awide range of sizes and profiles to fit your body.

Smooth Round UltraHigh Profile Implant

SILTEXTM Round UltraHigh Profile Implant

* As compared to saline-filled breast implants.

SILTEXTM Round High Xtra Profile Implant

SILTEXTM Round Moderate Plus Xtra Profile Implant

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Smooth RoundSPECTRUMTM Implant

SILTEXTM RoundSPECTRUMTM Implant

SILTEXTM

CONTOUR PROFILETM

SPECTRUMTM Implant

MENTOR® BREAST IMPLANTS-ANOTHER OPTION

The BECKER™ Expander/Implant is the only gel productthat gives you the option of a single or two-stagebreast reconstruction. These unique products havean inner lumen containing saline solution that allowsfor tissue expansion and an outer lumen of gel thatis designed to provide a so�er feeling implant. Theremote injection dome makes volume adjustmentssimple and can be easily removed when expansionis complete. BECKER™ Expander/Breast Implantsare a technological advancement in terms of offeringyour surgeon the ability to create exact outcomesin size, shape and fill, without compromising thenatural give of silicone gel.

MENTOR® SPECTRUMTM

ADJUSTABLE SALINEBREAST IMPLANTS

SILTEX™ BECKEREXPANDER/IMPLANT

An innovative line of adjustable implants

O�en, the most difficult decision for most women regarding breast reconstruction is choosing the breastsize. The innovative line of MENTOR® SPECTRUM™Adjustable saline implant makes the decision-makingprocess easier because the size can be adjusted a�ersurgery.

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SILICONE SAFETYMENTOR® Silicone Breast Implants have beensuccessfully used and trusted for over 30 years bymillions of women worldwide. Why? Our implantsfeel more like natural breast tissue withoutcompromising reliability or safety. Mentor hasconducted seven silicone gel breast implant clinicalstudies. Over 200, 000 women have participatedin Mentor’s studies in order to provide a significantbody of clinical evidence demonstrating the safetyand effectiveness of silicone-filled breast implants.As we have to date, Mentor will remain commi�ed toproviding objective, clinical information about breastimplant safety.1

Silicone used today versus silicone ofthe pastSilicone gel filled breast implants have undergonechanges over time to meet increasingly sophisticatedconsumer expectations. The very first silicone breastimplants used thick shells and contained firm gel. Thesecond generation of implants introduced in the late1970’s had thinner shells and used less firm gel to addressconcerns of patients and surgeons who believedthat implants were too firm, palpable and visible.

In the mid 1980s, concerns related to rupture ratesof the second generation thinner-shelled implantsled manufacturers to introduce a third generation ofimplants. The shell and gel of these third generationimplants were slightly thicker but still so�.

Today the fourth generation silicone gel filledimplants are available. They are referred to as highlycohesive gel implants.

1. Summary of the Safety and Effectiveness of Mentor’s MemoryGel™ Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013. MemoryGel™ Post Approval Study Seventh Annual Report, November 5, 2013. Adjunct Study Final Report for Mentor’s MemoryGel™ Silicone Gel-Filled Breast Implants, 02 November 2012. Mentor Worldwide, LLC. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015 Mentor Becker Expander/Breast Implant Clinical Trial 2013 Annual Report. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study. 2013 CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants in Subjects who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 2015 MemoryShape™ Post-Approval Continued Access Study (formerly Contour Profile Gel Continued Access Study). 2014

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ANOTHER IMPORTANTREASON TO TRUSTMENTOR:Nothing could be more important than thequality of the breast implant that you andyour surgeon chooseMentor is a world leader in breast implant manufacturing,research and testing. For over 30 years, wehave adhered to the high standards of 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 integrity2. Over 5 million women worldwide have used MENTOR® Gel Breast Implants.

Mentor is commi�ed to conductinglong-term, far-reaching clinical studies.In addition to FDA evaluations, Mentor is commi�edto conducting its own long-term, far-reaching clinicalstudies. Throughout the years, Mentor has done extensivesafety evaluations of both saline filled breastimplants and gel filled breast implants. Mentor is andwill remain commi�ed to providing objective, clinicalinformation about breast implant safety.1

1. Summary of the Safety and Effectiveness of Mentor’s MemoryGel™ Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013. MemoryGel™ Post Approval Study Seventh Annual Report, November 5, 2013. Adjunct Study Final Report for Mentor’s MemoryGel™ Silicone Gel-Filled Breast Implants, 02 November 2012. Mentor Worldwide, LLC. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015 Mentor Becker Expander/Breast Implant Clinical Trial 2013 Annual Report. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study. 2013 CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants in Subjects who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 2015 MemoryShape™ Post-Approval Continued Access Study (formerly Contour Profile Gel Continued Access Study). 2014

2. ISO: Non-active surgical implants — Mammary implants — Particular requirements. 14607. Second edition. 2007-02-15

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MENTOR LIFETIME PRODUCTREPLACEMENT POLICYWARRANTYWe are proud to offer a Mentor Lifetime Product ReplacementPolicy Warranty and Patient Safe Coverage Limited Warranty.

Your peace of mind is important to us. All MENTOR®

Products come with Mentor’s Lifetime ProductReplacement Policy Warranty which provides for thefree lifetime product replacement of our gel filled andsaline filled breast implants that rupture due to lossof shell integrity. The Patient’s surgeon must requestreplacement product from Mentor.

Please visit www.mentorwwlc.eu to learn more aboutthe terms of our Lifetime Product Replacement PolicyWarranty and and MENTOR® Patient Safe CoverageLimited Warranty.

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FREQUENTLY ASKEDQUESTIONS ABOUTBREAST IMPLANTSFor the most comprehensive information aboutreconstructive surgery, we invite you to visitwww.mentorwwllc.eu/for-patients

What is a breast implant?When someone says “breast implant,” they aredescribing a silicone shell that is filled with eithersilicone gel or saline solution. Breast augmentationand reconstructive surgeons insert these implantsunder breast tissue or under the chest muscle tocreate a fuller looking and feeling bust line.

What are MENTOR® MemoryGelTM

Breast ImplantsMENTOR® MemoryGel™ Breast Implants are prefilledwith Mentor’s propriety cohesive silicone gel.MENTOR® MemoryGel™ Breast Implants hold safelyand uniformly together to deliver a natural feel thatclosely resembles natural breast tissue.

*As compared to saline-filled breast implants.

1. Summary of the Safety and Effectiveness of Mentor’s MemoryGel™ Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013.2. MemoryGel™ Post Approval Study Seventh Annual Report, November 5, 2013.3. Adjunct Study Final Report for Mentor’s MemoryGel™ Silicone Gel-Filled Breast Implants, 02 November 2012. 4. Mentor Worldwide, LLC. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 20155. Mentor Becker Expander/Breast Implant Clinical Trial 2013 Annual Report. 6. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study. 20137. CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants in Subjects who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 20158. MemoryShape™ Post-Approval Continued Access Study (formerly Contour Profile Gel Continued Access Study). 2014

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We’re proud of ourMemoryGelTM Implantsand it’s easy to see why:•

MemoryGel™ Breast Implants are one of the moststudied medical devices in the world.

• The uniquely formulated cohesive gel creates the so�, natural feel preferred by millions of women.1

A PICTURE IS WORTH ATHOUSAND WORDSWe have cut a MENTOR® MemoryGel™ Breast Implantin half to demonstrate how the gel material holdstogether uniformly*. MemoryGel™ is a cohesive,gelatin-like substance that does not pour orseparate like a liquid, but acts more like a solid.Our adherence to strict qualitymanufacturing requirementshas resulted in silicone shellsthat have been tested andshown to possess excellentstrength, resilienceand elasticity.

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What is silicone?Silicone is derived from silicon, a semi-metallic ormetal-like element that in nature combines withoxygen to form silicon dioxide, or silica. Beach sand,crystals and quartz are silica. Silica is the mostcommon substance on earth. Heating silica withcarbon at a high temperature can produce silicon.Further processing can convert the silicon intosilicone, which can be a liquid, a gel or a rubberysubstance. Various silicones are used in lubricantsand oils, as well as in silicone elastomers. Silicone canbe found in many common consumer items, such aschewing gum, nail polishes, suntan and hand lotions,antiperspirants, bath soaps and processed foods.

Are silicone gel-filled implants safe?MENTOR® MemoryGel™ Breast Implants have beensuccessfully used and trusted for over 30 years bymillions of women worldwide. More than 200,000women have participated in Mentor’s studies in orderto provide a significant body of clinical evidencedemonstrating the safety and effectiveness ofsilicone filled breast implants. As we have for manyyears, Mentor will remain commi�ed to providingobjective information about breast implant safety.Detailed information regarding the risks andbenefits associated with MENTOR® Breast Implantsis provided in several educational brochures. It isimportant that you read and understand thesebrochures when considering MENTOR® BreastImplants. Breast implants are not lifetime devices.You may need additional unplanned surgeries on yourbreasts because of complications or unacceptablecosmetic outcomes. The most common complicationsare reoperation, implant removal and capsularcontracture. A lower risk of complication is rupture.Your doctor will monitor you in the years a�er yoursurgery to look for these potential complications.

How is the silicone gel used today differentfrom the silicone used in years past?Silicone gel filled breast implants have undergonechanges in the last three decades to meet increasinglysophisticated consumer expectations. The very firstsilicone breast implants used thick shells and containedfirm gel. Then, a second generation of implants withthinner shells and less firm gel was introducedin the late 1970s to address concerns of patients andsurgeons who believed that implants were too firm,palpable and visible.

In the mid 1980s, concerns related to rupture ratesof the second generation thinner-shelled implantsled manufacturers to introduce a third generation ofimplants. The shell and gel of these third and fourthgeneration implants are slightly thicker but still so�.

Today these third generation and fourth generationsilicone gel filled implants are typically referredto as cohesive gel implants and highly cohesive gelimplants, respectively. MENTOR® Products have keptpace with the ever-evolving expectations of surgeonsand women who desire a so� gel to retain the naturalfeel that resembles actual breast tissues.

Do MENTOR® Breast Implants includelatex?No. Because latex allergies are so common, MENTOR®Breast Implants are not made with natural rubber latex.

Is there active platinum in breast implants?The manufacture of silicone breast implantshells and gel-filling materials uses platinum as acatalyst. Because very small amounts of platinumremain in the product following its manufacture,concerns have been raised that platinum may enterthe body and cause adverse effects - either bydiffusing through the intact shell, or through animplant rupture.

However, in 2006, the United States Food and DrugAdministration (FDA) released the followingconclusion about platinum: “Based on the existingliterature, the FDA believes that the platinum

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contained in breast implants is in the zero oxidationstate, which would pose the lowest risk, and thus thatthe small amounts of platinum that leak through theshell do not represent a significant risk to womenwith silicone breast implants.”*

How much do breast implants weigh?You can use this formula to estimate the weightof your MENTOR® MemoryGel™ Breast Implants andSaline 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 tobra cup sizes.

How do breast implants affectmammography?With breast implants, routine mammographyscreening may be more difficult. The implant mayinterfere with finding breast cancer duringmammography and generally requires additionalx-rays and more potential exposure to radiation.If you are of the proper age for mammographyscreening, you should continue to undergo routinemammography screenings as recommended by yourprimary care surgeon. When you do, be sure to informthe mammography technician that you have implants.

What is the average life expectancyof a breast implant? It’s important to know that breastimplants don’t last a lifetime.While implant duration variesfrom woman to woman,implants need to be replacedat some time. Replacementis o�en prompted by choice,such as a desired size change,or implant style change.Some women undergobreast implant replacementbecause of a complication,such as salinedeflation or gel rupture.

*source: www.fda.gov/cdrh/breastimplants/platinum.html

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Should I be at my ideal weight beforeI have a breast implant procedure?You should be close to your ideal weight when youhave breast implant surgery. Why? Because womenwho lose or gain a significant amount of weight a�erreceiving breast implants sometimes alter the resultsin unpredictable and/or undesirable ways.

How long should I wait to resume exerciseand other strenuous activities a�er breastreconstruction?Your surgeon is in the best position to answer thisquestion. Because recovery periods vary fromwoman to woman, he or she will determine how muchdowntime you may need and when to resume normalactivities. Be sure to check with your surgeon beforereturning to your workouts.

What affect does smoking have onthe healing process following surgery?Smoking can compromise recovery a great deal bycausing the blood vessels to constrict, reducing bloodflow, and the oxygen it carries, to the surgical area.Your tissues need this blood and oxygen supply toheal properly. When your blood supply iscompromised, wound healing will be affected.

That’s why surgeons ask patients to refrain fromsmoking for one to five weeks prior to and a�er surgery.It is important that you ask your surgeon whathis or her specific recommendation for you would be.

Are MENTOR® Breast Implants coveredby a warranty?Your peace of mind is important to us. All MENTOR®Products come with Mentor’s Lifetime Product ReplacementPolicy Warranty which provides for the free lifetimeproduct replacement of our gel filled and saline filledbreast implants that rupture due to loss of shell integrity.The Patient’s surgeon must request replacementproduct from Mentor.

Please visit www.mentorwwlc.eu to learn more aboutthe terms of our Lifetime Product Replacement PolicyWarranty and and MENTOR® Patient Safe CoverageLimited Warranty.

What are all my options for breast reconstruction?What are the possible risks and complicationsfor each type of reconstructive surgery and howcommon are they?What if my cancer recurs or occurs in the otherbreast?Will reconstruction interfere with my cancertreatment?How many steps are there in each procedure, andwhat are they?How long will it take to complete myreconstruction?How much experience do you have with eachprocedure?Do you have before-and-a�er photos I can look atfor each procedure? What results are reasonablefor me?What will my scars look like?What kind of changes in my implanted breast can Iexpect over time?What kind of changes in my implanted breast can Iexpect with pregnancy?What are my options if I’m dissatisfied with thecosmetic outcome of my implanted breast?Can I talk with other patients about theirexperience?For staged reconstruction, what is the estimatedtotal cost of each procedure?How much pain or discomfort will I feel, and forhow 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 myown 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?

QUESTIONS TO ASKYOUR SURGEON

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WE’RE ALWAYS HERETO HELP

BREAST RECONSTRUCTIONRESOURCES

The following resource may help you obtainadditional information so you can make aninformed decision about breast reconstruction.

The following list of resources may help you tofind more information and support for yourbreast reconstruction decision.

FRANCEBreast Cancer Informationwww.cancerdusein.orgFrench Society of Plastic Surgeonsh�p://www.sfce.fr

GERMANYBreast Cancer Informationh�p://www.gbg.deGerman Association of Plastic Surgeonswww.vdpc.de

ITALYBreast Cancer Informationh�ps://www.europadonna.orgItalian Society of Plastic Surgeonswww.sicpre.org

SPAINBreast Cancer Informationwww.aecc.esSpanish Society of Plastic Surgeonswww.cirugia-plastica.org

UNITED KINGDOMBreast Cancer Carewww.breastcancercare.org.ukBritish Association of Plastic,Reconstructive and AestheticSurgeons (BAPRAS)www.bapras.org.uk.

IMPORTANT SAFETYINFORMATIONMENTOR® 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 thosewomen with active infection anywhere in their body, those withexisting cancer or pre-cancer of their breast(s), those who havenot received adequate treatment for these conditions or thosewho are pregnant or nursing. There are risks associated withbreast implant surgery. Breast implants are not lifetime devicesand breast implantation is not necessarily a one-time surgery.Patients may require additional unplanned surgeries on thebreast(s) because of complications or unacceptable cosmeticoutcomes. Many of the changes to the breast(s) followingimplantation are irreversible (cannot be undone) and breastimplants may affect the ability to breastfeed, either by reducingor eliminating milk production.

The most common complications with MENTOR® MemoryGel™Breast Implants include re-operation, implant removal, capsularcontracture, asymmetry, and breast pain. A lower risk ofcomplication is implant rupture, which is most o�en silent(meaning neither you nor your doctor will know you have arupture). The health consequences of a ruptured silicone gel-filledbreast implant have not been fully established. Screenings suchas mammography, MRI, or ultrasound are recommended a�erinitial implant surgery to assist in detecting implant rupture. Themost common complications with MENTOR® Saline-Filled BreastImplants include re-operation, implant removal, capsularcontracture, wrinkling, deflation, asymmetry, and breast pain.MENTOR® Smooth Round Tissue Expanders with Remote Domecan be utilized for breast reconstruction a�er mastectomy,correction of an underdeveloped breast, scar revision and tissuedefect procedures. The expander and remote injection dome arefor temporary subcutaneous or submuscular implantation and arenot intended for use beyond six months.

MENTOR® CPX™4 Breast Tissue Expanders can be utilized forbreast reconstruction a�er mastectomy, correction of anunderdeveloped breast, scar revision and tissue defectprocedures. These expanders are intended for temporarysubcutaneous or submuscular implantation; they should be usedwithin a time frame determined by the physician to achieve theclinically desired degree of tissue expansion.* CPX™ Breast TissueExpanders are devices that contain magnetic injection domes andare NOT MRI compatible. Do not use the CPX™ Tissue Expander inpatients where an MRI may be needed. DO NOT use the CPX™Tissue Expander in patients that have a previously implanteddevice that could be affected by a magnetic field. The devicecould be moved by the MRI causing pain or displacement,potentially resulting in a revision surgery. The incidence ofextrusion of the expander has been shown to increase when theexpander has been placed in injured areas: scarred, heavilyirradiated or burned tissue, crushed bone areas or where severesurgical reduction of the area has previously been performed.

Patients are reminded to discuss the indications, contraindications,warnings, precautions and the risks and benefits associatedwith MENTOR® Breast Implants with their surgeon and review theImportant Safety Information provided at www.mentorwwllc.eu.It is important that patients understand the risks associated withbreast implant surgery when considering MENTOR® BreastImplants.

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Mentor Medical Systems B.V.Zernikedreef 2, 2333 CL Leiden The NetherlandsEmail: contact@medgb.jnj.com

©Mentor Worldwide LLC 2018 077852-170803www.mentorwwllc.eu

Intended for use by or under the direction of a physician use,it is important to read the Instructions for Use and to understandthe contraindications, warnings, and precautions.

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