IMPLANT CATALOGUE - COF

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IMPLANT CATALOGUEF R O N T PA G E F I N I S H E S S H O R TMENTOR BREAST IMPLANTS Mentor Worldwide LLC 2018 062724-161103

F R O N T PA G E F I N I S H E S S H O R TIn 2002, we completed a plant in Leiden, The Netherlands.At 6,000 square meters, it is one of the largest of itskind in the world. This plant contains an automatedbreast implant dipping machine, which producesevery implant shell in a consistently uniformmanner. To meet an ever-increasing demandfor our products, plant produces morethan 300,000 breast implants ayear, distributed to more than100 nations. At Mentor allour products are madeunder strict standardsof design andtesting.

F R O N T PA G E F I N I S H E S S H O R T

F R O N T PA G E F I N I S H E S S H O R TFounded in 1969, Mentor Worldwide LLC is a leadingmanufacturer and supplier of medical products for theglobal Aesthetic medicine market and Reconstructivesurgery. As the world’s leading maker of high-qualitybreast implants for over 30 years, our experience resultsin quality products that you can rely on.Headquartered in Irvine, California, Mentor hasmanufacturing and research operations in the UnitedStates and the Netherlands. In 1995, Mentor became thefirst breast implant manufacturer to achieve CE-markingfor its products.Mentor has worked closely with surgeons throughoutthe world to develop innovative products such asMENTOR CONTOUR PROFILE BECKER 35 Expander/Breast Implant and the MENTOR CPG Gel BreastImplants.Mentor’s manufacturing capability is exceptional.We have substantial experience in biomaterials andbiopolymers manufacturing. At the same time, ourregulatory expertise has enabled the Company to bringproducts to market in the world’s most stringentlyregulated health care environments.Mentor is a manufacturer with a strong customer focus.Our sales representatives are skilled in technical productissues, enabling them to act as a valuable information

On Jan 23, 2009, Mentorwas acquired by Johnson &Johnson, one of the leadingproviders of suture, mesh,hemostats and other productsfor a wide range of surgicalprocedures. By joining forces,we aspire to be the trustedglobal leader in aestheticmedicine among bothconsumers and professionalsby providing a broad rangeof innovative, science andclinical-based solutionsto maintain, enhance, andrestore self-esteem and qualityof life. Simply said, our goal isto make life more beautiful.F R O N T PA G E F I N I S H E S S H O R Tresource. For questions oradditional information, pleasecontact your local Mentorbranch, Johnson & Johnsonoffice or distributor.

MemoryGel BREAST IMPLANTSA More Evolved Implant Strict US and EU manufacturing standards Highly compliant shell for ease of placementF R O N T PA G E F I N I S H E S S H O R T Lifetime product replacement policy MENTORPromise Protection Plan, the most comprehensiveprotection plan available1 Moderate Plus, Xtra Moderate Plus, High, Xtra High and UltraHigh projection Proprietary silicone gel formula for a natural touch thatresembles breast tissueAbout MemoryGel ImplantsMENTOR MemoryGel Breast Implants feature aproprietary cohesive silicone gel formulation used to fill allMENTOR Silicone Gel-Filled Breast Implants around theworld. By varying the components of the gel, Mentor is ableto produce a wide selection of products ranging from verysoft to very firm.

MemoryGel Breast ImplantsMemoryGel Breast Implants Product ScaleProduct ProfileCohesive I Cohesive II Cohesive III Memory GelTM Xtra Moderate PlusRound HighMemory GelTM Xtra HighRound Ultra HighCPGTM Gel Breast ImplantRound BECKERTM 25Expander/ Breast ImplantCONTOUR PROFILE TM BECKER Expander/ Breast Implant 35F R O N T PA G E F I N I S H E S S H O R TRound Moderate Plus

All Cohesive, all the time. F R O N T PA G E F I N I S H E S S H O R TAdvanced MemoryGel Breast Implants.The more evolved implant.All MENTOR Silicone Gel-Filled Breast Implants containgel that is cohesive, safe and aesthetically pleasing’.Cohesive I The standard cohesive level gel used in Mentor Breast Implants.This is the softest gel and has been preferred by millions of womenworldwide. Products are available textured and smooth Moderate Plus,Xtra Moderate Plus, High, Xtra High and Ultra High projection Gel BreastImplants as well as the MENTOR Becker Expander/Breast Implants.Cohesive II A slightly firmer gel, for surgeons wanting a firmer feeling implant.This gel is used in textured Moderate Plus, High Profile Gel BreastImplants and MENTOR Contour Profile Becker Expander/BreastImplants.Cohesive III Mentor’s most cohesive gel, providing shape retention with apleasing level of firmness for optimal aesthetic results. This gel isused in the Mentor CPG Gel Breast Implants.

PROVENTEXTURE YOUCAN TRUSTMENTOR :SILTEX Texture3*Allergan :Biocell Texturing3SurfaceDescriptionGentle patternedsurfaceAggressive, open-poredsurface with cuboid-shapedepressions and a stilted edgeManufacturingTechniqueNegative contactimprint off polyurethanetexturing foamShell is pressed onto bedof finely granular salt: lostsalt techniquePore SizeWidth (µm)70-150600-800Pore Size Depth/Height (µm)40-100 (height)100-150 arDepressionor NodulesNodulesDepressionsNot a head to head study. Based on the comparison of key complication rates reported in the 10 year CoreStudies for MemoryShape / CPG Gel Breast Implants, NATRELLE 410 TruForm 3 Gel Breast Implants.*Specification for MemoryGel Round Gel implantsThe third-party trademarks used herein are trademarks of their respective owners.F R O N T PA G E F I N I S H E S S H O R TMENTOR CPG Implants are proven to have a low risk of capsularcontracture and rotation in primary augmentation patients at 10 yearsand are covered by the most comprehensive warranty in the market.2

PROVENPERFORMANCEReliable implants continuously delivering world class clinical results.F R O N T PA G E F I N I S H E S S H O R TThe lowest reported risk of key complications in primarybreast augmentation for MENTOR CPG Gel BreastImplants at 10 years2PrimaryAugmentationMENTOR CPG BreastImplant Core Study,Long Term 10 years4Allergan Natrelle BreastImplant Core Study, LongTerm 10 years5,6Capsular Contracture (Baker III/IV)3.6%9.2%Suspected or ConfirmedRupture (MRI Cohort)6.6%17.7%(with or without replacement)9.2%19.6%Rotation1.3%4.7%Device RemovalKaplan-Meier estimated risk of first occurrence. Data presented in table isnot based on a head to head comparison of the Mentor CPG Gel BreastImplant and the Allergan Natrelle 410 Breast Implant Core Studies.

Multi-center Core Study95543SITES8080PERSON YEARS OFFOLLOW UP DATAF R O N T PA G E F I N I S H E S S H O R TSUBJECTS

PROVENPEACE of MINDTo our Mentor customers and patients, we pledge our commitmentto excellence. That is why we back our MemoryGelTM Breast Implantswith the most comprehensive plan in the industry.F R O N T PA G E F I N I S H E S S H O R TMentor Warranties & Product Replacement PolicyMENTORPromise Protection Plan OverviewFREE AND AUTOMATICENROLLMENTFREE LIFETIME PRODUCTREPLACEMENT FORRUPTURE † 10YEARFREE PRODUCT REPLACEMENTIN THE EVENTS OF CAPSULARCONTRACTURE (Baker III/IV),DOUBLE CAPSULE AND LATEβSTAGE SEROMAFREE CONTRALATERALIMPLANT at your surgeon’srequestUP TO 1000 FINANCIALASSISTANCE COVERAGEαFOR RUPTUREFor further information about MENTOR CPG Breast Implants or any otherMENTOR Products, talk to your Mentor sales representative today or visitmentorwwllc.eu†In the event of a confirmed rupture or deflation (leaking) of any MENTOR Breast Implant due to wear or delamination requiringsurgical intervention, regardless of the age of the implant, Mentor will provide a free replacement of a MENTOR Breast Implant ofany size in the same or similar style as the originally implanted product.αWhen a replacement surgery of a MENTOR Gel-Filled Breast Implant is required due to confirmed rupture occurs within ten(10) years from the date of implantation, provided that eligibility is proven and confirmed by Mentor based on its assessment andevaluation, Mentor will pay uninsured, out-of-pocket costs for operating room, anesthesia and/or surgical expenses directly relatedto revision surgery up to a maximum aggregate amount of 1000. Operating room and anesthesia charges shall be given paymentpriority. In such cases, the request for financial assistance under the MentorPromise Protection Plan must be made to your surgeon.Financial assistance does not imply a loan to you.βIn the events of capsular contracture (Baker III/IV), double capsule or late-stage seroma in augmentation surgery of a MENTOR Gel-Filled Breast Implant, Mentor will provide a replacement of a MENTOR Gel-Filled Breast Implant, free of charge for the periodof ten (10) years from the date of implantation, provided that eligibility is proven and confirmed by Mentor based on its evaluation ofexplanted product and assessment of all required documentation. Mentor will provide a replacement MENTOR Product of any size inthe same or similar style as the originally implanted product.

F R O N T PA G E F I N I S H E S S H O R TSILTEX Texture providingyou and your patients withpeace of mind.A closer look at MENTOR patented SILTEX TextureSEM images of SILTEXTM TextureAnterior ViewRadius ViewPosterior ViewCross Section ViewUncover the unique SILTEXTM Texture of MENTOR CPGTM GelBreast Implants today. Talk to your Mentor Sales Representativeor visit mentorwwllc.eu for more information.

F R O N T PA G E F I N I S H E S S H O R TRIGHT FROM THESTART. MADE TOMATCHExpansion matters. Texture you can trust.Natural shapePresenting the:CPX 4 Breast Tissue Expander and CPG Gel Breast Implants, giving yougreater control over the desired shape in two stage breast reconstruction:1. MENTOR is the only company to offer a breast tissue expander withproven directional lower pole expansion72. CPG Implants can help achieve a smooth transition from tissue to implant83. Unsurpassed Peace of Mind

CPX 4 BreastTissue ExpanderPATIENT COMFORTIncorporates two principle innovationsthat were designed to enhance patientcomfort while maintaining the sameexpansion profile9EASY TO DETECTThe CENTERSCOPE MagneticDetection Device locatesthe magnetic injection domefor absolute ease and acuracy.The injection dome containsa rare earth magnet that is48% stronger than previousexpanders9TEXTURED SURFACEThe patented SILTEXTM Texturehas a surface substantially free ofpores and intersticesThe manufacturing process for theSILTEXTM Texture on MENTOR Breast Tissue Expanders does notrequire the use of salt or sugarcrystals.γNATURAL SHAPEThe Combination of the BufferZoneTM Self-Sealing Patch andthe posterior Dacron Patchprovides directionally focusedexpansion to maximize lowerpole expansion to mimic theshape of a natural breast γThe third-party trademarks used herein are trademarks of their respective ownersF R O N T PA G E F I N I S H E S S H O R TPost operatively adjustable device

F R O N T PA G E F I N I S H E S S H O R T

She’s confident in what she wants - An innovation inbreast implants from the brand you trust.Soft, NaturalFeel δ10XtraFullness 11XtraProjection11XtraFirmness11δ In-person consumer survey with 452 respondents.F R O N T PA G E F I N I S H E S S H O R TMENTOR MemoryGel XtraBreast Implants

F R O N T PA G E F I N I S H E S S H O R T

RoundSiltex Round Breast Implants, Cohesive ITMSmooth Round Breast Implants, Cohesive ITMSiltex and Smooth MemoryGel Xtra Breast ImplantsSiltex Round Breast Implants, Cohesive IITMCPGExpandersCONTOUR PROFILE Tissue ExpandersBECKER Expander/Breast ImplantsOther ExpandersAccessoriesOtherSaline productsSizersF R O N T PA G E F I N I S H E S S H O R TCPG Gel Breast Implants, Cohesive III

RoundRound Gel Breast Implants,Cohesive I SILTEX Round Breast Implants,Moderate Plus Profile, Cohesive 24,44,54,85,0Catalog 001Resterilizable up to 10 times.-2-ResterilizableGel 1

Round Gel Breast Implants,Cohesive I 25,45,65,75,86,06,3Resterilizable up to 10 times.-3-Catalog 700354-4800RoundSILTEX Round Breast Implants,High Profile, Cohesive I ResterilizableGel 4RSZ-7004RSZ-8004

RoundRound Gel Breast Implants,Cohesive I SILTEX Round Breast Implants,Ultra High Profile, Cohesive I ,35,45,55,65,85,96,06,36,5Catalog -5455354-5480354-5535354-5590Resterilizable up to 10 times.-4-ResterilizableGel 430RSZ-5455RSZ-5480RSZ-5535RSZ-5590

RoundRound Gel Breast Implants,Cohesive I -5-

RoundRound Gel Breast Implants,Cohesive I Smooth Round Breast Implants,Moderate Plus Profile, Cohesive I 1Catalog #350-1251 BC350-1501 BC350-1751 BC350-2001 BC350-2251 BC350-2501 BC350-2751 BC350-3001 BC350-3251 BC350-3501 BC350-3751 BC350-4001 BC350-4501 BC350-5001 BC350-5501 BC350-6001 BC350-7001 BC350-8001 BCResterilizable up to 10 times.-6-ResterilizableGel 1

Round Gel Breast Implants,Cohesive I 15,35,55,65,75,86,0Resterilizable up to 10 times.-7-Catalog #350-1254 BC350-1504 BC350-1754 BC350-2004 BC350-2254 BC350-2504 BC350-2754 BC350-3004 BC350-3254 BC350-3504 BC350-3754 BC350-4004 BC350-4254 BC350-4504 BC350-5004 BC350-5504 BC350-6004 BC350-6504 BC350-7004 BC350-8004 BCRoundSmooth Round Breast Implants,High Profile, Cohesive I ResterilizableGel 4RSZ-7004RSZ-8004

RoundRound Gel Breast Implants,Cohesive I Smooth Round Breast Implants,Ultra High Profile, Cohesive I 15,25,35,45,65,75,86,16,3Catalog #350-5135 BC350-5160 BC350-5185 BC350-5215 BC350-5240 BC350-5270 BC350-5295 BC350-5320 BC350-5350 BC350-5375 BC350-5400 BC350-5430 BC350-5455 BC350-5480 BC350-5535 BC350-5590 BCResterilizable up to 10 times.-8-ResterilizableGel 430RSZ-5455RSZ-5480RSZ-5535RSZ-5590

RoundRound Gel Breast Implants,Cohesive I -9-

RoundMemoryGelTM Xtra Breast ImplantsSILTEX Round Moderate PlusProfile Xtra Gel Breast atalog e up to 10 times.- 10 -ResterilizableGel 5RSZMPX755

MemoryGelTM Xtra Breast ,26,36,56,66,76,7Resterilizable up to 10 times.- 11 -RoundSILTEX Round High ProfileXtra Gel Breast ImplantCatalog 765ResterilizableGel THPX570RSZTHPX620RSZTHPX680RSZTHPX725RSZTHPX765

RoundMemoryGelTM Xtra Breast ImplantsSmooth Round Moderate PlusProfile Xtra Gel Breast 13,33,43,63,73,84,04,14,14,1Catalog MPX-295SMPX-325SMPX-350SMPX-370ResterilizableGel RSZMPX545RSZMPX605RSZMPX645RSZMPX755Resterilizable up to 10 times.- 12 -

MemoryGelTM Xtra Breast 06,36,56,56,76,7Resterilizable up to 10 times.- 13 -RoundSmooth Round High ProfileXtra Gel Breast ImplantCatalog 790ResterilizableGel SHPX595RSZSHPX650RSZSHPX700RSZSHPX755RSZSHPX790

RoundRound Gel Breast Implants,Cohesive II SILTEX Round Breast Implants,Moderate Plus Profile, Cohesive II 0Catalog rilizable up to 10 times.- 14 -ResterilizableGel 1

Round Gel Breast Implants,Cohesive II 25,45,65,75,86,06,3Resterilizable up to 10 times.- 15 -Catalog 700324-4800RoundSILTEX Round Breast Implants,High Profile, Cohesive II ResterilizableGel SizerεRSZ-1254RSZ-1504RSZ-1754

Gel-Filled Breast Implant, Mentor will provide a replacement of a MENTOR Gel-Filled Breast Implant, free of charge for the period of ten (10) years from the date of implantation, provided that eligibility is

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