TrueMonobloc BluSeal Controlled Surfaces ProgressiveGel Ultima 3D Simulation TwinPack Qinside Safety Technology TrueTissue Technology Ergonomix The perfect harmony between quality, technology and safety.
Establishment Labs 30 Years of Experience in Breast Implant Manufacturing To Develop the Next Generation of HighTech Implants Establishment Labs Superior Breast Aesthetics. With more than 30 years of advanced breast implant manufacturing experience, building quality breast implants has always been a natural outcome for Establishment Labs founders and top executives. As a result, Motiva Implant Matrix has established a level of product innovation that always leads to safety. And while we respect our past, we re more focused on the present and the future one that s innovative, safe and progressive. We believe these goals can be achieved by bringing into our product design the current needs of plastic surgeons and patients. As a boutique manufacturer of next generation breast implants, we have partnered with the best minds in the industry to bring you Safety through Innovation. Olivier Tourniaire, Sales & Marketing Director EMEA fx: 16 fx: 15 fx: 14 From our breast implant families of comprehensive shapes and sizes for outstanding breast aesthetic results, to our new ProgressiveGel Ultima performance characteristics, to the innovative Q Inside Safety Technology, our patients and surgeons have come to expect only the best. Utilizing the most advanced, stateoftheart design and manufacturing technologies, Establishment Labs assures that Motiva Implant Matrix Silicone Breast Implants are the best choice for the most discriminating patients and surgeons. fx: 28 fx: 22 fx: 32 fx: 37 fx: 34 fx: 36 fx: 21 fx: 24 fx: 12 2 2 Innovación con Seguridad Safety through Innovation
Establishment Labs A Global Aesthetic Company. With regulatory offices in the United States, an European distribution center in Belgium and a manufacturing facility in Costa Rica, Establishment Labs is the next generation breast implant producer with regulatory approvals worldwide. The company is creating the most advanced levels of safety for women seeking to improve their appearance through Motiva s propietary technologies and higher quality standards. According to the prestigious Boyd Report, the central valley of Costa Rica, where Establishment Labs manufacturing unit is located, has become the success story of the technology and life industry with more than 50 medical devices companies operating there, including Baxter, St. Jude Medical, Hologic, Arthrocare, Allergan, Boston Scientific, Hospira, De Royal, Establishment Labs, Abbott Vascular and others. 3 We bring music to the Breast Aesthetics industry: High level engineering, product design expertise and a profound understanding of plastic surgery, all in symphony to create Motiva Implant Matrix. Juan José ChacónQuirós, CEO Our state of the art manufacturing process has eliminated the use of water and other materials like salt and sugar, that significantly reduces our environmental impact. Costa Rica Hightech Green Manufacturing E C O W A T E R L E S M A N U F A C T U R S I N G SA LT & SUGA R FREE T E X T U R I N G P R O C E S S www.motivaimplants.com 3
Motiva Implant Matrix Simplicity and Sophistication in the Most Comprehensive Round Implant Catalogue Motiva Implant Matrix Round MINI DEMI FULL CORSÉ Base (cm) P(cm) V (cc) P (cm) V (cc) P (cm) V (cc) 8.5 2.2 5 135 145 9 2.3 125 155 175 9.5 2.4 140 3.4 9.75.25 2.5 160 235 255.5 2.6 185 3.6 230.75 295 11 2.7 265 315 11.25 285 335 11.5 2.8 4.7 355 11.75 320 375 12 2.9 340 12.25 5.0 12.5 3.0 3 450 13 5.3 500 1 3.2 14 430 525 1 575 5.9 700 15 775 P (cm) V (cc) 2 240 260 280 325 5.2 350 5.4 4 440 5.8 6.0 5 6.3 590 6.6 650 6.9 725 7.2 825 7.5 925 7.8 50 P=Projection V=Volume Product Families and Features SilkSurface Mini Demi Full Corsé ProgressiveGel BluSeal Single Pack TwinPack Sizers Q Inside VelvetSurface Mini Demi Full Corsé ProgressiveGel BluSeal Single Pack TwinPack Sizers SilkSurface PLUS Mini Demi Full Corsé ProgressiveGel PLUS BluSeal Single Pack TwinPack Sizers Q Inside Q Inside VelvetSurface PLUS Mini Demi Full Corsé ProgressiveGel PLUS BluSeal Single Pack TwinPack Sizers Q Inside Ergonomix Mini Demi Full Corsé ProgressiveGel Ultima BluSeal Single Pack TwinPack Sizers Q Inside 4 4 Innovación con Seguridad Safety through Innovation
MORE THAN 350 ROUND IMPLANT CHOICES TO SUIT EVERY NEED A revolutionary and dynamic system that will change the way round breast implants are perceived. Within the matrix, surgeons can easily select the ideal implant for each patient, while taking into account individual aesthetic objectives. With the comprehensive selection of 350 Motiva Implant Matrix choices, surgeons will always have the ideal solution for the most discriminating patients. Because of the exceptional Establishment Labs experience and success in advanced product design and development, technological manufacturing and product support, Motiva Implant Matrix Silicone Breast Implants represent the most innovative implants available today. Innovative product features: The most adequate range of implant projections to meet patient and surgeon s expectations. TrueMonobloc shell design for outstanding strength, ease of insertion and durability. TrueTissue Dynamics for the most natural look and feel. 0% filled, 0% ultra soft, and 0% formstable ProgressiveGel, ProgressiveGel PLUS and ProgressiveGel Ultima for optimal shape retention and avoidance of unwanted fill material migration. Specialized choice of controlled surfaces for surgeons and patients. Q inside Safety Technology that enables breast implants traceability information to be retrieved externally. Our Matrix was developed in accordance to ISO 14607:2009 for NonActive Surgical Implants, Mammary Implants. (Sections 7.2.2.6 and 7.2.2.7) 4 All Motiva Implant Matrix references are fully CEmarked, utilizing only FDAfiled Nusil longterm implantable medical grade silicone. www.motivaimplants.com 5
Latest Innovations from Motiva Implant Matrix 1 TrueMonobloc High Performance Shell. Our TrueMonobloc configuration links all components of the implant to the same tensile strength. This allows the shell to act as a whole structure, making insertion easier and improving the implant mechanical qualities 5, 18. under stress. Motiva Implant Matrix mechanical testing results exceed the specifications of the ASTM F703: Standard Specification for Implantable Breast Prostheses (Section 9.2) 6, required by the FDA and ISO 14607:2009 (Section 7.0). 4 2 BluSeal Full Safety with our Visual BarrierLayer Indicator. Our unique and patented 7 barrier layer indicator provides a safety feature only present in Motiva Implant Matrix. The presence of a barrier layer minimizes silicone gel diffusion into the body, a feature that has been a standard in the industry for more than 20 years. By keeping gel bleed to the minimum we can significantly reduce the risk of capsular contracture in all Motiva implants. Now, with our BluSeal indicator, finally surgeons can verify the presence of this important safety component around the entire implant. This provides 0% assurance of its presence in every Motiva Implant used. The BluSeal indicator has complied with the most rigorous quality and safety standards of the American Society of Testing and Materials and ISO. 8 150x transverse view of the implant shell including the visual barrierlayer indicator BluSeal 6 Innovación con Seguridad 6 Safety Safety Through through Innovation Innovation
SAFETY THROUGH INNOVATION More than 665% Average Shell Elongation at Breaking. (ASTM standard: 350% minimum, ISO standard: 450% minimum) Average Force at Breaking of more than 25 Newtons. (ASTM standard: 11.12 Newtons) 5, 6 Average Tear Force at Breaking of more than 19.68 Newtons. (Standard: Newtons) 5, 6 (Tests performed by an independent certified laboratory, after two sterilization cycles and accelerated aging) 5 4, 5, 6 Our quality standards for breast implants are the strictest in the industry and our production process is continually inspected by health authorities from high vigilance countries, resulting in more than 60 countries with regulatory approval worldwide. Robert De Mezerville, Quality and Regulatory Affairs Manager Motiva 3D Inversion Manufacturing Process: SilkSurface & VelvetSurface Motiva Nanotechnology Imprint Standard Layer BluSeal Standard Layer Standard Layer BluSeal Standard Layer Motiva 3D Inversion Process www.motivaimplants.com 7
3 Rheological Properties Mastering Viscoelasticity. At Establishment Labs, we have developed all implants within the matrix with the possibility of three different highly cohesive gels, according to the specific design objectives that correspond to the look desired by the patient. 9, By mastering the rheological properties of our silicone gels, we have been able to control their viscosity and elasticity. Our silicone gels comply with ASTM F 70307 Specification for Implantable Breast Prostheses Section 9.2.1.4 accepted by the FDA for gel cohesion, and Section.2 used as a guideline to characterize the firmness of ProgressiveGel, Progressive Gel PLUS and Progressive Gel Ultima, and required by the FDA for breast implants gel characterization. 11 What is Rheology? Rheology is concerned with the flow and deformation of materials experiencing an applied force. Two extremes of rheological behaviour are: Elastic behaviour e.g. perfectly rigid solids where any deformation reverses spontaneously when an applied force is removed. Viscous (or plastic) behaviour e.g. ideal Newtonian liquids where any deformation ceases when the applied force is removed. In between elastic and viscous behaviour lies the real world of most substances, which are viscoelastic materials. Motiva Implant Matrix Silicone Gel Properties Viscosity High Cohesivity ProgressiveGel Maintains the UpperPole Fullness High Cohesivity High Viscosity Medium Elasticity ProgressiveGel PLUS A more Natural Look and Feel High Cohesivity Medium Viscosity High Elasticity ProgressiveGel Ultima The most Natural Look and Feel High Cohesivity Low Viscosity Super High Elasticity Elasticity 8 8 Innovación con Seguridad Safety through Innovation
4 AxisThree Make the Right Choice for the Patient. Surgeons using Axis Three report improved efficiency of their consultation process and increased business revenues of over 25%. Now you can easily take the necessary steps for accurate measurement of your patient and easily share the choice of your Motiva Implant by simulating the results with all available profiles and sizes in Motiva Implant Matrix. 12 Tissue Behaviour Simulation (TBS ) Another patented Siemens and Axis Three technology, which automatically defines skin elasticity, muscle and glandular tissue to enable XS. simulations that react as the body does in reality. Patented CCT Image Capture Using Color Coded Triangulation, a patented Siemens and Axis Three technology, the XS generates precise anatomically accurate models in a matter of seconds. 5 TwinPack Improved Traceability. Our TwinPack packaging system allows the surgeon to order and use a pair of implants of the same size from exactly the same production materials and sterilization lots. This gives the surgeon the maximum assurance to be implanting devices with the same expiration date, which improves implant traceability and patient safety. www.motivaimplants.com 9
6 Controlled Surfaces Motiva Implant Matrix surfaces 13 are obtained in a single step, with less manipulation of the shell. Controlled surface treatment is accomplished through Motiva 3D Inversion Manufacturing Process, with no foreign materials added, resulting in: SilkSurface NanoSurface 8000 contact points of 16 Microns depth per cm 2. T E X T U R SA LT & SUGAR FREE I N G P R O C E S S VelvetSurface MicroSurface 00 contact points of 400 Microns depth per cm 2. Features & Clinical Advantages Safe shell surface developed without the aggressive cavities caused by crystalline texture treatments. No residual salt or sugar granules or shapes. Optimized, uniform shell surface for improved implant insertion, enhanced tissue fixation and less risk of implant rotation. Consistent implant shell, without the traditional thin spots that may render the implant more fragile, compromise its durability and affect the barrier layer. Controlled surface that enhances implant insertion through smaller incisions and reduces the risk of double capsule and late seroma. The need for innovation in the breast implant industry is greater now than ever before: it requires a humancentered, creative, iterative and safe approach to find the best ideas and ultimate solutions for surgeons and patients. Salvador DadaSantos, Production and Operations Manager Innovación con Seguridad Safety through Innovation
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First and Only Innovations 7 Q Inside Safety Technology VeriTeQ s Q Inside Safety Technology, a passive radio frequency identification (RFID) transponder, is the world s first FDA cleared microtransponder for use in humans and the only one with CEMark when used in a breast implant. Including Q Inside Safety Technology allows healthcare providers a secure and accurate identification of a breast implant from outside of the body at the point of care. Q Inside Safety Technology consists of a biocompatible microtransponder programmed with a unique numeric sequence (15 digits) that is accessed by a proprietary handheld reader when waved over the breast area. The 15digit number delivered to the reader corresponds with a secure, online database that can be accessed via the Internet only by authorized persons. Q inside safety technology is an FDA cleared, first of its kind, technology that provides an electronic serial number from within the body for patient control and verification of their implant for safety, wellness and in the event of recall or adverse event. Scott Silverman, CEO VeriteQ Corporation Through Q Inside Safety Technology, physicians and patients have access to secure, noninvasive verification of implantspecific data. Unlike product and warranty cards that are typically provided to a patient undergoing breast augmentation or reconstruction, Q Inside Safety Technology can never be lost or misplaced. Providing your patients the option of breast implants with Q Inside Safety Technology can give them increased peace of mind in the event of a safety issue or device recall, thereby helping to ensure their safety and wellness. 12 Innovación con Seguridad 12 Safety through Innovation
First and Only Innovations 8 TrueTissue Technology Ergonomix Motiva Ergonomix implants are designed with the surgeons and patients in mind. Plastic Surgeons are complaining about the problems of rotation with the current anatomical implants. Patients and their partners are complaining about how unnatural those implants feel and behave after implantation. Our design team took the challenge to rethink what a natural implant should be and how to mimic a natural breast, using the latest tools available. The answer came from the skillful application of the principles of Ergonomics: Motiva Ergonomix are 0% filled implants that adapt shape after implantation to give the natural look of traditional anatomical implants, without the complications associated with rotation and implant hardness. TrueTissue Technology is the association of a specific elastic elastomer shell and the special rheological properties of ProgressiveGel Ultima, that combine with gravity to shift the maximum point of projection to the lower pole when the patient is in standing position. When the patient lays flat on her back the implants will react as a natural breast and the maximum point of projection wil move closer to the middle point of her breast. Motiva Ergonomix implants adjust with gravity to the patient s position to provide a very natural result. Why Ergonomix? We studied the rheological properties of the natural breast to create the highly elastic ProgressiveGel Ultima for a very soft, natural feeling that will give confidence to your patients. ProgressiveGel Ultima is made with the finest Nusil Technology silicone materials and does not fracture during implantation. TrueTissue Dynamics is the new gold standard for the natural behaviour of implants postimplantation. Both our TrueMonobloc configuration and ProgressiveGel Ultima act in sync to mimic the natural behaviour of the breast, instilling confidence to patients in their normal lifestyle situations. Our proprietary SilkSurface, with its NanoSurface Technology, does not adhere to surrounding tissues. Therefore, it allows the implant to adapt to the natural movement and eliminates the abrasion related to salt or sugar texturing, that can occur in physically active women. The look and feel of Motiva Ergonomix a natural breast Ergonomics is the scientific field that studies human interaction with other elements of a system. It applies theory, principles, data and methods to design in order to optimize human wellbeing and overall system performance. n Maximum Point of Projection MPP (50%) MPP (40%) MPP (35%) Before Implantation Horizontal Position Possible position of the MPP depending on the tecnique used for implantation (subglandular, subpectoral or dual plane). After Implantation Vertical Position www.motivaimplants.com 13
Do the math on safety and performance: Outstanding! Highest Safety Profile Medical grade, longterm implantable silicones with extensive chemical, physical and biological testing, filed with the FDA. Raw materials provided by the largest and most reputed silicone manufacturer in the US, with a safety record of more than 30 years in the medical industry. Enhanced safety profile, as demonstrated by the biological testing results, in accordance to the US Pharmacopeia (USP), 31 st Revision and the European Pharmacopeia (Ph.Eur.) 7 th Edition for Endotoxin LAL, as well as ISO 117371:2006. The level tested of inprocess Endotoxin Units (EU) per ml in Motiva Implant Matrix samples before sterilization was only 1% of the maximum value required by the Standard (US and European Pharmacopeias), which is an evidence of the process cleanliness and control. Mechanical testing results that exceed the requirements of the American Society for Testing and Materials 4, 5, 6 (ASTM) F703 Standards and the minimum value of 450% by the ISO 14607:2009. Shell elongation of twice the minimum value of 350% required by the ASTM F70307. 5,6 Force at breaking four times above the required by ASTM F70307 Standard. 5,6 Rupture rates below 0.1%. 15 9% Satisfaction rates. 15 Improved Performance 14 14 Innovación con Seguridad Safety through Innovation
Regulatory Approvals Motiva Implant Matrix has been awarded the prestigious CEMark designation, which means the products and company conform to rigorous safety, health and environmental performance standards. In addition to utilizing only FDA filed Nusil medical grade silicone materials, Establishment Labs has also created a world class Quality Management System certified by the distinguished British Standard Institution (BSI) notified body for ISO 9001:2008 19 and ISO 13485:2003 20 standards. We conduct 0% quality inspection on all Motiva Implant Matrix breast implants with the latest technological advancements. Microscopic optical measurement systems and 3Dimensional scanners are used in the Quality System Process. Regulatory approvals have been obtained in more than 60 countries: +20 countries in the Americas. +30 countries in Europe. + countries in Asia, Middle East and Africa. Always Confident Warranty Following FDA guidelines, Establishment Labs provides a limited warranty covering its Motiva Implant Matrix product range, providing a replacement product in the event of rupture up to years after implantation. Establishment Labs provides assistance in cases of capsular contracture Baker grades III and IV through its Product Replacement Policy Program. Ask for the complete terms of our Always Confident Warranty and our product replacement policy program. In select markets, through Lloyd s of London, we offer an industryfirst third party insurance program to provide financial assistance for revision surgeries in case of implant rupture, implant rotation and capsular contracture Baker grades III or IV. For special situations, ask for our industryfirst Always Confident Support Program. Visit www.motivaimplants.com for details regarding Always Confident Warranty. Ethical Charter At Establishment Labs all employees, from Operating Workers to Senior Management, sign and respect an Ethical Charter that reflects our commitment to the highest standards of corporate behavior. 16 Establishment Labs was the first breast implant manufacturer to make public all the results of its product validations, performed by third party laboratories, certified by the FDA and CE. Ethical and transparent corporate code of conduct. 0% scrutiny of implantable devices. Highest safety profile. www.motivaimplants.com 15
Motiva Implant Matrix Round Catalogue Available in 5 Implant Families to suit every need Motiva Implant Matrix SilkSurface MINI DEMI FULL CORSÉ Base (cm) P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # 8.5 9 9.5 9.75.25.5.75 11 11.25 11.5 11.75 12 12.25 12.5 13 1 14 1 15 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.2 5 125 140 160 185 3 430 RSM5 RSM125 RSM140 RSM160 RSM185 RSM RSM RSM RSM3 RSM RSM RSM430 3.4 3.6 135 155 230 265 285 320 340 525 575 RSD135 RSD155 RSD RSD RSD230 RSD RSD265 RSD285 RSD RSD320 RSD340 RSD RSD RSD RSD RSD525 RSD575 RSD 4.7 5.0 5.3 5.9 145 175 235 255 295 315 335 355 375 450 500 700 775 RSF145 RSF175 RSF RSF RSF235 RSF255 RSF RSF295 RSF315 RSF335 RSF355 RSF375 RSF RSF RSF450 RSF500 RSF RSF RSF700 RSF775 5.2 5.4 5.8 6.0 6.3 6.6 6.9 7.2 7.5 7.8 2 240 260 280 325 350 4 440 5 590 650 725 825 925 50 RSC RSC2 RSC240 RSC260 RSC280 RSC RSC325 RSC350 RSC RSC4 RSC440 RSC RSC5 RSC RSC590 RSC650 RSC725 RSC825 RSC925 RSC50 P=Projection V=Volume Motiva Implant Matrix SilkSurface PLUS MINI DEMI FULL CORSÉ 16 16 Base (cm) P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # 8.5 9 9.5 9.75.25.5.75 11 11.25 11.5 11.75 12 12.25 12.5 13 1 14 1 15 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.2 5 125 140 160 185 3 430 RSM5+ RSM125+ RSM140+ RSM160+ RSM185+ RSM+ RSM+ RSM+ RSM3+ RSM+ RSM+ RSM430+ 3.4 3.6 135 155 230 265 285 320 340 525 575 RSD135+ RSD155+ RSD+ RSD+ RSD230+ RSD+ RSD265+ RSD285+ RSD+ RSD320+ RSD340+ RSD+ RSD+ RSD+ RSD+ RSD525+ RSD575+ RSD+ 4.7 5.0 5.3 5.9 145 175 235 255 295 315 335 355 375 450 500 700 775 RSF145+ RSF175+ RSF+ RSF+ RSF235+ RSF255+ RSF+ RSF295+ RSF315+ RSF335+ RSF355+ RSF375+ RSF+ RSF+ RSF450+ RSF500+ RSF+ RSF+ RSF700+ RSF775+ 5.2 5.4 5.8 6.0 6.3 6.6 6.9 7.2 7.5 7.8 2 240 260 280 325 350 4 440 5 590 650 725 825 925 50 RSC+ RSC2+ RSC240+ RSC260+ RSC280+ RSC+ RSC325+ RSC350+ RSC+ RSC4+ RSC440+ RSC+ RSC5+ RSC+ RSC590+ RSC650+ RSC725+ RSC825+ RSC925+ RSC50+ Sizers are available for all Motiva Implant Matrix products. Innovación con Seguridad Safety through Innovation P=Projection V=Volume
MINI DEMI FULL CORSÉ Motiva Implant Matrix VelvetSurface MINI DEMI FULL CORSÉ Base (cm) P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # 8.5 9 9.5 9.75.25.5.75 11 11.25 11.5 11.75 12 12.25 12.5 13 1 14 1 15 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.2 5 125 140 160 185 3 430 RVM5 RVM125 RVM140 RVM160 RVM185 RVM RVM RVM RVM3 RVM RVM RVM430 3.4 3.6 135 155 230 265 285 320 340 525 575 RVD135 RVD155 RVD RVD RVD230 RVD RVD265 RVD285 RVD RVD320 RVD340 RVD RVD RVD RVD RVD525 RVD575 RVD 4.7 5.0 5.3 5.9 145 175 235 255 295 315 335 355 375 450 500 700 775 RVF145 RVF175 RVF RVF RVF235 RVF255 RVF RVF295 RVF315 RVF335 RVF355 RVF375 RVF RVF RVF450 RVF500 RVF RVF RVF700 RVF775 5.2 5.4 5.8 6.0 6.3 6.6 6.9 7.2 7.5 7.8 2 240 260 280 325 350 4 440 5 590 650 725 825 925 50 RVC RVC2 RVC240 RVC260 RVC280 RVC RVC325 RVC350 RVC RVC4 RVC440 RVC RVC5 RVC RVC590 RVC650 RVC725 RVC825 RVC925 RVC50 P=Projection V=Volume Motiva Implant Matrix VelvetSurface PLUS MINI DEMI FULL CORSÉ Base (cm) P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # 8.5 9 9.5 9.75.25.5.75 11 11.25 11.5 11.75 12 12.25 12.5 13 1 14 1 15 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.2 5 125 140 160 185 3 430 RVM5+ RVM125+ RVM140+ RVM160+ RVM185+ RVM+ RVM+ RVM+ RVM3+ RVM+ RVM+ RVM430+ 3.4 3.6 135 155 230 265 285 320 340 525 575 RVD135+ RVD155+ RVD+ RVD+ RVD230+ RVD+ RVD265+ RVD285+ RVD+ RVD320+ RVD340+ RVD+ RVD+ RVD+ RVD+ RVD525+ RVD575+ RVD+ 4.7 5.0 5.3 5.9 145 175 235 255 295 315 335 355 375 450 500 700 775 RVF145+ RVF175+ RVF+ RVF+ RVF235+ RVF255+ RVF+ RVF295+ RVF315+ RVF335+ RVF355+ RVF375+ RVF+ RVF+ RVF450+ RVF500+ RVF+ RVF+ RVF700+ RVF775+ 5.2 5.4 5.8 6.0 6.3 6.6 6.9 7.2 7.5 7.8 2 240 260 280 325 350 4 440 5 590 650 725 825 925 50 RVC+ RVC2+ RVC240+ RVC260+ RVC280+ RVC+ RVC325+ RVC350+ RVC+ RVC4+ RVC440+ RVC+ RVC5+ RVC+ RVC590+ RVC650+ RVC725+ RVC825+ RVC925+ RVC50+ P=Projection V=Volume www.motivaimplants.com 17
Motiva Implant Matrix Round Catalogue Available in 5 Implant Families to suit every need Exclusively for Europe Motiva Implant Matrix SilkSurface PLUS Qid MINI DEMI FULL CORSÉ Base (cm) P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # 8.5 9 9.5 9.75.25.5.75 11 11.25 11.5 11.75 12 12.25 12.5 13 1 14 1 15 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.2 5 125 140 160 185 3 430 RSM5+Q RSM125+Q RSM140+Q RSM160+Q RSM185+Q RSM+Q RSM+Q RSM+Q RSM3+Q RSM+Q RSM+Q RSM430+Q 3.4 3.6 135 155 230 265 285 320 340 525 575 RSD135+Q RSD155+Q RSD+Q RSD+Q RSD230+Q RSD+Q RSD265+Q RSD285+Q RSD+Q RSD320+Q RSD340+Q RSD+Q RSD+Q RSD+Q RSD+Q RSD525+Q RSD575+Q RSD+Q 4.7 5.0 5.3 5.9 145 175 235 255 295 315 335 355 375 450 500 700 775 RSF145+Q RSF175+Q RSF+Q RSF+Q RSF235+Q RSF255+Q RSF+Q RSF295+Q RSF315+Q RSF335+Q RSF355+Q RSF375+Q RSF+Q RSF+Q RSF450+Q RSF500+Q RSF+Q RSF+Q RSF700+Q RSF775+Q 5.2 5.4 5.8 6.0 6.3 6.6 6.9 7.2 7.5 7.8 2 240 260 280 325 350 4 440 5 590 650 725 825 925 50 RSC+Q RSC2+Q RSC240+Q RSC260+Q RSC280+Q RSC+Q RSC325+Q RSC350+Q RSC+Q RSC4+Q RSC440+Q RSC+Q RSC5+Q RSC+Q RSC590+Q RSC650+Q RSC725+Q RSC825+Q RSC925+Q RSC50+Q P=Projection V=Volume Exclusively for Europe Motiva Implant Matrix VelvetSurface PLUS Qid MINI DEMI FULL CORSÉ 18 18 Base (cm) P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # 8.5 9 9.5 9.75.25.5.75 11 11.25 11.5 11.75 12 12.25 12.5 13 1 14 1 15 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.2 5 125 140 160 185 3 430 RVM5+Q RVM125+Q RVM140+Q RVM160+Q RVM185+Q RVM+Q RVM+Q RVM+Q RVM3+Q RVM+Q RVM+Q RVM430+Q 3.4 3.6 135 155 230 265 285 320 340 525 575 RVD135+Q RVD155+Q RVD+Q RVD+Q RVD230+Q RVD+Q RVD265+Q RVD285+Q RVD+Q RVD320+Q RVD340+Q RVD+Q RVD+Q RVD+Q RVD+Q RVD525+Q RVD575+Q RVD+Q 4.7 5.0 5.3 5.9 145 175 235 255 295 315 335 355 375 450 500 700 775 RVF145+Q RVF175+Q RVF+Q RVF+Q RVF235+Q RVF255+Q RVF+Q RVF295+Q RVF315+Q RVF335+Q RVF355+Q RVF375+Q RVF+Q RVF+Q RVF450+Q RVF500+Q RVF+Q RVF+Q RVF700+Q RVF775+Q 5.2 5.4 5.8 6.0 6.3 6.6 6.9 7.2 7.5 7.8 2 240 260 280 325 350 4 440 5 590 650 725 825 925 50 RVC+Q RVC2+Q RVC240+Q RVC260+Q RVC280+Q RVC+Q RVC325+Q RVC350+Q RVC+Q RVC4+Q RVC440+Q RVC+Q RVC5+Q RVC+Q RVC590+Q RVC650+Q RVC725+Q RVC825+Q RVC925+Q RVC50+Q Sizers are available for all Motiva Implant Matrix products. Innovación con Seguridad Safety through Innovation P=Projection V=Volume
Motiva Ergonomix The look and feel of a natural breast Motiva Implant Matrix Ergonomix Round MINI DEMI FULL CORSÉ Base (cm) P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # 8.5 9 9.5 9.75.25.5.75 11 11.25 11.5 11.75 12 12.25 12.5 13 1 14 1 15 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.2 5 125 140 160 185 3 430 3.4 3.6 135 155 230 265 285 320 340 525 575 4.7 5.0 5.3 5.9 145 175 235 255 295 315 335 355 375 450 500 700 775 5.2 5.4 5.8 6.0 6.3 6.6 6.9 7.2 7.5 7.8 2 240 260 280 325 350 4 440 5 590 650 725 825 925 50 soon soon soon soon P= Projection V= Volume Exclusively for Europe Motiva Implant Matrix Ergonomix Round Qid MINI DEMI FULL CORSÉ Base (cm) P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # P (cm) V (cc) Catalogue # 8.5 9 9.5 9.75.25.5.75 11 11.25 11.5 11.75 12 12.25 12.5 13 1 14 1 15 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.2 5 125 140 160 185 3 430 3.4 3.6 135 155 230 265 285 320 340 525 575 ERSD135Q ERSD155Q ERSDQ ERSDQ ERSD230Q ERSDQ ERSD265Q ERSD285Q ERSDQ ERSD320Q ERSD340Q ERSDQ ERSDQ ERSDQ ERSDQ ERSD525Q ERSD575Q ERSDQ 4.7 5.0 5.3 5.9 145 175 235 255 295 315 335 355 375 450 500 700 775 ERSF145Q ERSF175Q ERSFQ ERSFQ ERSF235Q ERSF255Q ERSFQ ERSF295Q ERSF315Q ERSF335Q ERSF355Q ERSF375Q ERSFQ ERSFQ ERSF450Q ERSF500Q ERSFQ ERSFQ ERSF700Q ERSF775Q 5.2 5.4 5.8 6.0 6.3 6.6 6.9 7.2 7.5 7.8 2 240 260 280 325 350 4 440 5 590 650 725 825 925 50 soon soon P= Projection V= Volume www.motivaimplants.com 19
References 1. The Boyd Company Inc. Boyd Report Twin Cities Named Epicenter of U.S. Med Tech Industry Costa Rica The New NearShore Center. May 2011. 2. U.S. Food and Drug Administration Office of International Programs Latin America Office. http://www.fda.gov/aboutfda/centersoffices/ OfficeofGlobalRegulatoryOperationsandPolicy/OfficeofInternationalPrograms/ucm229.htm#latin 3. CINDE Costa Rica Investment Promotion Agency. www.cinde.org. 4. ISO 14607:2009. NonActive surgical implants: Mammary Implants Particular Requirements. 5. Motiva Implant Matrix Silicone Breast Implants Product Performance Qualification Summary. Establishments Labs S.A., August 2012. 6. ASTM (American Society for Testing and Materials) F 70307 Standard Specification for Implantable Breast Prostheses (Section 9.2.1.4). 7. Patent in process. 8. ISO 9931:2003: Biological evaluation of medical devices Part 1: Evaluation and testing within a Risk Management Process. 9. A comparison of outcomes involving highly cohesive, formstable breast implants from two manufacturers in patients undergoing primary breast augmentation. Jewell ML, Jewell JL. Aesthet Surg J. 20 Jan;30(1):5165.. Cohesive silicone gel breast implants in aesthetic and reconstructive breast surgery. Brown MH, Shenker R, Silver SA. Plast Reconstr Surg. 2005 Sep;116(3):76879; discussion 7801. 11. ASTM (American Society for Testing and Materials) F 70307 Standard Specification for Implantable Breast Prostheses (Sections 9.2.1.4 and.2). 12. Tissue Behavior Simulation (TBS ) and CCT Image Capture are trademarks or registered trademarks of Axis Three Limited and/or Siemens Technology Accelerator GmbH or its subsidiaries or parent companies. 13. ISO 14607:2009: Nonactive surgical implants: Mammary implants Particular requirements, Section 7.2.2.8 and Annex A: Test for surface characteristics. 14. ANSI/AAMI/ISO/20857:20 Sterilization Of Health Care Products Dry Heat: Requirements For The Development, Validation And Routine Control Of An Industrial Sterilization Process For Medical Devices. 15. Motiva Implant Matrix Silicone Breast Implant Summary of Clinical Data: 3Year follow up. Establishments Labs S.A., February 2014. 16. Establishment Labs S.A. Ethical Charter, 2011. 17. Internal Reference, Establishment Labs. 18. When compared to nontruemonobloc working prototypes. 19. ISO 13485:2003 Medical Devices Quality Management Systems Requirements for regulatory purposes. 20. ISO 90012008 Quality Management Systems Requirements. Establishment Labs: Coyol Free Zone, 4th Street, Building B15, COSTA RICA info@motivaimplants.com Motiva European Distribution Center: Metropoolstraat 1, 2900 Schoten, BELGIUM info@edcmotiva.com Motiva USA: 2121 SW 3rd Avenue, Miami, FL 33129, USA motivausa@establishmentlabs.com Distributed by: Safety Through Innovation