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Natrelle™ -Quality for confidence • When texture is important our unique BIOCELL™ texture contributes to lower incidence of capsular contracture1 Capsular contracture n=118, avg 21 months1 Capsular contracture n=492 primary and n=156 secondary augmentation at 3 years2 n=163, at 5-11 years3 • Unique shell design • Unique shape control All contribute to long-term safety and improved aesthetic outcomes4 1. Brown M H, et al (2005). Cohesive Silicone Breast Implants in Aesthetic and Reconstructive Breast Surgery. Plast Reconstr. Surg. 116(3) 768-779 2. Bengtson B P, et al (2007). Style 410 Highly Cohesive Silicone Breast Implant Core Study Results at 3 Years. Plast. Reconstr. Surg. 120(1), 40-48S 3. Hedén P, et al (2009). Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants. Aesth Plast Surg. 33, 430-436 4. Spear S L, Hedén P, (2007). Allergan’s silicone gel breast implants. Expert Rev. Med. Devices. 4(5), 699-708 Natrelle™ - Quality for confidence nique BIOCELL™ texture promotes tissue adherence Adapted from Danino1 Critical texturing parameters for tissue adherence Ultra structural aspect of the implant surface Large pore diameter (um) Irregular distribution Corresponding capsule (soft-tissue response) Mirror image Implant stability Capsule architecture Linear fibrosis May be prone to micro-movements Non-linear and disorganised Reduced risk of rotation Interface n=118, avg 21 months2 Capsule Rotation rate n=114, avg 27 months3 *Other studies have demonstrated a pore size between 300um and 800um 1.Danino A M, et al (2001). Comparisons of the Capsular Response to the Biocell RTV and Mentor 1600 Siltex Breast Implant Surface Texturing: A scanning Electron Microscopic Study. Plast. Reconstr. Surg. 108(7), 2047-2052 2.Brown M H, et al (2005). Cohesive Silicone Breast Implants in Aesthetic and Reconstructive Breast Surgery. Plast Reconstr. Surg. 116(3) 768-779 3.Hahn M, (2008). Sonographic Criteria for the Confirmation of Implant Rotation and the Development of an Implant- Capsule-Interaction (“Interface”) in Anatomically Formed Textured Breast Implants with Texturised Biocell® - Surface. Ultraschall in Med. 29, 399-404 Natrelle™ -Quality for confidence nique shell design 360º INTRASHIEL™ barrier layer (incl. patch area) minimises silicone diffusion1 High performance silicone elastomer layers for enhanced shell integrity Patented shell-patch bond* for optimum strength Tapered shell cut Diagrammatic representations - not to scale 1. Data on file. * Patent # 6,074,421 Natrelle™ - Quality for confidence nique shape control Form stability/Gel firmness Control over final breast shape1 Optimal long lasting breast shape1, 2, 3 roven safety profile1,3 Rupture rate Rippling rate n=492, primary augmentation at 3 years4 MRI Assessed n=225, primary reconstruction at 3 years4 n=941, (all cohorts) at 3 years4 n=144, at 5-9 years5 1. Spear S L, Hedén P, (2007). Allergan’s silicone gel breast implants. Expert Rev. Med. Devices. 4(5), 699-708 2. Brown M H, et al (2005). Cohesive Silicone Breast Implants in Aesthetic and Reconstructive Breast Surgery. Plast Reconstr. Surg. 116(3) 768-779 3. Adams W, (2007). Form-Stable Cohesive Gel Implants: Advantages and Technical Essentials. Innov in Plast Surg. 1(3), 7-14 4. Bengtson B P, et al (2007). Style 410 Highly Cohesive Silicone Breast Implant Core Study Results at 3 Years. Plast. Reconstr. Surg. 120(1), 40-48S 5. Hedén P, et al (2006). Style 410 Cohesive Silicone Breast Implants: Safety and Effectiveness at 5 to 9 Years after Implantation. Plast. Reconstr. Surg. 118(6), 12811287 Natrelle™ - Long-term patient Satisfaction High satisfaction* across all aspects of breast surgery at 3 years1 Unequalled long-term patient satisfaction 97%** at up to 9 years2 Augmentation Reconstruction Up to 11 years after surgery most patients reported improved self-esteem, body perception, feeling of wearing clothes, personal charisma and attraction ability3 Revision augmentation Revision reconstruction 1. 2. 3. Bengtson B P, et al (2007). Style 410 Highly Cohesive Silicone Breast Implant Core Study Results at 3 Years. Plast. Reconstr. Surg. 120(1), 40-48S Hedén P, et al (2006). Style 410 Cohesive Silicone Breast Implants: Safety and Effectiveness at 5 to 9 Years after Implantation. Plast. Reconstr. Surg. 118(6), 1281-1287 Hedén P, et al (2009). Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants. Aesth Plast Surg. 33, 430-436 * Satisfied or definitely satisfied with their implants on a five point scale ** Stated breast implantation had been advantageous Quality by confidence Optimal gel fill for minimal rippling1 When texture is important, our unique BIOCELL™ texture contributes to lower capsular contracture rates2 360º INTRASHIEL™ barrier layer minimises silicone gel diffusion3 High performance silicone elastomer layers for enhanced shell integrity 1. Adams W, (2007). Form-Stable Cohesive Gel Implants: Advantages and Technical Essentials. Innov in Plast Surg. 1(3), 7-14 2. Brown M H, et al (2005). Cohesive Silicone Breast Implants in Aesthetic and Reconstructive Breast Surgery. Plast Reconstr. Surg. 116(3) 768-779 3. Data on file. Natrelle™ INSPIRA™ • INSPIRA SMOOTH Natrelle™ 410 – uality for confidence Anatomical design provides a natural and proportionate breast shape1,2 Form Stable gel ensures predictable and long lasting shape with lower complication rates2,3 BIOCELL™ texture reduces rotation and contributes to lower capsular contracture rates1 360°INTRASHIEL™ barrier layer minimises silicone gel diffusion5 Orientation marks provide assistance in visual and tactile positioning within the surgical pocket 1. Brown M H, et al (2005). Cohesive Silicone Breast Implants in Aesthetic and Reconstructive Breast Surgery. Plast Reconstr. Surg. 116(3) 768-779 2. Spear S L, Hedén P, (2007). Allergan’s silicone gel breast implants. Expert Rev. Med. Devices. 4(5), 699-708 3. Adams W, (2007). Form-Stable Cohesive Gel Implants: Advantages and Technical Essentials. Innov in Plast Surg. 1(3), 7-14 4. Bengtson B P, et al (2007). Style 410 Highly Cohesive Silicone Breast Implant Core Study Results at 3 Years. Plast. Reconstr. Surg. 120(1), 40-48S 5. Data on file. Natrelle™ 410 hoice for individual solutions Tru Form2™ Low projection and Tru Form3 Gels TruForm3 Gel Only Moderate projection Full projection eXtra full projection Full Height FL 5 sizes ML 13 sizes ML 5 sizes MM 9 sizes LL 5 sizes LM 5 sizes FF 13 sizes FX 13 sizes Moderate Height FM 13 sizes MX 13 sizes Low Height LF 12 sizes LX 13 sizes 240 implant options 12 Anatomical shapes: 3 heights and 4 projection options 2 Gel options: Tru Form2™ and Tru Form3 Natrelle™ 510 - uality for confidence Anatomical design provides a natural and proportionate breast shape1,2 Concave base and tapered edges allow a superior fit to the thoracic wall reducing edge palpability Unique Form Stable Dual Gel combination Cohesive gel on the posterior portion ensures predictable, long lasting shape with lower complication rates3 Firm cohesive gel on the anterior portion maintains projection 4 BIOCELL™ texture reduces rotation5 and contributes to lower capsular contracture rates1 360° INTRASHIEL™ barrier layer minimises silicone gel diffusion6 Orientation marks provide assistance in visual and tactile positioning within the surgical pocket 1. Brown M H, et al (2005). Cohesive Silicone Breast Implants in Aesthetic and Reconstructive Breast Surgery. Plast Reconstr. Surg. 116(3) 768-779 2. Spear S L, Hedén P, (2007). Allergan’s silicone gel breast implants. Expert Rev. Med. Devices. 4(5), 699-708 3. Adams W, (2007). Form-Stable Cohesive Gel Implants: Advantages and Technical Essentials. Innov in Plast Surg. 1(3), 7-14 4. Beekman W H, et al (2007). Anatomically Shaped Breast Prosthesis in Vivo: A Change of Dimension? Aesth Plast Surg. 31, 540-543 5. Bengtson B P, et al (2007). Style 410 Highly Cohesive Silicone Breast Implant Core Study Results at 3 Years. Plast. Reconstr. Surg. 120(1), 40-48S 6. Data on file. Natrelle™ 510 n ideal solution for: Correcting mild ptotic breasts without extra scars Tubular breasts Poland’s syndrome eXtra Full Projection Full Height FX 13 sizes Thin tissue coverage in both augmentation and reconstruction cases Moderate Height MX 13 sizes Low Height LX 13 sizes TruForm™ gel names Previous gel names Responsive Soft Touch™ Cohesive Dual Gel Increasing firmness Control over final breast shape1 Constant distribution of gel throughout the shell in any position Optimal gel fill ‘One breast feel’ (single unified breast mound) 1 Optimal long-lasting shape control 1,2,3 Better long-term maintenance of breast shape 1,3 Maintenance of upper-pole fill 2 Less soft-tissue stretch 2 Improved longevity and improved aesthetic outcomes 1 Decreased likelihood of post-operative rippling 1 Reduced likelihood of significant capsular contracture 1 Reduced risk of implant rupture 1 1. 2. 3. Spear S, Heden P. (2007). Allergan’s silicone gel breast implants. Expert Rev. Med. Devices. 4(5). 699-708 Adams W (2007). Form-Stable Cohesive Gel Implants: Advantages and Technical Essentials. Innovations in Plastic Surgery. 1(3), 7-14 Brown M H, et al (2005). Cohesive Silicone Gel Breast Implants in Aesthetic and Reconstructive Breast Surgery. Plast. Reconstr. Surg. 116(3) 768-779 atisfaction the Natrelle™ way Jewel&Jewel ,2010 • 118 Mentor CPG comparison with 117 Natrelle 410 style • 6 Years (16-77 months) • Rippling 7,6% Natrelle vs 37,3% Mentor • Capsular contracture 2,5% Natrelle vs 0,8% Mentor; IV grade both manufacturers 0%, none undergone revision • Mentor devices were more palpable Abramo, 2010 • Capsular formation : Natrelle Biocell surface vs Mentor Siltex vs Polyurethane covered foam • 3 patients each group was observed every 3 month with palapation and MR • After 18 month : Biocell – soft, natural breast, I grade CC in MR ; Mentor III grade CC; Polyurethane III grade CC • Supports Danino paper Heden et al, 2009 • • • • 163 patients; 6 countries, 15 hospitals 8 Years 91% patients satisfaction 1,7% rupture in MR 5,3% CC in MR, none IV grade Bengston study, 2007 • • • • 941 patients, 10 Years; 48 surgeons USA After 3 Years 98% patients satisfied Rupture 1% CC III/IV grade 1,9% primary; 4,8% secundary augmentated • Rippling 0,5% primary; 2% secundary augmentated