Download Natrelle™ -Quality for confidence

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