MENTOR® CPG™ Gel Breast Implants
MENTOR® CPG™ Gel Breast Implants
MENTOR® CPG™ Gel Breast Implants are designed to help create your desired breast shape with youthful firmness.1 The proprietary cohesive gel holds together uniformly, while providing a natural silhouette and youthful feel.1 Unlike round breast implants, CPG™ Breast Implants are teardrop shaped, that means thinner at the top and gently sloping to a fuller projection near the base for a naturally tapered silhouette.2
Each CPG Implant features SILTEX® Microtexture, an imprinting process designed to help keep implants in place.3*
IMAGES
#1
Global Brand16
3.8%
Kaplan Meier estimated incidence rate of Baker III IV capsular contracture in primary augmentation4
1.5%
Kaplan Meier estimated incidence rate of implant rotation in primary augmentation4
Features & Benefits
Proven Design
MENTOR® Breast Implants are backed by 10‐year, prospective clinical trials that demonstrate their safety and effectiveness in primary and revision augmentation and reconstruction patients4-9, providing patient with proven safety, performance, and peace of mind.4-9
Performance: a low reported incidence of key complications in primary breast augmentation at 10 years. 4,5,10-12**,^
Proven Performance
Each MENTOR® product line undergoes a stringent inspection and rigorous testing to ensure quality and performance. Our process is robust for every product we make – and the process never stops.13,14
MENTOR® CPG™ Breast Implants study outcomes speak for themselves. Performance - MENTOR® CPG™ Breast Implants have a low reported rate of capsular contracture and rupture in primary augmentation patients at 10‐years in a prospective, multi-center study. 4,5,10-12**
Proven Peace of Mind
MENTOR® Breast Implants are backed by a highly comprehensive warranty.15 A highly comprehensive protection plan assured by Johnson & Johnson, a global leader in Healthcare with over 130 years of experience.15 Ask about the MENTORPromise protection plan.
Long-Lasting Results
Help create your patient's desired breast shape:
A – Our MENTOR® CPG™ Breast Implant is TEAR-DROP shaped.2
B - SILTEX® MICROTEXTURE* uses an imprinting process that is designed to help keep the implant in place.3*
C – PROVIDES MORE IMPLANT PROJECTION at the lower pole, offering maximum projection where needed.2
D- The proprietary cohesive gel holds together uniformly, while providing a natural shape and youthful firmness.1
Supporting Documentation
CPG Resources
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CPG Brochure
Helpful Links
Breast Augmentation Products
Breast Reconstruction Products
MENTOR® Home
MENTOR® Customer Support
References
*according to ISO14607
**Not a head to head study. Based on the comparison of key complication rates (capsular contracture and rupture) reported in the 10 year Core Studies for MemoryShape®/ CPG™ Gel Breast Implants, NATRELLE™ 410 TruForm™ 3 Gel Breast Implants, NATRELLE™ Round TruForm™ 1 Gel Breast Implants, Sientra Silicone Gel Breast Implants, and MemoryGel™ Breast Implants. The third party trademarks used herein are the properties of their respective owners.
^Based on key complication rates (rupture and capsular contracture).
1. B. Calobrace, The Design and Engineering of the MemoryShape Breast Implant. Plast Reconstr Surg. 2014 Sep;134(3 Suppl):10S‐ 5S.
2. Hammond DC, Canady JW, Love TR, et al. Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years Plastic Reconstr Surg, 2017.
3. Wixtrom R, Garadi V, Leopold J, Canady J, Device‐Specific Findings of Imprinted‐ Texture 2019, 1–7 Breast Implants: Characteristics, Risks, and Benefits.
4. MemoryShape Post‐Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. Mentor Worldwide, LLC; 02 June 2015.
5. MemoryGel Core Cel Clinical Study Final Report. Mentor Worldwide, LLC; April 2013.
6. Mentor MemoryShape Post‐Approval Continued Access Study (formerly Contour Profile Gel Continued Access Study), Final Report. October 2014.
7. Mentor MemoryGel Breast Implant Large Post Approval Study Re‐Op Phase Annual Report. 17 June 2016.
8. Adjunct Study Final Report for Mentor's MemoryGel Silicone Gel‐filled Breast Implants. 02 November 2012.
9. Mentor MemoryShape 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, Final Clinical Study Report. 20 October 2015.
10. Maxwell, G. Patrick; Van Natta, Bruce W.; Bengtson, Bradley P.; and Murphy, Diane K., "Ten‐Year Results From the Natrelle 410 Anatomical Form‐ Stable Silicone Breast Implant Core Study" (2015).
11. Public Health Resources. Health Canada: Summary Basis of Decision (SBD) for Natrelle™ Highly Cohesive Silicone‐ Filled Breast Implants. Application No. 88573. License No.72262. Date Issued: 2014/01/17.
12. Health Canada: Summary Basis of Decision (SBD) for Natrelle™ Silicone‐ Filled Breast Implants‐ Smooth Shell With Barrier and Narelle(TM) Silicone Filled Breast Implants ‐ Textured Shell with Barrier Layer. Application No. 61865 and 60524 License No License No 72264 and 72263. Date Issued: 2012/09/25.
13. Implant Testing and the "Strain Energy" Concept. David A. Caplin, MD. 2018
14. Smooth and SILTEX™ Round Xtra Gel Breast Implants (Project Goldilocks Breast Implants OUS, ADAPTIV # 100502574) 100525323 Design Requirements. May 2018.
15. MENTORPROMISE PROTECTION PLAN FOR MENTOR® BREAST IMPLANTS, Legal Document, 2021.
16. Mentor Worldwide LLC. Mentor Worldwide Expander and Share Sales Data through Q2 2020.
MENTOR® MemoryGel® 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 those women with active infection anywhere in their body, those with existing cancer or pre‐cancer of their breast(s), those who have not received adequate treatment for these conditions or those who are pregnant or nursing. There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation are not necessarily a one‐time surgery. The most common complications with MENTOR® MemoryGel® Breast Implants include re‐ operation, implant removal, capsular contracture, asymmetry, and breast pain. A lower risk of complication is implant rupture, which is most often silent. The health consequences of a ruptured silicone gel‐ filled breast implant have not been fully established. Screenings such as mammography, MRI, or ultrasound are recommended after initial implant surgery to assist in detecting implant rupture. Breast implants are also associated with the risk of breast implant‐associated anaplastic large cell lymphoma (BIA‐ ALCL), an uncommon type of lymphoma. An individual's risk of developing BIA‐ALCL with MENTOR® Breast Implants is low based on the data currently available on the incidence of worldwide cases.
Your patient needs to be informed and understand the risks and benefits of breast implants, and she should be provided with an opportunity to consult with you prior to deciding on surgery. For detailed indications, contraindications, warnings and precautions associated with the use of all MENTOR® Implantable Devices, please refer to the Product Insert Data Sheet provided with each product or review the Important Safety Information provided at www.mentorwwllc.eu.
Intended Use
For product details such as indications, contraindications, warnings and precautions please consult the IFU.
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Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.
