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MENTOR® Breast ImplantsFind the Breast Implant that’s Right for you

Whether your goal is a subtle change or a more dramatic diff erence, there is a breast implant that’s right for you

212072_190810_Mentor_Inspire_Book.indd 1 25/09/2019 21:23

Moderate Plus

Explore What Is Right For YouOnce you have a general understanding of the breast implant procedure, you are ready to explore

your breast implant options. The implant type you choose directly affects your final look.


Whether for augmentation or reconstruction, your breast implant choice is personal, important, and life changing. It is a choice which can empower you to own each day. To own each day. On your terms.

MENTOR® CPG™Breast Implants

MENTOR® MemoryGel™Breast Implants

Achieve your desired look with long lasting results.MENTOR® CPG™ Breast Implants helps createyour ideal breast shape with youthful firmness.

Millions of women all over the world have chosenMENTOR® MemoryGel™ Breast Implants for

more than 30 years.

Which MENTOR® Product Is Your Perfect Match?


MENTOR® CPG™ Breast Implants proprietary cohesive gel holds together uniformly, while providing a natural silhouette (shape) and youthful feel (fi rmness)*. Unlike round breast implants, MENTOR® CPG™ Breast Implants are teardrop shaped, meaning they’re thinner at the top and gently slope to a fuller projection point near the implant’s base to mimic the silhouette of a natural breast.

Clinical data reveals MENTOR® CPG™ Breast Implants have a very low reported incidence of key complications in primary augmentation at 10 years2. You can also get the peace of mind you deserve knowing that MENTOR®

CPG™ Breast Implants are covered by the most comprehensive warranty in the market1.

Why choose MENTOR®

CPG™ Breast Implants?

* As compared to saline-fi lled breast implants.

Not a head to head study. Based on the comparison of key complication rates reported in the 10 year Core Studies for MemoryShape®/CPG™Gel Breast Implants and some of the main competitors’ products.


MENTOR® CPG™ Breast ImplantsBe Confi dent Choosing MENTOR® Breast Implants

Breast implants are one of the most studied medical device in the US and worldwide

Backed by the peace of mind of the industry’s most comprehensive warranty3

Over 190,000 women with MENTOR®

Implants have been studied over the past 30 years4

Over 5 million women worldwide have MENTOR® Breast Implants

* As compared to saline-fi lled breast implants.

Not a head to head study. Based on the comparison of key complication rates reported in the 10 year Core Studies for MemoryShape®/CPG™Gel Breast Implants and some of the main competitors’ products.


MENTOR® CPG™ Breast Implants MENTOR® CPG™ Breast ImplantsWithstand the Test of Time

• Designed to have the implant deliver the desired shape of the augmented breast5

• Provide a smooth, tapered upper pole transition to encourage a natural contour of the breast6

• Provide a natural silhouette (shape) and softer than saline feel (fi rmness)*

• A very low reported incidence of key complications in primary augmentation at 10 years7

• Covered by the MENTOR® Warranty


MENTOR® CPG™ Breast ImplantsWithstand the Test of Time

These images depict a woman over the course of eight years after surgery with MENTOR® CPG™ Breast Implants.

* Mentor Worldwide, LLC. MemoryShape® Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015.


MENTOR® MemoryGel™ Breast Implants

of Satisfaction8

30YEARS


Why choose MENTOR® MemoryGel™ and MemoryGel™ Xtra Breast ImplantsMentor® MemoryGel™ Breast Implants feel more like natural breast tissue without compromising reliability or safety.* Millions of women all over the world have chosen MENTOR® MemoryGel™ Breast Implants for more than 30 years.

• Textured or smooth surface shell• Wide range of sizes and profi les to fi t your body• 3 MemoryGel™ and 2 MemoryGel™ Xtra Projection options• Filled with MENTOR® proprietary cohesive gel• Gel fi ller holds together uniformly to look and feel like natural breast tissue• Precision fi lled• Backed by the industry’s most comprehensive warranty

ExcellentPatient Satisfaction8

PrimaryAugmentation

PrimaryReconstruction

Patients HIGHLY SATISFIED with their decision

99%97%

* As compared to saline-fi lled breast implants Based on patient survey at 10 years in the MENTOR® MemoryGel® Breast Implant 10 Year Core Gel Clinical Study Final Report.


What kind of silicone is used?MENTOR® MemoryGel™ Breast Implants contain the latest generation of silicone. They are prefi lled with Mentor’s uniquely formulated silicone gel. This gel is not like a liquid or a semi-liquid. Instead, it is a cohesive gel that holds safely and uniformly together to deliver a natural feel that closely resembles breast tissue.9+

Introducing MemoryGel™ Xtra Breast Implants.The Soft, Natural Feel You Desire with Increased Projection and Fullness 10+

+ As compared to saline-fi lled breast implants.


Soft where you want itFirm where you need it

Introducing MemoryGel™ Xtra Breast Implants.The Soft, Natural Feel You Desire with Increased Projection and Fullness 10+


5MILLION+

women have MENTOR® Silicone Gel Breast Implants

10CLINICAL STUDIES4

OVER 190,000 WOMEN4

Successfully used and trusted for more than

30YEARS

TM


Before After

Before After

Dr. Aldo Guerra MemoryGel™ Xtra Follow Up


The Most Comprehensive Protection in the IndustryMENTOR® Warranties & Product Replacement Policy

FREE and AUTOMATIC enrollment

FREE lifetime product replacement for rupture*

Upto €1000 finacial assistance coverage for rupture†

FREE product replacement in the events of capsular contracture (Baker III/IV). Double capsule and late stage seroma‡

FREE contralateral implant at your surgeon’s request

MENTOR® PROMISE PROTECTION PLAN OVERVIEW

* In the event of a confirmed rupture or deflation (leaking) of any MENTOR® Breast Implant due to wear or delamination requiring surgical intervention, regardless of the age of the implant, Mentor will provide a free replacement of a MENTOR® Breast Implant of any size in the same or similar style as the originally implanted product.

† When 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 and evaluation, Mentor will pay uninsured, outof-pocket costs for operating room, anesthesia and/or surgical expenses directly related to revision surgery up to a maximum aggregate amount of €1000. Operating room and anesthesia charges shall be given payment priority. 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.

‡ In 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 period of ten (10) years from the date of implantation, provided that eligibility is proven and confirmed by Mentor based on its evaluation of explanted product and assessment of all required documentation. Mentor will provide a replacement MENTOR® Product of any size in the same or similar style as the originally implanted product.


IMPORTANT SAFETY INFORMATIONMENTOR® 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 is not necessarily a one-time surgery. Patients may require additional unplanned surgeries on the breast(s) because of complications or unacceptable cosmetic outcomes. Many of the changes to the breast(s) following implantation are irreversible (cannot be undone) and breast implants may affect the ability to breastfeed, either by reducing or eliminating milk production. 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 (meaning neither you nor your doctor will know you have a rupture). 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. The most common complications with MENTOR® Saline-Filled Breast Implants include re-operation, implant removal, capsular contracture, wrinkling, deflation, asymmetry, and breast pain. Patients are reminded to discuss the indications, contraindications, warnings, precautions and the risks and benefits associated with MENTOR® Breast Implants with their surgeon and review the Important Safety Information provided at https://www.jnjmedicaldevices.com/en-EMEA/companies/mentor It is important that patients understand the risks associated with breast implant surgery when considering MENTOR® Breast Implants.

https://www.jnjmedicaldevices.com/en-EMEA/companies/mentor © Mentor Worldwide LLC 2019. Intended for use by or under the direction of a physician use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions. All rights reserved.

All other companies’ brand names mentioned herein are the trademarks of their respective owners.

© Mentor Worldwide LLC 2019 121072-190819

This publication is not intended for distribution outside of the EMEA region.

1. Based on worldwide market share. Data as of December 20192. Mentor Worldwide, LLC. MemoryShape® Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02

June 20153. 1-Allergan Warranty. https://www.natrelle.com/gel-technology#warranty accessed 11/30/2018 -Sientra Product replacement policy and warranty.

http://www.sientra.com/Content/pdfs/Warranty_Terms_And_Conditions.pdf accessed 11/30/2018 -Sientra CapCon Warranty. http://www.sientra.com/Content/pdfs/CapCon_Care_Program_Terms_and_Conditions.pdf accessed 11/30/2018 -Sientra mailing to US Plastic Surgeons

4.1. Summary of the Safety and Effectiveness of MENTOR® MemoryGel™ Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013. 4.2. MENTOR® MemoryGel™ Post Approval Study Seventh Annual Report, November 5, 2013. 4.3. Adjunct Study Final Report for MENTOR® MemoryGel™ Silicone Gel-Filled Breast Implants, 02 November 2012. 4.4. Mentor Worldwide, LLC. MENTOR® MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report, 02 June 2015. 4.5. MENTOR® Becker Expander/Breast Implant Clinical Trial 2013 Annual Report. 4.6. MENTOR® MemoryShape™ Post-Approval Cohort Study(formerly Contour Profile Gel Core Study, 2013. 4.7. MENTOR® 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, 2015. 4.8. MENTOR® MemoryShape™ Post-Approval Continued Access Study (formerly Contour Profile Gel Continued Access Study), 2014. 4.9. Mentor MemoryGel Breast Implant Large Post Approval Study Re-Op Phase 3rd Annual Report 12 January 2018. 4.10. A Study of the Safety and Effectiveness of the Mentor Smooth and Textured Larger Size MemoryGel Ultra High Profile (UHP-L) Breast Implants in Subjects who are Undergoing Primary Breast Reconstruction or Revision Reconstruction; ClinicalTrials.gov Identifier: NCT02724371. 4.11. MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrolment Study: NCT02919592 22.

5. Hammond DC, Canady JW, Love TR, Wixtrom RN, Caplin DA. Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years. Plast Reconstr Surg. 2017;140(6):1142-1150.

6. Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-Term Safety of Textured and Smooth Breast Implants. Aesthetic Surg J. 2017;38(1):38-48. doi:10.1093/asj/sjx157.

7. Mentor Worldwide, LLC. MemoryShape® Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015 Mentor Worldwide LLC. Data on File. MemoryGel® Core Gel Clinical Study Final Report, April 2013 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). 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. 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. 2012/09/25.015

8. Summary of the Safety and Effectiveness of Mentor’s MemoryGel® Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013.

9. Bondurant, S., Ernster, V., and Herdman, R. Safety of Silicone Implants. Washington, DC: National Academy Press. 1999. Mentor Worldwide LLC. Mentor Worldwide Sales Data.

10. Product Dimensions for MemoryGel and MemoryGelTM Xtra Breast Implants and Mentor R&D Compression Benchtop Testing (Pinch Test) - July 2017. In-person consumer survey with 452 respondents. Mentor Consumer Preference Market Research Report - July 2017.


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