the most comprehensive breast reconstruction portfolio · mentor offers a comprehensive portfolio...
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The Most Comprehensive Breast Reconstruction Portfolio
Integrated system of productsare designed for her with your surgical needs in mind
Raise the Standard
1969
2000
2006
2009
2013
2016
2017
BREAST TISSUE EXPANDERS
BREAST IMPLANTS
TISSUE REINFORCEMENT
MENTOR® Breast Tissue Expanders are designed to be more:• Predictable1* • Stable2,3** • Safe4†
MENTOR® Breast Implants• 30 Year History7 • 6+ Million Women8 • #1 Highest Rated9
MTF FlexHD® Pliable is proud to offer better:5,6
• Industry Standards • Tissue Processing • Donor Selection
Trusted partner — then, now and into the future
Mentor founded
First tissue expander
Only company with an adjustable implant
1969
1984
2000
First bilateral breast kits
2010
First breast expander with directional expansion and safety feature
2001
First engineered breast tissue expander
2015
*ARTOURA™ Breast Tissue Expander compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression**CPX®4 Smooth and ARTOURA™ provide more suture tab options than competitors.†Proprietary BufferZone® Self-Sealing Patch
MENTOR ALLERGAN®
Full-filled round implant
Shaped implants
Saline implants
Utility breast tissue expander
Round, rectangular, eliptical and crescent-shaped
Breast tissue expander with controlled pocket formation
ADM
Pre-pec ADM
Body contouring (cannulas, handles, capital and disposables)
Mentor Deflation Protection Program
Mentor offers a comprehensive portfolio
BRE
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TISS
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MENTOR® BREAST TISSUE EXPANDER PORTFOLIO Designed to be more…
Breast contour shape for directional expansion with Dacron®*Patch and added Dynamic Control Technology™ in ARTOURA™
PREDICTABLE1*
Suture tab options for flexibility of fixation and proprietary SILTEX® microtexture to minimize movement
STABLE2,3**
ARTOURA™ and CPX®4 Breast Tissue Expander match with final implant selection100%
ARTOURA™ Breast Tissue Expander
Smooth & SILTEX® MicrotextureOnly expander with Dynamic Control Technology™1
Unsurpassed tissue expansion control1‡
CPX®4 Breast Tissue Expander
Smooth & SILTEX® MicrotextureEnhance patient comfort and help facilitate ease of use10
Directional expansion
CONTOURED DESIGN CONTROLLED CONTOURED DESIGN
Minimal lateral distortion
Limited superior pole distortion
Maximum lower pole projection
Limit posterior distortion
Pre-pec suitability 12 o’clock suture tab Dynamic Control Technology™
Surgeons report that CPX®4 Smooth feels softer and more pliable than CPX®411
BufferZone® Self-sealing Patch protects at least 50% more surface against accidental needle puncture and expander deflation
SAFE4†
200% Less lateral distortion than Allergan 133 Expanders when filled to indicated volume1‡
#1 Preferred premium tissue expander
DIRECTIONALlower pole expansion
3 TABS SILTEX® 6 TABS Smooth
BufferZone®
Dacron®* patch
BufferZone®
Dacron®† patch
3 TABS SILTEX® 5 TABS Smooth
*ARTOURA™ Breast Tissue Expander compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression**CPX®4 Smooth and ARTOURA™ provide more suture tab options than competitors.†Proprietary BufferZone® Self-Sealing Patch* The third-party trademarks used herein are trademarks of their respective owners.
‡In benchtop testing under body simulated conditions as compared to ALLERGAN® 133 Expanders. Test included ARTOURA™ Breast Tissue Expander code TEXP130RH and Natrelle® 133MX-13-T.
Through an alliance with the Musculoskeletal Transplant Foundation (MTF), the world’s largest tissue bank, Mentor is able to provide you with
seamless access to FlexHD® for use in breast reconstruction.12
MTF FlexHD® Pliable Acellular Hydrated Dermis
FlexHD® Pliable Acellular Hydrated Dermis is a registered trademark of MTF Biologics.
BETTER TISSUE PROCESSING5,6 NO this facilitates tissue incorporation
cross linking
terminal sterilization
MTF standards require more comprehensive testing and selection than required by AATB, FDA and most tissue banks
BETTER DONOR SELECTION5,6
LESS THAN of referred donors are accepted3%
Variety of sizes and thickness
Bilateral Breast Kits available
Used in sub muscular and pre-pec surgical technique
BETTER INDUSTRY STANDARDS5,6
Board of Directors governed and guided
by surgeons25Years
BREAST TISSUE REINFORCEMENT
She’s empowered knowing her breast reconstruction options
MENTOR® BREAST IMPLANT PORTFOLIO Range of options enhance your ability to individualize results13
Gently sloping silhouette filled with a natural saline solution
Saline Round Shaped to resemble the natural slope of a breast
MemoryShape®
Patient satisfaction rate for primary reconstruction17
100%
Successfully used and trusted730+YEARS
#1 HIGHEST RATED and most popular breast implant on RealSelf.com9
women have MENTOR® Silicone Gel Breast Implants86MILLION+
MemoryGel® Unsurpassed satisfaction14
Designed with patients in mind
in a blinded comparison as feeling more like natural breasts than Natrelle Inspira Responsive and Cohesive Breast Implants15
9out of10Consumers Prefer MemoryGel® Xtra
Patient satisfaction rate for primary reconstruction14
TEXTURE YOU CAN TRUSTMENTOR® SILTEX® Microtexture
Designed to minimize implant rotation and malposition3
In a recent study of SILTEX® Texture compared to BIOCELL implants at either the implant
muscle or implant-ADM interface18
O%BIOFILMFORMATION
Consistently shows
as compared with high-surface-area textured breast implants
low rates of BIA-ALCL
Surgeons most often chose MemoryGel® Xtra as the implant they would use in their practice16
99%SPECTRUM®
Adjustable Saline
MemoryGel® Xtra The soft, natural feel your patients desire
The ™ Protection PlanThe Best and Most Comprehensive Implant Warranty19,20
The MENTORPromise™—with FREE and automatic comprehensive coverage— brings the peace of mind that our breast implants are protected for years to come.20
The Deflation Protection Program
The MENTOR® Deflation Protection Program is backed by our Replacement Policy for CPX® and ARTOURA™ family of Tissue Expanders.21
Mentor Family of Tissue Expanders
The 90-Day Guarantee
When you choose MTF FlexHD® for breast reconstruction, you choose the highest quality ADM supported by a 90-day money-back guarantee.22
Breast Reconstruction Reimbursement HotlinePlease contact The Pinnacle Health Group
toll free at 866-369-9290 or email at [email protected]
or fax at 877-499-2986
Patient awareness of breast reconstruction
As part of Mentor’s commitment to advancing the awareness and practice of breast reconstruction, we offer a variety of support services to our customers
PROFESSIONAL SUPPORT
Professional Education
Mentor offers a comprehensive range of professional education opportunities to
support surgeons throughout their career
To support our customers, Mentor provides access to certified coding professionals with
The Pinnacle Health Group to assist with coding, coverage and payment for our comprehensive
breast reconstruction portfolio of products
BreastImplantsbyMentor.com offers your patients access to information
related to their reconstruction
Reimbursement Support
COMPREHENSIVE COVERAGE
REFERENCES:1. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report.2. Allergan Natrelle® 133 Plus Tissue Expander 510k. 3. G. Patrick Maxwell, MD; Michael Scheflan, MD; Scott Spear, MD; Maurizio B. Nava, MD; and Per Hedén, MD, PhD; Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness Aesthetic Surgery Journal 2014, Vol. 34(6) 876–881 © 2014.4. Mentor Worldwide, LLC, Internal Memo – Surface Area November 6, 2012.5. Todd J. Nilsen, BSME; Anouska Dasgupta, PhD; Yen-Chen Huang, PhD; Henry Wilson, MD, FACS; and Evangelia Chnari, PhD. Do ProcessingMethods Make a Difference in Acellular Dermal Matrix Properties? Aesthetic Surgery Journal 2016, S1-S16.6. MTF Biologics – MTF Biologics and FlexHD Pliable Muscular Transplant Foundation, Edison, NJ. November 2018.7. Bondurant, S., Ernster, V., and Herdman, R. Safety of Silicone Implant. Washington, DC: National Academy Press. 1999. Mentor Worldwide LLC.8. Mentor Worldwide Historical Implant Data 1985 - May 2018.9. RealSelf Worth It Ratings Data - September 2018.10. Mentor Worldwide, LLC 6: Design Requirements Matrix. Source 9: Patient Comfort VOC.11. Mentor Worldwide, LLC Surgeon VOC survey results.12. David J. Gocke, MD Tissue Donor Selection and Safety Clinical Orthopedics and Related Research Number 435, pp. 17-21.13. MENTOR Worldwide LLC. Implant Dimensions Spreadsheet.
IMPORTANT SAFETY INFORMATION:MENTOR® MemoryGel® Breast Implants, MENTOR® MemoryShape® Breast Implants, and MENTOR® Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel® Implants and MemoryShape® Implants, and 18 years old for Saline Implants) or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, or who are currently pregnant or nursing. Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation and reconstruction with MemoryGel® Implants include any reoperation, capsular contracture, and implant removal with or without replacement. The most common complications with MemoryShape® Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. The most common complications with MemoryShape® Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. The most common complications with MENTOR® Saline-filled Implants include reoperation, implant removal, capsular contracture, breast pain, and implant deflation. For MemoryGel® Implants, patients should receive a copy of Important Information for Augmentation Patients about MENTOR® MemoryGel® Breast Implants or Important Information for Reconstruction Patients about MENTOR® MemoryGel® Breast Implants. For MemoryShape® Implants, patients should receive a copy of Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants or Patient Educational Brochure – Breast Reconstruction with MENTOR® MemoryShape® Breast Implants, and a copy of Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants. For MENTOR® Saline-filled Implants, patients should receive a copy of Saline-Filled Breast Implants: Making an Informed Decision. Your patient needs to read and understand the information regarding the risks and benefits of breast implants, with an opportunity to consult with you prior to deciding on surgery. The ARTOURATM Breast Tissue Expander or CONTOUR PROFILE® Breast Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. Do not use the ARTOURATM Tissue Expander nor CONTOUR PROFILE® Tissue Expander in patients where an MRI may be needed. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas. For detailed indications, contraindications, warnings, and precautions associated with the use of all MENTOR® Implantable Devices, which include MENTOR® Saline-filled Implants, MemoryGel® Implants, MemoryShape® Implants, ARTOURA™ Expanders, and CONTOUR PROFILE® Expanders, please refer to the Instructions for Use (IFU) provided with each product or visit www.mentorwwllc.com.
FLEXHD® IMPORTANT SAFETY INFORMATION
For FlexHD ® Pliable or BellaDerm ® Possible adverse effects of using human skin include but are not limited to: • Local or systemic infection • Dehiscence and/or necrosis due to poor revascularization • Specific or nonspecific immune response to some component of the graft
The third party trademarks used herein are the properties of their respective owners
Caution: US law restricts this device to sale by or on the order of a physician.
14. Mentor Worldwide LLC. MemoryGel Core Gel Clinical Study Final Report, April 2013.15. Mentor Consumer Preference Market Research Report - July 2017.16. Mentor Surgeon Preference Market Research Report - July 2017.17. Summary of the Safety and Effectiveness of Mentor’s MemoryShapeTM Mammary Prosthesis in Subjects Who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision: MemoryShapeTMPost-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report 02 June 2015.18. Michael Danino. Capsular Biofilm Formation at the Interface of Textured Expanders and Human Acellular Dermal Matrix: A Comparative Scanning Electron Microscopy Study. Plastic and Reconstructive Surgery. 2018;141(4). doi:10.1097/prs.0000000000004216.19. Allergan Warranty http://www.natrellesurgeon.com/Content/assets/Natrelle_Warranty%20 Brochure_DFU. Accessed 04/12/2018. Sientra Product replacement policy and warranty . http://www.sientra.com/Content/pdfs/Warranty_Terms_And_Conditions.pdf. Accessed 04/12/2018. Sientra CapCon Warranty. http://www.sientra.com/Content/pdfs/CapCon_Care_Program_Terms_and_Conditions.pdf. Accessed 04/12/2018. Sientra mailing to US Plastic Surgeons.20. Mentor Warranty and Enhanced Warranty for MemoryGel® Breast Implants and MemoryShape® Breast Implants. Irvine, CA: Mentor Worldwide LLC; 2014.21. Mentor Replacement Policy for CPX®, Artoura™ Family of Tissue Expanders, Mentor Worldwide LLC., 2018.22. 90-day Terms and Conditions. MTF Biologics and FlexHD Pliable Muscular Transplant Foundation Edison, NJ. 2018.
33 Technology Drive | Irvine, CA 92618, USACustomer Service: (800) 235-5731 | Fax: (866) 225-2873www.mentorwwllc.comwww.breastimplantsbymentor.com © Mentor Worldwide LLC 2018 104587-181220
Raise the StandardIntegrated system of products
are designed for her with your surgical needs in mind
1969
2000
2006
2009
2013
2016
2017
BREAST TISSUE EXPANDERS
BREAST IMPLANTS
TISSUE REINFORCEMENT
MENTOR® Breast Tissue Expanders are designed to be more:
• Predictable1* • Stable2,3** • Safe4†
MENTOR® Breast Implants
• 30 Year History7 • 6+ Million Women8 • #1 Highest Rated9
MTF FlexHD® Pliable is proud to offer better:5,6
• Industry Standards • Tissue Processing • Donor Selection
*ARTOURA™ Breast Tissue Expander compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression**CPX®4 Smooth and ARTOURA™ provide more suture tab options than competitors.†Proprietary BufferZone® Self-Sealing Patch