the most comprehensive breast reconstruction portfolio · mentor offers a comprehensive portfolio...

7
The Most Comprehensive Breast Reconstruction Portfolio

Upload: others

Post on 15-May-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: The Most Comprehensive Breast Reconstruction Portfolio · Mentor offers a comprehensive portfolio BREAST ... Used in sub muscular and pre-pec surgical technique BETTER INDUSTRY STANDARDS5,6

The Most Comprehensive Breast Reconstruction Portfolio

Page 2: The Most Comprehensive Breast Reconstruction Portfolio · Mentor offers a comprehensive portfolio BREAST ... Used in sub muscular and pre-pec surgical technique BETTER INDUSTRY STANDARDS5,6

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

AST

IM

PLA

NTS

TISS

UE

E

XPA

ND

ER

SO

THE

R

Page 3: The Most Comprehensive Breast Reconstruction Portfolio · Mentor offers a comprehensive portfolio BREAST ... Used in sub muscular and pre-pec surgical technique BETTER INDUSTRY STANDARDS5,6

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.

Page 4: The Most Comprehensive Breast Reconstruction Portfolio · Mentor offers a comprehensive portfolio BREAST ... Used in sub muscular and pre-pec surgical technique BETTER INDUSTRY STANDARDS5,6

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

Page 5: The Most Comprehensive Breast Reconstruction Portfolio · Mentor offers a comprehensive portfolio BREAST ... Used in sub muscular and pre-pec surgical technique BETTER INDUSTRY STANDARDS5,6

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

Page 6: The Most Comprehensive Breast Reconstruction Portfolio · Mentor offers a comprehensive portfolio BREAST ... Used in sub muscular and pre-pec surgical technique BETTER INDUSTRY STANDARDS5,6

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.

Page 7: The Most Comprehensive Breast Reconstruction Portfolio · Mentor offers a comprehensive portfolio BREAST ... Used in sub muscular and pre-pec surgical technique BETTER INDUSTRY STANDARDS5,6

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