You are about to leave jnjmedicaldevices.com. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies.
UPDATE: FDA Final Guidance
Healthcare Professional View
Breast implant choice is personal, important, and life changing.
It’s a choice that can empower a woman to own each day, on her terms.
Inspired and deeply moved by their stories, we honor the fearlessness of women.
We proudly stand alongside surgeons and the millions of women who choose Mentor.
Mentor<sup>®</sup> Promise Protection Plan
The Mentor® Promise Protection Plan brings peace of mind
It's easier for potential patients to make the life-changing decision to get breast implants when they are guaranteed in the event of rupture for her lifetime. With the most comprehensive warranty in the industry, our patients enjoy lifelong confidence in their investment.1,2,3
Our Commitment to Safety
Our Commitment to Safety
Nothing is more important to Mentor than the health and safety of the women who choose our breast implants. The safety and clinical performance of MENTOR® Breast Implants is supported by completed and ongoing studies involving more than 200,000 women, including three, 10-year, prospective clinical trials.4,5,6
Mentor New Practice Program
Mentor New Practice Program
Mentor is proud to assist plastic surgeons in establishing their new practice. To make their first 5 years successful, we are pleased to offer special discounts, products, and services.
Empowering Breast Surgeons and Patients for Over 30 Years.
Not All Innovations Are Equal
At Mentor, we believe that innovation should be driven by what patients need and should be backed by solid research, high design and thorough testing. It takes some time to develop and launch safe, impactful innovations that significantly and positively affect patient outcomes.
This is why we stand by our proven portfolio of meaningful innovations. We are committed to earning and keeping your trust by offering new product innovations as they are needed and valued by your patients.
MENTOR<sup>®</sup> MemoryGel<sup>®</sup> Breast Implants
MENTOR® MemoryGel® Breast Implants
MENTOR® MemoryGel® Breast Implants provide the soft, natural feel patients desire and are available in a wide range of sizes and profiles to fit the patient’s body. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue.* MENTOR® MemoryGel® Breast Implants come in either a textured or smooth surface shell.
MENTOR<sup>®</sup> MemoryShape<sup>®</sup> Breast Implants
MENTOR® MemoryShape® Breast Implants
MENTOR® MemoryShape® Breast Implants shape the breast and have a unique, tapered appearance. Unlike round breast implants, MENTOR® MemoryShape® Breast Implants are teardrop shaped, meaning they are thinner at the top and gently slope to a fuller projection point near the implant’s bottom to mimic the silhouette of a natural breast. The SILTEX® Microtexture Breast Implant gentle imprinting process is designed to help keep implants in place.
MENTOR<sup>®</sup> SPECTRUM<sup>®</sup> Adjustable Saline Breast Implants
MENTOR® SPECTRUM® Adjustable Saline Breast Implants
The innovative line of MENTOR® SPECTRUM® Adjustable Saline Breast Implants makes the decision-making process easier than ever. Exclusive to Mentor, it is designed with proprietary technology that consists of a removable fill tube that offers the option for physicians to increase or decrease the size of the implant for up to six months after surgery.
MENTOR<sup>®</sup> ARTOURA<sup>®</sup> Breast Tissue Expanders
MENTOR® ARTOURA® Breast Tissue Expanders
MENTOR® ARTOURA® Breast Tissue Expanders, available in smooth or SILTEX® Textured Shell Surface, are designed with Dynamic Control Technology™ to help surgeons achieve a desirable expansion profile and a precise pocket for breast reconstruction patients. The ARTOURA® Expander is the first tissue expander featuring internal architecture to deliver precisely controlled pocket formation.
MENTOR<sup>®</sup> CPX<sup>®</sup>4 Breast Tissue Expander
MENTOR® CPX®4 Breast Tissue Expander
Used in breast reconstruction, MENTOR® CPX®4 Breast Tissue Expander, available in smooth or SILTEX® Shell Surface, is designed to expand primarily in the lower pole of the breast, so the resulting pocket will accommodate the implant and slope like a natural looking breast. It also has an integrated “injection dome” that allows surgeons to add saline solution to the expander and gradually stretch the breast tissue over several months.
MENTOR<sup>®</sup> Volume Sizing System
MENTOR® Volume Sizing System
Introducing the MENTOR® Volume Sizing System. Eighteen volume sizing devices designed to help your patient feel invested in her size decision and satisfied with her result. Featuring a unique shape that fits over her natural breast, creating a more realistic preview of her new size. All provided in a high-quality clear, acrylic display case for ease of storage and presentation.
MENTOR<sup>®</sup> Saline-Filled Breast Implants
MENTOR® Saline-Filled Breast Implants
MENTOR® Saline-Filled Breast Implants are inflated to the desired size with sterile isotonic saline before implantation, as well as postimplantation. Saline has the firmest feel and a number of options for volume, shape and projection. MENTOR® Saline-Filled Breast Implants can also help reduce the number of surgeries by eliminating the need for separate expanders.
News & Events
Breakthrough 2.0 Committed to Supporting You
Mentor's Response to COVID-19
Diane Gomez-Thinnes Appointed as Worldwide President of Mentor
Mentor Worldwide LLC, the global leader in breast aesthetics, announces the appointment of Diane Gomez-Thinnes to the position of Worldwide President. Diane has spent the past three years with Mentor, most recently serving as Vice President, Global
References
¹ Allergan Warranty. www.natrellesurgeon.com/Content/assets/Natrelle_Warranty%20Brochure_DFU.zip accessed 02/02/2015 Sientra Product replacement policy and warranty.www.sientra.com/Content/pdfs/Warranty_Terms_And_Conditions.pdf accessed 02/02/2015
² Sientra CapCon Warranty. www.sientra.com/Content/pdfs/CapCon_Care_Program_Terms_and_Conditions.pdf accessed 02/02/2015
³ Sientra mailing to US Plastic Surgeons
⁴ Summary of theSafety 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.
⁵ Mentor Worldwide, LLC. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015.
⁶ Bielefeld, B. A Prospective Clinical Study of Mentor Corporation Saline-filled MammaryProsthesis, Siltex® Saline-filled Mammary Prosthesis, and Siltex® Saline-filled Post-operatively Adjustable Mammary Prosthesis (SpectrumTM) for Augmentation Mammoplasty and Reconstruction Mammoplasty. Nov 10, 1999.
* As compared with saline-filled breast implants
This site is published by Mentor Worldwide LLC which is solely responsible for its contents.
It is intended for visitors from the United States.
© Mentor Worldwide LLC 2019. Last Updated on 01/10/2020.
100264-191113
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician.
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 ARTOURA® 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 ARTOURA® Tissue Expander nor CONTOUR PROFILE® Tissue Expander in patients where an MRI maybe 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 (IFUs) provided with each product.