MENTOR™ MemoryGel™ Breast Implants
As the first silicone-filled gel implants recommended for approval by the FDA, with proven results of the lowest reported capsular contracture rates at 10 years1-5A, MENTOR™ MemoryGel™ Breast Implants are backed by one of the industry’s best and most comprehensive warranties available.
About this device
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 proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue.6-8B MENTOR™ MemoryGel™ Breast Implants come in either a textured or smooth surface shell.
Specialties
Breast Augmentation, Breast Reconstruction
Procedures
Breast Augmentation, Breast Reconstruction
Gel and fill technology
- Uniquely formulated cohesive gel creates a soft, more natural feel preferred by millions of women6-8B
- Desired balance of softness and form stability.
Shell technology
- Shell material is the thinnest yet strongest material among competitors
- Multiple layers of silicone create a consistently smooth surface
- Low capsular contracture rate and 1% malposition at 10 yearsC
- The smoothest shell surface available
- Lower bacterial adherence and growth compared to all other breast implant manufacturersD
Clinical evidence
For 40 years we have made it our mission to design and manufacture a broad implant portfolio to meet the needs of women and surgeons. A 10-year prospective clinical study, initiated in September 2000, was designed to assess the safety and effectiveness of MENTOR™ MemoryGel™ Breast Implants in women undergoing primary breast augmentation, primary breast reconstruction, or revision surgery. Primary augmentation (n=552), revision augmentation (n=145), primary reconstruction (n=251), and revision reconstruction (n=60) patients were enrolled in the study.
#1
Breast Implant Brand in the US9
MENTOR™ MemoryGel™ Breast Implants are made in the USA.
9.8%
Confirmed rupture rate
In primary augmentation patients in the Core Study
98%
Satisfaction rate4E
For augmentation and reconstruction patients
Features & benefits
Gel
- Cohesive gel holds together uniformly and retains a natural resemblance to breast tissue6-8B
- Dynamic gel better resembles breast tissue for a soft, natural feel10,11
Shell
- Our proprietary robotic technology optimizes shell-to-shell uniformity.
- Reproducible processes produce an exceptional shell every time
Patient satisfaction
- Lowest reported incidence of capsular contracture, re-operation, and explantation at 10 years for round gel implants1-5A
- Low reported incidence of wrinkling
- High patient satisfaction4E
Supporting documentation
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MENTOR™ MemoryGel BOOST™ Breast Implants
All the benefits of MENTOR™ MemoryGel™ Xtra Breast Implants, plus shape retention designed to last. MemoryGel BOOST™ Implants help better reduce visible or palpable implant wrinkling while producing desired projection1-3A
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MENTOR™ MemoryGel™ Xtra Breast Implants
MENTOR™ MemoryGel™ Xtra Breast Implants are precision filled and provide increased fullness when compared to MENTOR™ MemoryGel™ Breast Implants.
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MENTOR™ MemoryGel™ Enhance Breast Implants
MENTOR™ MemoryGel™ Enhance Breast Implants are the first and only family of products that supports implant-based breast reconstruction for women with larger breast sizes with volume options ranging from 930 cc to 1445 cc.
References
Warning
Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.
Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.
A. Not a head to head clinical study. Based on a comparison of 10 year core clinical study data for Primary Augmentation, Revision Augmentation, and Primary Reconstruction for MENTOR™ MemoryGel™ Breast Implants and NATRELLE™ Round TruForm1 Gel Breast Implant
B. As compared to saline-filled breast implants.
C. In primary augmentation cohort
D. As compared to Silimed Polyurethane, Eurosilicone™ Textured, Allergan® Biocell®, Nagor™ Nagotex®, Polytech POLYtxt®, MENTOR™ SILTEX™ Microtextured Breast Implants, Motiva Implants® VelvetSurface™, Motiva Implants® SilkSurface®, Allergan® Smooth, Sientra® Smooth, MENTOR™ Smooth Breast Implants in an in vitro environment at 24 hours.
E. Based on patient survey at 10 years in the MENTOR™ MemoryGel™ Breast Implant 10-Year Core Gel Clincial Study Final Report
- Spear, Scott, et all. Natrelle Round Silicone Breast Implants:Core Study Results at 10 Years. Plas Reconstr Surg. 2014;133(6):1354-1361
- 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 Natrelle(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.
- MENTOR Worldwide LLC. MemoryGel™ Core Gel Clinical Study Final Report, April 2013
- FDA: Sientra, Inc. Summary of Safety and Effectiveness Data (SSED). Santa Barbara, Calif: Sientra; 2012
- Bondurant, S., Ernster, V., and Herdman, R. Safety of Silicone Implants. Washington, DC: National Academy Press. 1999.
- MENTOR Worldwide LLC. MENTOR Worldwide Sales Data
- MENTOR Worldwide LLC. PROC400623
- MENTOR Worldwide, LLC, 2024. Annual WW & US Market Share 2022 - 2024.
- Alderman A, Caplin D, Hammond DC, Keane A, Turetzky J, Kane WJ. Clinical results of MENTOR Memorygel Xtra breast implants from the glow clinical trial. Aesthetic Surgery Journal. 2023;43(12):NP1021-NP1032. doi:10.1093/asj/sjad272
- Parmar C, West M, Pathak S, Nelson J, Martin L. Weight versus volume in breast surgery: an observational study. JRSM Short Rep. 2011 Nov;2(11):87. doi: 10.1258/shorts.2011.011070. Epub 2011 Nov 15. PMID: 22140613; PMCID: PMC3227377.
The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.
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.
Important Safety Information
MENTOR™ MemoryGel™ Breast Implants are indicated for breast augmentation in women at least 22 years old 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 are pregnant or nursing.
Breast implants are not lifetime devices and breast implantation is not necessarily a one-time surgery. The chance of developing complications increases over time. The most common complications with the MemoryGel™ Breast Implants include reoperation, capsular contracture, asymmetry, and breast pain. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel-filled 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. 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 incidence of worldwide cases.
Patients should receive a copy of Important Information for Augmentation Patients about MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants or Important Information for Reconstruction Patients about MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants. 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.
For detailed indications, contraindications, warning and precautions associated with the use of MemoryGel™ Breast Implants. Please refer to the Instructions for Use (IFU) provided with each product, or online at mentorwwllc.com.
The third-party trademarks used herein are trademarks of their respective owners.
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