Intended for healthcare professionals

MENTOR™ MemoryGel™ Xtra Breast Implants

MENTOR™ MemoryGel™ Xtra Breast Implants are precision filled and provide increased fullness when compared to MENTOR™ MemoryGel™ Breast Implants.

About this device

MENTOR™ MemoryGel Xtra 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 a MENTOR proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue.1A

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 women2-4A
  • Desired balance of softness and form stability.
  • Proprietary Precision Fill, the optimized gel-to-fill ratio for each individual implant
  • Designed to better resist soft tissue deformation and reduce implant wrinkling, while producing desired projection5-7B

Shell technology

  • Shell material is the thinnest yet strongest material among competitors
  • Multiple layers of silicone create a consistently smooth surface from shell to shell
  • 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 over 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 2023 study was published to measure 3-year safety and effectiveness of MENTOR™ MemoryGel™ Xtra Breast Implants in the MENTOR™ MemoryGel™ and MENTOR™ MemoryShape™ Combined Cohort Clinical Study. Patients were enrolled in 4 cohorts (n=3171) - Primary Breast Augmentation (n=2396), Revisional Breast Augmentation (n=488), Primary Breast Reconstruction (n=226), Revisional Breast Reconstruction (n=61).8

0%

Rupture, malposition, wrinkling, infection

Delivered exceptional patient outcomes, with 0% rupture, infection, and malposition9E

1.5%

Capsular contracture

Performed through design, minimizing wrinkling, rippling, and related complications9E

100%

Committed to positive patient outcomes

Primary and Revision Reconstruction patients' satisfaction with breasts, psychosocial well-being, and
sexual well-being, and physical well-being all increased significantly from baseline.9

Features & benefits

MENTOR™ MemoryGel™ Xtra Breast Implants

Increased projection

In 90% of the corresponding profiles, MENTOR™ MemoryGel™ Xtra Breast Implants provide more projection by base width than implants from another leading brand (all cohesive levels).10,11F,G

Mentor MemoryGel Xtra Breast Implants

Increased fullness

MENTOR™ MemoryGel™ Xtra Breast Implants are
precision filled and provide increased fullness when compared to MENTOR™ MemoryGel™ Breast Implants.

MENTOR MemoryGel Xtra Breast Implants

Multiple profiles available

MENTOR provides the most extensive range of form stability in silicone gel implants along with the widest selection of profiles to deliver the soft natural feel she desires.H This innovative design results in a 97% patient satisfaction rate for primary augmentation.12I

Supporting documentation

PDF

MENTOR Product Catalog

PDF

MENTOR Promise Warranty Brochure

PDF

MENTOR MemoryGel Breast Implant Portfolio

PDF

MENTOR Company Overview One-Pager

PDF

MENTOR MemoryGel Implants and Tissue Expanders Order Form
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Related products

MENTOR™ MemoryGel BOOST™ Breast Implants

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

MENTOR™ MemoryGel™ Enhance Breast Implants

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.

MENTOR™ MemoryGel™ Breast Implants

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.

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. As compared to saline-filled breast implants.

B. Compared to MENTOR™ MemoryGel™ Xtra Breast Implants.

C. In primary augmentation cohort.

D. As compared to Silimed Polyurethane, Eurosilicone™ Textured, Allergan® Biocell®, Nagor™ Nagotex®, Polytech POLYtxt®, MENTOR™ SILTEX™ Texture, Motiva Implants® VelvetSurface™, Motiva Implants® SilkSurface®, Allergan® Smooth, Sientra® Smooth, MENTOR™ Smooth in an in vitro environment at 24 hours.

E. For the primary augmentation cohort, not including re-operation. No instances of MENTOR™ MemoryGel™ Xtra displacement/malposition or infection were reported in any cohort at 3 years using the Kaplan-Meier estimated cumulative incidence rate.

F. Published projection dimensions were compared between MemoryGel™ Xtra Moderate Plus Profile vs. Inspira Moderate Profile and MemoryGel Xtra High Profile vs. Inspira Full Profile.

G. Allergan Natrelle Inspira Product Catalog 2017

H. Based on benchtop testing comparing the MENTOR™ MemoryGel™ Portfolio of Round Breast Implants to the available Allergan® & Sientra® Portfolio of Round Gel Breast Implants for NATRELLE®, SoftTouch & Cohesive and Sientra®, HSC and HSC+.

I. For breast surgery.


  1. MemoryShape™ Breast Implant Shell on and shell off images Cohesive gel info Validation Case Study Report: Market Acceptance of the Contour Profile Gel Product Family - TX.820.081125.01 Gel Cohesivity Report
  2. Bondurant, S., Ernster, V., and Herdman, R. Safety of Silicone Implants. Washington, DC: National Academy Press. 1999.

  3. MENTOR Worldwide LLC. MENTOR Worldwide Sales Data

  4. MENTOR Worldwide LLC. PROC400623

  5. Heldman L. MemoryGel BOOST® Smooth Breast Implants Product Launch Support – 3D Scan Benchtop Testing Completion Report. ADAPTIV # 100751891, Released June 6, 2022

  6. Lateral Compression Testing Report, Rev. 2, Released Nov. 19, 2021

  7. Caplin D. Implant Testing and the “Strain Energy” Concept. Plast Reconstr Surg. 2018;142:12S-20S.
  8. Caplin DA, Calobrace MB, Wixtrom RN, Estes MM, Canady JW. MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up. Plast Reconstr Surg. 2021 Mar 1;147(3):556-566.
  9. 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
  10. Product Dimensions for MemoryGel Xtra Breast Implants
  11. Published Product Dimensions for Allergan Natrelle Inspira Breast Implants.
  12. MENTOR Worldwide, LLC. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015.

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.


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