Memory Gel and Shape Combined Cohort

NCT02919592 | Active Not Recruiting

• 1 other identifier: MEN-15-003
• Study Type: interventional
• Target: 3,603
• Locations: 1 country
• Sites: 78

Brief Summary

The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or revisional breast reconstruction.

Conditions

Revision Breast Reconstruction; Primary Breast Augmentation; Primary Breast Reconstruction; Revision Breast Augmentation

Outcome Measures

Primary Outcomes (1)

• 10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications

  10 years

Secondary Outcomes (8)

• Rates of occurrence of connective tissue disease

  10 years

• Rates of occurrence of rheumatological signs and symptoms

  10 years

• Rates of occurrence of neurological signs and symptoms

  10 years

• Rates of occurrence of cancer

  10 years

• Rates of occurrence of suicide

  10 years

Other Outcomes (2)

• PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue

  Baseline, 10 years

• PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities

  Baseline, 10 years

Study Arms (5)

Primary Breast Augmentation

EXPERIMENTAL

Participants who meet the requirements for primary breast augmentation (have not had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants

Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants

Revision Breast Augmentation

EXPERIMENTAL

Participants who meet the requirements for revision breast augmentation (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast implants

Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants

Primary Breast Reconstruction

EXPERIMENTAL

Participants who meet the requirements for primary breast reconstruction (have not had previous silicone or saline breast implants, not including tissue expanders) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants

Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants

Revision Breast Reconstruction

EXPERIMENTAL

Participants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants

Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants

Other Aesthetic Surgery

ACTIVE COMPARATOR

Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)

Procedure: Other Aesthetic Surgery

Interventions

MemoryShape® Breast Implants DEVICE

MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.

Primary Breast Augmentation; Primary Breast Reconstruction; Revision Breast Augmentation; Revision Breast Reconstruction

MemoryGel® Breast Implants DEVICE

MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.

Primary Breast Augmentation; Primary Breast Reconstruction; Revision Breast Augmentation; Revision Breast Reconstruction

Other Aesthetic Surgery PROCEDURE

Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)

Other Aesthetic Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a candidate for breast augmentation with MemoryShape or MemoryGel Breast Implants and is at least 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with MemoryShape or MemoryGel Breast Implants and is at least 18 years old;
• Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;
• Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
• Agrees to answer baseline questions;
• Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
• Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and
• Has a valid e-mail address and access to the internet to complete online questionnaires.

You may not qualify if:

• Has active infection anywhere in her body;
• For augmentation patients, has a history of cancer of any kind, except non-melanoma skin cancer; for reconstruction patients, has a history of cancer of any kind, except non melanoma skin cancer or adequately treated breast cancer;
• Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
• Is currently pregnant or nursing;
• Is planning on undergoing or has undergone bariatric surgery; or
• Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
• Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone or saline implants) and is at least 22 years of age;
• Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
• Agrees to answer baseline questions;
• Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and
• Has a valid e-mail address and access to the internet to complete online questionnaires.
• Has ever had unilateral or bilateral breast implants (including breast tissue expanders);
• Expects to undergo breast implant surgery during the study period;
• Has ever had silicone implants anywhere in her body;
• Has active infection anywhere in her body;

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead

Study Sites (78)

Hedden Plastic Surgery Center

Birmingham, Alabama, 35242, United States

Location

Plastic Surgery of Tuscaloosa

Tuscaloosa, Alabama, 35406, United States

Location

Advanced Plastic Surgery Institute

Gilbert, Arizona, 85295, United States

Location

Advanced Surgical Associates

Mesa, Arizona, 85297, United States

Location

Robles Plastic Surgery

Phoenix, Arizona, 85014, United States

Location

Berardi Aesthetics and Plastic Surgery

Scottsdale, Arizona, 85260, United States

Location

Guerra Plastic Surgery Center

Scottsdale, Arizona, 85260, United States

Location

Mark Malek, MD Plastic Surgery

Scottsdale, Arizona, 85260, United States

Location

Vanderpool Cosmetic Plastic Surgery

Fayetteville, Arkansas, 72703, United States

Location

Jaime Schwartz, MD

Beverly Hills, California, 90210, United States

Location

Susan E. Downey, MD Inc

Burbank, California, 91505, United States

Location

Mohebali Plastic Surgery

Corte Madera, California, 94925, United States

Location

Institute of Cosmetic and Reconstructive Surgery

Fountain Valley, California, 92708, United States

Location

Newport Beach Center for Plastic Surgery

Newport Beach, California, 92660, United States

Location

Newport Center for Special Surgery

Newport Beach, California, 92660, United States

Location

North Coast Plastic Surgery

Oceanside, California, 92056, United States

Location

Li Plastic Surgery

Ontario, California, 91764, United States

Location

Summit Plastic Surgery

Redding, California, 96001, United States

Location

Verve Plastic Surgery

Solana Beach, California, 92075, United States

Location

Kaweah Delta Health Care District

Visalia, California, 93291, United States

Location

Park Meadows Cosmetic Surgery

Lone Tree, Colorado, 80124, United States

Location

David Bogue MD, Plastic Surgery, PL

Boca Raton, Florida, 33431, United States

Location

The Plastic Surgery Institute of Miami

Coral Gables, Florida, 33134, United States

Location

University of Miami / Sylvester Comp Cancer Ctr

Coral Gables, Florida, 33146, United States

Location

South Florida Plastic Surgery

Fort Lauderdale, Florida, 33308, United States

Location

First Coast Plastic Surgery

Jacksonville, Florida, 32257, United States

Location

Sean A. Simon, MD

Miami, Florida, 33146, United States

Location

Pierini Esthetic Surgery

Miami, Florida, 33166, United States

Location

Imagos Plastic Surgery

Miami, Florida, 33173, United States

Location

Christopher Craft Cosmetic Surgery

Miami, Florida, 33176, United States

Location

Southeastern Plastic Surgery

Tallahassee, Florida, 32308, United States

Location

Dr. Joshua Halpern MD, PA

Tampa, Florida, 33607, United States

Location

The Swan Center for Plastic Surgery

Alpharetta, Georgia, 30005, United States

Location

Artisan Plastic Surgery

Atlanta, Georgia, 30342, United States

Location

North Atlanta Plastic Surgery

Atlanta, Georgia, 30342, United States

Location

Advanced Aesthetics

Fayetteville, Georgia, 30214, United States

Location

Marietta Plastic Surgery

Marietta, Georgia, 30060, United States

Location

Snodgrass and Robinson Plastic Surgery Specialists

Rome, Georgia, 30161, United States

Location

The Georgia Institute for Plastic Surgery

Savannah, Georgia, 31405, United States

Location

Barrington Plastic Surgery

Inverness, Illinois, 60067, United States

Location

MAE Plastic Surgery

Northbrook, Illinois, 60062, United States

Location

A New You Plastic Surgery & Laser Center

Oak Lawn, Illinois, 60453, United States

Location

Iowa Plastic Surgery

Davenport, Iowa, 52807, United States

Location

AMAE Plastic & Reconstructive Surgery

Birmingham, Michigan, 48009, United States

Location

Ellen A. Janetzke, MD

Bloomfield, Michigan, 48304, United States

Location

Partners in Plastic Surgery

Grand Rapids, Michigan, 49546, United States

Location

The Center for You

Traverse City, Michigan, 49684, United States

Location

Spa Renaissance & Renaissance Plastic Surgery

Troy, Michigan, 48083, United States

Location

Danielle DeLuca-Pytell, MD, PC

Troy, Michigan, 48084, United States

Location

Gryskiewicz Twin Cities Cosmetic Surgery

Burnsville, Minnesota, 55337, United States

Location

Parkcrest Plastic Surgery

St Louis, Missouri, 63141, United States

Location

Hankins and Sohn Plastic Surgery

Henderson, Nevada, 89074, United States

Location

Atlantic Plastic Surgery

Portsmouth, New Hampshire, 03801, United States

Location

Summit Medical Group

Berkeley Heights, New Jersey, 07922, United States

Location

Doctors Plastic Surgery

Long Island City, New York, 11106, United States

Location

Piedmont Plastic Surgery & Dermatology - Blakeney

Charlotte, North Carolina, 28277, United States

Location

Providence Plastic Surgery & Skin Center

Charlotte, North Carolina, 28277, United States

Location

Piedmont Plastic Surgery & Dermatology - Cox Road

Gastonia, North Carolina, 28054, United States

Location

Piedmont Plastic Surgery & Dermatology Center - New Hope

Gastonia, North Carolina, 28054, United States

Location

Piedmont Plastic Surgery & Dermatology - Hickory

Hickory, North Carolina, 28602, United States

Location

Forsyth Plastic Surgery

Winston-Salem, North Carolina, 27103, United States

Location

Advanced Surgical Arts Center

Bismarck, North Dakota, 58503, United States

Location

The Columbus Institute for Plastic Surgery

Columbus, Ohio, 43212, United States

Location

Carp Cosmetic Surgery

Uniontown, Ohio, 44685, United States

Location

Tim R. Love, M.D., P.C.

Oklahoma City, Oklahoma, 73120, United States

Location

Paul Glat, MD, PC

Bala-Cynwyd, Pennsylvania, 19087, United States

Location

Upstate Plastic Surgery

Greer, South Carolina, 29650, United States

Location

The Center for Dermatology and Plastic Surgery

Alcoa, Tennessee, 37701, United States

Location

Plastic Surgery Group

Chattanooga, Tennessee, 37403, United States

Location

Music City Plastic Surgery

Nashville, Tennessee, 37215, United States

Location

Ciaravino Plastic Surgery

Houston, Texas, 77098, United States

Location

Premier Plastic Surgery

Draper, Utah, 84020, United States

Location

Michael D. Marion Plastic Surgery

Lehi, Utah, 84043, United States

Location

Plastic Surgery of Fredericksburg

Fredericksburg, Virginia, 22401, United States

Location

Plastic Surgery Center of Hampton Roads

Newport News, Virginia, 23606, United States

Location

The Hague Center for Cosmetic and Plastic Surgery

Norfolk, Virginia, 23510, United States

Location

Richmond Plastic Surgeons

Richmond, Virginia, 23233, United States

Location

Kai Morimoto MD PLLC

Spokane Valley, Washington, 99216, United States

Location

Study Officials

• Medical Director

  Mentor Worldwide, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 29, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): September 16, 2031
• Study Completion (Estimated): September 16, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (78)