Memory Gel and Shape Combined Cohort

Last updated: March 27, 2025
Sponsor: Mentor Worldwide, LLC
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

MemoryGel® Breast Implants

MemoryShape® Breast Implants

Other Aesthetic Surgery

Clinical Study ID

NCT02919592
MEN-15-003
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):

  1. 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;

  2. Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;

  3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;

  4. Agrees to answer baseline questions;

  5. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;

  6. 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

  7. Has a valid e-mail address and access to the internet to complete online questionnaires.

Exclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):

  1. Has active infection anywhere in her body;

  2. 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;

  3. 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;

  4. Is currently pregnant or nursing;

  5. Is planning on undergoing or has undergone bariatric surgery; or

  6. 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.

Inclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):

  1. 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;

  2. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;

  3. Agrees to answer baseline questions;

  4. Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety; and

  5. Has a valid e-mail address and access to the internet to complete online questionnaires.

Exclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):

  1. Has ever had unilateral or bilateral breast implants (including breast tissue expanders);

  2. Expects to undergo breast implant surgery during the study period;

  3. Has ever had silicone implants anywhere in her body;

  4. Has active infection anywhere in her body;

  5. Has a history of cancer of any kind, except non-melanoma skin cancer;

  6. 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;

  7. Is currently pregnant or nursing;

  8. Is planning on undergoing or has undergone bariatric surgery; or

  9. 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.

Inclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):

  1. Received MemoryShape Breast Implants for breast augmenation after January 01, 2015 and was at least 22 years old (primary or revision) at the time of surgery OR underwent breast reconstruction (primary or revision) with MemoryShape Breast Implants after January 01, 2015. A women who has since had her MemoryShape Breast Implants explanted may still be enrolled in the study.

  2. Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery;

  3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;

  4. Agrees to answer baseline questions;

  5. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;

  6. 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

  7. Has a valid e-mail address and access to the internet to complete online questionnaires.

Exclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):

  1. Had an active infection anywhere in her body at the time of surgery;

  2. For augmentation patients, had a history of cancer (prior to implantation) of any kind, except non-melanoma skin cancer; for reconstruction patients, had a history of cancer (prior to implantation) of any kind, except non melanoma skin cancer or adequately treated breast cancer;

  3. Had a confirmed diagnosis of connective tissue disease or neurological disease prior to implantation OR was being evaluated for symptoms suggestive of connective tissue disease or neurological disease;

  4. Was pregnant or nursing at the time of surgery;

  5. Was planning on undergoing bariatric surgery at the time of breast implant surgery or has undergone bariatric surgery since breast implant surgery; or

  6. 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.

Study Design

Total Participants: 3613
Treatment Group(s): 3
Primary Treatment: MemoryGel® Breast Implants
Phase:
Study Start date:
September 01, 2016
Estimated Completion Date:
June 30, 2032

Study Description

The post-approval study will include a maximum of 3500 women undergoing breast augmentation or reconstruction with MemoryShape or MemoryGel Breast Implants. Four cohorts will be included: primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction. For the purpose of assessing rheumatological and neurological signs and symptoms, a control group with 300-480 women will be selected from the participating investigators' practices, who are undergoing an aesthetic surgery other than breast implant surgery. Breast implant patients and the concurrent control group patients will be followed for 10 years. Baseline and operative data will be collected at the beginning of the study, and follow-up data will be collected annually for 10 years through online questionnaires.

Connect with a study center

  • Hedden Plastic Surgery Center

    Birmingham, Alabama 35242
    United States

    Site Not Available

  • The Park Clinic

    Mobile, Alabama 36606
    United States

    Site Not Available

  • Plastic Surgery of Tuscaloosa

    Tuscaloosa, Alabama 35406
    United States

    Site Not Available

  • Advanced Plastic Surgery Institute

    Gilbert, Arizona 85295
    United States

    Site Not Available

  • Advanced Surgical Associates

    Mesa, Arizona 85297
    United States

    Site Not Available

  • Robles Plastic Surgery

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • Berardi Aesthetics and Plastic Surgery

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Guerra Plastic Surgery Center

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Mark Malek, MD Plastic Surgery

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Vanderpool Cosmetic Plastic Surgery

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Tehrani Plastic Surgery

    Apple Valley, California 92307
    United States

    Site Not Available

  • Jaime Schwartz, MD

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Susan E. Downey, MD Inc

    Burbank, California 91505
    United States

    Site Not Available

  • Mohebali Plastic Surgery

    Corte Madera, California 94925
    United States

    Site Not Available

  • Institute of Cosmetic and Reconstructive Surgery

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Newport Beach Center for Plastic Surgery

    Newport Beach, California 92660
    United States

    Site Not Available

  • Newport Center for Special Surgery

    Newport Beach, California 92660
    United States

    Site Not Available

  • North Coast Plastic Surgery

    Oceanside, California 92056
    United States

    Site Not Available

  • Li Plastic Surgery

    Ontario, California 91764
    United States

    Site Not Available

  • Summit Plastic Surgery

    Redding, California 96001
    United States

    Site Not Available

  • Verve Plastic Surgery

    Solana Beach, California 92075
    United States

    Site Not Available

  • Kaweah Delta Health Care District

    Visalia, California 93291
    United States

    Site Not Available

  • Park Meadows Cosmetic Surgery

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • David Bogue MD, Plastic Surgery, PL

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • The Plastic Surgery Institute of Miami

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • University of Miami / Sylvester Comp Cancer Ctr

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • South Florida Plastic Surgery

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • First Coast Plastic Surgery

    Jacksonville, Florida 32257
    United States

    Site Not Available

  • Christopher Craft Cosmetic Surgery

    Miami, Florida 33176
    United States

    Site Not Available

  • Imagos Plastic Surgery

    Miami, Florida 33173
    United States

    Site Not Available

  • Pierini Esthetic Surgery

    Miami, Florida 33166
    United States

    Site Not Available

  • Sean A. Simon, MD

    Miami, Florida 33146
    United States

    Site Not Available

  • Southeastern Plastic Surgery

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Dr. Joshua Halpern MD, PA

    Tampa, Florida 33607
    United States

    Site Not Available

  • The Swan Center for Plastic Surgery

    Alpharetta, Georgia 30005
    United States

    Site Not Available

  • Artisan Plastic Surgery

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • North Atlanta Plastic Surgery

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Advanced Aesthetics

    Fayeteville, Georgia 30214
    United States

    Site Not Available

  • Advanced Aesthetics

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • Marietta Plastic Surgery

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Snodgrass and Robinson Plastic Surgery Specialists

    Rome, Georgia 30161
    United States

    Site Not Available

  • The Georgia Institute for Plastic Surgery

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Barrington Plastic Surgery

    Inverness, Illinois 60067
    United States

    Site Not Available

  • MAE Plastic Surgery

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • A New You Plastic Surgery & Laser Center

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Iowa Plastic Surgery

    Davenport, Iowa 52807
    United States

    Site Not Available

  • AMAE Plastic & Reconstructive Surgery

    Birmingham, Michigan 48009
    United States

    Site Not Available

  • Ellen A. Janetzke, MD

    Bloomfield, Michigan 48304
    United States

    Site Not Available

  • Partners in Plastic Surgery

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • The Center for You

    Traverse City, Michigan 49684
    United States

    Site Not Available

  • Danielle DeLuca-Pytell, MD, PC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Spa Renaissance & Renaissance Plastic Surgery

    Troy, Michigan 48083
    United States

    Site Not Available

  • Gryskiewicz Twin Cities Cosmetic Surgery

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • Parkcrest Plastic Surgery

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Parkcrest Plastic Surgery

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Hankins and Sohn Plastic Surgery

    Henderson, Nevada 89074
    United States

    Site Not Available

  • Atlantic Plastic Surgery

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Summit Medical Group

    Berkeley Heights, New Jersey 07922
    United States

    Site Not Available

  • Doctors Plastic Surgery

    Long Island City, New York 11106
    United States

    Site Not Available

  • Piedmont Plastic Surgery & Dermatology - Blakeney

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Providence Plastic Surgery & Skin Center

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Renaissance Plastic Surgery

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Piedmont Plastic Surgery & Dermatology - Cox Road

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Piedmont Plastic Surgery & Dermatology Center - New Hope

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Piedmont Plastic Surgery & Dermatology - Hickory

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Hunstad Kortesis Center for Plastic Surgery

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Forsyth Plastic Surgery

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Advanced Surgical Arts Center

    Bismarck, North Dakota 58503
    United States

    Site Not Available

  • The Columbus Institute for Plastic Surgery

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Carp Cosmetic Surgery

    Uniontown, Ohio 44685
    United States

    Site Not Available

  • Tim R. Love, M.D., P.C.

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Paul Glat, MD, PC

    Bala-Cynwyd, Pennsylvania 19087
    United States

    Site Not Available

  • Upstate Plastic Surgery

    Greer, South Carolina 29650
    United States

    Site Not Available

  • The Center for Dermatology and Plastic Surgery

    Alcoa, Tennessee 37701
    United States

    Site Not Available

  • Plastic Surgery Group

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Music City Plastic Surgery

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Ciaravino Plastic Surgery

    Houston, Texas 77098
    United States

    Site Not Available

  • Premier Plastic Surgery

    Draper, Utah 84020
    United States

    Site Not Available

  • Michael D. Marion Plastic Surgery

    Lehi, Utah 84043
    United States

    Site Not Available

  • Plastic Surgery of Fredericksburg

    Fredericksburg, Virginia 22401
    United States

    Site Not Available

  • Plastic Surgery Center of Hampton Roads

    Newport News, Virginia 23606
    United States

    Site Not Available

  • The Hague Center for Cosmetic and Plastic Surgery

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Richmond Plastic Surgeons

    Richmond, Virginia 23233
    United States

    Site Not Available

  • Kai Morimoto MD PLLC

    Spokane Valley, Washington 99216
    United States

    Site Not Available

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