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Primary Breast AugmentationGlowNCT02919592

Memory Gel and Shape Combined Cohort

A study testing MemoryShape® Breast Implants, MemoryGel® Breast Implants and Other Aesthetic Surgery in people with Primary Breast Augmentation and Primary Breast Reconstruction, run by Mentor Worldwide, LLC at 78 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
MemoryShape® Breast Implants, MemoryGel® Breast Implants and Other Aesthetic Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,603 participants
Where
78 sitesUnited States
Study dates
1 Sep 2016to 16 Sep 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

United States78 sites
  • The Center for Dermatology and Plastic Surgery

    Alcoa, Tennessee, 37701

  • The Swan Center for Plastic Surgery

    Alpharetta, Georgia, 30005

  • Artisan Plastic Surgery

    Atlanta, Georgia, 30342

  • North Atlanta Plastic Surgery

    Atlanta, Georgia, 30342

  • Paul Glat, MD, PC

    Bala-Cynwyd, Pennsylvania, 19087

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Jaime Schwartz, MD

    Beverly Hills, California, 90210

  • Hedden Plastic Surgery Center

    Birmingham, Alabama, 35242

  • AMAE Plastic & Reconstructive Surgery

    Birmingham, Michigan, 48009

  • Advanced Surgical Arts Center

    Bismarck, North Dakota, 58503

  • Ellen A. Janetzke, MD

    Bloomfield, Michigan, 48304

  • David Bogue MD, Plastic Surgery, PL

    Boca Raton, Florida, 33431

  • Susan E. Downey, MD Inc

    Burbank, California, 91505

  • Gryskiewicz Twin Cities Cosmetic Surgery

    Burnsville, Minnesota, 55337

  • Piedmont Plastic Surgery & Dermatology - Blakeney

    Charlotte, North Carolina, 28277

  • Providence Plastic Surgery & Skin Center

    Charlotte, North Carolina, 28277

  • Plastic Surgery Group

    Chattanooga, Tennessee, 37403

  • The Columbus Institute for Plastic Surgery

    Columbus, Ohio, 43212

  • The Plastic Surgery Institute of Miami

    Coral Gables, Florida, 33134

  • University of Miami / Sylvester Comp Cancer Ctr

    Coral Gables, Florida, 33146

  • Mohebali Plastic Surgery

    Corte Madera, California, 94925

  • Iowa Plastic Surgery

    Davenport, Iowa, 52807

  • Premier Plastic Surgery

    Draper, Utah, 84020

  • Vanderpool Cosmetic Plastic Surgery

    Fayetteville, Arkansas, 72703

  • Advanced Aesthetics

    Fayetteville, Georgia, 30214

  • South Florida Plastic Surgery

    Fort Lauderdale, Florida, 33308

  • Institute of Cosmetic and Reconstructive Surgery

    Fountain Valley, California, 92708

  • Plastic Surgery of Fredericksburg

    Fredericksburg, Virginia, 22401

  • Piedmont Plastic Surgery & Dermatology - Cox Road

    Gastonia, North Carolina, 28054

  • Piedmont Plastic Surgery & Dermatology Center - New Hope

    Gastonia, North Carolina, 28054

  • Advanced Plastic Surgery Institute

    Gilbert, Arizona, 85295

  • Partners in Plastic Surgery

    Grand Rapids, Michigan, 49546

  • Upstate Plastic Surgery

    Greer, South Carolina, 29650

  • Hankins and Sohn Plastic Surgery

    Henderson, Nevada, 89074

  • Piedmont Plastic Surgery & Dermatology - Hickory

    Hickory, North Carolina, 28602

  • Ciaravino Plastic Surgery

    Houston, Texas, 77098

  • Barrington Plastic Surgery

    Inverness, Illinois, 60067

  • First Coast Plastic Surgery

    Jacksonville, Florida, 32257

  • Michael D. Marion Plastic Surgery

    Lehi, Utah, 84043

  • Park Meadows Cosmetic Surgery

    Lone Tree, Colorado, 80124

  • Doctors Plastic Surgery

    Long Island City, New York, 11106

  • Marietta Plastic Surgery

    Marietta, Georgia, 30060

  • Advanced Surgical Associates

    Mesa, Arizona, 85297

  • Sean A. Simon, MD

    Miami, Florida, 33146

  • Pierini Esthetic Surgery

    Miami, Florida, 33166

  • Imagos Plastic Surgery

    Miami, Florida, 33173

  • Christopher Craft Cosmetic Surgery

    Miami, Florida, 33176

  • Music City Plastic Surgery

    Nashville, Tennessee, 37215

  • Newport Beach Center for Plastic Surgery

    Newport Beach, California, 92660

  • Newport Center for Special Surgery

    Newport Beach, California, 92660

  • Plastic Surgery Center of Hampton Roads

    Newport News, Virginia, 23606

  • The Hague Center for Cosmetic and Plastic Surgery

    Norfolk, Virginia, 23510

  • MAE Plastic Surgery

    Northbrook, Illinois, 60062

  • A New You Plastic Surgery & Laser Center

    Oak Lawn, Illinois, 60453

  • North Coast Plastic Surgery

    Oceanside, California, 92056

  • Tim R. Love, M.D., P.C.

    Oklahoma City, Oklahoma, 73120

  • Li Plastic Surgery

    Ontario, California, 91764

  • Robles Plastic Surgery

    Phoenix, Arizona, 85014

  • Atlantic Plastic Surgery

    Portsmouth, New Hampshire, 03801

  • Summit Plastic Surgery

    Redding, California, 96001

  • Richmond Plastic Surgeons

    Richmond, Virginia, 23233

  • Snodgrass and Robinson Plastic Surgery Specialists

    Rome, Georgia, 30161

  • The Georgia Institute for Plastic Surgery

    Savannah, Georgia, 31405

  • Berardi Aesthetics and Plastic Surgery

    Scottsdale, Arizona, 85260

  • Guerra Plastic Surgery Center

    Scottsdale, Arizona, 85260

  • Mark Malek, MD Plastic Surgery

    Scottsdale, Arizona, 85260

  • Verve Plastic Surgery

    Solana Beach, California, 92075

  • Kai Morimoto MD PLLC

    Spokane Valley, Washington, 99216

  • Parkcrest Plastic Surgery

    St Louis, Missouri, 63141

  • Southeastern Plastic Surgery

    Tallahassee, Florida, 32308

  • Dr. Joshua Halpern MD, PA

    Tampa, Florida, 33607

  • The Center for You

    Traverse City, Michigan, 49684

  • Spa Renaissance & Renaissance Plastic Surgery

    Troy, Michigan, 48083

  • Danielle DeLuca-Pytell, MD, PC

    Troy, Michigan, 48084

  • Plastic Surgery of Tuscaloosa

    Tuscaloosa, Alabama, 35406

  • Carp Cosmetic Surgery

    Uniontown, Ohio, 44685

  • Kaweah Delta Health Care District

    Visalia, California, 93291

  • Forsyth Plastic Surgery

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study ("Glow Study")

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.

Read the detailed 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.

Being tested
MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MemoryShape® Breast ImplantsDevice

    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.

  • MemoryGel® Breast ImplantsDevice

    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.

  • Other Aesthetic SurgeryProcedure or surgery

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

Study groups in NCT02919592
Study groupRoleWhat they receive
Primary Breast AugmentationExperimentalParticipants 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
Receives: Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants
Revision Breast AugmentationExperimentalParticipants 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
Receives: Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants
Primary Breast ReconstructionExperimentalParticipants 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
Receives: Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants
Revision Breast ReconstructionExperimentalParticipants 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
Receives: Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants
Other Aesthetic SurgeryActive comparatorParticipants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)
Receives: Procedure: Other Aesthetic Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications

    Measured: 10 years

Secondary outcomes (8)
  1. Rates of occurrence of connective tissue disease

    Measured: 10 years

  2. Rates of occurrence of rheumatological signs and symptoms

    Measured: 10 years

  3. Rates of occurrence of neurological signs and symptoms

    Measured: 10 years

  4. Rates of occurrence of cancer

    Measured: 10 years

  5. Rates of occurrence of suicide

    Measured: 10 years

  6. Rates of lactation complications

    Measured: 10 years

  7. Rates of MRI confirmed rupture

    Measured: 10 years

  8. Effectiveness

    Patient satisfaction rates

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2016 (estimated)
  2. Study start1 Sep 2016
  3. Primary completion16 Sep 2031 (estimated)
  4. Study completion16 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02919592
Sponsor's protocol ID
MEN-15-003
Acronym
Glow
Status last verified
Sep 2026
First submitted
23 Sep 2016
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MemoryShape® Breast Implants, MemoryGel® Breast Implants and Other Aesthetic Surgery in people with Primary Breast Augmentation and Primary Breast Reconstruction, run by Mentor Worldwide, LLC at 78 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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