Memory Gel and Shape Combined Cohort (Glow)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Breast Augmentation; Primary Breast Reconstruction; Revision Breast Augmentation; Revision Breast Reconstruction
• Intervention / Treatment: Device: MemoryShape® Breast Implants; Device: MemoryGel® Breast Implants; Procedure: Other Aesthetic Surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 3603
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Hedden Plastic Surgery Center
    • Tuscaloosa, Alabama, United States, 35406
      • Plastic Surgery of Tuscaloosa
  • Arizona
    • Gilbert, Arizona, United States, 85295
      • Advanced Plastic Surgery Institute
    • Mesa, Arizona, United States, 85297
      • Advanced Surgical Associates
    • Phoenix, Arizona, United States, 85014
      • Robles Plastic Surgery
    • Scottsdale, Arizona, United States, 85260
      • Berardi Aesthetics and Plastic Surgery
    • Scottsdale, Arizona, United States, 85260
      • Guerra Plastic Surgery Center
    • Scottsdale, Arizona, United States, 85260
      • Mark Malek, MD Plastic Surgery
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Vanderpool Cosmetic Plastic Surgery
  • California
    • Beverly Hills, California, United States, 90210
      • Jaime Schwartz, MD
    • Burbank, California, United States, 91505
      • Susan E. Downey, MD Inc
    • Corte Madera, California, United States, 94925
      • Mohebali Plastic Surgery
    • Fountain Valley, California, United States, 92708
      • Institute of Cosmetic and Reconstructive Surgery
    • Newport Beach, California, United States, 92660
      • Newport Beach Center for Plastic Surgery
    • Newport Beach, California, United States, 92660
      • Newport Center for Special Surgery
    • Oceanside, California, United States, 92056
      • North Coast Plastic Surgery
    • Ontario, California, United States, 91764
      • Li Plastic Surgery
    • Redding, California, United States, 96001
      • Summit Plastic Surgery
    • Solana Beach, California, United States, 92075
      • Verve Plastic Surgery
    • Visalia, California, United States, 93291
      • Kaweah Delta Health Care District
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Park Meadows Cosmetic Surgery
  • Florida
    • Boca Raton, Florida, United States, 33431
      • David Bogue MD, Plastic Surgery, PL
    • Coral Gables, Florida, United States, 33134
      • The Plastic Surgery Institute of Miami
    • Coral Gables, Florida, United States, 33146
      • University of Miami / Sylvester Comp Cancer Ctr
    • Fort Lauderdale, Florida, United States, 33308
      • South Florida Plastic Surgery
    • Jacksonville, Florida, United States, 32257
      • First Coast Plastic Surgery
    • Miami, Florida, United States, 33146
      • Sean A. Simon, MD
    • Miami, Florida, United States, 33166
      • Pierini Esthetic Surgery
    • Miami, Florida, United States, 33173
      • Imagos Plastic Surgery
    • Miami, Florida, United States, 33176
      • Christopher Craft Cosmetic Surgery
    • Tallahassee, Florida, United States, 32308
      • Southeastern Plastic Surgery
    • Tampa, Florida, United States, 33607
      • Dr. Joshua Halpern MD, PA
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • The Swan Center for Plastic Surgery
    • Atlanta, Georgia, United States, 30342
      • Artisan Plastic Surgery
    • Atlanta, Georgia, United States, 30342
      • North Atlanta Plastic Surgery
    • Fayetteville, Georgia, United States, 30214
      • Advanced Aesthetics
    • Marietta, Georgia, United States, 30060
      • Marietta Plastic Surgery
    • Rome, Georgia, United States, 30161
      • Snodgrass and Robinson Plastic Surgery Specialists
    • Savannah, Georgia, United States, 31405
      • The Georgia Institute for Plastic Surgery
  • Illinois
    • Inverness, Illinois, United States, 60067
      • Barrington Plastic Surgery
    • Northbrook, Illinois, United States, 60062
      • MAE Plastic Surgery
    • Oak Lawn, Illinois, United States, 60453
      • A New You Plastic Surgery & Laser Center
  • Iowa
    • Davenport, Iowa, United States, 52807
      • Iowa Plastic Surgery
  • Michigan
    • Birmingham, Michigan, United States, 48009
      • AMAE Plastic & Reconstructive Surgery
    • Bloomfield, Michigan, United States, 48304
      • Ellen A. Janetzke, MD
    • Grand Rapids, Michigan, United States, 49546
      • Partners in Plastic Surgery
    • Traverse City, Michigan, United States, 49684
      • The Center for You
    • Troy, Michigan, United States, 48083
      • Spa Renaissance & Renaissance Plastic Surgery
    • Troy, Michigan, United States, 48084
      • Danielle DeLuca-Pytell, MD, PC
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Gryskiewicz Twin Cities Cosmetic Surgery
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Parkcrest Plastic Surgery
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Hankins and Sohn Plastic Surgery
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Atlantic Plastic Surgery
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group
  • New York
    • Long Island City, New York, United States, 11106
      • Doctors Plastic Surgery
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Piedmont Plastic Surgery & Dermatology - Blakeney
    • Charlotte, North Carolina, United States, 28277
      • Providence Plastic Surgery & Skin Center
    • Gastonia, North Carolina, United States, 28054
      • Piedmont Plastic Surgery & Dermatology - Cox Road
    • Gastonia, North Carolina, United States, 28054
      • Piedmont Plastic Surgery & Dermatology Center - New Hope
    • Hickory, North Carolina, United States, 28602
      • Piedmont Plastic Surgery & Dermatology - Hickory
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Plastic Surgery
  • North Dakota
    • Bismarck, North Dakota, United States, 58503
      • Advanced Surgical Arts Center
  • Ohio
    • Columbus, Ohio, United States, 43212
      • The Columbus Institute for Plastic Surgery
    • Uniontown, Ohio, United States, 44685
      • Carp Cosmetic Surgery
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Tim R. Love, M.D., P.C.
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19087
      • Paul Glat, MD, PC
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Upstate Plastic Surgery
  • Tennessee
    • Alcoa, Tennessee, United States, 37701
      • The Center for Dermatology and Plastic Surgery
    • Chattanooga, Tennessee, United States, 37403
      • Plastic Surgery Group
    • Nashville, Tennessee, United States, 37215
      • Music City Plastic Surgery
  • Texas
    • Houston, Texas, United States, 77098
      • Ciaravino Plastic Surgery
  • Utah
    • Draper, Utah, United States, 84020
      • Premier Plastic Surgery
    • Lehi, Utah, United States, 84043
      • Michael D. Marion Plastic Surgery
  • Virginia
    • Fredericksburg, Virginia, United States, 22401
      • Plastic Surgery of Fredericksburg
    • Newport News, Virginia, United States, 23606
      • Plastic Surgery Center of Hampton Roads
    • Norfolk, Virginia, United States, 23510
      • The Hague Center for Cosmetic and Plastic Surgery
    • Richmond, Virginia, United States, 23233
      • Richmond Plastic Surgeons
  • Washington
    • Spokane Valley, Washington, United States, 99216
      • Kai Morimoto MD PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Breast Augmentation; 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; 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.; Device: MemoryGel® Breast Implants; 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.
Experimental: Revision Breast Augmentation; 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; 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.; Device: MemoryGel® Breast Implants; 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.
Experimental: Primary Breast Reconstruction; 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; 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.; Device: MemoryGel® Breast Implants; 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.
Experimental: Revision Breast Reconstruction; 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; 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.; Device: MemoryGel® Breast Implants; 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.
Active Comparator: Other Aesthetic Surgery; Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)	Procedure: Other Aesthetic Surgery; Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rates of lactation complications		10 years
Rates of MRI confirmed rupture		10 years
Effectiveness	Patient satisfaction rates	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue	Short Form 4a	Baseline, 10 years
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities	Short Form 6a	Baseline, 10 years

Collaborators and Investigators

• Sponsor: Mentor Worldwide, LLC
• Investigators: Study Director: Medical Director, Mentor Worldwide, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Estimated): September 16, 2031
• Study Completion (Estimated): September 16, 2031

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimated): September 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MEN-15-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO