Glow: Memory Gel and Shape Combined Cohort

Sponsor
Mentor Worldwide, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02919592
Collaborator
(none)
3,613
78
5
189.9
46.3
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MemoryShape® Breast Implants
  • Device: MemoryGel® Breast Implants
  • Procedure: Other Aesthetic Surgery
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
3613 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study ("Glow Study")
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Jun 30, 2032

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Rates of occurrence of connective tissue disease [10 years]

  2. Rates of occurrence of rheumatological signs and symptoms [10 years]

  3. Rates of occurrence of neurological signs and symptoms [10 years]

  4. Rates of occurrence of cancer [10 years]

  5. Rates of occurrence of suicide [10 years]

  6. Rates of lactation complications [10 years]

  7. Rates of MRI confirmed rupture [10 years]

  8. Effectiveness [10 years]

    Patient satisfaction rates

Other Outcome Measures

  1. PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue [Baseline, 10 years]

    Short Form 4a

  2. PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities [Baseline, 10 years]

    Short Form 6a

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hedden Plastic Surgery Center Birmingham Alabama United States 35242
2 Plastic Surgery of Tuscaloosa Tuscaloosa Alabama United States 35406
3 Advanced Plastic Surgery Institute Gilbert Arizona United States 85295
4 Advanced Surgical Associates Mesa Arizona United States 85297
5 Robles Plastic Surgery Phoenix Arizona United States 85014
6 Berardi Aesthetics and Plastic Surgery Scottsdale Arizona United States 85260
7 Guerra Plastic Surgery Center Scottsdale Arizona United States 85260
8 Mark Malek, MD Plastic Surgery Scottsdale Arizona United States 85260
9 Vanderpool Cosmetic Plastic Surgery Fayetteville Arkansas United States 72703
10 Jaime Schwartz, MD Beverly Hills California United States 90210
11 Susan E. Downey, MD Inc Burbank California United States 91505
12 Mohebali Plastic Surgery Corte Madera California United States 94925
13 Institute of Cosmetic and Reconstructive Surgery Fountain Valley California United States 92708
14 Newport Beach Center for Plastic Surgery Newport Beach California United States 92660
15 Newport Center for Special Surgery Newport Beach California United States 92660
16 North Coast Plastic Surgery Oceanside California United States 92056
17 Li Plastic Surgery Ontario California United States 91764
18 Summit Plastic Surgery Redding California United States 96001
19 Verve Plastic Surgery Solana Beach California United States 92075
20 Kaweah Delta Health Care District Visalia California United States 93291
21 Park Meadows Cosmetic Surgery Lone Tree Colorado United States 80124
22 David Bogue MD, Plastic Surgery, PL Boca Raton Florida United States 33431
23 The Plastic Surgery Institute of Miami Coral Gables Florida United States 33134
24 University of Miami / Sylvester Comp Cancer Ctr Coral Gables Florida United States 33146
25 South Florida Plastic Surgery Fort Lauderdale Florida United States 33308
26 First Coast Plastic Surgery Jacksonville Florida United States 32257
27 Sean A. Simon, MD Miami Florida United States 33146
28 Pierini Esthetic Surgery Miami Florida United States 33166
29 Imagos Plastic Surgery Miami Florida United States 33173
30 Christopher Craft Cosmetic Surgery Miami Florida United States 33176
31 Southeastern Plastic Surgery Tallahassee Florida United States 32308
32 Dr. Joshua Halpern MD, PA Tampa Florida United States 33607
33 The Swan Center for Plastic Surgery Alpharetta Georgia United States 30005
34 Artisan Plastic Surgery Atlanta Georgia United States 30342
35 North Atlanta Plastic Surgery Atlanta Georgia United States 30342
36 Advanced Aesthetics Fayetteville Georgia United States 30214
37 Marietta Plastic Surgery Marietta Georgia United States 30060
38 Snodgrass and Robinson Plastic Surgery Specialists Rome Georgia United States 30161
39 The Georgia Institute for Plastic Surgery Savannah Georgia United States 31405
40 Barrington Plastic Surgery Inverness Illinois United States 60067
41 MAE Plastic Surgery Northbrook Illinois United States 60062
42 A New You Plastic Surgery & Laser Center Oak Lawn Illinois United States 60453
43 Iowa Plastic Surgery Davenport Iowa United States 52807
44 AMAE Plastic & Reconstructive Surgery Birmingham Michigan United States 48009
45 Ellen A. Janetzke, MD Bloomfield Michigan United States 48304
46 Partners in Plastic Surgery Grand Rapids Michigan United States 49546
47 The Center for You Traverse City Michigan United States 49684
48 Spa Renaissance & Renaissance Plastic Surgery Troy Michigan United States 48083
49 Danielle DeLuca-Pytell, MD, PC Troy Michigan United States 48084
50 Gryskiewicz Twin Cities Cosmetic Surgery Burnsville Minnesota United States 55337
51 Parkcrest Plastic Surgery Saint Louis Missouri United States 63141
52 Hankins and Sohn Plastic Surgery Henderson Nevada United States 89074
53 Atlantic Plastic Surgery Portsmouth New Hampshire United States 03801
54 Summit Medical Group Berkeley Heights New Jersey United States 07922
55 Doctors Plastic Surgery Long Island City New York United States 11106
56 Piedmont Plastic Surgery & Dermatology - Blakeney Charlotte North Carolina United States 28277
57 Providence Plastic Surgery & Skin Center Charlotte North Carolina United States 28277
58 Piedmont Plastic Surgery & Dermatology - Cox Road Gastonia North Carolina United States 28054
59 Piedmont Plastic Surgery & Dermatology Center - New Hope Gastonia North Carolina United States 28054
60 Piedmont Plastic Surgery & Dermatology - Hickory Hickory North Carolina United States 28602
61 Forsyth Plastic Surgery Winston-Salem North Carolina United States 27103
62 Advanced Surgical Arts Center Bismarck North Dakota United States 58503
63 The Columbus Institute for Plastic Surgery Columbus Ohio United States 43212
64 Carp Cosmetic Surgery Uniontown Ohio United States 44685
65 Tim R. Love, M.D., P.C. Oklahoma City Oklahoma United States 73120
66 Paul Glat, MD, PC Bala-Cynwyd Pennsylvania United States 19087
67 Upstate Plastic Surgery Greer South Carolina United States 29650
68 The Center for Dermatology and Plastic Surgery Alcoa Tennessee United States 37701
69 Plastic Surgery Group Chattanooga Tennessee United States 37403
70 Music City Plastic Surgery Nashville Tennessee United States 37215
71 Ciaravino Plastic Surgery Houston Texas United States 77098
72 Premier Plastic Surgery Draper Utah United States 84020
73 Michael D. Marion Plastic Surgery Lehi Utah United States 84043
74 Plastic Surgery of Fredericksburg Fredericksburg Virginia United States 22401
75 Plastic Surgery Center of Hampton Roads Newport News Virginia United States 23606
76 The Hague Center for Cosmetic and Plastic Surgery Norfolk Virginia United States 23510
77 Richmond Plastic Surgeons Richmond Virginia United States 23233
78 Kai Morimoto MD PLLC Spokane Valley Washington United States 99216

Sponsors and Collaborators

  • Mentor Worldwide, LLC

Investigators

  • Study Director: Medical Director, Mentor Worldwide, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT02919592
Other Study ID Numbers:
  • MEN-15-003
First Posted:
Sep 29, 2016
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Aug 9, 2022