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.
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
- Conditions the study is for
- Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation
- What is being tested?
- MemoryShape® Breast Implants, MemoryGel® Breast Implants and Other Aesthetic Surgery
- Type of treatment
- Medical device, Surgery or procedure
- 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):
- 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.
Exclusion Criteria MemoryShape and MemoryGel Breast Implant Patients (Prospectively Enrolled):
- 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.
Inclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):
- 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.
Exclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients (Prospectively Enrolled):
- 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;
- Has a history of cancer of any kind, except non-melanoma skin 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.
Inclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):
- 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.
- Signed an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement is available from the time of surgery;
- 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.
Exclusion Criteria MemoryShape Breast Implant Patients (Retrospectively Enrolled):
- Had an active infection anywhere in her body at the time of surgery;
- 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;
- 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;
- Was pregnant or nursing at the time of surgery;
- Was planning on undergoing bariatric surgery at the time of breast implant surgery or has undergone bariatric surgery since breast implant 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.
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
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.
- Conditions
- Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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) Receives: Procedure: Other Aesthetic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications
Measured: 10 years
Secondary outcomes (8)
Rates of occurrence of connective tissue disease
Measured: 10 years
Rates of occurrence of rheumatological signs and symptoms
Measured: 10 years
Rates of occurrence of neurological signs and symptoms
Measured: 10 years
Rates of occurrence of cancer
Measured: 10 years
Rates of occurrence of suicide
Measured: 10 years
Rates of lactation complications
Measured: 10 years
Rates of MRI confirmed rupture
Measured: 10 years
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.
- First posted29 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion16 Sep 2031 (estimated)
- Study completion16 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mentor Worldwide, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Mentor Worldwide, LLC
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study ("Glow Study")
- ClinicalTrials.gov ID
- NCT02919592
- Acronym / sponsor ID
- Glow / MEN-15-003
- Conditions
- Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,603 participants (actual)
- Lead sponsor
- Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 16 Sep 2031 (estimated)
- Study completion
- 16 Sep 2031 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Primary Breast Augmentation | Experimental | Device: MemoryShape® Breast Implants, Device: MemoryGel® Breast ImplantsParticipants 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 |
| Revision Breast Augmentation | Experimental | Device: MemoryShape® Breast Implants, Device: MemoryGel® Breast ImplantsParticipants 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 |
| Primary Breast Reconstruction | Experimental | Device: MemoryShape® Breast Implants, Device: MemoryGel® Breast ImplantsParticipants 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 |
| Revision Breast Reconstruction | Experimental | Device: MemoryShape® Breast Implants, Device: MemoryGel® Breast ImplantsParticipants 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 |
| Other Aesthetic Surgery | Active comparator | Procedure: Other Aesthetic SurgeryParticipants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemoryShape® Breast ImplantsMENTOR® 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 | Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction |
| MemoryGel® Breast ImplantsMENTOR® 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. | Device | Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction |
| Other Aesthetic SurgeryOther aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants) | Procedure or surgery | Other Aesthetic Surgery |
Primary outcome
10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications
Time frame: 10 years
8 secondary outcomes
Rates of occurrence of connective tissue disease
Time frame: 10 years
Rates of occurrence of rheumatological signs and symptoms
Time frame: 10 years
Rates of occurrence of neurological signs and symptoms
Time frame: 10 years
Rates of occurrence of cancer
Time frame: 10 years
Rates of occurrence of suicide
Time frame: 10 years
Rates of lactation complications
Time frame: 10 years
Rates of MRI confirmed rupture
Time frame: 10 years
Effectiveness
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Mentor Worldwide, LLC
78 sites in 1 country: see every site and its status.
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.