Breast ReconstructionAthenaNCT02724371
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
A study testing Mentor Larger Size MemoryGel Ultra High Profile Breast Implant in people with Breast Reconstruction and Revision Breast Reconstruction, run by Mentor Worldwide, LLC at 30 sites in United States.
Trial summary
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Revision Breast Reconstruction
- What is being tested?
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 30 sitesUnited States
- Study dates
- 1 Apr 2016to 31 Jan 2029
- 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
Who may be able to join
- Subject is female and is at least 18 years old
- A candidate for:
- Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction [tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement] to replace breast tissue post-mastectomy)
- Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement)
- Subject understands and signs the Informed Consent
- Subject agrees to return device to Mentor if device is explanted
- Subject agrees to comply with follow-up procedures, including returning for all follow-up visits
- Physician determines implant volume appropriate for the patient taking into account the subject's BMI and chest width
Who cannot join
- Subject is pregnant at time of enrollment
- Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment
- Currently has uncontrolled diabetes (at time of screening or enrollment)
- Has nursed a child within 3 months of study enrollment
- Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
- Currently has a condition that could compromise or complicate wound healing. Note, obesity alone is not an exclusion. All surgical risk factors (obesity, diabetes, smoking history, and prior radiation) should be considered in totality for proper subject selection
Show all 16Show fewer
- Infection or abscess anywhere in the body
- Demonstrates tissue characteristics that are clinically incompatible with successful use of a breast implant (e.g. inadequate tissue or compromised vascularity)
- Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
- Anatomic or physiologic abnormality that could lead to significant postoperative adverse events
- Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
- Untreated active, or inappropriately/inadequately treated breast malignancy, without surgical treatment
- Anticipated need for use of ADM/mesh at the time of implant or implant exchange
- Subject is HIV positive
- Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor
- Implanted metal or metal devices that make a MRI scan prohibitive, history of claustrophobia or other condition that would make a MRI scan prohibitive
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
The Center for Dermatology and Plastic Surgery at Springbrook
Alcoa, Tennessee, 37701
Buckhead Plastic Surgery, P.C
Atlanta, Georgia, 30342
Adventist Health Bakersfield
Bakersfield, California, 93301
Paul Glat, MD, PC
Bala-Cynwyd, Pennsylvania, 19087
Susan E Downey MD, Inc
Burbank, California, 91505
Plastic Surgery Institute of Dayton
Centerville, Ohio, 45458
UVA Health System
Charlottesville, Virginia, 22903
The Plastic Surgery Group PC
Chattanooga, Tennessee, 37403
The Plastic Surgery Group
Cincinnati, Ohio, 45227
The Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Plastic Surgery
Columbus, Ohio, 43212
Houston Methodist Hospital
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
The University of Kansas
Kansas City, Kansas, 66160
Liu Plastic Surgery
Los Gatos, California, 95032
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
The Centre, PC
Mishawaka, Indiana, 46545
Plastic Surgery Associates of Montgomery
Montgomery, Alabama, 36117
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
The Mount Sinai Medical Center
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mosharrafa Plastic Surgery
Phoenix, Arizona, 85028
Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)
Phoenix, Arizona, 85054
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210
Georgia Institute of Plastic Surgery
Savannah, Georgia, 31405
Andres Plastic Surgery
Scottsdale, Arizona, 85260
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University School of Medicine
Stanford, California, 94305
Baylor Scott & White Health
Temple, Texas, 76508
About this study
Official title: Post-Approval Study of the Safety and Effectiveness of the Mentor Smooth Larger Size MemoryGel Ultra High Profile (UHP-L) Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
Read the detailed description
Subjects, whose body shape is suited to a larger size implant than are currently available, will have their breasts reconstructed using the UHP-L Breast Implants either for the first time after a full mastectomy or as a revision of a previous breast reconstruction.
- Being tested
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentor Larger Size MemoryGel Ultra High Profile Breast ImplantDevice
Also called UHP-L Breast Implant
The Mentor smooth larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
| Study group | Role | What they receive |
|---|---|---|
| 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 Larger Size MemoryGel Ultra High Profile Breast implants Receives: Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant |
| 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 Larger Size MemoryGel Ultra High Profile Breast implants Receives: Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant |
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 Any Reoperation
Measured: 10 years
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
Measured: 10 year
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
Measured: 10 year
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement
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 posted31 Mar 2016 (estimated)
- Study start1 Apr 2016
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT02724371
- Sponsor's protocol ID
- MEN-15-001
- Acronym
- Athena
- Status last verified
- Nov 2026
- First submitted
- 21 Mar 2016
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of the Safety and Effectiveness of the Mentor Smooth Larger Size MemoryGel Ultra High Profile (UHP-L) Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
- ClinicalTrials.gov ID
- NCT02724371
- Acronym / sponsor ID
- Athena / MEN-15-001
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 31 Mar 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 study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
Detailed description
Subjects, whose body shape is suited to a larger size implant than are currently available, will have their breasts reconstructed using the UHP-L Breast Implants either for the first time after a full mastectomy or as a revision of a previous breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Breast Reconstruction | Experimental | Device: Mentor Larger Size MemoryGel Ultra High Profile Breast ImplantParticipants 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 Larger Size MemoryGel Ultra High Profile Breast implants |
| Revision Breast Reconstruction | Experimental | Device: Mentor Larger Size MemoryGel Ultra High Profile Breast ImplantParticipants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor Larger Size MemoryGel Ultra High Profile Breast implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is female and is at least 18 years old
- A candidate for:
- Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction [tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement] to replace breast tissue post-mastectomy)
- Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement)
- Subject understands and signs the Informed Consent
Key exclusion criteria (16 listed)
- Subject is pregnant at time of enrollment
- Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment
- Currently has uncontrolled diabetes (at time of screening or enrollment)
- Has nursed a child within 3 months of study enrollment
- Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
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 |
|---|---|---|
| Mentor Larger Size MemoryGel Ultra High Profile Breast ImplantAlso: UHP-L Breast ImplantThe Mentor smooth larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity. | Device | Primary Breast Reconstruction, Revision Breast Reconstruction |
Primary outcome
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
Time frame: 10 years
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
Time frame: 10 year
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
Time frame: 10 year
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentor Larger Size MemoryGel Ultra High Profile Breast Implant in people with Breast Reconstruction and Revision Breast Reconstruction, run by Mentor Worldwide, LLC at 30 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?
The sponsor lists 8 inclusion and 16 exclusion criteria. 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 Any Reoperation (time frame: 10 years). The study lists 4 primary outcomes in all. 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 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.