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
Athena
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
1 other identifier
interventional
400
1 country
30
Brief Summary
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
May 5, 2026
April 1, 2026
12.8 years
March 21, 2016
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
10 years
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
10 year
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
10 year
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement
10 years
Study Arms (2)
Primary Breast Reconstruction
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Plastic Surgery Associates of Montgomery
Montgomery, Alabama, 36117, United States
Mosharrafa Plastic Surgery
Phoenix, Arizona, 85028, United States
Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)
Phoenix, Arizona, 85054, United States
Andres Plastic Surgery
Scottsdale, Arizona, 85260, United States
Adventist Health Bakersfield
Bakersfield, California, 93301, United States
Susan E Downey MD, Inc
Burbank, California, 91505, United States
Liu Plastic Surgery
Los Gatos, California, 95032, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Buckhead Plastic Surgery, P.C
Atlanta, Georgia, 30342, United States
Georgia Institute of Plastic Surgery
Savannah, Georgia, 31405, United States
The Centre, PC
Mishawaka, Indiana, 46545, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
The University of Kansas
Kansas City, Kansas, 66160, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
Plastic Surgery Institute of Dayton
Centerville, Ohio, 45458, United States
The Plastic Surgery Group
Cincinnati, Ohio, 45227, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Plastic Surgery
Columbus, Ohio, 43212, United States
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210, United States
Paul Glat, MD, PC
Bala-Cynwyd, Pennsylvania, 19087, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Center for Dermatology and Plastic Surgery at Springbrook
Alcoa, Tennessee, 37701, United States
The Plastic Surgery Group PC
Chattanooga, Tennessee, 37403, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Baylor Scott & White Health
Temple, Texas, 76508, United States
UVA Health System
Charlottesville, Virginia, 22903, United States
Related Publications (1)
Garvey PB, Larsen AN, Skoracki RJ, Djohan RS, Migliori MR, Tenenbaum MM, Friedman JD, Serletti JM, Rebecca AM, Kane WJ. Larger-volume Silicone Breast Implants Are Safe in Breast Reconstruction: the Athena Multicenter, Prospective Study of 400 Patients. Plast Reconstr Surg. 2026 Jan 22. doi: 10.1097/PRS.0000000000012840. Online ahead of print.
PMID: 41568948DERIVED
Study Officials
- STUDY DIRECTOR
Medical Director
Mentor Worldwide, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2016
First Posted
March 31, 2016
Study Start
April 1, 2016
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
January 31, 2029
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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